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Ethical guidelines for human medical research
guidance

February 9, 2015
(Partially revised on March 31, 2015)
(Partially revised on March 8, 2017)
(Partially revised on May 29, 2017)

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This guidance explains the interpretation of each provision and points to be noted in specific procedures.
We plan to revise it from time to time in consideration of future operational status, so we have any opinions or questions.
If so, please contact the following inquiries.

【contact information】
○ Bioethics and Safety Measures Office, Life Science Division, Research Promotion Bureau, Ministry of Education, Culture, Sports, Science and Technology
Address: 3-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-8959
Phone: 03-5253-4111 (Representative)
E-mail: ethics@mext.go.jp
Homepage: Ministry of Education, Culture, Sports, Science and Technology Life Science Square Efforts for bioethics and safety
http://www.lifescience.mext.go.jp/bioethics/seimei_rinri.html
○ Ministry of Health, Labor and Welfare Minister's Secretariat Health Science Division, Medical Affairs Bureau Research and Development Promotion Division
Address: 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-8916
Phone: 03-5253-1111 (Representative)
FAX: 03-3503-0183, 03-3503-0595
Homepage: Guidelines for research
http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/hokabunya/kenky
ujigyou / i-kenkyu / index.html

【Revision history】
Established on February 9, 2015
Revised on March 31, 2015
Revised on March 8, 2017
Revised on May 29, 2017

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table of contents
Chapter 1 General Rules ........................................................ .................... 1
1st purpose and basic policy ...................................................... .......... 1
Definition of the second term ........................................................ ............... 3
Third scope of application ........................................................ ............... 34
Chapter 2 Responsibilities of Researchers, etc ..................................... ............ 40
Fourth Basic Responsibilities of Researchers, etc ..................................................... ........ 40
Fifth Research Director's Responsibilities ..................................................... .......... 43
Responsibilities of the Director of the 6th Research Institute ..................................................... ......... 49
Chapter 3 Research Plan ...................................................... ............... 56
7th Research Plan Procedures ..................................................... .... 56
Items to be stated in the 8th research plan ..................................................... ....... 61
Registration / publication of 9th research ..................................................... .... 71
Chapter 4 Ethics Review Committee ..................................................... ............ 74
Establishment of the 10th Ethics Review Committee, etc .................................................. ..... 74
Roles and responsibilities of the 11th Ethics Review Committee .................................................. . 77
Chapter 5 Informed Consent, etc .................................................. 84 84
Procedures for receiving 12th informed consent, etc ............................. 84
Procedures, etc. when receiving informed consent from the 13th surrogate, etc ......... 126
Chapter 6 Personal information and anonymously processed information .................................................. .. 132
14th Basic Responsibilities Regarding Personal Information, etc .................................................. . 132
15th Safety Management ........................................................ ............. 136
16th Disclosure of personal information held ..................................... .. 139
17th Handling of Anonymous Processing Information ..................................................... .... 149
Chapter 7 Response to Serious Adverse Events .................................................. ....... 151
Eighteenth Serious Adverse Event Response .................................................. ..... 151
Chapter 8 Ensuring the reliability of research ..................................... .......... 156
19th Conflict of Interest Management ...................................................... ......... 156
20th Storage of samples and information related to research ..................................... 157
21st Monitoring and Audit ....................................................... .. 159

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1st purpose and basic policy

Chapter 1 General Rules
1st purpose and basic policy
This guideline stipulates matters to be observed by all parties involved in medical research targeting humans.
By doing so, human dignity and human rights will be protected, and research will be promoted appropriately.
aimed to. All parties concerned shall comply with this guideline based on the following matters as a basic policy.
Research must proceed.
① Implementation of research with social and academic significance
(2) Ensuring scientific rationality according to the characteristics of the research field
(3) Comprehensive evaluation of the burden on the research subjects and the expected risks and benefits
④ Examination by the Ethics Examination Committee from an independent and fair standpoint
⑤ Sufficient explanation in advance and voluntary consent of the research subjects
⑥ Special consideration for vulnerable people
⑦ Protection of personal information, etc.
⑧ Ensuring the quality and transparency of research
1 This guideline aims to protect the human rights of the research subjects, maintain safety, and improve welfare, while dealing with people.
Ensuring the scientific quality of elephant medical research, the reliability of the results, and the ethical validity
Responsibilities of researchers (Chapter 2), research plan (Chapter 3), ethics review committee
(Chapter 4), informed consent, etc. (Chapter 5), personal information, etc. and anonymously processed information (Chapter 5)
Research on (Chapter 6), response to serious adverse events (Chapter 7), ensuring research reliability (Chapter 8), etc.
It stipulates the matters to be observed by researchers, heads of research institutes, ethics review committees, and other related parties.
is there. For all parties involved in conducting medical research targeting humans,
Guidelines are applied as unified rules.
Researchers, heads of research institutes, ethics review committees, and other related parties are required to comply with the provisions of this guideline.
In addition, if necessary, applicable laws and regulations regarding the protection of personal information (related to the protection of personal information)
Law (Law No. 57 of 2003; hereinafter referred to as "Personal Information Protection Law"), owned by administrative organs
Law Concerning Protection of Personal Information (Law No. 58 of 2003; hereinafter referred to as "Administrative Organization Personal Information Protection Law"
That is. ), Law Concerning the Protection of Personal Information Held by Incorporated Administrative Agencies, etc. (Law No. 59 of 2003)
issue. Hereinafter referred to as the "Incorporated Administrative Agency Personal Information Protection Law". ) And established by local governments
Ordinances, etc.) must be observed. Basic policies ① to ⑧ are basic matters related to research
Is listed.
2 ① "Research with social significance" refers to the maintenance and promotion of the health of the people and the injury and illness of patients.
This refers to research that contributes widely to the recovery of people and the improvement of quality of life, and contributes to the development of human health and welfare.
3 ② "Scientific rationality according to the characteristics of the research field" is generally accepted in that field.
Based on scientific literature and other science-related information and sufficient experimentation, in accordance with the scientific principles obtained.
Refers to that.

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1st purpose and basic policy

4 ③ “Burden” is an unfavorable event that definitely occurs in the research subject as the research is conducted.
Refers to, for example, physical or mental distress, health disadvantages (including those that are not conscious),
In addition to those related to "invasion" such as unpleasant conditions, research subjects for conducting research
It also includes the labor (labor and time) and financial expenses spent by the person.
5 ③ “Risk” is the possibility of harm that is uncertain whether or not it actually occurs with the implementation of research.
Refers to sex. In addition to physical and mental harm, the harm was caused by the research being conducted.
There is a possibility of economic and social harm.
6 ③ “Profit” refers to the results and expected benefits obtained from research. Research is carried out
If this is expected to bring health benefits to the research subject, it will be given to the individual research subject.
It will be a concrete benefit. Also, are the results of research general in terms of social and academic value?
It is an intangible profit.
7 ⑥ “Persons in a socially vulnerable position” are, for example, those who do not have sufficient judgment ability or research.
Anticipating the benefits associated with implementation or the disadvantages of refusing to implement
Economically or medically, such as those whose voluntary decision-making may be unduly affected by
Refers to the case where you are in a disadvantageous position due to reasons such as. Japan-US EU International Council for Harmonization of Pharmaceutical Regulations (hereinafter referred to as "ICH"
That is. ) Guide to Standards for Conducting Clinical Trials of Drugs (GCP)
In the line (hereinafter referred to as "ICH-GCP"), it is indicated as "Vulnerable Subjects".
It may be used as a reference depending on the content of the research.
8 Regarding “special consideration” in ⑥, knowledge in the ethics review committee pursuant to the provisions of 11-2 ⑷
In addition to hearing opinions from persons and obtaining informed consent pursuant to the provisions of 13-2 (1),
For example, when a person with a disability is the subject of research, an explanation and information transmission method (visual view) that takes the disability into consideration.
Braille translation for the visually impaired, sign language interpreter for the hearing impaired, etc.), and if necessary
In addition, take measures to ensure the free will of the research subjects (such as the presence of fair witnesses).
Can be considered. In addition, when selecting research subjects, we consider them to be "socially vulnerable."
"Special consideration" also includes sufficient consideration of the need to include those who are eligible for research.
Is done.

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Definition of the second term

Definition of the second term
The definitions of terms in this guideline are as follows.
(1) Medical research targeting humans
For humans (including samples and information), the causes of injury and illness (frequency of various health-related events)
Includes degree and distribution and factors that affect them. ) And understanding of the pathophysiology and prediction of injury and illness
Through verification of improvement or effectiveness of diagnostic and therapeutic methods in prevention and medical care, the national government
Knowledge that contributes to maintaining and improving the health of the people, recovering from injuries and illnesses of patients, and improving the quality of life
It refers to activities carried out for the purpose of obtaining. In this guideline, it is simply called "research."
In the case, it refers to medical research targeting humans.
1 The second provision is the basics regarding objects, subjects, acts, etc. that are the targets of each provision of this guideline.
It provides a definition of typical terms and defines the scope of application of this guideline.
2 The definition of "medical research targeting humans" has the following structure.

3 Medical research includes, for example, medical science, clinical medicine, public health, preventive medicine, dentistry, pharmacy, and nursing.
In addition to welfare, rehabilitation, laboratory, medical engineering, long-term care / welfare, food hygiene / nutrition
Epidemiological hands using information on personal health in fields, environmental hygiene, occupational health and safety, etc.

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Definition of the second term

Includes legal and qualitative research. Even if it is related to medical care, long-term care, welfare, etc.
Some research in the humanities and social sciences such as law and social welfare is not included in "medical research"
There is also.
4 Use samples and information newly obtained from the research subjects without invasion and without intervention.
Research and research using existing samples and information also fall under the category of "human-targeted" research.
5 For human health only by analyzing microorganisms such as bacteria, molds and viruses isolated from the human body
If the related event is not the subject of research, it is judged that it does not correspond to "human-targeted" research.
You may decline.
However, using the information obtained from the analysis and investigation of pathogenic microorganisms isolated from patients, other information
By combining medical information, maintaining and improving the health of the people through understanding the etiology and pathophysiology of infectious diseases
When implemented for the purpose of gaining knowledge that contributes to the recovery of patients from infectious diseases, etc.
Corresponds to "research".
6 ⑴ “Frequency and distribution of various health-related events” refers to various types obtained through epidemiological methods.
Health indicators, such as frequency of occurrence of certain diseases, regional distribution, sex / age distribution and improvement rate, survival
It refers to rate, prevalence, healthy life expectancy, life expectancy, etc. Also, as "factors that influence them"
Is the lifestyle habits of individuals such as smoking, eating, exercising, and sleeping, and the medical treatment contents in individual medical care.
In addition, there are environmental factors and social factors in the region.
When investigating the effects of ingestion of specific foods and nutritional components on human health,
Corresponds to "research".
7 Medical treatment exclusively for the prevention, diagnosis or treatment of injuries and illnesses falls under the category of "research" in this guideline.
Absent. Regarding the outcomes and prognosis of patients in what medical professionals have done in such medical care
For example
○ Look back at the medical records or follow up with discharged patients for reference in future medical care.
Consider by doing etc.
○ In order to share information with other medical professionals, case review meetings within the institution to which they belong and doctors outside the institution
Report individual cases in study sessions between medical professionals, related academic societies, specialized journals for medical professionals, etc.
(So-called case report)
○ Publications and public relations to disseminate the understanding of patients and the general public about existing medical knowledge, etc.
Post on things, etc.
○ As a medical institution, medical treatment results within a certain period (visiting) for medical evaluation at your own facility
The number of persons, the number of treatments, treatment results, etc.) are totaled and displayed to the medical staff to which they belong, or the business report.
Post in notifications, etc.
○ Ensuring the quality of medical care provided at your facility (standard medical care is provided)
In-facility data for confirmation, prevention of nosocomial infections and medical accidents, quality control of examinations, etc.)
Accumulate and consider

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Definition of the second term

When it can be regarded as a part of medical treatment that is not for research purposes, "research" in this guideline
It may be judged that it does not correspond to.
8 Occupational Safety and Health Regulations Article 14, Paragraph 1, Paragraph 1 based on the Industrial Safety and Health Act (Act No. 57 of 1972)
"Investigation of the causes of health problems of workers" according to the provisions of No. 7 and the School Health and Safety Law (No. 1958)
Similarly, "health surveys" under Article 11 of the Enforcement Regulations of No. 56) are also non-research purposes.
It can be regarded as a part of, and it may be judged that it does not correspond to the research.
On the other hand, samples obtained through the work beyond the scope of the work stipulated by those laws and regulations.
When using data, etc., it may fall under "research".
9 Regarding health services (examination, dissemination of favorable lifestyles, etc.) conducted by local governments in the area
For example, in order to control the accuracy of the examination, a part of the sample data obtained in the examination, etc.
Sharing and considering everything among related parties and organizations can be regarded as part of the health business.
It can be judged that it does not correspond to "research".
On the other hand, using information and samples related to human health obtained from the health business, lifestyle-related diseases
Knowledge that contributes to the maintenance and promotion of the health of the people through understanding the condition and verifying the effectiveness of preventive methods.
Activities carried out for the purpose of obtaining "research" correspond to "research".
10 Experiments and practical training on academically known events such as health and hygiene training conducted exclusively for educational purposes.
If the obtained sample or data is not used for any purpose other than educational purposes, it does not fall under "research".
You may judge that it is bad.
11 Regarding whether or not a specific activity falls under “research”, the law for carrying out the activity is unique.
It is the responsibility of people, government agencies, and sole proprietors to make decisions, but if it is difficult to make a decision, this is the responsibility.
It is recommended to listen to the opinions of the Ethics Review Board as stipulated in the guidelines.

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Definition of the second term

⑵ Invasion
Sen

Punching for research purposesQuestions about punctures, incisions, drug administration, radiation, trauma, etc.
This means that the body or psyche of the research subject is injured or burdened.
Among the invasions, those with less injury and less burden on the body and mind of the research subject are "minor".
Invasion ".
1 Punctures, incisions, etc. in medical care that are not for research purposes are accompanied by "invasion" by the definition of this guideline.
Blood, body fluids, tissues, cells, placenta / umbilical cord after delivery, etc.
When (so-called residual sample) is used as existing sample / information, the body of the research subject is injured.
And it may be judged that there is no burden (= no "invasion").
2 ⑵ “Drug administration” is related to ensuring the quality, effectiveness and safety of pharmaceuticals, medical devices, etc.
Approval, etc. based on the Act on Securing Quality 1960 (Act No. 145 of 1960; hereinafter referred to as the "Pharmaceuticals and Medical Devices Act")
Received drugs (hereinafter referred to as "approved drugs") for research purposes within the scope of the approval.
It also includes the case of administration. However, even when an approved drug is administered for research purposes
Depending on the ingredients, usage, dosage, etc., the physical and mental injuries and burdens of the research subjects may occur.
In some cases it can be considered very small and without "invasion".
In addition, for example, a study in which a patient suffering from a certain injury or illness is used as a research subject and the outcome is followed.
(Prospective study without intervention) may be conducted, but in clinical practice that is not for research purposes
If medication causes injury or strain to the person's body, it is defined as "invasive" in this guideline.
Not included in.
Regarding "irradiation" in 3 (2), the research subject receives similar radiation in medical treatment that is not for research purposes.
Even if it is expected to be affected, the effect on the research subject will be measured directly.
Irradiation that is performed under certain conditions for research purposes, even if it is not possible, is studied accordingly.
It is considered that the subject's body is injured or burdened (= accompanied by "invasion").
4 ⑵ "Question that touches trauma" is a painful experience that the person does not want to remember (example)
For example, it refers to questions about disasters, accidents, abuse, past serious illnesses and serious illnesses, etc.). For questions like this
In addition to the case of, for example, intentionally giving tension, anxiety, etc. for research purposes, etc.
"Invasion" also includes the fact that the act of disturbing causes a burden on the mind of the research subject.
5 ⑵ "Injury or burden on the body or mind of the research subject" is a constant that exceeds the range that is incurred in normal times.
Changes in normality, health effects (including those that are not recognizable), etc., which are definitely the subjects of research
It refers to something that occurs in a person's body or mind, and there is a possibility of harm that is uncertain whether or not it actually occurs (eg)
For example, the risk of adverse events caused by drug administration for research purposes) is not included.
In determining the degree of injury and burden that occurs in the research subject's psyche, with the research subject
Judgment may be made based on the mental distress that is generally assumed in the group.

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Definition of the second term

6 ⑵ “Minor invasion” is an ethical guideline for epidemiological research (2007 Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labor and Welfare)
Ministry notification No. 1. Hereinafter referred to as "Epidemiological Research Ethics Guidelines". ) And ethical guidelines for clinical research (flat)
20 years Ministry of Health, Labor and Welfare Notification No. 415. Hereinafter referred to as "Clinical Research Ethics Guidelines". ) In each bylaw
"Minimum risk" (possible physical, psychological and social harm in daily life and routine medical examinations
It was stipulated that it is a danger that does not exceed the limit of possibility and is of a socially acceptable type).
However, in this guideline, it is uncertain whether or not it will actually occur.
Of the injuries or burdens that definitely occur on the body or mind of the research subject, not including the possibility of
Is specified as a small degree.
Something that is socially acceptable for less injury and less burden on the study subject, eg
Regarding blood collection and irradiation, blood collection and chest performed in general health examination based on the Industrial Safety and Health Act
If it is about the same as the part simple X-ray photography (including the age and condition of the subject, the frequency of the radiography, etc.), it should be "light".
It may be judged that it is accompanied by "a slight invasion".
In addition, when puncture, incision, blood sampling, etc. are performed in medical treatment that is not for research purposes, it is added and studied.
Puncture, incision, puncture for non-research purposes, etc., when puncture, incision, increase of blood collection volume, etc. are performed for research purposes
Relative injuries and burdens to the body and psyche of the study subject compared to incisions, blood sampling, etc.
If it is slight, it may be judged as "minor invasion".
In addition, for example, if MRI imaging without contrast medium is performed for research purposes, it will be used accordingly.
Injuries and burdens on the body of the research subject are considered to be small, and long-term behavioral restrictions, etc.
If this does not cause any physical or mental burden on the research subject, judge it as a "minor invasion".
I.
In addition, for example, a questionnaire survey may include content that causes mental distress to the research subjects.
In advance, the research subject can answer anonymously or refuse to answer, etc.
If sufficient consideration is given, the injury and burden on the research subject's psyche will be small.
It can be considered and can be judged as "minor invasion".
7 Whether or not it can be regarded as a "minor invasion" depends on the age and condition of the research subjects.
It is necessary to make a comprehensive judgment, for example, when studying minors under the age of 16
Judgment carefully, considering the possibility that physical and mental injuries and burdens may not necessarily be small
There is a need to.
8 Regarding the case of ingesting a specific food / nutrition component for research purposes, the group to be studied
If the eating experience is well within the acceptable range, it will hurt the study subject's body.
It may be judged that it does not cause any harm or burden (= does not involve "invasion").
Research purpose of naturally excreted urine, feces, sputum, saliva, sweat and other secretions, and lost hair and body hair
For research purposes, such as when collecting at the site, measuring surface electromyograms and electrocardiograms, and imaging ultrasonic images.
In some cases, the physical and mental burden of the research subject is burdened by long-term behavioral restrictions.
If it does not occur, it may be judged that it is not accompanied by "invasion".

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Definition of the second term

9 Whether or not applying some kind of exercise load to the research subject for research purposes involves "invasion", and
Regarding whether or not it can be regarded as a "minor invasion" when accompanied by an "invasion",
In addition to the content of the exercise load, the selection criteria of the research subjects, the environment to which the exercise load is applied, etc. are also considered.
It is necessary to consider and make a comprehensive judgment.
Changes in physical homeostasis (increased breathing, heart rate, sweating, etc.) caused by the exercise load
Physically within the range that occurs in normal times when relieving in a short time by appropriate rest or replenishment of water
It is considered to be a change in homeostasis, and there is no injury or burden on the body of the research subject (= accompanied by "invasion").
I don't know). In addition, it does not cause any injury or burden to the body and mind of the research subject.
Socially acceptable types, such as physical fitness and athletic ability surveys conducted by the Ministry of Education, Culture, Sports, Science and Technology (new
Similar to the exercise load performed in the physical fitness test) (including the subject's age / condition, frequency of exercise, etc.)
If so, it may be judged that there is no "invasion".
10 For each study, whether or not the study involves "invasion" and the place where it involves "invasion"
In that case, whether or not the "invasion" can be regarded as a "minor invasion" is described above.
The principal investigator will make a judgment when preparing the research plan, and its validity will be uniquely referred to.
It shall be examined by the Ethics Examination Committee including.

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Definition of the second term

⑶ Intervention
Factors that influence various events related to human health for research purposes (maintaining and improving health)
Includes medications, tests, etc. for the prevention, diagnosis or treatment of long-term behavior and medical injuries. )
The act of controlling the presence or absence or degree of illness (medical practice that goes beyond normal medical care and is actually used for research purposes
Including what to apply. ).
1 ⑶ "Various events related to human health" refers to the condition of injury and illness in individual patients, as well as
Health trends and outbreak trends of certain diseases in a cohort of individuals with passing attributes

Etc.
"Behaviors that lead to maintenance and promotion of health" and "Injury and illness in medical care" exemplified in this guideline
Affects preventative, diagnostic or therapeutic medications, tests, as well as human health events
Factors that can control the presence or absence and degree of such factors include, for example, nursing care, lifestyle guidance, and nutritional fingers.
Guidance, diet, occupational therapy, etc. can be considered. "Actions that lead to the maintenance and promotion of health" include
Behaviors in daily life such as moderate exercise, sleep, balanced diet, and smoking cessation are conceivable.
2 ⑶ "Controlling" means intentionally changing or not changing.
It is thought that it will affect the health of the research subjects, such as treatment methods, diagnostic methods, preventive methods, etc. of injuries and illnesses.
Random or random allocation based on the research plan (blinded)
Or, it includes the case of shielding. ) Is the key to influencing human health events for research purposes
It is an act of controlling the presence or absence or degree of cause, and corresponds to "intervention". For allocation, compare between groups
Therefore, in addition to the case where the group of study subjects is divided into multiple groups, a single group (Shin) without a control group is provided.
Guruarm) is considered to affect the health of the study subjects, including specific treatment methods and preventive methods.
It also includes the case of allocating the factors that can be obtained.
3 ⑶ "Medical practice that goes beyond normal medical care and is carried out for research purposes"
Since the clinical research ethics guideline stipulates intervention, this guideline continues to "intermediate".
It is shown to clarify that it corresponds to "Enter".
"Medical practice that goes beyond normal medical care" is approved based on the Pharmaceuticals and Medical Devices Act.
No drugs (including in-vitro diagnostic drugs) or medical devices (hereinafter referred to as "unapproved drugs / medical devices"
That is. ) Use, approval of approved drugs / medical devices, etc. (indication / effect, usage / dose, etc.)
Refers to medical practice using more than or other new medical technologies. Also, medical insurance is already applied
If the medical validity is recognized and it is widely practiced, such as
It may be judged that it is not included in "medical practice beyond usual medical care". In addition, it corresponds to "intervention"
It is "a medical practice that goes beyond normal medical care and is carried out for research purposes".
It does not mean that "intervention" is immediately made only by medical practice that exceeds the usual medical treatment.
"Medical practice" includes not only patients but also healthy people and injuries and illnesses.
For structural functions of the human body, such as cosmetic formation and breast augmentation surgery, which are not intended for prevention, diagnosis and treatment.
It also includes cases where the purpose is to influence. No medical practice beyond normal medical care
Even in some cases, people for research purposes, such as random or random allocation based on the research plan.

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Definition of the second term

If you control the presence or degree of factors that affect your health-related events, you can perform "intervention".
It becomes a research.
4 To continue the treatment method that was previously received for medical treatment that is not for research purposes for a certain period of time for research purposes.
And actions that constrain the choice of other treatments affect the patient's injury or illness status for research purposes.
It controls the presence or absence or degree of factors that give the above, and corresponds to "intervention".
On the other hand, for example, for the purpose of diagnosis and treatment of a patient suffering from a certain injury or illness.
Collect medical information such as outcomes and prognosis without controlling the presence and degree of medication, tests, etc.
If only, it involves "intervention", including when it is carried out prospectively.
It may be judged that there is no research (observational study).
5 “Intervention” does not always involve “invasion”. For example, smoking cessation guidance, meals
Methods such as implementing new methods such as therapy and allocating to verify differences from conventional methods
Prospectively different care to compare and verify the effects of different care
When it is carried out, it usually does not involve "invasion", but it falls under "intervention".

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Definition of the second term

⑷ Sample obtained from the human body
Set

Blood, body fluids, tissues, cells, excretion
In parts of the human body, such as objects and DNA extracted from them
Those used for research (including those related to the dead).
⑸ Information used for research
Injury / disease name, dosing content, test or measurement results obtained through diagnosis and treatment of study subjects
Information on human health and other information used in research (related to the dead)
Including. ).
⑹ Sample / Information
Refers to samples obtained from the human body and information used in research.
⑺ Existing sample / information
Samples / information that falls under any of the following.
(1) Samples and information that already exist by the time the research plan is created
(2) Samples and information acquired after the preparation of the research plan, and at the time of acquisition
Those that were not intended to be used in the research of the research plan
⑻ Research subjects
A person (including the dead) who falls under any of the following.
① Those who carry out research (including those who are required to carry out research)
(2) Persons who have acquired existing samples and information that will be used for research
1 ⑸ "Information used for research" is information on human health and other information for research.
It is stipulated that it will be used for, regardless of whether it is anonymized or not.
⑸ "The name of the injury or illness, the content of medication, the test or measurement obtained through the diagnosis and treatment of the research subject
"Results" include those recorded in nursing records, etc., in addition to those recorded in medical records.
In addition to the information obtained from the research subjects, for example, vital statistics surveys, national health and nutritional conditions
Includes information on events related to human health published in surveys, infectious disease outbreak trend surveys, etc.
Is done.
2 Regarding "existing samples / information" in ⑺, "(1) Already exists by the time the research plan is created.
"Sample / Information" is already taken directly from the research subject by the time the research plan for the research is prepared.
The obtained sample / information is applicable. Background of obtaining the sample / information directly from the research subject (such as
It doesn't matter if it was acquired by an institution or for what purpose).
In addition, "(2) Samples and information acquired after the preparation of the research plan, at the time of acquisition
It was not intended to be used in the research of the research plan. "
Of the samples and information directly obtained from the research subjects after the preparation of the research plan for the research, the relevant research institute
Excluding samples and information newly obtained directly from the research subject for the purpose of research
Is applicable. Specifically, the following are included.
・ Purpose different from that used for the research at the research institution (providing medical care, research institute)
Samples / information obtained directly from the research subject (for use in research other than research, etc.)

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Definition of the second term

・ Obtained directly from the research subject for a purpose different from that of the research other than the research institution
Samples / information provided by the research institution for use in the research
The "existing samples / information" referred to in this guideline is directly referred to by the research subject after the research plan was created.
Note that the samples and information obtained may also be included. For example, medical treatment that is not for research purposes
Therefore, samples (so-called residual samples) or information (medical notes) obtained directly from patients (research subjects)
The medical information recorded in the record, the test data obtained in the process of medical treatment, etc.) are the patients (research subjects).
If the time of acquisition directly from is before the preparation of the research plan, then in ①, after the preparation of the research plan.
If so, it corresponds to (2), and in any case, it corresponds to the "existing sample / information" specified in this guideline.
It will hit. However, before it is used for medical treatment that is not for research purposes, it is equivalent to the remaining portion.
If the sample is divided based on the above assumption and a part of it is used for research, it is added and studied.
It may be considered to have been obtained for research purposes and will be added to medical treatment for non-research purposes.
Therefore, samples and information directly from patients (research subjects) for the purpose of being used in research in advance
When obtaining information, it does not correspond to "existing sample / information".
Similarly, after the research plan was prepared,
○ “Labor” pursuant to the provisions of Article 14, Paragraph 1, Item 7 of the Industrial Safety and Health Regulations based on the Industrial Safety and Health Act
Investigation of the causes of health problems of people "
○ "Health survey" pursuant to Article 11 of the Enforcement Regulations of the School Health and Safety Law
○ Health services in local public organizations, etc.
Even when the information or residual sample obtained through such as is used for research, it corresponds to "existing sample / information".
To do. However, it is used in advance for research by adding it to work / activities that are not for research purposes.
If it is acquired for the purpose of doing so, it does not fall under "existing sample / information".
<Reference: Classification of "samples / information" in this guideline>
Obtained directly from the research subject for a purpose different from that of the research
Samples / information
(Example)
Existing sample / information

○ Residual samples, medical records
○ Are you a research subject in conducting a research different from the research concerned?
Samples and information obtained directly from
○ Genome data obtained by genome analysis of existing samples and information
Trial obtained directly from the research subject for use in the research
Fees / Information

Samples / information other than the(Example)
above
(Newly acquired sample / information)

○ Research in advance by adding it to medical treatment that is not for research purposes
From patients (research subjects) for the purpose of being used in
Samples and information to be acquired directly

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Definition of the second term

⑼ Research institute
A corporation, government agency, or sole proprietor who conducts research. Storage of samples and information, statistical processing
Excludes cases where only a part of other research-related work is outsourced.
⑽ Joint research institute
A research institution that jointly conducts research based on a research plan, and is a research institute for the research.
Includes institutions that newly acquire samples and information from research subjects and provide them to other research institutes.
⑾ Institution that collects and sells samples and information
Of the research institutes, samples and information are obtained from the research subjects or provided by other institutions.
An institution that keeps a research institute and repeatedly provides it to other research institutes.
1 ⑼ “Corporate” refers to various legal persons, for example, the Local Autonomy Law (Act No. 67 of 1947).
Local public organizations stipulated by (No.), medical corporations stipulated by the Medical Care Act (Law No. 205 of 1948), private schools
School corporations and independent administrative corporation general rules law (1999 law) stipulated by the School Law (Law No. 270 of 1945)
Incorporated administrative agency stipulated by Ritsu No. 103), stipulated by the National University Corporation Law (Law No. 112 of 2003)
National University Corporations, Companies stipulated by the Companies Act (Act No. 86 of 2005), General Incorporated Associations and General
General Incorporated Associations and General Incorporated Foundations stipulated by the Law Concerning Foundations (Law No. 48 of 2006)
Etc. are included.
When conducting research in a voluntary organization that does not have legal personality, the sole proprietor who participates in the research
Or, if the corporation is a "research institution" and the individual participating in the research belongs to the corporation
In that case, the corporation is regarded as a "research institution" and is positioned as research jointly conducted by them.
And.
2 ⑼ “Administrative agency” refers to the administrative agency stipulated in Article 2 of the Personal Information Protection Law of the administrative agency.
Regarding 3 ⑼ "Self-employed", the epidemiological research ethics guideline is "Research that does not belong to a research institution"
Persons ”were stipulated, but in this guideline, individuals who do not belong to corporations or government agencies conduct research.
In the case of conducting research, it falls under the category of "research institution" as a sole proprietor who conducts research.
To For example, doctors in clinics established by individuals acquire new samples and information from research subjects.
It is possible that the research institute will become a joint research institute.
4 ⑼ "Consigned to perform only part of the research-related work" "Received"
Is part of the research-related work undertaken by another corporation or sole proprietor (to dispatched workers)
Including the case of letting go. same as below. ).
In addition to the "storage of samples and information, statistical processing" illustrated in the guideline, it is possible to outsource.
Possible tasks include preparation for research implementation (procurement of research materials, etc.), monitoring and supervision.
Handling of personal information, etc. acquired in connection with the work related to inspection and the implementation of research (including safety management),
Examples include work such as biochemical analysis of samples obtained from the human body.
Regarding whether or not the content of the work to be entrusted in each research is appropriate, a research plan
The principal investigator decides when creating the research plan, and if necessary, includes the validity of the consignment.

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Definition of the second term

It is desirable to describe it in a document.
5 Companies provide research funds and materials, and utilize the results obtained through research.
Research is usually carried out (research-related work), unless the research practice is carried out solely.
This includes cases where part of the research is outsourced and cases where it is carried out jointly with other research institutes. ) Companies
Corresponds to "research institute". In addition, to jointly carry out research at medical institutions and universities
If a company participates in, the company may fall under the category of "joint research institute". In addition, it should be noted.
Companies can be regarded as one entity because the main purpose of establishment is usually not academic research.
Except when conducting academic research through this research, Article 76, Paragraph 1, Item 3 of the Personal Information Protection Law, "Large
Ordinary case for "academic or other institutions or groups for the purpose of academic research or persons belonging to them"
Not applicable.
6 When a program production company or a newspaper / magazine company carries out activities that fall under "research" by itself
Corresponds to "research institute". In addition, "people" conducted by research institutes such as corporations and companies that have universities.
When cooperating with "medical research targeting", it is a program production company or a newspaper / magazine company.
May also fall under the category of "joint research institute".
7 The national government, local governments, etc. provide funds and facilities to corporations that have medical institutions and universities as consignment projects.
It may be provided, but in that case, the "research institution" will receive funding and facilities for research institutes.
It is a corporation that has a medical institution or university that conducts research, and utilizes the results obtained through research.
An entity that does not carry out research practice does not fall under the category of "research institution".
8 In ⑿, "Persons who only provide existing samples and information other than research institutes" are referred to as "Researchers, etc."
It stipulates that it should be excluded, and the institution to which the person belongs does not fall under "research institution".
Regarding 9 ⑽ "Joint research institute", 12th 1 ⑶ "Institution that provides existing samples and information"
Does not necessarily have to be a joint research institute.
On the other hand, the samples and information newly obtained from the research subjects for a specific research are "existing samples and information."
It does not correspond to "information", and new samples and information are obtained from the research subjects based on the research plan.
The institutions provided to the research institutes in Japan fall under the category of "joint research institutes".
10 ⑾ “Institutions that collect and sell samples and information” are not limited to specific research institutes, but are widely tested.
So-called banks and operations where it is clarified in advance to secure the provision of fees and information
Refers to an archive and is a patient obtained in a medical institution with a medical treatment that is not for research purposes.
Use blood, cells, tissues, etc. of the above only for research conducted by corporations, etc. that have the medical institution.
It is not included when it is stored for the purpose of. In addition, iterative continuation at the time of possession
Not applicable if you do not plan to provide samples / information to other research institutes.
However, if you intend to provide such information, please contact the "institution that collects and sells samples and information".
Applicable and must comply with the provisions of this guideline.

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Definition of the second term

Ethical Guidelines for Human Genome / Gene Analysis Research (2013 Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labor and Welfare,
Ministry of Economy, Trade and Industry Notification No. 1. Hereinafter referred to as "Genome Research Ethics Guidelines". ) "Collection of samples and information
"Institutions that sell products" stipulates only when samples and information are provided by other organizations.
This guideline obtains samples and information directly from research subjects in order to support a wider variety of forms.
It is stipulated including the case.

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Definition of the second term

⑿ Researchers, etc.
Principal Investigator and other research implementation (work at an institution that collects and sells samples and information)
Including implementation. ), Which means the provision of existing samples and information outside of research institutes.
Excludes those who perform research and those who are commissioned to engage in part of research-related work.
⒀ Principal Investigator
Involved in conducting research and supervising the work related to the research at the research institution to which he belongs
The person who does.
⒁ Head of research institute
A representative of a corporation conducting research, a head of an administrative agency, or a sole proprietor.
⒂ Ethics Review Committee
Ethical and scientific regarding the adequacy of conducting or continuing research and other necessary matters concerning research
A collegial body established to investigate and deliberate from various perspectives.
1 ⑿ “Persons involved in the implementation of other research” includes the research coordinator and research institutes.
It also includes staff engaged in technical assistance and clerical work of research.
In this way, there are a wide variety of people included in "researchers, etc.", but based on the provisions of Chapter 2 and subsequent chapters,
We will respond according to each role and responsibility in the research involved in the implementation.
2 ⑿ “A person who only provides existing samples / information other than research institutes” refers to existing samples / information.
Refers to a person who is not involved in research other than providing information. For example, a doctor belonging to a medical institution is the doctor concerned.
Part of the medical information held by the medical institution, or a person who belongs to a health center, etc.
Conduct research using this information on some of the information on the health of residents held by
This applies to cases such as when only providing is provided in response to a request from a researcher who intends to do so. In addition, trial
When newly obtaining fees and information from the research subject and providing them to other research institutes, "Samples and information"
Engaged in conducting research as a "researcher, etc." of a "institution that collects and sells information" or a "joint research institution"
It shall be wrong.
3 ⑿ "Persons who are entrusted to engage in part of research-related work" are from research institutes to research.
A person who has undertaken a part of the related business (a corporation or a sole proprietorship that has concluded a consignment contract with the head of a research institution)
Main) and those who are engaged in the relevant work under it and are not involved in research other than the relevant work.
4 ⒀ “Principal Investigator” is responsible for the research related to the research conducted by the research institution to which he / she belongs.
It is stipulated as a person in charge, and when conducting research in collaboration with other research institutes,
Regarding whether or not you have a role and responsibility for the work related to the research at the joint research institution, the 7th
According to the provisions of 1 (2) of the above, as stipulated in the research plan.
5 ⒁ "Head of research institute" is included in "Researchers, etc." in the Epidemiological Research Ethics Guidelines and Clinical Research Ethics Guidelines.
Unlike the "head of research institute" and "head of clinical research institute" that were stipulated in the above, the epidemiological research ethics finger
Corresponds to the "head of the institution conducting research" of the needle and the "representative of the organization" of the clinical research ethics guidelines.

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Definition of the second term

To In addition, when multiple organizations within the same corporation are jointly or collaborated to carry out research, "Research"
The "institution" is the corporation, and the "head of the research institution" is the representative of the corporation.
6 ⒂ "Ethics Review Committee" is not limited to the one established by the head of the research institution, but the research institution
Includes institutions that are set up in other places and conduct examinations at the request of the head of research institutes.

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Definition of the second term

⒃ Informed consent
Regarding research that the research subject or his / her representative, etc. intends to carry out or continue, the relevant research institute
Purpose, significance and method of research, burden on research subjects, expected results (risks and
Including profit. ) Etc., based on free will after receiving sufficient explanation and understanding them
The research (sample / information) to be given to researchers, etc. or those who provide existing samples / information.
Including handling. ) Consent to implement or continue.
⒄ Substitute
A person who is considered to be able to represent the will and interests of a surviving research subject and who is involved in the research.
When it is objectively determined that the subject lacks the ability to give informed consent
To researchers, etc. or those who provide existing samples / information on behalf of the research subject
A person who can give informed consent.
⒅ Substitutes, etc.
Informed consent is given when the research subject is dead in addition to the surrogate
It means those who can do it.
⒆ Informed Ascent
Research subjects who are objectively judged to lack the ability to give informed consent
However, easy-to-understand words according to the understanding of research that is going to be carried out or continued.
To understand that the research will be conducted or continued, and to express your support.
Regarding 1 ⒃ "Person who provides existing samples and information", ⑿ "Existing trials other than research institutes"
If it is a person who only provides fees and information, it is not included in "researchers, etc." in the definition of this guideline.
On the other hand, "the person who provides the existing sample / information" provides the existing sample / information at the research institution.
In addition to providing existing samples and information, he is also involved in creating research plans and writing research treatises.
If this is the case, it may fall under the category of "researcher, etc." In addition, ⑿ "Collection of samples and informationIf you are a person involved in "implementation of business at the institution that sells", "research" is defined in this guideline.
Included in "persons, etc."
2 ⒄ and ⒆ "It is objectively judged that the person lacks the ability to give informed consent."
Means that even those who are not involved in conducting the research will be judged as such.
The ability to give informed consent is a study that is about to be implemented or continued.
Relationship with the content of (the burden on the research subject and the presence or absence of expected risks and benefits, content, etc.)
Informed consent for a study by the same person
Lack of ability to give informed consent, but for another study
It is also possible to have.
3 In other countries, "Acent" or "Informed Ascent" refers to children as research subjects.
Often used for cases where this guideline is not limited to children, but informs.
Research subjects who are objectively judged to lack the ability to provide outlets are conducted research.

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Definition of the second term

If you can express your intention to do something, depending on the degree and situation,
It stipulates that you should get Mud Ascent.

19

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Definition of the second term

⒇ Personal information
Information about a living individual that falls under any of the following.
(1) Name, date of birth and other descriptions included in the information (documents, drawings or electromagnetic notes)
Recording (Electromagnetic method (electronic method, magnetic method, etc.) can be recognized depending on human perception
A method that cannot be used. (22) Same as in ②. ) Is a record made. )
Or any matter recorded or expressed using voice, action or other methods (individual)
The identification code is excluded. ). same as below. ) Can identify a specific individual
(Can be matched with other information, thereby identifying a particular individual
Including what will be different. )
② Those that include a personal identification code
(21) Personal information, etc.
In addition to personal information, information about an individual that identifies a particular individual about the dead
It refers to information that can be used.
(22) Personal identification code
Of the characters, numbers, symbols and other codes that fall under any of the following, personal information protection
This refers to those stipulated in the Law Enforcement Ordinance on Protection (Cabinet Order No. 507 of 2003) and other laws and regulations.
(1) Characters and numbers converted to use some characteristics of a specific individual's body for use in a computer
Numbers, symbols and other codes that can identify the specific individual
(2) Allocation regarding the use of services provided to individuals or the purchase of products sold to individuals
Cards or other documents issued to individuals, or electromagnetically
Characters, numbers, symbols or other codes recorded by the user or purchase
Assigned or described to be different for each person or person who receives the issue,
Or by being recorded, a specific user or purchaser or a person who receives the issue
What can be identified
(23) Personal information requiring consideration
The person's race, beliefs, social status, medical history, criminal history, facts of being harmed by the crime
Special arrangement for handling so as not to cause unfair discrimination, prejudice or other disadvantages against other persons
Personal information that includes sensitive descriptions.

1 Regarding "personal information" in ⒇, those that fall under any of the following are "individuals" specified in this guideline.
Corresponds to "personal information".
(1) Information that can identify a specific individual (person's name, face image, etc.)
(2) It is not possible to identify a specific individual by information alone, but it is special by collating with other information.
What can identify a certain individual
③ Those that include a personal identification code (see the explanation in (22))
Regarding (1) and (3), the relativity of each facility is not recognized in the judgment of applicability.
As a reminder, ② is a facility because the range of other information that can be collated differs from facility to facility.
The relativity of each can be recognized. That is, it corresponds to "personal information" referred to in this guideline.

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Definition of the second term

Whether or not it depends on the range of other information that can be collated in (2) above.
It is necessary to make a judgment according to the actual situation of each institution. About "can be collated with other information"
For details, see Explanation 7 in the latter part.
2 (21) "Personal information, etc." means, in addition to "Personal information" in ⒇, identifies a specific individual about the dead.
Refers to information that can be used. Personal Information Protection Law revised in September 2015
"Personal information, etc." means "personal information or anonymously processed information", and "individual" specified in this guideline
It is different from "information, etc."
3 ⒇ "Personal information" and (21) "Personal information, etc." are ⑸ "Information used for research".
Informed consent from, for example, a surrogate, as well as those that have not been anonymized.
⑸ "For research," such as the name, relationship, contact information, etc. of the person who accepted the request.
It may not be "information that can be entered". In addition, among the "information used for research" in ⑸, examples
For example, when the family history of injury and illness was heard from the research subject, the research subject A
A specific individual, even if it does not include a description such as the name of the maternal grandmother, such as the medical history of the mother.
(In the above example, Mr. A's maternal grandmother) can be identified as "personal information" (deceased)
If it is a person, it is included in "personal information, etc.").
4 ⒇ and (21) “Personal information” refers to individuals such as name, address, gender, date of birth, and facial image.
Facts and judgments regarding attributes such as personal body, property, occupation, title, etc.
All information that expresses the judgment, evaluation, personal inner feelings, appearance, activities, etc., evaluation information, publications, in
Information published by the Internet, etc., video and audio information is also included, and encryption, etc.
It doesn't matter if it is kept secret by.
5 ⒇ "Name, date of birth and other descriptions contained in the information" is a part of "Personal information"
Therefore, it is not appropriate to assume that these are the only "personal information". "Other descriptions, etc."
Examples include address, age, gender, telephone number, health insurance card number, medical record number, and the like. Also,
Video and audio recordings such as facial photographs can also identify specific individuals.
In that case, it is included in "personal information" ("personal information, etc." in the case of a deceased person) referred to in this guideline.
To
6 ⒇ "Can identify a specific individual" means a single piece of information or a combination of multiple pieces of information.
It means something that can be judged in that way according to social conventions, and it is born with the judgment or understanding of the general public.
It also depends on whether it is possible to recognize the identity between the specific person and the information that exists.
It is.
7 ⒇ "Can be collated with other information" means that the institution actually owns or obtains it.
It can be collated with other available information by means that the institution considers feasible.
Refers to the state in which it can be done.

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Definition of the second term

The "other information" to be collated includes cases where the holder is another institution, and
Publicly known information and publicly available information in public facilities such as libraries can usually be obtained by the general public.
Contains information. For information that may be available through special research, please contact us.
The example does not need to be included in "other information".
In addition, for the means that can be implemented to identify an individual, the means will be implemented.
Consideration within a reasonable range while considering who is the person who is considered to be
Appropriate.
8 (22) “Personal identification code” can identify a specific individual from the information alone.
It was stipulated in the Law Enforcement Ordinance on the Protection of Personal Information (Cabinet Order No. 507 of 2003).
Characters, numbers, symbols and other codes, and the information that includes those corresponding to them is personal information.
Become.
"(1) Characters converted to use some characteristics of a specific individual's body for use in a computer,
Numbers, symbols and other codes that can identify the specific individual "
The characters that have been converted to use any of the following physical characteristics for use in a computer,
Numbers, symbols and other codes ensure a level that can identify a specific individual
So, what was converted to use the right range for the computer by the right method,
Corresponds to the personal identification code.
(1) Sequence of bases constituting deoxyribonucleic acid (also known as DNA) collected from cells
Genome data (bases that make up deoxyribonucleic acid (also known as DNA) collected from cells)
Of the sequence of), whole nuclear genome sequence data, all exo
Sequencing data, whole genome single nucleotide polymorphism (single nucleotide polymorphism:
SNP) data, sequence data consisting of more than 40 independent SNPs, 9
Genotype information such as a 4-base repeat sequence (short tandem repeat: STR) above the locus
It is possible to authenticate the person by
(2) Depending on the color of the skeleton and skin of the face and the position and shape of the eyes, nose, mouth and other parts of the face
Appearance to be decided
(3) A linear pattern formed by the undulations of the surface of the iris
(4) Determined by the vibration of the vocal cords during vocalization, the opening and closing of the glottis, the shape of the vocal tract, and its changes.
Voice quality
(5) Posture during walking, movement of both arms, stride length and other walking modes
(6) The staticity determined by the branching and end points of the veins under the skin of the palm or back of the hand or fingers.
Pulse shape
(7) Fingerprint or palm print
(8) Combination of (1) to (7) above
In addition, "(2) Regarding the use of services provided to individuals or the purchase of products sold to individuals
Cards or other documents that are assigned or issued to individuals, or electromagnetic
Characters, numbers, symbols or other codes recorded by the formula, the user or purchaser

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Definition of the second term

Or assigned or described to be different for each person who receives the issue,
Is recorded to identify a specific user or purchaser or the person who receives the issue.
As for "things that can be done", the following items correspond to personal identification codes.
(1) Passport number (Passport Act (Act No. 267 of 1951), Article 6, Paragraph 1, Item 1 Passport
Number)
(2) Basic pension number (Basic year stipulated in Article 14 of the National Pension Act (Act No. 141 of 1959)
Gold number)
(3) Driver's license number (Road Traffic Act (Act No. 105 of 1960), Article 93, Paragraph 1, Item 1)
License number)
(4) Resident's card code (Stipulated in Article 7, Item 13 of the Basic Resident Registration Act (Act No. 81 of 1967)
Resident's card code)
(5) My number (related to the use of numbers to identify specific individuals in administrative procedures, etc.
Act (Act No. 27 of 2013) Personal number prescribed in Article 2, Paragraph 5)
(6) It is stated in the following certificate that it will be different for each person who receives the issuance.
Characters, numbers, symbols and other codes specified by the rules of the Personal Information Protection Commission
○ National Health Insurance Insured Certificate (National Health Insurance Act (Act No. 192 of 1958) Article 9
Insured person's card in paragraph 2)
○ Insured person's certificate of the medical system for the elderly (Showa 57)
Year Law No. 80) Insured person's card in Article 54, Paragraph 3)
○ Long-term care insurance insured person's card (Long-term care insurance law (Act No. 123 of 1997), Article 12, Paragraph 3)
Insured person's card)
(7) Other characters specified by the rules of the Personal Information Protection Commission as equivalent to (1) to (6),
Numbers, symbols and other codes
For a detailed definition of personal identification code, please refer to the Law Concerning the Protection of Personal Information.
Guidelines (general rules) (2016 Personal Information Protection Commission Notification No. 6)
Idline (general rules) ". ) Etc.
9 (23) "Personal information requiring consideration" refers to the person's race, beliefs, social status, medical history, criminal history, etc.
There is no fact that the person has been harmed by the crime or any other unfair discrimination, prejudice or other disadvantages against the person.
Personal information that includes information that requires special consideration in its handling, specifically, the following
Personal information that includes the descriptions from (1) to (11). However, the following (1) to (11)
Information that only infers the information listed above (eg, purchasing or lending books on religion)
Information related to the information) is not included in the sensitive personal information.
(1) Race
(2) Creed
(3) Social status
(4) Medical history

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Definition of the second term

It means a history of illness and shows a specific medical history (eg, a specific individual).
A person has cancer, schizophrenia, etc.).
(5) Crime history
(6) Facts of being harmed by crime
(7) Physical disability, intellectual disability, mental disability (including developmental disability) and other personal information protection commissioners
There is a physical or mental disability stipulated by the rules of the society
Refers to the information listed in (1) to (4) below. In addition, there is such a disability or in the past
Information that identifies what happened (eg, comprehensive support for the daily and social life of persons with disabilities
Receiving disability welfare services based on the Act for Acts (Act No. 123 of 2005)
That or what you have received in the past) also applies.
(1) "Physical disabilities listed in the attached table of the Welfare Law for Persons with Disabilities (Law No. 283 of 1945)"
Information that identifies that
(2) That there is "intellectual disability referred to in the Welfare Law for Persons with Intellectual Disabilities (Law No. 37 of 1960)"
Information to identify
③ "Act on Mental Health and Welfare for Persons with Mental Illness (Act No. 123 of 1950)
Mental disorders (Stipulated in Article 2, Paragraph 2 of the Developmental Disability Support Act (Act No. 167 of 2004)
Including developmental disabilities, and excluding intellectual disabilities referred to in the Intellectually Disabled Persons Welfare Law. ) ”
Information to identify
④ "Daily life of persons with disabilities due to illnesses for which no treatment method has been established or other special illnesses
Those specified by Cabinet Order under Article 4, Paragraph 1 of the Act for Comprehensive Support for Activities and Social Life
The degree of disability due to the above is the degree specified by the Minister of Health, Labor and Welfare in the same paragraph. "
Information to identify
(8) In the person engaged in medical duties such as a doctor for the person ((9), "Doctor"
Etc. " ) For prevention and early detection of diseases and other medical examinations
Results of examination (referred to as "health diagnosis, etc." in (9))
Health checkups, health checkups, and specific health checkups conducted for the purpose of disease prevention and early detection
Health measurement, stress check, genetic test (excluding those performed in the course of medical treatment)
Etc., the result of the test that reveals the health condition of the examinee is applicable.
As a specific example, it is based on the Industrial Safety and Health Act (Act No. 57 of 1972).
As a result of the health examination, the result of the stress check conducted based on the law, the elderly
Specified health carried out based on the Act on Ensuring Medical Care (Act No. 80 of 1982)
The result of the examination is applicable. In addition, it is limited to the results of health examinations stipulated by law.
Inspections that are voluntarily carried out or subsidized by insurers and business owners such as human docks
The result is also applicable. In addition, it is obtained by genetic testing performed without going through a medical institution.
Includes the genotype of the person and the results corresponding to the susceptibility to the disease of the genotype.
To The fact that you have undergone a medical examination, etc. does not apply.
In addition, information on personal health such as height, weight, blood pressure, pulse, body temperature, etc.
Applicable if you can find out by a method that is not related to the business such as medical treatment and related business
do not.

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Definition of the second term

(9) Based on the results of medical examinations, etc., or because of illness, injury or other physical or mental changes
Guidance, medical treatment, or dispensing for improving the physical and mental condition of the person by a doctor, etc.
Was done
As a result of health examinations, especially for those who need to maintain their health, doctors or health
The contents of health guidance provided by the teacher are applicable.
As a concrete example of the guidance given, a doctor or a doctor based on the Industrial Safety and Health Act
Contents of health guidance given by a public health nurse, interview guidance given by a doctor based on the law
By doctors, public health nurses, registered dietitians based on the law on ensuring medical care for the elderly
The contents of the specific health guidance provided are applicable. In addition, the health guidance stipulated by law
It is not limited to the content, but the insurer or business owner voluntarily implements or receives a medical examination with a subsidy.
The content of the health guidance provided also applies. The fact that he received health guidance, etc. also applies.
"Based on the results of medical examinations, etc., or because of illness, injury or other physical or mental changes.
"The person was treated by a doctor, etc." means hospitals, clinics, and other doctors.
In the process of medical treatment at a facility that provides medical treatment, the patient's physical condition, medical condition, treatment status, etc.
All the information that doctors, dentists, pharmacists, nurses and other healthcare professionals could know about
For example, medical records and the like correspond to this. In addition, the fact that he visited a hospital, etc.
Also applies.
"Based on the results of medical examinations, etc., or because of illness, injury or other physical or mental changes.
"The dispensing was done by a doctor, etc. to the person" means hospitals, clinics, pharmacies, and their
The patient's physical condition, medical condition, and treatment status during the dispensing process at other medical facilities.
For example, when a pharmacist (a doctor or a dentist dispenses by himself / herself according to his / her prescription)
Including. ) Refers to all the information that can be obtained, and is described in the dispensing record, medication history, and medication notebook.
Information etc. is applicable. The fact that the drug was dispensed at a pharmacy is also applicable.
In addition, information on personal health such as height, weight, blood pressure, pulse, body temperature, etc.
If you can find out by a method that is not related to the business such as medical treatment and related business,
Not correct.
(10) Arrest, search, seizure, detention, and prosecution of the person as a suspect or accused.
Procedures related to other criminal cases have been carried out (excluding criminal background)
(11) The juvenile or the juvenile whose person is stipulated in Article 3, Paragraph 1 of the Juvenile Law (Law No. 168 of 1948)
As a suspect, investigation, guardianship, refereeing, protective measures and other juvenile protection cases
The procedure for
It should be noted that the samples and information used in the research only include the descriptions from (1) to (11).
It does not correspond to "personal information requiring consideration", and the sample / information identifies a specific individual.
If it is not possible to do so, the sample / information corresponds to "personal information requiring consideration".
Keep in mind that it does not. In addition, a single gene is included in the genomic data corresponding to the personal identification code.
Add interpretations such as disease, susceptibility to disease, selection of therapeutic agents, etc., medically
Keep in mind that meaningful "genome information" may correspond to sensitive personal information.
To do.

twenty five

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Definition of the second term

For detailed definitions of sensitive personal information, refer to the Personal Information Law Guidelines (General Rules), etc.
See.

26

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Definition of the second term

(24) Anonymization
Descriptions, etc. that can identify a specific individual (including the dead. The same shall apply hereinafter).
Includes person identification code. ) To delete all or part (all or part of the description, etc.)
Includes replacement with a description or the like that is not related to the individual. ).
(25) Correspondence table
The anonymized information is relevant so that the research subject can be identified when necessary.
Make it possible to collate the research subject with the description etc. that was replaced at the time of anonymization.
Table and other similar items.
(26) Anonymous processing information
The following personal information (Act on the Protection of Personal Information (Act No. 57 of 2003; hereinafter "Individual"
It is called "Personal Information Protection Law". ) Is limited to the personal information specified in. The same shall apply hereinafter in this (26). )
It is not possible to identify a specific individual by taking the following measures according to the classification of
It is information about an individual obtained by processing personal information in this way, and the personal information is restored.
It means something that cannot be done (limited to those that are subject to the provisions of the law).
① ⒇ ① Personal information to delete a part of the description etc. contained in the personal information
(Other descriptions by a method that does not have regularity that can restore the part of the description, etc.
Including replacing with etc. ).
② ⒇ ② Personal information Delete all personal identification codes included in the personal information
(By a method that does not have regularity that can restore the personal identification code.
Including replacing with the description of. ).
(27) Non-identifying processing information
The following personal information (Act on the Protection of Personal Information Held by Administrative Organizations (2003)
Law No. 58. Hereinafter referred to as the "Administrative Agency Personal Information Protection Law". ) Or owned by an incorporated administrative agency, etc.
Law Concerning the Protection of Personal Information (Law No. 59 of 2003; hereinafter referred to as "Incorporated Administrative Agencies, etc.
It is called the Information Protection Law. ), Individuals who are subject to processing related to non-identified processing information
Limited to information. The same shall apply hereinafter in this (27). ), The following measures are taken
Individuals obtained by processing personal information so that it is not possible to identify a specific individual
Information about personal information that cannot be restored (administration)
Institutions subject to the provisions of the Personal Information Protection Law or the Personal Information Protection Law of Incorporated Administrative Agencies, etc.
Limited. ).
① ⒇ ① Personal information to delete a part of the description etc. contained in the personal information
(Other descriptions by a method that does not have regularity that can restore the part of the description, etc.
Including replacing with etc. ).
② ⒇ ② Personal information Delete all personal identification codes included in the personal information
(By a method that does not have regularity that can restore the personal identification code.
Including replacing with the description of. ).
1 Regarding "anonymization" in (24), the term "anonymization" in this guideline refers to a specific individual.
Delete all or part of the description, etc. (including the personal identification code) that can identify

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Definition of the second term

By making it impossible to identify a specific individual.
Samples and information that have been "anonymized" are referred to as "anonymized" in this guideline.
However, some of the "anonymized things" include other information available within the institution and anonymization.
Specific research subjects by collating with the correspondence table between the code or number attached to the personal information and personal information, etc.
Can or cannot identify a particular individual
Both can be included. Therefore, in this guideline, among the "anonymized ones", especially "special"
When referring to "things that cannot identify a certain individual", "even if they are anonymized"
(Limited to those that cannot identify a specific individual.) ".
2 Information on personal medical care, etc. may represent physical characteristics by itself, for example.
Machine name, date of birth and other "descriptions that can identify a specific individual"
It is said that it is not possible to identify a specific individual only by masking
It may be difficult to say. For this reason, "anonymization" of personal information, etc. acquired as a result of conducting research
If you want to "cannot identify a specific individual" by doing so,
It is a processing method that sufficiently reduces the possibility that a specific individual will be identified according to the content and use.
As well as needing, "identify a particular individual by matching it with information available elsewhere.
You need to be careful not to be able to do it.
In addition, "anonymization" is originally intended to protect personal information, etc., and researchers, etc.
Is a convenient way for the person who provides the existing sample / information to avoid the procedure of consent of the person.
Is not suitable. Regarding this point, (26) "anonymous processing information" and (27) "non-identification processing information" were created.
The same applies when it is formed.
3 In the research to be carried out, the sample obtained from the human body is analyzed by genome analysis, etc.
If you plan to acquire new nom data (corresponding to the personal identification code),
Even if the sample itself is anonymized and cannot identify a specific individual,
Treat the sample as being able to identify a particular individual.
4 (25) “Correspondence table” identifies research subjects when necessary from anonymized samples and information.
Widely refers to and must be able to collate with other information that can be
It is not limited to the one in the form of "table". For example, the research ID is written directly in the medical record.
Even if it is recorded, the correspondence between the medical record and the anonymized sample / information can be immediately identified.
This is also included in the case of holding the "correspondence table" referred to in this guideline. Also, hash functions, etc.
Is used to generate a research ID, which can be used instead of a description that can identify a specific individual.
The case of adding is also applicable to the "correspondence table".
If another organization within the same corporation has a "correspondence table", the research institution will handle it.
It is considered to hold the table. For example, a corporation with a medical institution conducts research as a research institution.
Create a "correspondence table" that connects the medical record number and the patient and use it for research.
Even if access to the "correspondence table" is restricted when the medical information is anonymized
The anonymized medical information is specified by the "correspondence table" held by another organization of the same corporation.

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Definition of the second term

Knowing a particular individual because it can be collated with other information that can identify a particular individual
It cannot be said that it corresponds to something that cannot be separated. That is, the anonymized medical information
Is the report limited to those who can identify a specific individual within the research institution?
It also identifies a particular individual, regardless of who has access to it.
It does not correspond to what cannot be done. For example, in Hospital A and Research Institute B under the jurisdiction of the same corporation
Then, create a "correspondence table" to anonymize the samples and information obtained at Hospital A, and send them to Laboratory B.
If you provide it, even if you do not keep the correspondence table at Research Institute B, it will be the corporation (research institution).
It is necessary to properly handle it as personal information, etc. without changing to holding a correspondence table.
5 If the research institution or another organization within the same corporation does not have a correspondence table, the research institution concerned
Basically, information that can identify a specific individual by the correspondence table
It may be considered that it is not in a state where it can be collated with. However, for example, the research machine
Information that can identify a specific individual from other institutions according to the instructions of Seki (correspondence)
Includes table. ), The information should be used to identify a specific individual.
It is necessary to properly handle the information that can be obtained as personal information.
This guideline stipulates the proper handling of personal information, etc. held by research institutes, and is appropriate.
As a convenient way to avoid proper management, it is not possible to entrust or transfer the possession of the correspondence table to another person.
Not suitable.
6 “Anonymously processed information” in (26) and “Non-identified processed information” in (27) are anonymous as defined in 17 (1).
In accordance with the standards for creating processing information or non-identification processing information (hereinafter referred to as "anonymous processing standards")
As for the definition and handling, personal information is protected as necessary.
See applicable legislation regarding.
In addition, "anonymously processed information" and "non-identified processed information" simply include information described in medical records.
Not only the processed personal information of, but also the personal information attached to the sample obtained from the human body is concealed.
It also includes those processed according to the name processing standards. However, the genome of the sample obtained from the human body
It is expected that genomic data corresponding to the personal identification code will be obtained by analysis.
In this case, since the genome analysis corresponds to "personal identification", anonymously processed information or non-identification is added.
Note that it cannot be used as construction information.
<Reference>
Guidelines for Law Concerning Protection of Personal Information (Anonymously Processed Information) (2016)
Personal Information Protection Commission Notification No. 9)

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Definition of the second term

<Regarding the classification of "personal information" and "anonymously processed information" in this guideline>
type

Definition

Concrete example

Information about a living individual, specific
Items that can identify individuals (* 1)
① Identifying a specific individual by information alone
What you can do
personal information

(2) By collating with other information (* 2)
Can identify a specific individual
thing

Name, face image, etc.
Special by "correspondence table"
Identifying a certain individual
With other information that can be
Things that can be collated

③ Those that include a personal identification code

Genome data, etc.

Medical records, receipts, health
Of personal information, special consideration is required for its handling
Personal information requiring consideration
As a result of examination, genomic information
What contains the description to
etc
Anonymously processed information
Satisfy
/ non-identification
the anonymous added
processing standards stipulated in the Personal Information Protection Law, etc.
Construction information

Processed personal information to add
Descriptions that can identify a specific individual, etc.

What is anonymized

All or part deleted (including replacement)

Put your name on your research ID

(Note: Although it can identify a specific individual

Replaced ones, etc.

Includes both things that can and cannot be done)
Being anonymized
Things (specific individuals Specific individuals who have been anonymized
Can be identified

Items that cannot be identified ("Personal information" above

Only for things that can't be done
Those that do not include (1) to (3) in the definition of "report")
To )
Being anonymized

Of the anonymized ones, the description alone

Things (which research subjectA description that can immediately identify a specific research subject
With the sample and information
the personto remove all etc.
It isofprocessed
Immediately determine whether
or not(If you have a correspondence table, the correspondence table is appropriate
Things
Processing so that it cannot be(Only
done when the management is done)
Or managed

(Note: Although it can identify a specific individual

Limited to. )

Includes both things that can and cannot be done)

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Definition of the second term

* 1 "Can identify a specific individual" is stored as a single piece of information or a combination of multiple pieces of information.
It means something that can be judged as such from what is known in society, and also has the judgment or understanding of the general public.
It depends on whether it is possible to recognize the identity between the specific person who survives and the information.
Is. In this guideline, "personal information" and specific individuals can be identified for the dead.
The information that can be provided is collectively referred to as "personal information, etc."

* 2 In this guideline, "it can be collated with other information" is actually owned by the relevant institution.
Can be matched with other available information by means deemed feasible by the institution.
Refers to the state in which it can be done. The "other information" to be collated includes the case where the holder is another institution.
Rarely, publicly known information and publicly available information in public facilities such as libraries are usually obtained by the general public.
Contains the information you get. For information that may be available through special research, it is customary.
Does not need to be included in "other information". In addition, it is considered that it can be carried out to identify an individual.
With regard to the means, while considering who is the person who is considered to implement the means, etc.
It is appropriate to consider it within a reasonable range.

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Definition of the second term

(28) Adverse events
All favorables that occur in the study subject, with or without a causal relationship with the study conducted
Or unintended injury or illness or its signs (including abnormal laboratory test values).
(29) Serious adverse events
Adverse events that fall under any of the following.
① Things that lead to death
② Life-threatening things
③ Those that require hospitalization for treatment or extension of hospitalization period
④ Permanent or significant disability / dysfunction
⑤ Those that cause birth defects in descendants
(30) Serious adverse events that cannot be predicted
Among serious adverse events, in research plans, informed consent explanatory documents, etc.
What is not described, or even if it is described, its nature or severity is described
It means something that does not match.
1 Regarding “abnormal laboratory test values” in (28), slight deviations from the standard values ​may occur even in normal times.
If it is, it is not necessarily included in "abnormality", but it may be a sign of an adverse event.
Also need to be considered.
2 Regarding “serious adverse events” in (29), in addition to the ones listed in ① to ⑤, immediate life
Even if you do not threaten or be hospitalized, you can endanger the research subject, such as ① to ⑤
In the case of a serious event that requires treatment so as not to lead to an unsuccessful result, the 18th 3 (1) rule
In addition to taking necessary measures according to the prescribed procedure manual, etc., depending on the content of the research, specific injuries and illnesses
If there are adverse event evaluation standards, etc. that are internationally standardized in the area, those standards, etc.
It is desirable to refer to and reflect it in the research plan.
3 (30) “Research plan, informed consent explanatory documents, etc.” includes approved drugs
Includes package inserts for the item in research using medical devices.
For research using unapproved drugs and medical devices, refer to “Research” in the research plan (8 ⑴ ④).
Outline of unapproved drugs / medical devices used in the research in "Method of research" (so-called "trial"
"Outline of study drug" and "Outline of test equipment") shall be described, and the description in the research plan is also predictable.
It may be a judgment factor.

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Definition of the second term

(31) Monitoring
How well the research is progressing to ensure that the research is done properly
To the person designated by the principal investigator as to whether or not the research is carried out in accordance with the guidelines and research plan of
This is a survey that can be passed on.
(32) Audit
Research was conducted in accordance with this guideline and research plan to ensure the reliability of research results.
This is a survey conducted by a person designated by the principal investigator.
Conduct research in collaboration with other research institutes regarding "persons designated by the principal investigator" in (31) and (32)
In the case of application, according to the provisions of 7th 1 (2), each joint research institution prepares a research plan.
The role and responsibility of the principal investigator will be clarified, and research at joint research institutes will be supervised.
If a principal investigator (general manager) is appointed, monitoring or monitoring at a joint research institution
Is to be supervised by the principal investigator (general manager), including the designation of the person engaged in the audit.
Good.
In addition, if the attribute is clarified and specified, it is not always necessary to appoint a specific individual.
Absent.

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Third scope of application

Third scope of application
1 Applicable research
This guideline is implemented by Japanese research institutes or in Japan.
The target is medical research. However, for studies that fall within the scope of other guidelines
If there are, matters not stipulated in the guideline will be carried out in accordance with the stipulations of this guideline.
And.
In addition, for research that falls under any of the following, this guideline (anonymous addition that has already been created)
Engineering information or non-identified processed information (for the purpose of university and other academic research stipulated in the Personal Information Protection Law)
Used for the purpose of providing academic research by an institution or organization or a person belonging to them
Limited to what can be done. For studies that use only), the 17th is excluded. ) Is not applicable.
A. Research conducted in accordance with the provisions of laws and regulations
B. Research included in the scope of application of standards stipulated by laws and regulations
C. Research using only the following samples / information
(1) Academic value has already been determined, widely used for research, and generally available.
Samples and information
(2) Information that has already been anonymized (information that cannot identify a specific individual)
Therefore, it is limited to those for which a correspondence table has not been created. )
③ Anonymous processing information or non-identification processing information that has already been created
1 The third provision of 1 is the guideline of "medical research targeting humans" defined in 2 (1).
It defines the studies that apply or do not apply.
This guideline is an ethical guideline for "medical research targeting humans" and "targets humans".
Research that does not fit the definition of "medical research" is not covered by this guideline. For example, psychology,
Of the research related only to the humanities / social science fields such as sociology and pedagogy, and research in the engineering field, etc.
Gaining knowledge that contributes to maintaining and improving the health of the people, recovering from injuries and illnesses of patients, and improving quality of life
Those who do not aim to acquire knowledge that contributes to the research are not the subject of this guideline, but are they research subjects?
This guideline is a reference for proper implementation according to the content, such as using the information obtained from
Can be.
2 Regarding "implemented in Japan", invasion or intervention is carried out in Japan
Samples and information are available not only for research, but also for research that does not involve invasiveness and does not involve intervention.
A place to obtain samples and information from research subjects in Japan or from Japanese institutions
In that case, overseas research institutes may analyze the sample / information outside Japan.
Including, it corresponds to research "conducted in Japan".
3 What is "other guidelines"?
○ Ethical guidelines for human genome / gene analysis research
(2013 Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health, Labor and Welfare, Ministry of Economy, Trade and Industry Notification No. 1)
○ Guidelines for clinical research such as gene therapy

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Third scope of application

(2015 Ministry of Health, Labor and Welfare Notification No. 344)
○ Ethical guidelines for assisted reproductive technology research to create fertilized human embryos
(2010 Ministry of Education, Culture, Sports, Science and Technology / Ministry of Health, Labor and Welfare Notification No. 2)
And so on. For example, research involving human genome / gene analysis is a guideline for genome research ethics.
Included in the scope of application of, first, after the provisions of the Genome Research Ethics Guideline are applied, Genome Research Ethics
Matters not stipulated in the guidelines (eg, compensation for health hazards in invasive studies,
For registration in public databases related to research involving intervention, etc.), the provisions of this guideline are appropriate.
To use. Other guidelines as provided in both the other guidelines and this guideline for a given matter.
Even if there is a difference in strictness between the provisions of this guideline and the provisions of this guideline, the provisions of other guidelines will be applied with priority.
Is done.
4 "Anonymously processed information or non-identified processed information that has already been created" means that it should be used for the research.
This research refers to existing anonymously processed information or non-identified processed information that has been created before the attempt.
When trying to use it for, or when trying to provide it to other research institutes, new information from personal information, etc.
Not included when creating in.
"By a university or other institution or organization for the purpose of academic research, or a person belonging to them
"Used for the purpose of academic research" is stated in Article 76, Paragraph 1, Item 3 of the Personal Information Protection Law.
Refers to the applicable case. That is, here, it corresponds to Article 76, Paragraph 1, Item 3 of the Personal Information Protection Law.
In that case, only the "anonymously processed information or non-identified processed information that has already been created" in (3)
When conducting research using, only comply with the 17th provision (handling of anonymously processed information).
I am seeking.
Regarding 5a, "Research conducted under the provisions of laws and regulations," for example, regarding the promotion of cancer registration, etc.
National Cancer based on the Act on Cancer Registration (Act No. 111 of 2013; hereinafter referred to as the "Cancer Registration Promotion Act")
In addition to the registration database and prefectural cancer database, prevention of infectious diseases and patients with infectious diseases
Survey of infectious disease outbreaks based on the Medical Care for Persons Act (Act No. 114 of 1998),
Implementation of the National Health and Nutrition Survey based on the Health Promotion Act (Act No. 103 of 2002)
Specific authorities and responsibilities are stipulated by law for specific administrative agencies, incorporated administrative agencies, etc.
The thing is applicable.
6 Regarding the conventional cancer registration projects that have been carried out mainly by prefectures, epidemiological research ethics
At the time of enactment of the guideline, it was regarded as a health business and was not covered by the guideline.
After that, the prefectural cancer database based on the Cancer Registration Promotion Law was also introduced under the law.
Although it is stipulated for use in research, it is also implemented under the provisions of the Cancer Registration Promotion Law.
Therefore, this finger includes hospitals that report morbidity information to these databases.
Not subject to needles.
The national cancer registration database and prefectural cancer database based on the Cancer Registration Promotion Law
Regarding "medical research targeting humans" using the information provided by Su, separately a to c
Unless excluded from the subject of this guideline by the provisions of, it is subject to this guideline.

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Third scope of application

7 Regarding the "standards stipulated by laws and regulations" in B,
For example, as a standard stipulated by the Pharmaceuticals and Medical Devices Act,
○ Ministerial Ordinance on Standards for Conducting Clinical Trials of Pharmaceuticals
(Ministry of Health and Welfare Ordinance No. 28, 1997)
○ Ministerial Ordinance on Standards for Post-Manufacturing and Sales Surveys and Testing of Pharmaceuticals
(2004 Ministry of Health, Labor and Welfare Ordinance No. 171)
○ Ministerial Ordinance on Standards for Conducting Clinical Trials of Medical Devices
(2005 Ministry of Health, Labor and Welfare Ordinance No. 36)
○ Ministerial Ordinance on Standards for Post-Manufacturing and Sales Surveys and Testing of Medical Devices
(2005 Ministry of Health, Labor and Welfare Ordinance No. 38)
○ Ministerial Ordinance on Standards for Conducting Clinical Trials of Products such as Regenerative Medicine
(2014 Ministry of Health, Labor and Welfare Ordinance No. 89)
○ Ministerial Ordinance on Standards for Post-Manufacturing and Sales Surveys and Testing of Regenerative Medicine Products
(2014 Ministry of Health, Labor and Welfare Ordinance No. 90)
Has been enacted, and products such as pharmaceuticals, medical devices and regenerative medicine regulated by the law
These criteria apply to floor tests and post-marketing surveys and tests, respectively.
Not subject to this guideline.
Regenerative medicine stipulated by the Act on Ensuring the Safety of Regenerative Medicine (Act No. 85 of 2013)
Standards for providing medical treatment (Act Enforcement Regulations on Ensuring the Safety of Regenerative Medicine, etc. (2014 Ministry of Health, Labor and Welfare)
Similarly, Ministerial Ordinance No. 110) Articles 4 to 26) are also included in the scope of application of the standard.
Research is not subject to this guideline.
In addition, a core statistical survey conducted in accordance with the procedures stipulated by the Statistics Act (Act No. 53 of 2007).
And in general statistical surveys, it fits the definition of "medical research targeting humans" for that purpose.
If there is something, it can be regarded as "research included in the scope of application of the standards stipulated by laws and regulations".
8 C ① "The academic value has already been determined, it is widely used for research, and it is generally available.
"Academic value has already been determined" in "capable samples and information" means peer-reviewed academic papers and related studies.
It has been evaluated to a certain extent at meetings, etc., and is widely used in major journals without annotations.
It refers to something that has a fixed value as a general thing.
Regarding "widely used for research", for example, the Centers for Disease Control and Prevention (CDC) in the United States
In addition to the information published on the web for research purposes, peer-reviewed
Research on the information published in the published academic papers and the original materials published by the authors of the papers.
Information that is widely available for research is applicable.
"Generally available samples / information" is not necessarily limited to those sold.
It can be obtained by researchers if you ask the provider, for example, HeLa cells and human-derived details.
Among the iPS cells established from vesicles, those provided as research materials are applicable,
Whether or not it is generally available will be determined in accordance with domestic laws and regulations.

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Third scope of application

9 C② "Information that has already been anonymized (information that cannot identify a specific individual)
Therefore, it is limited to those for which a correspondence table has not been created. ) ”Is before trying to use it in the research
Refers to existing information that has been anonymized from, and when it is intended to be used for the research or other research machines.
It does not include the case of newly anonymizing when trying to provide to Seki. In addition, "A correspondence table has been created.
"Not" is not limited to the case where the correspondence table was not created when anonymizing.
A response table has been created, but it is intended to be conducted when conducting research or to be provided to other research institutes.
Sometimes it is already destroyed and does not exist in any institution.
In addition, the information that other institutions created a correspondence table and anonymized was provided by other institutions.
If the research institution that conducts research using that information does not have a correspondence table
"Information that has already been anonymized (those that cannot identify a particular individual and
Limited to those for which a correspondence table has not been created. ) ”Does not apply to research. In this case, separately
Unless excluded from the scope of this guideline by the provisions of a to c, carry out in accordance with the provisions of this guideline.
However, compared to the case where the research institution conducting the research has a correspondence table,
The procedure for receiving informed consent has been reduced, and accordingly, it is included in the research plan.
The volume is reduced, and the ethics review committee can handle expedited review.
10 C Refer to the explanation in 4 for "anonymously processed information or non-identified processed information that has already been created" in ③.
However, this is not included when using a sample obtained from the human body.

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Third scope of application

2 Research conducted outside Japan
(1) When a research institution in Japan conducts research outside Japan (jointly with an overseas research institution)
Including the case of conducting research. ) Follows this guideline, as well as the laws and regulations of the place of implementation.
Must comply with standards such as needles. However, compared to the provisions of this guideline,
If the provisions of standards such as laws and guidelines are strict, instead of the provisions of these guidelines, the place of implementation
Research shall be conducted in accordance with the provisions of standards such as laws and guidelines.
(2) The provisions of this guideline are stricter than the provisions of standards such as laws and guidelines at implementation sites outside Japan.
There are cases where it is difficult to carry out research under the provisions of this guideline, and are listed below.
Matters are described in the research plan, and the opinion of the Ethics Review Committee regarding the implementation of the research is heard.
When the head of a research institution in Japan approves, instead of the provisions of this guideline, the place of implementation
Research can be conducted in accordance with the provisions of standards such as laws and guidelines.
① Appropriate measures will be taken for informed consent
(2) Appropriate measures will be taken to protect personal information, etc. acquired as a result of conducting research.
To be
1 The third and second provisions refer to this when a Japanese research institution conducts research outside Japan.
It stipulates the application of needles.
2 Regarding "regulations of this guideline" and "regulation of standards such as laws and regulations of the place of implementation", this guideline and implementation
It will be judged which is stricter for each regulation with the standards such as local laws and guidelines. example
For example, regarding the Ethics Review Committee, the provisions of this guideline are the provisions of the standards such as the laws and regulations of the place of implementation.
Strict and informed consent is implemented in comparison with the provisions of this guideline.
It is possible that the provisions of standards such as local laws and guidelines are strict. In some provisions
Even if the standards such as the laws and regulations of the place of implementation are stricter than this guideline, there are some parts that are not.
It is necessary to comply with the regulations, guidelines, etc. of the place of implementation in accordance with the provisions of the guidelines. Need
For example, the stricter of the "regulations of this guideline" and "regulations of standards such as laws and regulations of the place of implementation" is appropriate.
The purpose is to use it.
3 Regarding "according to the provisions of the standards such as the laws and guidelines of the place of implementation", the laws and guidelines of the place of implementation
In the provisions of the standard, approval by the national agency at the place of implementation, or the decree of the place of implementation,
To an ethics review committee established at the site of implementation in accordance with standards such as guidelines, or an organization equivalent thereto
It is stipulated that the implementation will be permitted by the head of the research institution at the site of implementation.
In such cases, the approval or permission shall be obtained.
4 ⑵ "The provisions of this guideline are stricter than the provisions of standards such as laws and guidelines at implementation sites outside Japan.
If it is difficult to carry out research due to the provisions of this guideline, ”is mainly developed.
Based on laws and guidelines regarding matters that researchers must comply with in developing countries / regions
It is assumed that the standards are not sufficiently developed, but the provisions of this guideline are simply the laws and regulations of the place of implementation.

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Third scope of application

Immediately after the stricter than the provisions of the standards such as the guidelines, the laws and guidelines of the place of implementation
The provisions of the standards do not allow the study to be carried out.
Regarding individual studies, it is difficult to carry out under the provisions of this guideline.
Uniquely, the principal investigator makes a decision when preparing the research plan, and the ethics trial includes its validity.
It is examined by the Examination Committee, and the director of the research institution permits or disapproves based on the opinion of the Ethics Examination Committee.
Etc. need to be decided.
Even if it is difficult to carry out research due to the provisions of this guideline, consultations with international medical organizations
Conduct research in accordance with the provisions of internationally recognized standards such as the Council for International Organizations of Ethics (CIOMS)
If possible, it is desirable to carry out the study in accordance with the provisions of the relevant standard.

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4th Basic responsibilities of researchers, etc.

Chapter 2 Obligations of researchers, etc.
4th Basic responsibilities of researchers, etc.
1 Consideration for research subjects, etc.
(1) Researchers, etc. must carry out research with respect for the life, health and human rights of the research subjects.
It doesn't become.
(2) As a general rule, researchers, etc. should inform in advance when conducting research.
You must receive a de outlet.
(3) Researchers, etc. are research subjects or their substitutes (hereinafter referred to as “research subjects, etc.”) and
Appropriate and prompt for consultations, inquiries, complaints, etc. (hereinafter referred to as "consultations, etc.") from the parties concerned
Must correspond to.
(4) Researchers, etc. must not divulge information that they have learned in conducting research without a justifiable reason.
Not. The same shall apply even after the research is no longer involved.
⑸ Researchers respect the human rights of research subjects, such as leaks of information related to research.
Or, if there is a serious concern from the viewpoint of conducting research, the director of the research institution will promptly take over.
And must be reported to the principal investigator.
1 The fourth and first provisions are the basis for researchers, etc. to consider the research subjects, etc. when conducting research.
It defines the main responsibilities.
2 ⑵ "In principle" is the research content regarding the procedure for receiving informed consent.
Some do not require the procedure to receive informed consent in advance.
(See the twelfth provisions 1, 6 and 7).
3 (3) “The person concerned” is related to the research subject, such as the relatives of the research subject other than the surrogate.
Refers to a person who is deeply involved.
4 ⑷ “Information obtained from conducting research” includes information obtained from research subjects for research purposes.
In addition to the information, for example, information related to research originality such as research methods and designs is also included.
5 ⑸ "There are serious concerns from the perspective of respecting the human rights of the research subjects, etc., or from the perspective of conducting research.
In addition to the "leakage of information related to research" shown in (4), for example,
Participation in the study When the voluntary decision-making of the study subject is restricted or a serious adverse event
It is also possible that you may have learned information that will affect the continuation of your research, such as when a problem occurs.

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4th Basic responsibilities of researchers, etc.

2 Ensuring ethical validity and scientific rationality of research, etc.
(1) Researchers, etc. shall comply with laws and regulations, guidelines, etc., and shall be examined by the Ethics Review Committee and approved by the head of the research institution.
The research must be carried out properly in accordance with the approved research plan.
(2) Researchers, etc., facts or information that impair the ethical validity or scientific rationality of research.
Or, if you obtain information that may be damaged (excluding cases that fall under (3)), promptly
Must be reported to the principal investigator.
(3) Researchers, etc., have facts or information that impair the appropriateness of conducting research or the credibility of research results.
When information or information that may be damaged is obtained, the principal investigator or research institution promptly asks.
I have to report to the chief.
1 The 4th and 2nd provisions are the contents that researchers should comply with in order to carry out research properly, and I learned about them.
It stipulates how to respond to information reports.
2 ⑴ "Decrees, guidelines, etc." includes rules and procedures prepared by the head of the research institution in accordance with the provisions of 6-2 ⑴.
Includes a sequence.
The fact that impairs the "ethical validity of the research" in 3 (2) is that when conducting the research,
Research subjects such as inadequate procedures for receiving informed consent and improper handling of personal information
Refers to the facts that should be dealt with appropriately when conducting research from the perspective of protecting human rights and giving consideration to welfare.
Su. In addition, "facts that impair scientific rationality" were found after the start of the research.
New scientific knowledge and contents, and information on safety measures implemented by domestic and foreign regulatory authorities
The burden on the research subject, which was stated in the research plan by the principal investigator before the start of the research, is the same as the burden on the research subject.
It refers to the fact that the overall assessment of expected risks and benefits can change. In addition, "Loss
"Information that may be lost" is determined to be true after knowing the above contents.
Information up to.
4 (3) Facts and information that impair the “appropriateness of conducting research” are the research plans in conducting research.
Refers to facts and information such as deviations from the research target selection policy and research method based on. In addition, "Lab
Facts and information that "damage the credibility of research results" are facts and information such as falsification and falsification of research data.
Refers to information. Furthermore, "information that may be damaged" means that after knowing the above contents,
Information that is true or has not been finalized. If you report to the principal investigator,
If there is a concern about concealment by the principal investigator, it is necessary to report directly to the director of the research institution.

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4th Basic responsibilities of researchers, etc.

3 Education / Training
Prior to conducting the research, researchers, etc. should be aware of the ethics of the research and the knowledge necessary to carry out the research.
You must receive education and training on knowledge and technology. In addition, it will continue as appropriate during the research period.
You must receive education and training.
1 The 4th and 3rd provisions stipulate the education and training that researchers should receive.
2 The content of education and training is in addition to various rules that should be generally observed regarding research such as ethical guidelines.
Including education and training on fraudulent activities in research activities and conflicts of interest related to research activities
To be. In addition, if special skills or knowledge are required to carry out the research, the relevant research institute
Prior to conducting the research, it is necessary to receive education and research related to those technologies and knowledge.
3 As a form of education / training, workshops held within each research institution and other institutions (society)
Etc. are included. ), E-learning (for example, CITI Japan (Ministry of Education, Culture, Sports, Science and Technology)
Inter-university collaborative joint education promotion project), e-Training center for clinical trials (Japan Medical Association Center for Clinical Trials)
Promotion Center), Introduction to ICR clinical research, etc. ) Etc. are conceivable.
4 For those who have to receive education / training, those who are engaged in the affairs when conducting research and the research institute
It also includes those who assist the researcher. The content of education and training is uniform for all participants
It is not necessary to do so, and it is desirable to make it appropriate according to the business content.
5 It is desirable to receive education and training at least once a year for “continue as appropriate”.
6 Those who are entrusted to engage in part of the research-related work are not included in the researchers, so they are taught.
It is not always necessary to receive education and training, but as appropriate depending on the content of the work to be entrusted
It is conceivable that the consignment contract stipulates the attendance of education and training.

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Responsibilities of the 5th Research Director

Responsibilities of the 5th Research Director
1 Preparation of research plan and thorough compliance with researchers, etc.
(1) The principal investigator must prepare an appropriate research plan prior to conducting the research.
The same applies when changing the research plan.
(2) The principal investigator plans the research to ensure the ethical validity and scientific rationality of the research.
I have to make a book. In addition, when creating a research plan, for the research subjects
Comprehensive evaluation of burdens and expected risks and benefits, as well as burdens and risks
Must be taken to minimize.
(3) The principal investigator is a research that involves invasion (excluding minor invasion) and goes beyond normal medical care.
If you are going to carry out something that involves medical treatment, the research subject in connection with the research
In order to compensate for the health damage caused by the above, it is necessary to take out insurance and other matters in advance.
Necessary measures must be taken appropriately.
(4) The principal investigator should appropriately provide the outline of the research and other information related to the research in accordance with the ninth provision.
Along with registration, the results of the study must be published.
(5) The principal investigator will properly carry out the research in accordance with the research plan, and the reliability of the results will be assured.
Guidance and management of researchers and other related parties involved in the implementation of the research so that it can be maintained.
There must be.
1 The fifth and first provisions are with the principal investigator from the preparation of the research plan to the end and publication of the research.

It stipulates the responsibilities for carrying out the research.
2 Regarding the provisions of (2), the principal investigator shall ensure the safety of the research when conducting the research.
It is especially important to ensure, the dangers associated with research can be predicted, and sufficient safety can be ensured.
If it cannot be determined that the research is not conducted, the research will not be conducted.
See the first commentary for the concept of "expected risk". ).
3 Regarding the provisions of (3), side effects that occur when approved drugs are used within the scope of the approval.
Regarding the efficacy / effect, usage / dose, etc. in the phytotoxicity damage relief system, it is attached.
Those that can be covered by the relief system if used properly in light of documents, etc.
Therefore, it is considered that compensation measures have already been taken.
Depending on the content of the research plan, even if it is an approved drug, it may be used off-label, and it may be stated in the package insert.
When it corresponds to "medical practice beyond the scope of normal medical care" such as not observing the precautions etc.
There is a risk that you will not be covered by the side effect damage relief system, so take out insurance for compensation.
It is necessary to take measures such as (about the idea of ​"medical practice beyond the scope of normal medical care"
See the second commentary. ).
In addition, under the relief system, welfare labor is carried out after the victim requests the benefits from the Pharmaceuticals and Medical Devices Agency.
Judgment of whether or not payment is possible based on the results of deliberation by the Judgment Subcommittee of the Ministry of Labor, exemption from the system
It should be noted that there is something that becomes.

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Responsibilities of the 5th Research Director

4 Regarding the provisions of (3), as a concrete idea of ​compensation contents, there is already a track record in clinical trials.
"Subjects" released on November 25, 2009 by the Pharmaceutical Enterprise Legal Study Group (Medical Research Institute)
You may refer to "Guidelines for Health Damage Compensation".
5 Regarding the provisions of (3), be sure to take compensation measures in the event of health damage to the research subjects.
Is not limited to payment of money based on insurance. Frequent serious side effects
Not necessarily familiar with the concept of compensation insurance, such as drugs that are expected to occur, and setting up compensation insurance products
If uncertain, medical care will be provided, not limited to compensation insurance, depending on the characteristics of the drug used in the study.
It is considered that it can be substantially complemented by taking measures such as.
Regarding whether or not to provide financial compensation and the extent to which it is acceptable, the contents of the research plan
Depending on the type of drug / medical device involved in the research, the characteristics of the target disease, and the negative impact on the research subject.
The responsibility and expected risks and benefits should be evaluated and individually considered by the principal investigator.
However, after being examined by the Ethics Review Committee, the research subjects will be specifically documented in advance.
It is considered at least necessary to explain and obtain written consent.
6 ⑸ “Researchers and other related parties involved in conducting research” includes research at research institutes.
In addition to researchers, including staff engaged in technical assistance and clerical work, research-related work on consignment
Those who engage in part of the duties are also included.

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Responsibilities of the 5th Research Director

2 Management and supervision of research progress and understanding and reporting of adverse events, etc.
(1) The principal investigator collects necessary information related to the implementation of the research, and conducts the research appropriately.
And efforts must be made to ensure the reliability of research results.
(2) The principal investigator is the fact or information that impairs the ethical validity or scientific rationality of the research.
Information or information that may be damaged and may affect the continuation of research.
(Except for cases that fall under (3)), without delay, to the head of the research institution
Report and, if necessary, suspend or discontinue research, or do not change the research plan
Must be.
(3) The principal investigator is a fact that impairs the appropriateness of conducting the research or the credibility of the research results.
If you obtain information or information that may be damaged, promptly report it to the director of the research institution.
Research must be suspended or discontinued, or the research plan must be changed as necessary.
Not.
(4) The principal investigator predicts the benefits expected from the research in conducting the research.
If it is judged that the risk is high, or if the research has achieved sufficient results
If it is determined that sufficient results will not be obtained, the study must be discontinued.
Absent.
⑸ When the principal investigator becomes aware of the occurrence of a serious adverse event in conducting an invasive study
Must promptly take necessary measures.
(6) The principal investigator shall determine the progress of the research and the implementation of the research as stipulated in the research plan.
The occurrence of adverse events associated with this must be reported to the head of the research institution.
⑺ When the principal investigator completes the research (including the case of cancellation, the same shall apply hereinafter), the research director shall use the research machine.
You must report the necessary matters to the chief of the seki.
⑻ When conducting research jointly with other research institutes, the principal investigator is the research institute of the joint research institution.
Necessary information related to the research must be shared with the principal investigator.
1 The fifth and second provisions are judgments regarding the continuation or discontinuation of research during the research implementation period, and research.
It stipulates the responsibilities of the principal investigator, such as the obligation to report to the head of the institution.
2 Regarding the provisions of (1), the principal investigator shall be responsible for conducting the research until the research is completed.
Academic societies in Japan and overseas related to the research regarding information necessary for predicting and ensuring safety
Strive to grasp information such as presentations and treatise presentations (hereinafter referred to as "presentation information, etc.")
If the announced information, etc. falls under the provisions of (2), it may be reported to the head of the research institution.
is necessary.
When conducting research jointly with other research institutes, the research of the joint research institution shall be carried out in accordance with the provisions of ⑻.
It is necessary to share the grasped announcement information, etc. with the person in charge at any time.
3 ⑴ As a response to "strive to properly carry out research and ensure the reliability of research results," "research
In addition to "collecting necessary information on implementation", monitoring and necessity according to the content of the research
It is also possible to carry out audits as necessary and save samples and information.

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4 ⑵ "Facts or information that impair the ethical validity or scientific rationality of research, or impair
The same applies to the fourth 2 (2) for "information that may occur". The principal investigator obtains the information
If so, it is necessary to determine whether it will affect the continuation of the study. Research machine
"Without delay" in the report to the chief of Seki means without causing unreasonable delay.
This is the purpose, considering that it takes a certain amount of time to make a decision.
Wait for the head of the research institution that received the report to take measures under the provisions of 6th 3 (2).
Instead, the principal investigator needs to take the necessary measures voluntarily.
5 ⑶ "Facts or information that impairs the appropriateness of conducting research or the credibility of research results, or damages
“Information that may be lost” is the same as in the fourth 2 (3). For the information,
It is necessary to report to the head of the research institute.
Do not wait for the head of the research institution that received the report to take measures under the provisions of 6th 3 (4).
Therefore, the principal investigator needs to take the necessary measures voluntarily.
6 ⑷ “When it is judged that the expected risk is higher than the expected benefit from the study”
Regarding, until the research is completed, the principal investigator will be other researchers, etc. according to the provisions of the 4th 2 (2).
In addition to the facts and information reported by, and the serious adverse events reported under Article 18-1.
We scrutinized the necessary information related to the implementation of the research collected by ourselves in accordance with the provisions of (1), and conducted it before the start of the research.
It is necessary to continuously evaluate the burden on the research subjects and the expected risks and benefits.
There is.
7 ⑷ When it is judged that "sufficient results have been obtained", for example, in the middle of the research period
The target number of cases specified in the research plan has been reached, and the research purpose stated in the research plan has been achieved.
It means when it is achieved. "Sufficient results" do not necessarily support the hypothesis.
The case shall be included. That is, the principal investigator is responsible for continuing the research.
Whether or not the purpose of the above was achieved, or even if the research is continued, the purpose is clearly not achieved.
It is necessary to judge at any time about how.
8 ⑸ "Mandatory" in "When a serious adverse event occurs in the conduct of an invasive study"
For "necessary measures", see 18-2 and its explanation.
9 Regarding the provisions of ⑹, the report should be made in writing once a year in principle, but depending on the research content, examples
For example, once every three years, the period may be determined according to the nature of the research. However, on the spot
In that case, the frequency of reporting and the timing of reporting shall be determined in advance in the research plan.
It does not require regular reporting.
10 Regarding the matters to be reported to the director of the research institution in "When the research is completed" in ⑺, specifically
See 7th 4 (1) and its explanation.

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11 Regarding the provisions of ⑻, the necessary information related to the research is shared among the principal investigators of the joint research institute.
Necessity related to the research, such as setting up a secretariat for the research so that the existence will be smooth.
It is desirable to clarify the contact point for sharing information (including serious adverse events).
I. In addition, the principal investigator collaborates with the principal investigator of the joint research institution to ensure proper and smooth research.
A principal investigator (general manager) is appointed to supervise each joint research institution.
Is desirable. These will be described as the research implementation system in the research plan.
There is a need.

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3 Response to research subjects after conducting research
If the principal investigator conducts research that involves medical practice that goes beyond normal medical care, the research director concerned
Even after the study, the study subjects have the best prevention, diagnosis and cure obtained from the results of the study.
You must try to get medical treatment.
The principal investigator who conducted the research involving medical practice beyond the usual medical practice tells the research subject the research.
You will still receive the best possible prevention, diagnosis and treatment from the results.
I must try. In particular, the use of unapproved medicines / medical devices or approved medicines / medicines
After conducting research involving use beyond the scope of approval of medical devices (indication, dosage, dosage, etc.)
In deciding whether or not to receive the treatment, etc., it is possible to obtain from the results of conducting the research.
In addition to the findings, the research subjects, etc., including the financial burden required to continue the treatment, etc.
Need to be explained to.

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Obligation of the head of the 6th research institute

Obligation of the head of the 6th research institute
1 Comprehensive supervision of research
(1) The head of the research institution supervises the research that is permitted to be carried out so that it can be carried out properly.
And take ultimate responsibility.
(2) The head of the research institution tells the people involved in the research the life, health and human rights of the research subject.
It is necessary to make sure that the research is carried out with respect.
(3) The head of a research institution must not divulge any information that he / she has learned in the course of his / her work without a justifiable reason.
The same shall apply even after he / she is no longer engaged in the work.
(4) When the head of a research institution outsources a part of research-related work, the person who has been outsourced
Conclude a written contract regarding matters to be observed, and for those who have been entrusted
Must be supervised as necessary and appropriate.
1 The sixth provision is to supervise and supervise the research conducted at the research institution.
It stipulates the responsibilities of the head of a research institution in the field.
2 ⑴ “Ultimate responsibility” means that the research was not conducted properly at the research institution.
It means having the ultimate responsibility, including the appropriate response.
3 ⑵ "Persons involved in the implementation of research" are entrusted in addition to researchers, etc., as in the case of 5th 1 ⑸.
It also includes those who receive and engage in part of the research-related work.
4 ⑷ “Matters to be observed by the entrusted person”, for example, taken in the entrusted business
Safety management of samples and information handled (according to what is required of researchers, etc. in the 20th regulation)
In addition to the above measures, when handling personal information, etc., request researchers, etc. under the 15th provision.
Including measures according to what is done. ), Confidentiality of information obtained in the outsourced business, re-delegation
Restrictions on entrustment, attendance of education and training, etc. can be considered. Of the business entrusted when concluding a contract
Depending on the content, the required compliance items are set and the contract is ensured to be complied with.
Or it is necessary to proactively confirm from the research institution whether there are any matters that violate the contract.
Appropriate supervision is required.

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2 Establishment of systems and regulations for conducting research, etc.
(1) The head of a research institution must establish the necessary systems and regulations to carry out research properly.
It doesn't become.
(2) The head of the research institution causes health hazards to the research subjects in connection with the research conducted by the research institution.
If it does occur, ensure that compensation and other necessary measures are taken appropriately.
There must be.
(3) The head of the research institution ensures that information related to research, such as research results, is properly published.
There must be.
(4) The head of the research institution said that the research at the research institution conforms to this guideline.
If necessary, perform inspections and evaluations on your own, and take appropriate measures based on the results.
Must be.
(5) The head of the research institution is concerned with the ethics of research and the knowledge and skills necessary to carry out research.
Do not take measures to ensure that researchers at the research institution receive the education and training.
Must be. In addition, they must also receive these educations and trainings themselves.
(6) The head of the research institution shall be stipulated in this guideline in accordance with the regulations established by the research institution.
Authority or affairs may be delegated to an appropriate person within the research institution.
1 The sixth and second provisions are for the appropriate implementation of research conducted at the relevant research institution.
Responsibilities of the head of the research institution regarding the development of the system and the system for managing and supervising researchers, etc.
It is a fixed one.
2 ⑴ “Systems and regulations necessary to properly carry out research” are appropriate based on laws and guidelines.
It is a system of organization, personnel, etc. necessary for conducting research, and rules and procedure manuals related to various research.
Specifically, it includes the following. In addition, regarding the established rules and procedure manuals, the researchers, etc. to which they belong
It is also important to make it known to. In addition, the procedure manual is always suitable for research-related work.
A document that defines standard procedures that are just implemented.
(A) Research-related work Researchers, etc. are actually involved in serious adverse events pursuant to the provisions of 18-3 (1).
Formulation of a procedure manual regarding matters to be performed
(B) Take necessary measures to prevent information leakage regarding research subjects, etc.
Building an organization / system that can be done
(C) Establishment of a contact point for consultation, etc.
3 Regarding the provisions of ⑷, the inspection and evaluation performed by the head of the research institution, and the method and timing of its implementation
Will be determined by the head of the research institution according to the content of the research conducted by the research institution.
And. In addition, it is necessary for each research institution to prepare check sheets for inspections.
4 Regarding the provisions of ⑸, the person who has been entrusted with the authority and affairs of the director of the research institution is concerned with the authority and affairs.
It is necessary to receive the necessary education and training.

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5 Based on the provisions of ⑹, authority or office work (in the research plan) according to the regulations established by the research institution.
Outsourced part of the work to the ethics review committee, approval of research plans, and research implementation
Concluding a contract when doing so, responding to serious adverse events, safety management measures related to personal information held, etc.
Appropriate person (eg,) who has sufficient authority to supervise research activities within the institution.
It can be delegated to the dean, hospital director, facility director (health center director, research institute director, etc.).

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Obligation of the head of the 6th research institute

3 Research permission, etc.
(1) The head of the research institution is requested by the principal investigator for permission to carry out the research or change the research plan.
If so, ask the Ethics Review Board for an opinion, respect that opinion, and permit or disapprove the opinion.
Other necessary measures for research must be decided.
(2) The head of the research institution influences the continuation of research from the principal investigator and other researchers.
Ethical review as necessary when receiving reports of facts or information that may be considered
Ask the committee for their opinions, respect their opinions, and promptly conduct research as necessary.
Appropriate measures must be taken, such as stopping and investigating the cause.
(3) The head of the research institution must cooperate with the investigation conducted by the Ethics Review Committee.
(4) The head of the research institution is a fact that impairs the appropriateness of conducting research or the credibility of research results.
Needs promptly when receiving a report of information or information that may be damaged
Measures must be taken.
(5) When the head of the research institution receives a report from the principal investigator about the completion of the research, the research institute concerned
You must report on the necessary matters to the Ethics Review Board, which reviewed the research.
Absent.
1 The sixth and third provisions apply to the procedure from the start to the end of research conducted at the research institution.
It stipulates the responsibilities of the head of the related research institute.
2 Regarding the provisions of (1), if the head of a research institution conducts research jointly with another research institution,
A joint research institute when submitting a proposal to the Ethics Review Committee regarding the appropriateness of conducting or continuing the research.
Information on the status of approval of research plans and the status of receipt of informed consent in Japan
It is also desirable to provide.
3 ⑵ "Facts or information that may affect the continuation of research" is the 5th 2 ⑵ or ⑶
Reported by the principal investigator according to the provisions of 4-2 (3), directly from the researchers, etc.
In addition to what is reported, when a report is received from a whistleblower who does not belong to the research institution.
included. Specifically, for example, the director of the research institution permits it, taking into account the characteristics of the research.
If the deviation from the research plan is serious, or if the information or data is forged or falsified, it is permitted.
In that case, the burden on the research subjects and the expected risks due to the occurrence of serious adverse events, etc.
If the overall evaluation of profits can change, informed consent procedures, etc. will be carried out appropriately.
If not, it is possible that personal information has been leaked.
4 ⑶ “Investigation conducted by the Ethics Review Committee” refers to the investigation under the provisions of 11-1 ⑵ or ⑶.
5 In ⑷ "Necessary measures", the facts of the received report are confirmed, and the confirmed facts and information
To suspend or discontinue research as necessary based on the above, and to respond to the research subjects, etc.
In addition, the researchers who made the initial report and the whistleblowers should not suffer any disadvantages.
It also includes taking necessary and appropriate measures.

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6 Regarding the way of thinking in the provisions of ⑷, "Regarding the response to fraudulent activities in research activities, etc."
"Guidelines" (decided by the Minister of Education, Culture, Sports, Science and Technology on August 26, 2014) and "Research activities in the field of welfare and labor"
"Guidelines for dealing with fraudulent activities in Japan" (January 16, 2015, Ministry of Health, Labor and Welfare)
See also (Determined by Chief of Health Science Division, Secretariat).

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4 Report to the Minister, etc.
(1) The head of the research institution should discuss the research conducted by the research institution or conducted in the past.
If you find that you do not comply with this guideline, promptly give the opinion of the Ethics Review Board.
Listen and take necessary measures, and if the degree of nonconformity is serious, the state of the measures
The situation and results are described by the Minister of Health, Labor and Welfare (Minister of Health, Labor and Welfare and Minister of Education, Culture, Sports, Science and Technology at universities, etc.)
Is called "Minister". ) Must be reported and published.
(2) The head of the research institution said that the research at the research institution conforms to this guideline.
And cooperate with the investigation conducted by the Minister or a person entrusted by him (hereinafter referred to as "Minister, etc.")
Must.
(3) The head of the research institution is a research that involves invasion (excluding minor invasion) and intervenes.
When an unpredictable serious adverse event occurs in the implementation of
If a direct causal relationship cannot be denied, promptly report the status and results of the response in 3 (2) to the Ministry of Health, Labor and Welfare.
It must be reported to the Minister and made public.

1 The 6th and 4th provisions conform to this guideline in the research conducted at the research institution.
If something serious happens, or if an unpredictable serious adverse event occurs
It stipulates the responsibilities and measures as the head of a research institution in Japan.
2 Regarding the provisions of (1), is the content of the research covered by this guideline extremely diverse?
The Ethics Review Committee will determine whether or not the degree of nonconformity is serious for each study.
To the extent that the ethical validity and scientific rationality of the study are impaired.
It is necessary to judge from the viewpoint of whether it deviates from the guideline of.
However, in the cases illustrated below, the degree of nonconformity is significant regardless of the content of the research.
It is considered that this is the case, and it is necessary to report to the Minister and make it public.
・ When the research is conducted without the examination of the Ethics Review Committee or the permission of the director of the research institution.
・ When conducting research without performing the necessary informed consent procedures
・ When it is discovered that the research results have been forged or falsified, which impairs the reliability of the research content.
3 ⑴ “Universities, etc.” means research institutes under the jurisdiction of the Ministry of Education, Culture, Sports, Science and Technology.
4 Regarding the provisions of (1), in the case of research conducted in collaboration with other research institutes,
When a principal investigator (general manager) who supervises each participating joint research institution is appointed, this is the case.
The head of the research institution to which the principal investigator (general manager) belongs takes the report contents of each joint research institution.
You may report to the Minister in a lump sum. When the principal investigator (general manager) has not been appointed,
Of the collaborative research institutes participating in the research, the heads of those involved in the serious nonconformity are
Need to report to the Minister.
5 Regarding the content of "reporting to the Minister" pursuant to the provisions of (1), it is necessary to listen to the opinions of the Ethics Review Committee.

After that, the report will include the response status and results. Therefore, report each case

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The timing is different, but it is necessary to respond "promptly". Also, "It does not conform to this guideline.
"If you know that," this guideline is retroactive to the studies conducted before the enforcement of this guideline.
Although the guidelines are not applied, they are included in the "Ethical Guidelines for Clinical Research" revised in 2008.
However, there is the same provision, and in clinical research conducted in accordance with this clinical research ethics guideline,
It may be subject to reporting to the Minister of Health, Labor and Welfare in accordance with the provisions of the clinical research ethics guidelines.
6 The method of publication pursuant to the provisions of (1) should be considered according to the content of the publication.
For example, holding a press conference with the news media or posting it on the website of the research executing agency.
Etc. are conceivable.
7 ⑵ “Survey” is conducted by the Japan Agency for Medical Research and Development every year, for example.
The "ethical guideline conformity survey" that is being conducted is conceivable. For the survey contents and results, please see the following
See.
http://www.amed.go.jp/program/list/05/02/056.html
8 Regarding the method of publication pursuant to the provisions of (3), for example, the research executing agency has launched it.
It is conceivable to post it on the homepage.
9 For research conducted overseas, if conducted in accordance with this guideline based on the third 2 (1)
In that case, it may be subject to reporting based on the provisions of (1) and (3).

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7th Research Plan Procedure

Chapter 3 Research Plan
7th Research Plan Procedure
1 Creation / change of research plan
(1) The principal investigator carries out the research (including the case where the research plan is changed and carried out. The same shall apply hereinafter).
When trying, prepare a research plan in advance and do not obtain permission from the director of the research institution.
Must be.
(2) If the principal investigator intends to carry out research in collaboration with other research institutes, each joint
A research plan must be prepared after clarifying the roles and responsibilities of the principal investigator of the research institution.
Must be.
(3) The principal investigator is one of the tasks related to research at the research institution to which the principal investigator belongs.
If you intend to outsource the department, determine the content of the outsourced work and then write a research plan.
Must be created.
1 The 7th 1 provision stipulates the procedure for the principal investigator to create or change the research plan.
It is. The principal investigator should ensure the ethical validity and scientific rationality of the research.
It is necessary to prepare or change the research plan and obtain the permission of the director of the research institution. Researchers, etc.
Research is conducted based on the research plan with the permission of the director of the research institution (including permission to change. The same shall apply hereinafter).
Need to be done.
2 Regarding “Role and responsibility of the research director of each joint research institution” in ⑵, the implementation system of 8 ⑴②
Must be described as. Regarding "clarification of roles and responsibilities", each joint research institution
If a principal investigator (general manager) is appointed from among the principal investigators, it is necessary to state that fact.
There is.
3 Regarding the provisions of (3), the principal investigator shall determine the content of the outsourced work and the supervision method of the outsourcee before conducting research.
It is necessary to prepare or change the research plan. In this case, the content and consignment of the 8th ⑴㉓ consignment work
It is necessary to describe it as the above supervision method. The consignment contract is approved by the director of the research institution.
It is necessary to conclude based on the contents of the research plan.

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2 Submission to the Ethics Review Committee
(1) The head of the research institution requests permission from the principal investigator to carry out research at the research institution.
If so, please listen to the opinion of the Ethics Review Committee regarding the suitability of conducting the study.
Must be. However, the head of the research institution will prevent the occurrence or spread of public health hazards.
Therefore, if it is determined that the research needs to be conducted urgently, the opinion of the Ethics Review Committee should be taken into consideration.
You can decide the permission before listening. In this case, the head of the research institution shall, after permission
The ethics review committee shall listen to the opinions of the ethics review committee without delay, and the ethics review committee suspends research.
When he / she gives an opinion that the research plan should be canceled or changed, he / she respects the opinion.
It is important to ask the principal investigator to suspend or discontinue the research, or change the research plan.
Appropriate measures such as renewal must be taken.
(2) The head of the research institution is the ethics review committee for research conducted in collaboration with other research institutes.
When listening to opinions, permission to conduct research at joint research institutes, other ethics review committees
Information necessary for the examination, such as the examination results and the status of the progress of the research
Must also be provided to the Ethics Review Board.
(3) The head of the research institution should discuss the research plan for research conducted in collaboration with other research institutes.
Therefore, it is possible to request a collective examination by one ethics examination committee.
1 The 7th and 2nd provisions are procedures for the head of a research institution to judge the suitability of conducting research.
It stipulates that it is necessary to hear the opinions of the Ethics Review Committee.
2 ⑴ “Urgent research is needed to prevent the occurrence or spread of public health hazards.
If it is determined that there is an imminent occurrence or spread of public health hazards, the Ethics Review Board
It is intended for a situation where it is difficult to hear opinions. Listen to the opinions of the Ethics Review Board
The procedure for informed consent is the first, even if the study was previously approved.
It is necessary to carry out based on the provisions of 6 of 12.
3 Regarding the provisions of (2), the head of the research institution obtains the information necessary for the examination by the Ethics Examination Committee.
It needs to be provided to the Ethics Review Board. "Information required for examination" is to the joint research institute
The status of the permit (including the conditions attached to the permit) and other ethical trials that have already been conducted.
As a result of the examination by the inspection committee, the progress of research already being carried out at the joint research institute
Information such as is conceivable. Regarding the scope and degree of "information required for examination", please refer to the individual research.
It is necessary for each research institution to make a judgment according to the content. In addition, we will carry out a batch examination
If so, the research implementation system at the research institution will also be examined in accordance with 11-4 (1).
Therefore, it is necessary to provide information on the system.
4 The provisions of (3) are based on the examination of the entire research before the head of each joint research institution permits the research to be conducted.
It is intended to be applied when requesting an inspection. For this reason, the laboratory has already started.
If you want to participate in the research as a joint research institute later, you need to hear the opinion of the Ethics Review Committee separately.
There is. Research institutes seeking a lump sum review will coordinate with related research institutes in advance.

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After that, the head of each research institution requests the establishment of one ethics review committee for review, etc.
Procedures are required. In addition, regarding the specific procedure of the collective examination, each research institution is placed.
It is necessary for the research institution to make a judgment according to the situation. Ethics trial together with joint research institute
It may be examined by the ethics examination committee of each research institution without being examined by the examination committee.

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3 Permission from the head of the research institution
The head of the research institution respects the opinion of the Ethics Review Board and permits or disapproves the conduct of the research.
Necessary measures must be determined for other studies. In this case, of the research institution
When the Chief said that the Ethics Review Board was inappropriate for conducting the study,
Do not allow the study to be conducted.
The seventh and third provisions are for the head of a research institution to decide on necessary measures such as permission to carry out research.
It stipulates that the opinions of the Ethics Review Board must be respected. "About other research
"Necessary measures" means instructions such as conditions for conducting research, changes in research plans, and research.
Refers to the cancellation of.

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4 Response after the end of research
(1) When the principal investigator completes the research, he / she will delay the fact and the summary of the research results in writing.
You must report to the head of the research institute without delay.
(2) When the head of the research institution receives a report from the principal investigator under the provisions of (1), he / she will be involved in the research.
Document the end of the research and the summary of the research results to the Ethics Review Committee, which conducted the review.
Must be reported.
The seventh and fourth provisions stipulate the procedure when the research is completed. "The research is over
"Tatoki" means when the research period stated in the research plan has expired, the research is stopped, and the research is resumed.
It is also included when there is no prospect of opening. ⑴ Report should be made within 3 months after the end of the research.

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Items to be stated in the 8th research plan

Items to be stated in the 8th research plan
(1) In principle, the matters to be stated in the research plan (excluding the case of (2)) are as follows.
To However, regarding matters approved by the director of the research institution in response to the opinion of the Ethics Review Committee,
This is not the case.
① Name of research
(2) Research implementation system (including the name of the research institution and the name of the researcher, etc.)
③ Purpose and significance of research
④ Research method and period
⑤ Policy for selecting research subjects
⑥ Basis for scientific rationality of research
⑦ Procedures for receiving informed consent, etc. pursuant to the 12th provision (informed consent)
When receiving an outlet, it includes matters related to explanation and consent under the same provisions. )
⑧ Handling of personal information (method of anonymization, anonymous processing information or non-identification processing)
When creating information, include that fact. )
⑨ Burden on research subjects and expected risks and benefits, as well as comprehensive evaluation of these
Measures to minimize the burden and risk
⑩ Method of storing and disposing of samples and information (including materials related to information used in research)
⑪ Contents and method of reporting to the director of the research institution
⑫ Research institutes such as research funding sources, conflicts of interest related to research by research institutes, personal profits, etc.
Situation regarding conflicts of interest related to research
⑬ How to disclose information about research
⑭ Response to consultations, etc. from research subjects and related parties
⑮ When receiving informed consent from a substitute, etc., the provisions of 13th shall apply.
Procedures (Regarding the selection policy, explanation and consent of substitutes, etc. pursuant to the provisions of 12th and 13th)
Including matters. )
⑯ When obtaining informed ascent, the procedure according to the 13th provision (related to explanation)
Including matters. )
⑰ If you intend to carry out research under the 12-6 provisions, the requirements listed in the same provisions
How to determine that everything is met
⑱ If there is an economic burden or reward for the research subject, etc., that fact and its contents
⑲ In the case of research involving invasion (excluding minor invasion), when a serious adverse event occurs
Correspondence
⑳ In the case of invasive research, whether or not there is compensation for health damage caused by the research
And its contents
㉑ In the case of research involving medical practice that exceeds normal medical care, after conducting the research to the research subjects
Correspondence about provision of medical care in
㉒ With the implementation of the research, it is related to the health of the research subjects, genetic characteristics that can be inherited by offspring, etc.
If there is a possibility that important findings can be obtained, the research results (accidental) related to the research subject
Including findings. ) Handling

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㉓ When outsourcing a part of research-related work, the content of the work and the supervision method of the outsourcee
㉔ When obtaining consent from the research subject, etc. regarding the samples and information obtained from the research subject, etc.
Possibility to be used for future research not specified in terms of points or provided to other research institutes
If there is a possibility of doing so, what is expected at the time of receiving consent to that effect
㉕ When conducting monitoring and auditing pursuant to the 21st provision, the implementation system and
Implementation procedure
1 The provisions of item 8 (1) stipulate the items to be stated in the research plan (excluding the work specified in (2)).
is there. In the research plan, all items from ① to ㉕ (only when applicable from ⑮ to ㉕)
In principle, However, depending on the content of the research, etc., it is not always necessary to describe it.
Some items may not be needed. Whether or not to omit a specific item is primarily decided by the principal investigator.
After refusing, showing the reason, and examining it by the Ethics Review Committee, we received the opinion that it was appropriate, and the research machine
It is necessary to obtain the permission of the chief of Seki. In this case, the ethics review committee will discuss the items that are omitted.
It is necessary to state the fact that the description is omitted in the relevant item of the meeting record or research plan and the reason for it.
desirable.
In addition to the matters listed in (1), matters deemed necessary depending on the content of the research, etc.
Therefore, the items to be described may be added as appropriate at the discretion of each research institution.
Documents required for conducting research (for example, where approved drugs / medical devices are used)
In the case of receiving informed consent by the package insert or document of the item concerned
(Books, etc.) will be included in the research plan by associating them with each item.
Need to be.
2 In the "research implementation system" of ②, the responsibility for setting up a secretariat and managing personal information, etc.
If there is a person in charge, that system is also included. When conducting research in collaboration with other research institutes,
To that effect, the names of all joint research institutes, the names of researchers, etc., and the research responsibilities of each joint research institution.
It is necessary to clearly state the role and responsibility of the person in charge (see 7th 1 (2)). Of each joint research institute
If a principal investigator (general manager) is assigned to supervise the creation and modification of the research plan, the name of the principal investigator
Roles and responsibilities need to be stated.
In addition, existing samples and information other than joint research institutes will be clarified so that the entire research implementation system will be clarified.
Even if the existing sample / information is provided by a person who only provides the information, that person belongs to the person.
Clearly state the name of the institution and the name of the person. Joint research institute and existing trial
If there are a large number of people who only provide fees and information, they may be arranged as an attachment to the research plan.
In principle, if you want to add a person who only provides existing samples and information after starting the research,
Therefore, it is necessary to carry out the procedure for changing the research plan in accordance with the seventh provision. However, the research plan
It is difficult to identify in advance who will only provide existing samples and information at the time of writing the document.
However, research that is expected to provide an extremely large number of providers (for example, the registry)
-For (research applicable), existing samples and information will be provided by persons with any attributes.
The research plan describes as specifically as possible whether or not this is expected, and all of them are described.
After hearing the opinion of the Ethics Review Committee about not listing and listing individually,

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Only with the permission of the chief, in addition to the periodic report stipulated in 5-2 ⑹, the period until the periodic report
The name of the institution to which the person who only provides the existing samples and information provided in the meantime belongs and the person's
How to write your name in the research plan and report the contents to the director of the research institution.
It is also acceptable (in this case, it is not always necessary to submit to the Ethics Review Board).
3 ④ "Research method" includes the design of the research, the number of planned research subjects, and the basis for setting it (statistics).
This includes the case where the number of research subjects is set regardless of scientific grounds. ), Statistical analysis method, evaluation section
Includes eyes and methods. In the case of research using unapproved drugs / medical devices, the relevant doctor
The outline of drugs and medical devices (so-called "outline of test drug", "outline of test equipment") is the approved drug.
In the case of research using medical devices, the package insert information of the drug / medical device is included. Use
If the purpose includes providing samples / information to other institutions, it is necessary to state that fact.
There is. For example, provide the samples and information used in the research to institutions that collect and sell the samples and information.
When registering data in a database, etc. for use in other research, etc.
It is conceivable to state that.
In addition, genome day corresponding to the personal identification code by genome analysis of the sample used for research etc.
When acquiring data, it is necessary to state that fact as well.
"Research period" refers to the period from the start of research to the completion of research, so the beginning and end of the research are clarified.
Need to be shown in.
4 Regarding the provisions of ⑦, when receiving informed consent, the provisions of the twelfth shall be followed.
It is necessary to include matters related to the explanation and consent. Informed consent
If you do not receive it, notify or disclose the reason and the research subject, etc. about the reason and the implementation of the research.
It is necessary to describe the matters to be done and the method (such as a sample of the document to be notified or published).
In addition, when receiving informed consent by document, the relevant document (12-3)
Informed consent (form of document and consent form) that describes the matters explained in accordance with the provisions of
If you do not receive the report, attach a sample of the document to be notified or published to the research plan, and the ethics trial
It is necessary to provide it for examination by the inspection committee.
5 Regarding the provisions of ⑦, joint research institutes and persons who only provide existing samples / information and samples / information
If you plan to give or receive the information, please refer to "Provision of samples and information" specified in Section 12-1.
How to create a "record to be created" (time to create, medium of recording, name of researcher to create, etc., separately
Whether or not there is a substitute for the documents to be created, etc.) and storage method (location, 12th 1 ⑴ Explanation 5)
It is necessary to include the description including whether or not the institution of the provider to be determined acts on behalf of the obligation (sample, etc.)
If there is a large amount of information exchanged, it may be arranged as an attachment). In this case, arrange as shown in the table below.
You may reasonably describe it. In addition, the source organization specified in 12th 1 (1) and (4) is the sample / information.
How to confirm the contents of informed consent taken by the provider's institution when receiving
It is desirable to also describe.
In addition, the necessary items related to "Records regarding provision of samples and information" are described in the research plan.
If so, keep some of the obligations regarding the record by keeping the research plan itself.

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Can be met. In this case, every exchange of samples and information carried out in the research plan
It is not necessary to specify the institution of the provider and the institution of the provider and describe it in the research plan, and a series of trials
Describe the details of the transfer of fees and information to the extent necessary so that they can be tracked after the fact.
Just do it. For details, refer to the explanation in 1 (1) of the twelfth.
<List of obligations to create and store records related to the provision of samples and information>
The retention period of records is 3 years after provision at the provider and 5 years after the completion of research is reported at the provider.
Recorded items

provider

Providing destination

Recorded item A (must be stated)
○ Name of the research institution to which it is provided

3 years

3 years
○ Name of the principal investigator of the research institution to which
the research is provided
○ Name of the provider's institution, etc.

5 years

○ Name of the principal investigator of the provider's institution, etc.

5 years

○ Sample / information items

5 years

3 years

○ Background of acquisition of samples and information

5 years

Record item B (stated when consent is obtained)
○ Names of research subjects, etc.

3 years

5 years (* 1)

○ That the consent of the research subjects has been obtained

3 years

5 years (* 1)

(Recorded matter C (matter that should be recorded)) (* 2)
desirable

・ Address of the provider's institution

(5 years)
desirable

・ Name of the head of the institution of the provider

(5 years)

(* 1) Not applicable for samples / information that cannot identify a specific individual at the destination.
Need
(* 2) It may be necessary to record. For details, refer to the explanation of 12th 1 (1).

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<Example of organizing methods for creating and storing records related to the provision of samples and information to be described in the research plan>
Recorded items

provider

Providing destination

Recorded item A (must be stated)
○ Name of the research institution to which it is provided

→ At the destination
Research Plan
Acting

5 years

→ At the destination
Research Plan
○ Name of the principal investigator of the research institution to which the research is provided
Acting
5 years
Research Plan

○ Name of the provider's institution, etc.

5 years

○ Name of the principal investigator of the provider's institution, etc.

Research Plan
5 years

→ At the destination
Research Plan

○ Sample / information items

Acting

○ Background of acquisition of samples and information

5 years
Research Plan
5 years

Record item B (stated when consent is obtained)

○ Names of research subjects, etc.

A specific individual
To identify
Consent document
I can't
3 years
Provided
Receive

○ That the consent of the research subjects has been obtained

A specific individual
To identify
Consent document
I can't
3 years
Provided
Receive

(Recorded matter C (Matters that should be recorded))
・ Address of the provider's institution

Do not record

・ Name of the head of the institution of the provider

Do not record

6 Regarding the provisions of ⑦, when there is a plan to provide samples and information to persons overseas (by consignment)
Including the case of providing. ), It was necessary to carry out the procedure in accordance with the provisions of 12-9.
Therefore, the content of the procedure (a system that conforms to the standards stipulated in the Personal Information Protection Law Enforcement Regulations is secured.
How to create a record regarding the provision of samples and information (including that fact if it is confirmed that the information is provided)
It is necessary to include the law.
7 Regarding the provisions of ⑧, when anonymizing, the timing and method (whether or not to create a correspondence table, etc.)
It is necessary to describe including. In addition, regarding safety management measures for personal information, etc. pursuant to the 15th provision.
If so, it is necessary to include specific measures according to the nature of the personal information handled. Concealment
When and how to create name processing information or non-identification processing information (17th rule)

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It is necessary to include regular safety management measures, publication, grievance handling and other necessary measures).
is there.
In the case of joint research, items such as personal information to be shared (information such as name, age, gender, medical history, etc.)
Information on safety management measures at joint research institutes and transfer of personal information between institutions
It is necessary to describe the points to be noted in the delivery of.
8 “Risk” in ⑨ is as explained in 1 ③, but it can occur in connection with the implementation of research.
Adverse events (eg, adverse effects due to side effects of the drug in the case of a drug administration study)
Elephants, etc.) are also included. In addition, when blood is collected in a study of children, etc.
Even if it is a minor invasion for adults, it should be taken care of for children with sufficient advance response and implementation.
It is conceivable to describe consideration such as ingenuity to distract.

9 ⑩ “Materials related to information used in research” refers to research such as data correction history and experiment notebooks.
When providing samples and information to other research institutes in addition to the materials that support the information used in
And when provided, it refers to the record regarding the provision of samples and information used in the research. "Storage
In "Method", it is necessary to include the storage period from the viewpoint of traceability of samples and information.
There is a need.
10 It is desirable that the “report” in ⑪ be done in writing, but the specific content and method of the report (of the report)
Including frequency. ) Depends on the research content, so each research institution will make a decision.
There is a need.
11 Regarding the “source of research funding” in ⑫, clarify the forms of self-procurement, donations, contracts, etc.
It is necessary to describe how the funds were procured and the relationship with the funding source.
To For example, regarding the source of funding for research, related companies such as pharmaceuticals and medical devices used in research
If funds or materials are provided by, it is necessary to state that fact. For example
Funds related to the research (scholarship donations, research grants) from persons / organizations that have provided funds or requested research
Etc. are included. ), Provision of materials and labor, lecture fee, manuscript fee, implementation fee, etc.
And that stock (including private equity and stock options) should be stated.
It can be considered as the content. In addition, researchers, etc. have provided funds or requested research with persons / organizations.
Researchers, etc., who have employment relationships including part-time advisors, etc., and personal relationships such as relatives, etc.
It is considered that the contents should be described, such as problems related to the relationship with related organizations. these
Regarding the extent to which the matter should be described, the relevant research institution or researcher was placed.
Since various cases can be considered depending on the position, etc., each research institution manages conflicts of interest.
It is necessary to make an appropriate decision while taking into account the regulations, etc. In addition, to each research institution
Therefore, determine the criteria for requesting that the status of conflicts of interest be included in the research plan.
It is desirable to do so. If you are uncertain about your decision, it is recommended to hear the opinion of the Ethics Review Committee.
Is done.
Regarding the concept of conflicts of interest, for example, the following guidelines and guidelines can be used as a reference.

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it is conceivable that.
・ "Conflict of Interest Working Group Report" (November 1, 2002, Science and Technology, Ministry of Education, Culture, Sports, Science and Technology)
Academic Council, Technology and Research Infrastructure Subcommittee, Industry-Academia-Government Collaboration Promotion Committee, Conflict of Interest Working Group
loop)
・ "Guidelines for formulating conflict of interest policies for clinical research" (March 2006, Ministry of Education, Culture, Sports, Science and Technology)
Commissioned project Tokushima University Study group on ethics and conflicts of interest in clinical research)
・ "Management of Conflict of Interest (COI) in Health, Labor and Welfare Science Research"
Guidelines ”(March 31, 2008, No. 0331001, Health Sciences Section Chief, Decided by Nikka)
12 ⑬ “Disclosure of information on research” includes registration / publication pursuant to the 9th provision.
It is necessary to describe the method of.
13 Regarding ⑭ “Response to consultations, etc.”, for example, clarifying the process for dealing with consultations, etc., consultations, etc.
It is conceivable to set up a window and post the FAQ on the homepage.
14 ⑯ “Matters related to explanation” refers to the matters to be explained and the method of explanation to the research subjects.
15 Regarding the provisions of ⑲, in the case of other studies, the response when a serious adverse event occurs is uniform.
It is not necessary to describe it in the research plan, but it is serious in conducting research with minor invasion.
In the event of an adverse event, take necessary measures in accordance with the procedure manual pursuant to the provisions of 18-3 (1).
Need to cheat. To "respond to serious adverse events" under the 18th provision, to the head of the research institution
Since the report is included, it is necessary to describe the range of adverse events to be reported, the method of reporting, etc.
There is a need.
16 ⑳ “Content” is not necessarily limited to payment of money, but a doctor for health hazards
It also includes the provision of medical treatment.
Regarding the provisions of 17 ㉑, in 5th-3, research involving medical practice beyond normal medical care was conducted.
The best medical care (prevention, diagnosis and treatment) obtained from the results of the study
We ask the principal investigator to make an effort to receive the benefits. In addition, "To research subjects
"After conducting the research" does not mean when the research period stated in the research plan has expired, but for each individual.
Refers to after completing medical treatment that exceeds normal medical care for the research subject.
Regarding the provisions of 18 ㉒, with the implementation of the research, the health of the research subjects and the inheritance that can be inherited by offspring
If there is a possibility that important knowledge about the characteristics of the research subject can be obtained, the research conclusion of the research subject
It is necessary to describe the handling of fruits (including accidental findings). Inspected by research subjects for research purposes
Handling of research results related to the research subject, including the test results when
Includes whether or not to disclose to elephants. ) Must be defined in the research plan in advance. "Even
"Extraordinary findings" are accidentally found in the course of research and may have a significant life-threatening effect.

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Information (for example, morbidity with cancer or genetic disease). "Handling of research results" means research
It refers to the policy of disclosure of research results, the method of disclosure, etc.
Regarding the "supervision method of the contractor" of 19 ㉓, for example, the forecast specified by the consignor in the consignment contract.
How to show the contents of certain safety management measures and confirm that the contents are complied with
(Regular field surveys, etc.), describe what to do if the content is not observed, etc.
Can be considered. Describe in the same way when outsourcing to a person overseas.
Regarding the "expected content" of 20 ㉔, the general purpose of research that may be used in the future
And the content, the purpose of providing to other research institutes, and the names of research institutes that may provide
Conceivable.
Regarding the "implementation system" of 21 ㉕, the name of the person engaged in monitoring / audit and the research machine concerned
It is necessary to describe the relationship with Seki. Monitoring and auditing of "implementation procedure"
It is necessary to describe the method of reporting the results of.

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(2) Obtain samples / information from the research subject, or receive and store it from another institution, and repeat the process.
When carrying out operations that are subsequently provided to other research institutes (hereinafter referred to as "collection / sales")
As a general rule, the matters to be stated in the research plan of are as follows. However, ethical review
This does not apply to matters approved by the director of the research institution in response to the opinion of the committee.
(1) Implementation system for collecting and selling samples and information (name of the institution that collects and sells samples and information)
And include the names of researchers, etc. )
(2) Purpose and significance of collecting / selling samples / information
③ Method and period for collecting and selling samples and information
④ Types of samples and information to be collected and sold
⑤ Procedures for receiving informed consent, etc. pursuant to the 12th provision (informed consent)
When receiving an outlet, it includes matters related to explanation and consent under the same provisions. )
⑥ Handling of personal information (method of anonymization, anonymous processing information or non-identification processing)
When creating information, include that fact. )
(7) Burden on research subjects and expected risks and benefits, as well as comprehensive evaluation of these
Measures to minimize the burden and risk
⑧ Storage of samples / information and quality control method
⑨ Handling of samples and information after collection and sales
⑩ Collection of samples / information / collection of institutions that collect / sell samples / information, such as funding sources for sales / sales
Conflicts of interest related to sales and personal profits, etc.
Situation
⑪ Response to consultations, etc. from research subjects and related parties
⑫ If there is an economic burden or reward for the research subject, etc., that fact and its contents
⑬ Regarding the health of the research subjects, genetic characteristics that can be inherited by offspring, etc. with the implementation of the research
If there is a possibility that important findings can be obtained, the research results (accidental) related to the research subject
Including findings. ) Handling
⑭ When obtaining consent from the research subject, etc. regarding the samples and information obtained from the research subject, etc.
If there is a possibility of providing it to other research institutes for future research that is not specified in terms of points
What is expected at the time of receiving consent to that effect
1 The provisions of item 8 (2) are research plans for conducting work that is repeatedly provided to other research institutes.
(Excluding the business specified in (1)) It defines the items to be described, so-called banks and archives.
This is the case. "Obtain samples / information from research subjects or receive provision from other institutions
In the case of carrying out the work of storing it and repeatedly providing it to other research institutes ", the second ⑾
Collects and sells samples and information as an "institution that collects and sells samples and information" specified in
Refers to the case. As a general rule, the research plan should include all items from ① to ⑭.
To However, depending on the content of the research, there may be some items that do not necessarily need to be described. specific
Whether or not to omit the matter is primarily decided by the principal investigator, and the reason is indicated for ethical examination.
After examination by the committee, permission from the director of the research institution was obtained after receiving the opinion of the ethics examination committee that it was appropriate.
Need to get. In this case, the records and research of the Ethics Review Committee regarding the items to be omitted.

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Items to be stated in the 8th research plan

It is desirable to state that the description is omitted in the relevant item of the plan and the reason.
In addition to the matters listed in (2), matters deemed necessary depending on the content of the research, etc.
Items may be added as appropriate at the discretion of each research institution.
Documents required for conducting research should be associated with each item.
Therefore, it is necessary to include it in the research plan.
2 For the provisions of ①, refer to the explanation of 8 ⑴ ②. In addition, the "researchers, etc." in (1) include samples and information.
Includes those involved in the collection and sale of information.
3 Regarding the provisions of ③, if the period is not set, it is necessary to state that fact.
4 For the provisions of ⑤, refer to the explanation of 8 ⑴ ⑦.
5 For the provisions of ⑥, refer to the explanation of 8 ⑴ ⑧.
6 For the provisions of ⑦, refer to the explanation of 8 ⑴ ⑨.
7 For the provisions of ⑧, refer to the explanation of 8th ⑴⑩.
8 ⑨ “After collection / sale” means “period of collection / sale of samples / information” according to the provisions of ③.
It means when it expires. The 20th provision regarding the sample / information even after the collection / sale is completed.
It is necessary to store properly according to the above.
9 For the provisions of ⑩, refer to the explanation of 8 ⑴ ⑫.
For the provisions of 10 ⑪, refer to the explanation of 8 ⑴ ⑭.
11 For the provisions of ⑬, refer to the explanation of 8 ⑴㉒.
12 For the provisions of ⑭, refer to the explanation of 8 ⑴㉔.

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Registration / publication of 9th research

Registration / publication of 9th research
1 Outline of research and registration of results
The principal investigator is the National University Hospital Directors' Meeting, General Incorporated Foundation Japan, regarding the research to be intervened.
In the public database established by the Pharmaceutical Information Center or the Japan Medical Association,
Register the outline of the research prior to its implementation, and respond to changes in the research plan and progress of the research.
When the research is completed, the research will be concluded without delay.
The fruit must be registered. However, the human rights of the research subjects and their related parties or researchers
Etc., as content that needs to be kept private in order to protect the rights and interests of the parties concerned, ethics
This does not apply to those approved by the director of the research institution in response to the opinion of the review committee.
1 The 9th 1st provision stipulates the outline of the research and the registration of the results. Intervene
Regarding research, it is convenient for researchers, etc., despite intervening for research.
In order to prevent only good research results from being published, it is necessary to register the research outline in advance.
In addition, it is necessary to register the progress status from the viewpoint of ensuring transparency in the research process.
2 The contents to be registered as the outline of the research are the name, purpose, method, implementation system, and research subject of the research.
Selection policy etc. can be considered. If multiple research institutes carry out research jointly, a research plan
The general manager, etc. may register centrally according to the roles specified in. In that case, participate in the research
It should be noted that it is necessary to register information on all the collaborative research institutes to be added.
Registration is for the research period stated in the research plan that has been approved by the director of the research institution.
You need to do it before you start. "Without delay" means without causing unreasonable stagnation
That is the purpose.
3 "Not limited to this" means to keep it private from the viewpoint of protection of personal information and intellectual property.
Regarding some of the contents approved by the director of the research institution in response to the opinion of the Ethics Review Committee as appropriate
The purpose is that registration is not required. Therefore, except for the relevant content, the outline of the research is registered.
It is necessary to record / update and register research results.
4 From the viewpoint of enabling batch search of information, etc., National University Hospital Directors' Meeting, General Incorporated Foundation Japan
A public database set up by the Pharmaceutical Information Center or the Japan Medical Association.
Register in the wrong place. These databases can be found on the homepage of the National Institute of Public Health.
Centralized search is possible. Whether to register in an overseas public database
May be judged by each research institution.
○ University Hospital Medical Information Network Research Center Clinical Trial Registration System (UMIN-CTR)
http://www.umin.ac.jp/ctr/index-j.htm
○ Japan Pharmaceutical Information Center iyaku Search (pharmaceutical database)
http://database.japic.or.jp/is/top/index.jsp
○ Japan Medical Association Center for Clinical Trials Clinical Trial Registration System (JMA CCT)
https://dbcentre3.jmacct.med.or.jp/jmactr/

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Registration / publication of 9th research

○ Homepage of National Institute of Public Health
http://www.niph.go.jp/entrance/index1.html

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Registration / publication of 9th research

2 Publication of research results
When the research is completed, the principal investigator shall be the research subject, etc. and related persons without delay.
After taking necessary measures to protect the rights or the rights and interests of researchers, etc. and their related parties, this
The results of the study must be published. In addition, research with invasion (excluding minor invasion)
When the final publication of the results of the research and intervention is made, the research will be conducted without delay.
You must report to the head of the institution.
1 The 9th and 2nd provisions stipulate the publication of research results. "Without delay" means
The purpose is to prevent unreasonable stagnation. Only existing samples and information are provided.
The institution that conducted the research is not obliged to publish the research results.
2 As a method of publishing the results, presentations at academic conferences, publication of papers, registration in public databases (specified in 1)
Includes registration of research results. ) Etc. are conceivable. Not necessarily limited to these methods
However, it cannot be said that a method that can be viewed only by a specific limited number of people is not appropriate. this
Therefore, regarding the validity of the publication method, based on the contents described in the research plan (8th ⑴⑬),
It is necessary for each research institution to make an appropriate judgment. If the expected result is obtained
Not only that, it is necessary to announce when the expected result is not obtained.
3 "Protection of the human rights of research subjects and their related parties or the rights and interests of researchers and their related parties"
Research using samples and information that can identify a specific individual for "measures necessary for this"
In the case of research, it is possible to identify a specific research subject by deleting the name, date of birth, address, etc.
It is necessary to prevent it from being possible. Research subjects can be identified by case or case
If it is difficult to prevent it, obtain the consent of the research subject in advance, including that fact.
There is a need.
4 “Final publication” is less likely to publish research results than previously published.
Refers to the case. The research results should be published after reporting that the final publication has been made.
If it becomes, it is necessary to promptly report to that effect to the director of the research institution.

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Establishment of the 10th Ethics Review Committee, etc.

Chapter 4 Ethics Review Committee
Establishment of the 10th Ethics Review Committee, etc.
1 Requirements for establishing an ethics review committee
The founder of the Ethics Review Board must meet the following requirements.
(1) Have the ability to carry out the affairs related to the examination accurately.
(2) Have the ability to continuously operate the Ethics Review Committee.
(3) Have the ability to operate the Ethics Review Committee in a neutral and fair manner.
1 The 10th provision is the ability required of the installer when trying to establish an ethics review committee.
It is defined about.
2 ① "Ability to accurately perform examination-related affairs" corresponds to the examination request from the head of the research institution.
Establishing a secretariat to do so, clarifying the contact point, and ethics according to the provisions of 2 ⑴
Create rules regarding the organization and operation of the Physical Examination Committee, and carry out ethical examination-related affairs with this guideline.
It means that it is possible to establish a system that can be carried out smoothly.
3 ② "Ability to continuously operate the ethics examination committee" means the continuous operation of the ethics examination committee.
To be able to secure human resources such as clerical staff necessary to properly carry out the work related to
Has a financial base that allows ethics review committees to meet regularly over a long period of time
Point to that.
4 ③ “Ability to operate the Ethics Review Committee in a neutral and fair manner” is defined in Article 11-2 (1).
The members should be in an independent position and properly publish the Ethics Review Committee pursuant to the provisions of 2 (3).
Point to. In addition, the establishment of the ethics review committee shall be those who are involved in the research to be reviewed and the relevant persons.
It is also necessary to confirm the interests of the members of the Ethics Review Committee as appropriate.
5 The person who establishes the ethics review committee is not limited to one, but multiple ethics, as long as the above requirements are met.
A review committee may be set up.
In addition, due to circumstances, the person who established the ethics examination committee suspended or took over the establishment and operation of the ethics examination committee.
If you decide to cancel, the ethics review committee established by another installer will take over the review.
Proposals for promptly contacting the head of the research institution that requested the review and conducting the review up to that point
It is necessary to take appropriate measures such as providing information as requested for records related to the matter.
6 The Clinical Research Ethics Guidelines stipulate various corporations and academic societies as the founders of the Ethics Review Committee.
However, in this guideline, those representatives, etc. are designated as "establishers of the Ethics Review Committee".
The "establisher of the ethics review committee" in this guideline is not necessarily limited to representatives of corporations, etc.
If it meets the requirements stipulated in 10-1, it will not be stipulated, and it will be stipulated by a corporation, etc.
Directors of organizations / facilities clearly classified according to the organizational regulations (for example, dean, research institute, illness)
The director, etc.) can also be the "establisher of the ethics review committee".

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Establishment of the 10th Ethics Review Committee, etc.

2 Responsibilities of the Establisher of the Ethics Review Committee
(1) The establishment of the ethics review committee establishes rules regarding the organization and operation of the ethics review committee.
Therefore, in accordance with the relevant regulations, we will work for the members of the Ethics Review Committee and those who are engaged in their affairs.
I have to do it.
(2) The founder of the ethics review committee shall review the research conducted by the ethics review committee.
Period until the date when the material is reported for the end of the study (invasion (excluding minor invasion))
For studies involving interventions that involve intervention, at the end of the study
It must be stored properly for the period from the date it was reported to the date five years later).
Absent.
(3) The founder of the ethics review committee shall be responsible for starting the operation of the ethics review committee.
The ethics review committee report on the rules and list of members regarding the organization and operation of the physical review committee.
Must be published on the stem.
In addition, the establishment of the ethics review committee shall be held at least once a year regarding the status of the ethics review committee.
And the outline of the examination must be published in the Ethics Examination Committee reporting system.
I. However, in the outline of the examination, the human rights of the research subjects and their related parties or the researchers, etc.
Ethical examination as content that needs to be kept private in order to protect the rights and interests of the parties concerned
This does not apply to what the committee has decided.
(4) The person who establishes the ethics review committee is a member of the ethics review committee and a person engaged in its affairs.
Necessary measures to ensure that the company receives education and training on examination and related work
Must be taken.
(5) For those who have established an ethics review committee, the organization and operation of the ethics review committee conform to this guideline.
You must cooperate with the investigation conducted by the Minister, etc. regarding what you are doing.
1 Is the 10th-2 provision when the Ethics Review Committee is established as the founder of the Ethics Review Committee?
Procedures that must be continued from the beginning, formulation of rules related to the operation of examinations, storage of examination materials, etc.
It stipulates the responsibilities of the installer.
2 Regarding the provisions of (1), the ethics review committee may be set up according to the content of the research plan, etc.
We categorize cases where it is judged that sufficient examination is possible due to rotation, and prescribe them in the regulations.
You may decide.
3 ⑴ “Rules for Organization and Operation of the Ethics Review Committee” includes the following examples.
In order to fulfill the role and responsibilities of the ethics review committee,
It is necessary to determine the procedures to be carried out and the storage of examination materials.
(A) Composition and term of office of committee members, etc.
(B) How to appoint a chairperson
(C) Voting method when unanimous consent is difficult
(D) Storage location and storage method of examination materials, etc.
(E) Other necessary matters related to operation

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4 Regarding the provisions of (3), the meeting status includes the examination date and venue, as well as the attendance status of the committee members.
The deliberation time of the meeting is also included.
5 ⑶ "Ethics Review Committee Reporting System" is a service of the Japan Agency for Medical Research and Development.
It is published at https://www.rinri.amed.go.jp/. In the 10th 2 (3) provisions
If the Ethics Review Committee determines that it is necessary to keep it private, please refer to the outline of the review.
It is necessary to make public by masking the part related to the content.
6 Regarding the provisions of ⑷, education and training are conducted by members of the Ethics Review Committee and those engaged in their affairs.
Appropriateness of research implementation, including various rules to be observed regarding research such as scientific guidelines
In order to acquire the knowledge necessary for the examination, the establishment of the Ethics Examination Committee shall be responsible for the examination and related matters.
It is necessary to secure opportunities for education and training regarding the work to be done.

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Roles and responsibilities of the 11th Ethics Review Committee

Roles and responsibilities of the 11th Ethics Review Committee
1 Role / Responsibilities
(1) The Ethics Review Committee is asked by the head of the research institution for opinions on the suitability of conducting research.
In that case, based on this guideline, from an ethical and scientific point of view, research institutes and researchers
We will conduct a neutral and fair examination, including information on conflicts of interest, and give written opinions.
I have to say.
(2) The Ethics Review Committee will consider the ethical viewpoints and departments of the research conducted under the provisions of (1).
Conduct necessary research from a scientific point of view, change the research plan, and ask the director of the research institution about the research.
Can state discontinuation and other necessary opinions regarding the research.
(3) The Ethics Review Committee has conducted invasion (minor invasion) among the studies examined under the provisions of (1).
except. ), And the appropriateness of conducting the study and the intervention
Conduct the research necessary to ensure the reliability of the research results, and conduct research with the head of the research institution.
Can state changes to the plan, discontinuation of the research, and other necessary opinions regarding the research.
(4) Members of the Ethics Review Committee and those engaged in their affairs should correct the information that they have learned in the course of their work.
Do not leak without good reason. The same shall apply even after he / she is no longer engaged in the work.
(5) The members of the Ethics Review Committee and those engaged in their affairs conducted the review in accordance with the provisions of (1).
From the perspective of respecting the human rights of the research subjects, such as leakage of information related to the research, and the research concerned
Where serious concerns arise from the perspective of implementation and the neutrality or fairness of the examination
In that case, you must promptly report to the founder of the Ethics Review Board.
⑹ The members of the Ethics Review Committee and those engaged in their affairs prior to the review and related work.
Education and research to acquire the knowledge necessary for examination from an ethical and scientific point of view.
Must be repaired. In addition, after that, you must continue to receive education and training as appropriate.
Must be.
1 The 11th and 1st provisions are the responsibilities of the ethics review committee in the examination and business, and the ethics review committee's responsibilities.
It stipulates the responsibilities required of members and those engaged in their affairs.
2 Regarding the provisions of (1), the Ethics Review Committee conducts research when examining the adequacy of conducting research.
It is necessary to consider the situation regarding conflicts of interest described in the plan. In addition, profit
If a Conflict of Interest Committee has been established, the Opinion of the Conflict of Interest Committee will be examined by the Ethics Review Committee.

Cooperate with the Ethics Review Committee and the Conflict of Interest Committee by attaching them to documents.
Is desirable.
3 Regarding the provisions of (1), the Ethics Examination Committee will examine other materials necessary for the examination depending on the research content to be examined.
If there is (materials related to the implementation system of the research institution, outline of the medicines used, etc.), add it.
You can request the submission of materials.
4 Regarding the provisions of (1), the types of examination results of the Ethics Examination Committee are "approval" and "after amendment".
In addition to "approved by", "conditional approval", and "disapproval", "pending (continuation examination)" and "suspension (to continue research)"

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Needs further explanation) ”,“ Discontinuation (continuation of research is not appropriate) ”, etc. are conceivable.
5 (2) “Investigation necessary from an ethical and scientific point of view” was examined by the ethical review committee in the past.
Regarding the research conducted, from the viewpoint of protecting the human rights of the research subjects and considering welfare, and also research
Presence or absence of facts that may change the overall assessment of the expected benefits and expected risks of the subject
It can be carried out when it is judged that the investigation is necessary from the viewpoint of.
6 (3) “Survey necessary to ensure the appropriateness of research implementation and the reliability of research results” is
Regarding the research that the ethics review committee has reviewed in the past, it is said that the research content is forged or falsified.
This can be done when it is determined that an investigation is necessary from the viewpoint of the existence of facts.
7 According to the provisions of (2) and (3), all investigations conducted by the Ethics Review Committee shall be conducted by the Ethics Review Committee.
If the meeting deems it necessary, it will be conducted after clarifying the purpose of the survey.
8 Regarding the provisions of ⑹, the content of education and training should be observed in various rules regarding research such as ethical guidelines.
It is necessary to acquire the knowledge necessary for judging the suitability of research implementation, including
To The method of education and training is not limited to the workshops held by the founders of the Ethics Review Committee, but externally.
It also includes workshops and e-learning held by institutions.
9 ⑹ “Continue as appropriate” should be educated and trained at least once a year.
I.

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2 Composition and requirements for establishing a meeting, etc.
(1) The composition of the Ethics Review Committee is as follows so that operations such as review of research plans can be carried out appropriately.
For those who must meet all of the requirements listed in (1) to (3),
Each cannot serve as the other at the same time. Similar requirements apply to the establishment of a meeting
To
(1) Natural science experts such as medical and medical specialists must be included.
(2) Experts in the humanities and social sciences, such as ethics and law experts, must be included.
(3) Includes those who can express their opinions from a general standpoint, including the perspectives of the research subjects.
Being done.
(4) There must be multiple persons who do not belong to the institution to which the ethics review committee is established.
⑤ Must be composed of both men and women.
⑥ There must be 5 or more people.
(2) Researchers involved in the implementation of the research subject to the review shall be deliberated and commented by the Ethics Review Committee.
Do not attend the decision. However, at the request of the ethics review committee, the meeting
You can attend the meeting and give an explanation about the study.
(3) The head of the research institution that requested the examination participates in the deliberation and decision of opinion of the Ethics Examination Committee.
Must not be. However, it is necessary to understand the content of the examination by the Ethics Examination Committee.
In such cases, you may be present at the meeting with the consent of the ethics review committee.
To
(4) The Ethics Review Committee can solicit opinions from experts according to the subject and content of the review.
To
(5) The Ethics Review Committee examines research plans for those who require special consideration.
When conducting an inspection and expressing an opinion, if necessary, be willing to have an insight into these persons.
I have to ask for a look.
(6) The opinion of the Ethics Review Board must be unanimously decided.
1 The 11th and 2nd provisions are based on the ideal structure of the Ethics Review Committee and the nature of the research.
It stipulates the contents to be requested from.
2 Regarding the provisions of (1), not only the expertise of the members but also the members in different positions
It is the ethics trial that a consensus is formed after thorough discussion and the result of the deliberation is fair and balanced.
Expected by the inspection committee. In addition, it is necessary to clarify which member (1) to (4) each member corresponds to.
There is.
3 Regarding the provisions of (1), a member may concurrently serve as a member of multiple ethics review committees.
4 ⑴ ② Ethics / Law in “Ethics / Law Experts, Humanities / Social Science Experts”
Academic specialists are educated at universities, etc. based on their specialized knowledge of ethics or law.
Or a person who is engaged in research, or a person who is engaged in business as a lawyer or a judicial scrivener, etc.

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included.
5 ⑴ ③ "General position including the viewpoint of the research subject" has sufficient knowledge about medical research.
From the perspective of the research subject who does not necessarily have it, the consent explanation document, etc. based on the content of the research
It means that you are in a position to give an objective opinion, such as whether the content is generally understandable.
6 ⑴ ④ “Persons who do not belong to the institution to which the ethics review committee is established” (hereinafter referred to as “external members”
U. ), For example, at a university that has an affiliated hospital, the director of the hospital or the director of the Faculty of Medicine said, "Ethics Tribunal.
If it is the "establisher of the inspection committee", the "institution to which the establishment of the ethics examination committee belongs" is
Faculty / staff who are the hospital and medical school, respectively, and do not belong to the hospital or medical school at the university.
However, any person who has no business relationship with those institutions may be an outside committee member.
7 Regarding the provisions of ⑵ and ⑶, the Ethics Review Committee will carry out the research regarding the validity of the research.
Since it is an organization for expressing opinions to the heads of research institutes, it is possible to be involved in the research.
The head of the research institution (including those who have been entrusted with its authority or affairs) and the research institute
It is not appropriate for the parties conducting the research to participate as members. Therefore, ethical review
The person who establishes the committee is involved in the research to be examined in establishing and operating the ethics examination committee.
The head of the research institution in the field and the parties conducting the research will not participate as members.
It is necessary to consider such things as selection of people and leaving the seat at the time of examination.
8 Regarding the idea of ​"persons who need special consideration" in ⑸, the first "purpose and basic policy"
In addition to referring to the explanation regarding the basic policy (6) of
Particular care needs to be taken.
The Ethics Review Board, when reviewing research plans that target these individuals, will do so.
Have sufficient knowledge of these persons and research as necessary at the time of examination or before examination
It is desirable to seek the opinions of others and obtain their cooperation. In addition, there is no expert who corresponds to the committee
In some cases, you may ask for your opinion in writing in advance.
9 Regarding the provisions of ⑹, if it is difficult to “unanimously”, opinions will be gathered even after deliberation.
Only if it doesn't fit, it can be voted unanimously. Also, unanimously
Even if you vote without it, a majority vote is not possible, and the opinion of the majority of the attending committee members
Can be the opinion of the ethics review committee. The ethics review committee was established by
It is also necessary to prescribe the requirements for voting in the regulations.

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3 Rapid examination
The Ethics Review Committee shall be a member of the Ethics Review Committee for any of the following reviews.
Conduct an examination by a member appointed by the association (hereinafter referred to as "quick examination") and state your opinion.
Can be done. The results of the expedited examination shall be treated as the opinion of the Ethics Examination Committee, and the examination concerned
Results must be reported to all members.
(1) This research is conducted in collaboration with other research institutes, and the entire research has already been shared.
The research institute has been examined by the Ethics Review Committee, and it is appropriate for its implementation.
Examination when opinions are obtained
(2) Examination of minor changes to the research plan
③ Examination of non-invasive research without intervention
④ Examination of studies with minor invasion that do not involve intervention
1 The 11th-3rd provisions indicate that one of the types of examination is possible even in a rapid examination.
It is a thing. It also stipulates reports in the case of accelerated examination.
2 The person who establishes the Ethics Review Committee shall, in the case of conducting a rapid review, the 10th 2 (1) in advance.
In the regulations concerning the operation of the Ethics Examination Committee, the scope of application of rapid examination, examination method, etc.
It is also necessary to determine the implementation procedure.
3 Regarding the rapid examination, the ethics examination committee appoints not only one member but several members for research.
Different members may be elected depending on the field.
4 The person in charge of the accelerated examination is the research subject of the examination, and the establishment of this guideline and the ethics examination committee.
If it is judged that the rapid examination is difficult in light of what the resident stipulates, an ethical examination will be conducted again.
A review by the committee can be requested.
5 The committee member who received the report of the result of the accelerated examination will give a reason to the chairperson and then address the matter.
Therefore, the ethics review committee can request another review. In this case
When the chairman finds that there is a good reason, he / she promptly holds an ethics review committee and the matter concerned.
It is necessary to examine the item.
6 Regarding the provisions of (1), regardless of whether a rapid examination is conducted or a normal examination is conducted.
The responsibility of the Ethics Review Board remains unchanged. Based on the necessary information for proper examination
Is required to evaluate. For expedited review, the Ethics Review Board will cover the entire study.
It is appropriate to confirm the fact that the opinion that it is appropriate and the background of the examination are also included.
is there.
7 (2) “Minor changes in the research plan” means the research subjects within the range that does not affect the implementation of the research.
Refers to changes that do not increase the burden or risk on. For example, changing the job title of the principal investigator, and other research

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It is conceivable to improve the description of the plan, but the person who set up the ethics review committee can conduct a quick review.
Regarding eyes, it is necessary to establish in advance the rules concerning the operation of the Ethics Review Committee.

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4 Examination of research conducted by other research institutes
(1) The head of a research institution requests an ethics review committee established outside the research institution for review.
In such cases, the ethics review committee will review the research after fully understanding the research implementation system.
And have to give an opinion.
(2) The Ethics Review Committee will continue after reviewing research conducted by other research institutes.
If the director of the research institution requests a review of the research, the review will be conducted.
I have to give my opinion.
1 The 11th-4th provisions are related to the obligation when entrusting the examination of research conducted by an external research institution.
It was decided.
2 Regarding the provisions of (1), the Ethics Review Committee is a place to review research conducted by other research institutes.
In that case, the secretariat system in the research of the research institution and the body considered necessary for conducting the research
It is necessary to consider the system, etc. and examine it. In addition, the head of the research institution is from his own research institution.
When requesting an examination from an outside ethics examination committee, the procedure manual of the ethics examination committee requesting the examination, etc.
It is necessary to make a request after fully understanding the regulations of.
3 ⑵ "When the director of the research institution continuously requests a review of the research" means
Opinions were asked regarding suspension or cancellation of research, changes in research plans, etc., such as the occurrence of serious adverse events.
Refers to the case.

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Procedures for receiving 12th informed consent, etc.

Chapter 5 Informed consent, etc.
Procedures for receiving 12th informed consent, etc.
1 Procedures for receiving informed consent, etc.
When a researcher, etc. intends to carry out research, or a person who provides existing samples and information already exists
When providing samples / information, it is stipulated in the research plan approved by the director of the research institution.
As a general rule, follow the procedures from ⑴ to ⑷ below, respectively.
Must receive an informal outlet. However, existing trials are required according to the provisions of laws and regulations.
This applies only when providing fees / information or when receiving existing samples / information.
Not.
1 The twelfth provision of 1 stipulates procedures for receiving informed consent, etc.
is there. "Procedures from the next (1) to (4)" are the burden / risk (degree of invasion and intervention) on the research subjects.
It is organized according to the presence or absence of. Which procedure to choose is unique
The principal investigator makes a decision when preparing a research plan, and ethics including the validity of the decision.
It is necessary to be examined by the examination committee.
Regarding procedures for receiving informed consent, etc., in addition to 1 ⑴ to ⑷,
It is necessary to comply with the provisions of 2 to 9 depending on the content of the research plan and the implementation status of the research.
Therefore, it is necessary to keep in mind.
<List of 12th 1 to 9 provisions and points to note regarding application>
Twelfth provision

Precautions regarding application
・ In conducting research, in each research plan ⑴
One or more of the provisions from ⑷ apply

1 Informed consent

・ ⑶ applies to those who only provide existing samples and information.
Procedures for receiving payments, etc.
To be
・ However, existing samples and information will be provided in accordance with the provisions of laws and regulations.
Does not apply if you receive or receive an offer
・ Applicable when conducting research by changing the research plan
To be

2 Change of research plan

・ Informed consent in procedures ⑴ to ⑷ of 1
Applies when receiving a cent (appropriate consent)

3 Explanation items

(Except when receiving)
4 Notify the research subjects, etc.
Or matters to be disclosed

・ In the procedure from ⑴ to ⑷ of 1
Applicable when notifying or disclosing information about
Be done

・ A trial that is expected when consent is obtained from the research subjects, etc.
Explained as much as possible the purpose of use of fees and information
Trial to research that was not done
In some cases, after that, the purpose of use, etc. is newly specified.
Procedures for using fees and information
Applies when

5 Specified at the time of consent

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6 Urgent and clear to the research subjects
A white life crisis has arisen

・ There is an urgent and obvious life threat to the research subjects.
Applicable when trying to conduct research in a certain situation

Of research in the situation
Handling
7 Informed Conce

・ Simplify the procedures from ⑴ to ⑷ in 1 and carry out the research.
Simplification of procedures, etc. Applies when
・ When the consent is withdrawn or refused by the research subjects, etc.
Applies to

8 Withdrawal of consent, etc.

9 Samples and information for those overseas
・ Providing samples and information used for research to those overseas
Handling when providing information
(Entrust all or part of the handling of samples and information
I

Applies to (including cases of entrustment)

2 "When a person who provides existing samples / information intends to provide existing samples / information" means the sample / information.
In addition to researchers at institutions that collect and sell information, persons other than researchers (other than research institutes)
It should be noted that this also applies to those who only provide existing samples and information.
That is, persons other than researchers (persons who only provide existing samples and information) and the machines to which they belong.
The 4th to 6th provisions do not apply to the chief of Seki, but the 12th 1 "(3) has already been applied to other research institutes."
The provisions of "informed consent when attempting to provide existing samples / information" apply.
The Rukoto.
3 As a general rule, "you must receive informed consent in advance"
What is "not necessarily informed consent" in "procedures from ⑴ to ⑷ next"
This is because it stipulates things that do not need to be done. In addition, according to the progress of research, it is stepwise
When conducting research in Japan, describe the content of future research in the research plan.
It is necessary to post it and explain it to the research subjects in advance.
4 “When providing existing samples / information pursuant to the provisions of laws and regulations” means, for example, promotion of cancer registration, etc.
National Cancer Registration Database or Prefectural Roads pursuant to the provisions of the Act on Law (Act No. 111 of 2013)
Providing registration information for prefectural cancer databases and complying with the provisions of the Statistics Act (Act No. 53 of 2007)
It is envisioned that information such as questionnaires for statistical surveys will be provided.
5 In the case of "when receiving provision of existing samples / information pursuant to the provisions of laws and regulations", as existing samples / information
For example, according to the provisions of the Act on Promotion of Cancer Registration, etc. (Act No. 111 of 2013), the whole country
Statistics when receiving registration information from the registration database or prefectural cancer database
In some cases, the information on the questionnaire for statistical surveys may be provided in accordance with the provisions of the Act (Act No. 53 of 2007).
included.
In addition, based on Article 16, Paragraph 2 of the Act on Assurance of Medical Care for the Elderly (Act No. 80 of 1982)
For the use and provision of information provided by the insurer and the wide-area medical care for the elderly to the Minister of Health, Labor and Welfare
When receiving data according to the provisions of the related guidelines (2010 Ministry of Health, Labor and Welfare Notification No. 424)

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Can also be regarded as "when receiving provision according to the provisions of laws and regulations".
6 A place to acquire new genome data by analyzing the genome of a sample obtained from the human body.
In that case, the information used for research including the genomic data corresponds to personal information or personal information requiring consideration.
If you plan to analyze the genome in your research plan, you can analyze the genome.
In the research plan, the sample itself is personal information or personal information requiring consideration, regardless of before or after the research.
Informed consent specified in 1 ⑴ to ⑷ on the premise that it will be handled in accordance with
Carry out procedures for receiving outlets.
In addition, the genome day corresponding to the personal identification code by genome analysis of the sample used for the research etc.
When obtaining data, state that fact in the research plan (including the consent explanation document).
When. In addition, if you want to perform genome analysis that was not originally planned to start the research, please write a research plan.
In addition to the procedure for changing the informed consent, review the procedure for informed consent, etc. as necessary.
There is a need.

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(1) Informed consent when newly acquiring samples / information and attempting to conduct research
To
Researchers, etc. must carry out their research in accordance with the following procedures a or b, respectively.
In this case, when providing samples and information used for research to joint research institutes,
A record of the provision of the sample / information must be made.
The principal investigator shall use the record created by the researcher, etc. from the day when the sample / information is provided.
It must be stored for a period of time up to the date when the year has passed.
In addition, when receiving samples and information used for research from other research institutes, researchers
Confirm that appropriate procedures have been taken by the person who provides the sample / information.
At the same time, a record regarding the provision of the sample / information must be created.
The principal investigator is the date when the record created by the researcher, etc. is reported regarding the end of the research.
It must be stored for a period of up to 5 years from the beginning.
A. Invasive research
Researchers, etc. should give informed consent by writing a document that describes the matters explained in accordance with the provisions of 3.
I have to receive a cent.
B. Research without invasion
(A) Intervention research
Researchers need to receive informed consent in writing
If you do not receive informed consent in writing, the provisions of 3
Those who receive informed consent orally and explain the matters explained by
A record of the law and content and the content of the consent received must be made.
(B) Research without intervention
① Research using samples obtained from the human body
Researchers, etc. do not necessarily receive informed consent in writing
Not required, but if you do not receive informed consent in writing,
Orally received informed consent and explained the matters explained by the regulations
A record of the method and content of the Ming dynasty and the content of the consent received must be made.
I.
(2) Research that does not use samples obtained from the human body
(I) When attempting to carry out research by acquiring sensitive personal information
Researchers do not necessarily have to receive informed consent
However, if informed consent is not received, in principle, the research subject
Etc. must be obtained with appropriate consent.
However, if it is difficult to obtain appropriate consent, it will be used for academic research.
Attempts to carry out research by acquiring information used for other research
If there is a particular reason, please refer to 4 ① to ⑥ regarding the implementation of the research.
Notifying or disclosing the section to the research subjects, etc., and conducting or continuing the research
By guaranteeing the opportunity for the research subjects to refuse, the required distribution obtained
Consideration Personal information can be used.

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(Ii) Other than (i)
Researchers do not necessarily have to receive informed consent
However, if informed consent is not received, the study will be conducted.
4 ① to ⑥ are notified to the research subjects, etc., or made public, and the research is carried out.
Or, we must guarantee the opportunity for the research subjects to refuse to continue.
Must be used for academic research if provided to a joint research institution
To acquire information used for other research and provide it to joint research institutes
Only when there is a special reason. ).
1 The twelfth 1 (1) provision is a when trying to carry out research by newly acquiring samples and information.
It stipulates the procedure for informal outlets. 1 ⑴ "New sample / information
"When trying to carry out research by acquiring" is used for the research in the implementation of the research.
This refers to the case where samples and information are obtained directly from the research subject. Is the sample / information a research subject?
For example, blood sampling, tests, and questionnaires conducted for the research concerned can be obtained directly from the researchers.
Inspection etc. can be considered.
In addition, as explained in Explanation 2 of the provisions of "⑺ Existing samples / information" in Chapter 1, Chapter 2, it is different from the research concerned.
Samples / information obtained directly from the research subjects for the purpose of becoming "existing samples / information"
Therefore, when the existing sample / information is used for the secondary research, "Obtain a new sample / information.
It does not correspond to "when trying to carry out research." For example, for medical treatment that is not for research purposes
For medical records that contain information obtained directly from the research subjects, the medical records are examined.
When it is used for secondary research, it is applicable when it is obtained directly from the research subject for the research.
Therefore, it does not correspond to "when trying to carry out research by acquiring new samples / information".
In addition, we will newly acquire samples and information from the research subjects and carry out research in collaboration with other research institutes.
If you do, please contact the research subject, etc. at any one of the joint research institutes based on the provisions of 1 (1).
It is permissible to receive informed consent directly.
2 "When providing samples / information used for research to joint research institutes", "The sample / information"
Distribution of samples and information that is considered inappropriate to create and store "records regarding the provision of information"
The provider's institution and the provider's machine so that the distribution channel can be tracked after the fact when
At Seki, it is said to keep a record so that you can know when, who, and what kind of information was provided.
That is the purpose. Specifically, the institution of the provider provides samples and information by referring to the table below.
Period maintenance from the date when the related record is created and the sample / information is provided to the date when 3 years have passed.
Need to tube.
When conducting research jointly with other research institutes, please contact the provider and the joint research institution of the provider.
It is necessary to create and keep records regarding the provision of samples and information.
In the table below, "Recorded matter A" is the recorded matter that is absolutely necessary when providing it, "Recorded matter".
Item B ”is in“ Record Item A ”when informed consent or consent is provided.
In addition, it is a necessary record item.

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<Recorded items when providing samples and information>
Obligation

Recorded items

Example of recorded contents

To let you know who you provided it to
Therefore, the following is described (provided to those who are overseas)
If so, please include it)
① Name of joint research institute
・ Name of the joint research institution to which the research is provided

Record
Sample / Information Name / Research Director
Record
Thing
I will provide a
First name, etc.
Term
A If always
Record

・ Research responsibility at the joint research institution of the provider
Name of the person in charge
(In addition, inter for an unspecified number of people
Including that when publishing on the net etc.
To describe)
Know what kind of sample / information was provided

② Sample / information items

Described to the extent necessary
(Example: test data, medical records, blood, etc.)

You can see who provided the sample / information
Infor
Record
③ Names of research subjects, etc.
Described in
Mud Con
Record
(Example: Name, research ID)
Thing
Cent or
Term
Inf regarding provision for each research subject
B Received consent
④
Consent
of
research
subjects,
etc.
To provide
Aimed outlet or with consent
That you are receiving
Record in case
Described so that you can see that

3 "Relevant" in "When receiving samples and information used for research from other research institutes"
"Confirm that appropriate procedures have been taken by the person who provides the sample / information, etc."
Informed consent and other measures for conducting research at the original institution are appropriate
The purpose is to confirm that it has been taken, and if informed consent has been received.
Refers to the facts and contents of receiving informed consent, and is used for research by research subjects, etc.
If you notify or disclose information about the matter and guarantee an opportunity to refuse it (by opt-out)
In the case of), it refers to the facts and contents of the notification or disclosure.
As for the method of confirmation, it depends on the method of receiving the declaration from the provider's organization or other appropriate method.
Specifically, the following methods can be considered.
Case 1) How to receive a tax return verbally
Case 2) How to accept the sending of documents written in the prescribed form
Case 3) How to check on the homepage
Case 4) How to accept by email
For "records related to the provision of samples and information", refer to the table below at the institution to which the information is provided.
Created in consideration and stored for a period of 5 years from the date when the end of the study was reported.
There is a need to. "Recorded item C" in the table below is a recorded item that should be uniquely recorded.

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However, the institution that receives the offer is a private company, etc. (Of the businesses to which the Personal Information Protection Law is applied,
A business that does not fall under the category of a university or other institution or organization for the purpose of academic research)
If you receive a formed outlet or consent, you must include it.
It can be found.
<Recorded items when receiving samples and information>
Obligation

Recorded items

Recorded content
So that you can see who received the offer

① Name of joint research institute
Describe the following to
Name / Research Director

・ Name of the provider's institution

First name, etc.

・ The principal investigator of the provider's institution or an existing trial
Name of the person who only provides the fee and information

Record
Sample / Information
Record
Thing
Received the offer
Term
② At the provider's institution
A If you can
Be sure to record
Background of acquisition

The sample / information is appropriate at the provider's institution.
The one obtained by the procedure
Describe the contents confirmed in the required range
(Example: In the process of medical treatment at the institution of XX
In the process of conducting the acquired XX research
Acquired etc.)
What kind of samples and information were provided

③ Sample / information items

Describe as much as necessary so that you can understand (Example:
Test data, medical records, blood, etc.)

Infor

Do you know who received the sample / information?

Mud Con
④ Names of research subjects, etc.
Described as
Record
Record
Cent or
(Example: Name, research ID)
Thing
TermReceived consent
B Received the offer
Inf regarding provision for each research subject
⑤ Consent of research subjects, etc.
Aimed outlet or with consent
When
That you are receiving
Described so that you can see that
Record (* 1)
(
Record
(Record
Record
Thing
Is desired
Term
C Castanopsis
) (* 2)

(⑥ Joint research institute

(・ Address of the provider's institution)

Location, etc.)

(・ Name of the head of the institution that provided it)

(* 1) Even if informed consent or consent is obtained, the offer will be received.
The sample / information is anonymized and the specific individual can be identified at the institution that receives the information.
If you can't, you don't need to record
(* 2) The institution that receives the offer is a private company, etc. (a business operator to which the Personal Information Protection Law is applied, and a university

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(If it is not an institution or organization for the purpose of academic research) and informed
Be sure to mention it when receiving the offer with an outlet or consent.

4 Records related to the provision of samples and information shall be created by substituting documents, etc. prepared separately with reference to the table below.
And storage is conceivable.
If the method shown in the table below is not used, use any format including the items shown in 2 and 3 above.
Records can be created, but for example, the form shown in the latter part by the provider's institution (12th 1⑴)
Fill in the necessary items (attached at the end of the explanation) and provide it together with the sample and information.
A method is conceivable in which the institution confirms and stores the contents described in the form. Also, some kind of electricity
It can also be recorded using a child method (eg, EDC (*), electronic medical record, etc.).
If you want to create a record regarding the provision of samples / information without using the method in the table below, provide it.
The basic method is to create each time, but when the series of services is completed, the rules specified in 5-2 ⑹
Make a batch record when making a period report or a report after the end of the research specified in 7-4.
You can also do it. In this case, it will be provided for each exchange of samples and information implemented in the research plan.
It is not necessary to specify the original institution and the institution to which it is provided, and the contents of the exchange of a series of samples and information.
It suffices if it is described to the extent necessary so that it can be tracked after the fact.
* EDC (Electronic Data Capturing): Research data in electronic data format without going through paper media
A terminal for collecting directly or collecting at

<Method of substituting documents created separately when providing samples and information>
Recorded items

How to substitute documents created separately
・ Keep a "research plan" with necessary information
To do

(
・ (For those who only provide existing samples and information)
Record
Record
"Already to other research institutes" with necessary information
Record
Record
Thing
Thing
① Names of joint research institutes, etc.Storage of "Notification Form for Provision of Existing Samples and Information"
TermTerm
To do
A C ② Sample / information items
)
・ "Contract regarding provision" that describes necessary items
(MTA ( material transfer agreement ), DT
A ( data transfer agreement ), etc.) ”is stored
Ru
・ (Receive informed consent in writing
If) Keep the "Consent Document"

Record
Record③ Names of research subjects, etc. ・ (Verbal informed consent,
Thing
A place to record that consent has been received for medical records
④
Receive
the
consent
of
the
research
subjects,
etc.
Term
C) Keep "medical records"
B
To the effect
・ (Research subject with appropriate consent
Created a record of the content of consent for each person
If) Keep the record

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<Method of substituting documents, etc. created separately when receiving samples and information>
Recorded items

How to substitute documents created separately

(
Record
Record
① Names of joint research institutes, etc.
・ Keep a "research plan" with necessary information
Record
Record
Thing
Thing
② Taken by the provider's institution To do
TermTerm
Background of profit
・ "Contract regarding provision" that describes necessary items
A C
)
③ Sample / information items
(MTA, DTA, etc.) ”
Record
・ Store "provided sample / information itself"
Record
④ Names of research subjects, etc.
Thing
To do
Term⑤ Receive the consent of the research subjects, etc.
・ (Receive the consent document (original or copy)
B
To the effect
If) Keep the "Consent Document"

(
*
)

(*) Provided even if informed consent or consent is obtained.
The sample / information to be received is anonymized and a specific individual at the receiving institution
No record required if cannot be identified
5 Regarding the obligation to create and keep records of the provider's institution explained in 2 above, the provider's institution
We have built a system that allows you to check the record at any time by contacting the institution of the provider.
In that case, the institution of the provider keeps the record, which means that the institution of the provider creates and keeps the record.
It can be carried out on behalf of the business (however, the matters to be recorded by the provider's institution are the relevant records.
Only when it is described in). In addition, by ensuring a similar system, the institution to which the service is provided
It is also possible for the provider's institution to carry out the obligations on behalf of the provider (in this case, the period to be stored).
Note that is different between the provider's institution and the recipient's institution).
6 Part of the research work (analysis of samples and information, etc.) for other corporations or sole proprietors in Japan
In the case of outsourcing, necessary matters between the institution that outsources the business and the outsourced institution
(Contents of provided samples / information, disposal method / timing, provider organization in case of multicenter joint research
If the one (contract, confirmation, memorandum, etc.) with the name etc. is stored, the sample / information
It is not possible to create a record regarding the provision of samples and information specified in this guideline even when exchanging information.
It is important.
On the other hand, for the contents for those who are overseas, refer to the explanation of the twelfth nine.
7 “Receive informed consent in writing” is explained in writing and written in the document.
Refers to receiving more consent. "Receiving informed consent verbally" means
It refers to explaining verbally and receiving verbal consent. Either explanation or consent
For cases where one is written and the other is verbal, "verbally informed consent"
It is treated as corresponding to "Receive".
8 Regarding the provisions of a, written explanation when receiving informed consent is required.

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You don't have to do it individually or face-to-face, just distribute the document to the group to explain or read it.
It can also be done by mailing an explanatory document created so that the contents can be fully understood.
it can. However, the manifestation of consent is given to each research subject, including the case of replying by mail.
It is necessary to confirm in writing for each. In addition, just posting the explanation at the explanation venue will make it a document.
It is not recognized as an explanation by.
Informed consent for study subjects who cannot read the explanation and consent documents
Written from a research subject who cannot sign consent due to paralysis, etc.
When receiving an informal outlet, consider making witnesses present and allowing ghostwriting.
It is desirable to do it. The "witness" here is unfairly influenced by researchers, etc.
Those who are not involved in the implementation of the research concerned shall be those who are not involved in the implementation of the research.
In addition, written consent based on free will is, at this stage, prevention of spoofing, etc.
Due to problems, electronic methods, magnetic methods, and other methods that cannot be recognized by human perception
It is not supposed to be (agreement by e-mail etc.).
9 Regarding the provisions of (a), the written explanation needs to be based on the contents of 7 above. Also,
Oral explanations when receiving informed consent are not necessarily individual or face-to-face.
You don't have to do it, you can hold a briefing session or call. However, the intention of consent is
It is necessary to confirm for each individual research subject, including the case of replying by telephone or mail. "same
"Record of the content of intention" includes the date and time of consent, explanation method, explainer, consent matters, etc.
Need to be stated. Regarding the provision of samples and information to other collaborative research institutes
If you include any items, keep the "record of consent".
It can be used as a record regarding the provision of samples and information.
In addition, even if the procedure is oral, the explanation and consent given to the research subjects, etc.
Consideration such as handing over materials related to the content of the explanation and consent so that the content can be remembered
It is desirable to do.
10 (a) Regarding the provisions of (1), written or oral explanations must be based on the contents of 8 above.
11 Researches that fall under (a) (2) are questionnaires and interviews without invasion and without intervention.
It is assumed that information used for research will be collected by viewing, observing, etc. collect
Informed consent with and without "sensitive personal information"
It should be noted that the procedures are different. Regarding the definition of "personal information requiring consideration",
See the explanation in the second (23) "Personal information requiring consideration".
12 Regarding the “appropriate consent” of (a) ( 2) (i) , "informed consent" is not necessarily received.
We do not require you to do so, but by an appropriate method in line with the purpose of the Personal Information Protection Law, etc.
I agree that the personal information of the research subject will be handled by the handling method indicated by the research institution.
It is also possible for the research institution to recognize the manifestation of intention of the research subject to that effect.
To In other words, when receiving "informed consent", the provisions of 12-3 shall apply.

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Consent to conduct or continue the research after giving sufficient explanation based on the explanations
On the other hand, if "appropriate consent" is received, the research subject will make a decision regarding consent.
To the extent necessary, clarify the purpose of use for research that is considered necessary for this purpose by a rational method.
After showing, consent to the extent necessary (consent regarding acquisition of information used for research, provided to third parties
In that case, consent to that effect, when providing overseas (by consignment or public database)
Including the case of registering with a service, etc. ) Is different in that it receives (including consent to that effect).
To
Examples of cases where appropriate consent has been obtained are oral manifestations of intention and receipt of documents (electromagnetic records).
including. ), Receive emails, check confirmation fields, click buttons on the homepage, etc.
Can be mentioned. In addition, only the outline of the research will be notified, and the confirmation column for matters for which consent should be obtained.
When conducting research using a questionnaire that does not have a, collect the questionnaire.
It is not considered that proper consent has been obtained based solely on the facts.
If appropriate consent is received, it is unique to create a record of the content of the consent.
Is not required, but will provide the samples and information obtained to the joint research institute with appropriate consent.
If so, create "Record Item B" as a record regarding the provision of samples and information explained in 2 to 5 above.
Since it is necessary to prepare and store, if appropriate consent is obtained, we will also provide samples and information.
Create a record of consent for each research subject, including necessary records
However, it is conceivable to store this.
13 Obtain appropriate consent for “when it is difficult to obtain appropriate consent” in (a) (b) ( 2) (i).
Due to difficult circumstances, "information used for other research when used for academic research"
Specially for trying to carry out research (including providing it to other research institutes)
If there is a reason for this, omit obtaining appropriate consent and go to the first place in advance.
Notify or disclose the information listed in 12-4 to the research subjects, etc., and carry out or continue the research.
By a method (opt-out) that guarantees the opportunity for research subjects to refuse
it can.
In the case of opt-out, at least the information listed in 12-4 will be provided to the research subjects.
Sending documents to, etc., distributing pamphlets, posting on the homepage, confirming the research subjects, etc.
It is necessary to put the research subject in a state where it can be easily known by posting or providing a document in a place where it can be done.
There is a need. If there is a change in the content, the research subject can easily know the change.
Need to put in.
14 About "when used for academic research", for example, a place to use for pure product development
If not included here. "Get the information used for other research and carry out the research.
"When there is a special reason for doing so" means that the law / ordinance is not used for academic research.
It refers to the case where there is a concrete basis for such things as, for example, the "public" stipulated by the Personal Information Protection Law.
It is difficult to obtain the consent of the person, especially when it is necessary to improve hygiene.
"Ki" etc. are applicable. In accordance with applicable laws and regulations regarding the protection of personal information, we are primarily researching
The person in charge of research will make a decision, indicate the reason, and after examination by the Ethics Review Committee, obtain the permission of the head of the institution.

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What you need to do.
15 (a) Regarding the provisions of (2), if the research subject refuses to carry out the research, the research will be conducted.
It is not possible to make it the target of, and take appropriate measures based on the provisions of the 12th-8th. in this case,
Although we do not collect personal information about the research subjects, we will join the research target group when aggregating the research results.
Eh, it is possible to use the basic demographic characteristics (gender, age, etc.) of the person.

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sample
Year

Month

Day

Records regarding the provision of samples and information to other research institutes
The head of the institution to which it is provided
Institution name of the provider:
Street address:
Name of the head of the institution:
Person in charge Job title:
Full name:

mark

Name of the institution to which it is provided:
Principal Investigator Name:

For the research subject "○○○○", we will provide samples and information used for research to your facility. Contents
Is as follows.

Contents

Details

Items of samples and information to be provided Example) Blood, hair

Background of acquisition

Status of consent acquisition

With or without anonymization

Example) Residual of sample obtained in the process of medical treatment at the provider's institution
Specimen

□ Yes (Method:

)

□ None

□ Yes (whether or not a correspondence table is created □ Yes □ No)
□ None

that's all

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⑵ Try to carry out research using existing samples and information held by your own research institution.
Informed consent
A. Research using samples obtained from the human body
Researchers, etc. are required to receive informed consent in writing.
No, but if informed consent is not received in writing, according to the provisions of 3.
Orally received informed consent about the explanations, and the method of explanation and
A record of the content and the content of the consent received must be made. However, this
If it is difficult to carry out these procedures and falls under any of the following (a) to (c)
In the meantime, existing samples held at your own research institution without performing the relevant procedure
Information is available.
(A) The existing sample / information corresponds to any of the following.
① Anonymous (limited to those that cannot identify a specific individual)
To be.
(2) Must be anonymously processed information or non-identified processed information.
(B) If the existing sample / information does not correspond to (a), the research will be conducted at the time of acquisition.
Only the consent of the research subjects, etc. for another research whose use is not specified is given.
If so, the following requirements must be met.
(1) Regarding the implementation of the research, 4 Notify the research subjects, etc. of the matters from (1) to (4), and also
Is open to the public.
(2) It is reasonably recognized that the consent has a considerable relevance to the purpose of the research.
(C) When the existing sample / information does not correspond to either (a) or (b), it is socially important.
The following requirements when the existing sample / information is used for highly important research
Must meet all of the above.
(1) Regarding the implementation of the research, 4 Notify the research subjects, etc. of the matters from (1) to (6), and also
Is open to the public.
(2) In principle, opportunities for research subjects to refuse to carry out research
To guarantee.
B. Research without samples obtained from the human body
Researchers do not necessarily have to receive informed consent, but
If you do not receive an integrated outlet, it corresponds to one of the following (a) to (c)
Must be done.
(A) The information used in the research falls under any of the following.
① Anonymized (limited to those that cannot identify a specific individual)
There is.
(2) Must be anonymously processed information or non-identified processed information.
(B) If the information used in the research does not correspond to (a), the research institute should be obtained at the time of acquisition.
Only the consent of the research subjects, etc. for another research whose use in the research is not specified
When given, meet the following requirements.

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(1) Regarding the implementation of the research, 4 Notify the research subjects, etc. of the matters from (1) to (4), and also
Is open to the public.
(2) It is reasonably recognized that the consent has a considerable relevance to the purpose of the research.
(C) When the information used in the research does not correspond to either (a) or (b), academic
Specially in trying to carry out research using other relevant information when using it for research
If there is a reason for the step, the following requirements must be met.
(1) Regarding the implementation of the research, 4 Notify the research subjects, etc. of the matters from (1) to (6), and also
Is open to the public.
(2) As a general rule, the research subjects refuse to carry out or continue the research.
Guarantee the opportunity to do it.
1 The twelfth 1 (2) provision uses existing samples and information held by the research institution.
It stipulates the procedure for informed consent when conducting research.
is there. In the case of a (when using a sample obtained from the human body), written or verbal inf.
As a general rule, the procedure for a warm outlet is performed. However, informed consent
If it is difficult to carry out the procedure, it falls under any of the items listed in a (a) to (c).
Only occasionally, existing samples held at one's own research institution without performing the relevant procedure
Information is available. In the case of a (when the sample obtained from the human body is not used),
It is not always necessary to receive informed consent, but it may be due to opt-out, etc.
it can.
2 Regarding the provisions of a, "owned by one's own research institution" is different from that of the research institution in the past.
In addition to cases where the research was acquired and owned when the research was conducted, at corporations that have medical institutions, etc.
This refers to cases such as possession of samples and information obtained through medical treatment that is not for research purposes.
3 Regarding the provisions of a, "when it is difficult to carry out the procedure" is, for example, taken from the research subject.
Since a considerable number of years have passed since it was obtained, the subject of the research is due to death, retirement, relocation, etc.
It may be difficult to contact the person.
4 A (A) ① "Anonymized items (limited to items that cannot identify a specific individual)"
The sample / information used in the research is anonymized and cannot identify a specific individual.
Refers to the case. For "Unable to identify a specific individual", refer to the explanation in Section 2⒇.
Teru.
The following cases can be considered as examples included here.
① When anonymizing the sample / information used for the research for the purpose of conducting the research
(2) When using samples / information that has already been anonymized before the start of the research
Regarding (1), when creating a correspondence table and anonymizing it, collate it with the original information using the correspondence table.
It is not included here as it can identify a specific individual. Also, the genome
If you plan to perform analysis and obtain genomic data corresponding to the personal identification code,

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Even if the sample / information before genome analysis cannot identify a specific individual.
But it is not included here.
Regarding (2), the correspondence table was not created before the research was started, and it was anonymized.
When the sample / information is anonymized by another institution for use in research other than the relevant research.
A correspondence table has been created, and the anonymized samples and information are provided by other organizations and held.
However, it may include cases where the correspondence table has not been provided. However, I have a correspondence table
If the department you are in and the department that conducts research are in the same corporation, you have a correspondence table as the corporation.
It does not apply here because it is in a state where it can be collated with the original information using the correspondence table.
I. In addition, even if the location of the correspondence table is not within the same corporation, it is practically a research machine.
If it is possible for Seki researchers, etc. to collate with the original information using the correspondence table, here
Not applicable. For details of the correspondence table, refer to the second (25).
5 A (A) ② Conduct the relevant research on "anonymously processed information or non-identified processed information"
Create new anonymous processing information or non-identification processing information by analyzing and processing existing samples and information for the purpose of
Or the sample obtained from the human body with the anonymously processed information or non-identified processed information that has already been created.
It is conceivable to use only.
When using anonymously processed information or non-identified processed information, it applies in addition to the provisions of this guideline.
It should be noted that compliance with the obligations stipulated by law is required. For more information, individual
Guidelines on the Law Concerning the Protection of Personal Information (Anonymously Processed Information) and the 17th of these guidelines
Please refer to the regulations of.
<Reference>
Guidelines for Law Concerning Protection of Personal Information (Anonymously Processed Information) (2016)
Year Personal Information Protection Commission Notification No. 9)
6 A (b) "Research on another research whose use in the research is not specified at the time of acquisition.
"When only the consent of the research subject, etc. is given" means in the preceding research that received the consent.
It refers to the case where the sample is to be used for a purpose other than the specified purpose.
7 A (b) ② "It is reasonably recognized that the consent has a considerable relevance to the purpose of the research."
Is going to carry out previous research, for example, conducting additional research for the same purpose as the previous research.
The head of the research institution has completed the review by the Ethics Review Committee regarding its relevance to the research to be conducted.
Refers to when accepted.
8 A (c) “Socially important research” refers to, for example, prevention and cure of diseases important for public health.
A sample obtained from the human body through the systematic cooperation of society as a whole for research on medical treatment.
Refers to the case where it is necessary to utilize something that has not been anonymized.
If you intend to carry out research using samples obtained from the human body according to this regulation,
"R & D using human tissue removed by surgery, etc." (Answer from the Health Science Council)

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With reference to the report (December 16, 1998), etc., the protection of the research subjects and the ratio of the results obtained in the research
From the point of view of the amount of comparison, the ethics review committee should judge the suitability.
In addition, when conducting research based on the provisions of a (c), individuals who are separately applied to each research institution
It is also necessary to consider the consistency with laws and ordinances related to the protection of information. Law
Regarding the consistency with the rules and ordinances, the principal investigator will uniquely judge and indicate the reason for the morality.
It is necessary to obtain the permission of the head of the institution after being examined by the Physical Examination Committee and receiving the opinion that it is appropriate.
thing.
9 Regarding (c) (2) "Guaranteeing opportunities for research subjects to refuse", the 12th 1 (1)
Refer to the explanation of (a) (2) (opt-out).
In addition, "in principle" is a personal identification code for samples and information used in research.
It is necessary to handle it as personal information due to the inclusion of the number etc., but I have the contact information of the person
It is assumed that it is difficult to guarantee the opportunity for the research subjects to refuse due to lack of information.
To In such a case, from ① to ④ of "4 Matters to be notified or disclosed to the research subjects"
It suffices to notify or disclose the research subjects.
10 B. (c) “When using for academic research” and “Use other relevant information to carry out research.
For "when there is a special reason to try" , refer to the explanation of 12th 1 (1) (a) ( 2) (i) .
11 B (c) Regarding (2) "in principle" and "guaranteeing opportunities for research subjects to refuse"
See the explanation in 9 above.

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(3) Informed consent when providing existing samples and information to other research institutes
To
Those who provide existing samples and information to other research institutes are not necessarily informed in writing.
No need to receive informed consent, but informed consent in writing
If you do not receive the information, the explanation according to the provisions of 3 (including the provision of existing samples and information)
Mu. ) Orally received informed consent, and explained the method and contents.
A record of the content of the consent received must be made. However, these procedures
If it is difficult to do and any of the following a to c is applicable,
Existing samples and information can be provided without any procedure.
In addition, when providing existing samples and information, the machine to which the person who provides the existing samples and information belongs
The head of Seki (hereinafter referred to as "the institution that provides existing samples and information") properly describes the existing samples and information.
The systems and regulations necessary to provide the information must be in place. In addition, existing samples
The person who provides the information creates a record regarding the provision of the existing sample / information and keeps the record.
It must be stored for a period of 3 years from the date of provision of the sample / information.
I.
A. Existing test that the existing sample / information corresponds to any of the following
So that the head of the institution that provides the fee / information can understand the provision of the existing sample / information.
What you are doing.
(A) Anonymized (limited to those that cannot identify a specific individual)
That.
(B) Anonymously processed information or non-identified processed information.
(C) Specially for providing other existing samples and information when used for academic research.
There is a reason, and 4 ① to ④ are notified to the research subjects, etc., or made public.
If so, it is anonymized (which research subject's sample / information is
Limited to those that have been processed or controlled so that they cannot be identified immediately. ).
B. When existing samples / information do not correspond to a and are used for academic research, etc.
If there is a particular reason for providing the existing sample / information, the following requirements shall be met.
After hearing the opinion of the Ethics Review Committee regarding the requirements, the existing samples and information
Obtaining the permission of the head of the institution that provides the information.
(A) Regarding the implementation of the research and the provision of the existing samples and information to other research institutes 4 ①
Notify or disclose the matters from to ⑥ to the research subjects.
(B) As a general rule, there is an opportunity for research subjects to refuse to carry out research.
To guarantee.
C. When existing samples and information used for research of high social importance are provided.
Therefore, due to the method and content of the research, the content of the sample / information used in the research, and other reasons.
If it is not possible to do so, take other appropriate measures to the extent necessary.
An organization that provides existing samples and information after hearing the opinions of the Ethics Review Committee.
Have the permission of the head of the. In this case, all the requirements from 7 ⑴ ① to ④
Must be applicable. In addition, 7 ⑵ Appropriate measures from ① to ③

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Must be taken.
1 The twelfth provision of 1 ⑶ is an institution when trying to provide existing samples and information to other research institutes.
It stipulates the procedure for foamed outlets. The procedure in this case is a document or
In principle, oral informed consent procedures are carried out.
2 (3) “Provision of existing samples / information” means, for example, acquired through medical treatment at a medical institution.
Information on a part of the patient's body and the patient's health can be obtained by a person belonging to the medical institution using another research machine.
In addition to providing samples and information to Seki, we have conducted research at our own research institute in the past.
The samples and information acquired and held at the time are presented for another research conducted by another research institution.
When providing, the institution that collects and sells existing samples and information owns the existing samples and information.
This includes cases such as providing information to other research institutes. In either case, provision of existing samples and information
It is necessary to follow the rules of each institution regarding personal information and intellectual property.
3 (3) “When it is difficult to carry out the procedure” means, for example, the phase after being obtained from the research subject.
Since the current year has passed, contact the research subject, etc. due to death, retirement, relocation, etc.
It may be difficult to do so.
4 Regarding ⑶ "Establishment of systems and regulations necessary to properly provide existing samples and information"
In advance, the head of the institution will report to the head of the institution about the handling and procedures when providing it to other research institutes.
To establish rules regarding methods for this purpose and methods for preserving records regarding the provision of samples and information)
Can be considered. In addition, the person who only provides existing samples and information submits to the head of the institution "Others"
Notification form regarding the provision of existing samples and information to research institutes in Japan "(attached to the end of the explanation in 12-1 (3))
You may operate using the model of.
For 5 ⑶ "Records regarding provision of samples and information", refer to the explanation of 12-1 ⑴. In addition, it should be noted.
By stating the application form for reporting to the heads of the above 4 organizations in an appropriate format, the record
It is also possible to use it as a method.
6 ⑶ A (A) "Anonymized (limited to those that cannot identify a specific individual)"
For more information, see 12th 1 (2).
7 ⑶ A (b) "being anonymously processed information or non-identified processed information" is described in 12-1 ⑵.
See commentary.
8 ⑶ A (c) “When using for academic research” and “Providing other existing samples / information
For "there is a particular reason" , refer to the explanation of 12th 1 (1) (a) ( 2) (i) .
9 ⑶ A (c) "Immediately determine which research subject's sample / information is anonymized.

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Limited to those that have been processed or controlled so that they cannot be done. ) ”Is included in existing samples and information
Delete all the descriptions that can immediately identify a specific research subject by the description alone.
Refers to those that have been processed in such a way. Here, "the description alone is a specific research subject.
Specifically, "a description that can immediately identify" is, for example, a name, a face image, and a personal identification code (ge).
Nom data, health insurance card number, etc.) are applicable. For disease names, test data, etc., the description, etc.
Even if it is a relatively peculiar case, basically, "the description alone can immediately identify a specific research subject.
It may be treated as not corresponding to "declarable descriptions, etc."
The following cases can be considered as examples included here.
① When anonymizing the sample / information used for the research for the purpose of conducting the research
(2) When using samples / information that has already been anonymized before the start of the research
"Correspondence table" has already been created before the research was started or the "correspondence table" was created and anonymized.
If it is anonymized in the form of being made, it can be included here. However, the research institute "corresponds"
If you have a "table", you must not provide the "correspondence table" to other research institutes, and the following
If the "correspondence table" is not properly managed, it is not included here.
・ Safety management measures in the correspondence table are not properly implemented (see 15-2).
・ Regulations for inquiries regarding original data from other organizations are not properly established.
10 (3) Regarding “after hearing the opinions of the Ethics Review Committee” in (a), the research institute conducted the research.
We will listen to the opinions of the Ethics Review Committee, but only provide existing samples and information outside the research institute.
Regarding the possibility of providing existing samples and information to those who perform the above, the Ethics Review Committee
I need to hear your opinion. In this case, ask the ethics review committee established in another institution for review.
can do. A place to listen to the opinions of the Ethics Review Committee regarding the appropriateness of providing existing samples and information
In that case, a method such as utilizing the research plan prepared by the institution of the provider can be considered. U
The same shall apply.
11 ⑶ Regarding “guaranteeing opportunities for research subjects to refuse” in (a), item 12 (1) (a)
For (2) (opt-out) and "in principle", refer to the explanation of 12-1 (2) A (c) (2).
The procedure specified in (3) B is to guarantee the opportunity to refuse participation or non-participation in the research (op.
Opt-out), Article 23, Paragraph 2 of the Personal Information Protection Law (provided by a third party by opt-out)
It is different from the opt-out regarding the provision of personal data to a third party as stipulated by. That is, the same law
Procedures such as notification to the Personal Information Protection Commission required in Section are not required.
12 (3) “Socially important research” refers to, for example, prevention and cure of diseases important to public health.
Samples and information related to medical treatment that have not been anonymized due to the systematic cooperation of society as a whole.
It is conceivable that it is necessary to utilize the information. Provision of existing samples and information according to this regulation
When doing this, from the perspective of protecting the research subjects and comparing the results obtained in the research, the ethics trial
Appropriateness should be judged by the inspection committee.
When conducting research based on the provisions of (3) C, the requirements of 12th 7 (1) to (4) are met.
All must be true, see Exhibit 12-7 for more information. Also, another

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Consistency with laws and ordinances related to the protection of personal information applied to each research institution
Also need to be considered. Regarding the consistency with laws and ordinances, it is primarily the responsibility of research.
After making a judgment, showing the reason, and examining it by the Ethics Examination Committee, we received the opinion that it was appropriate.
Must obtain permission from the head of the institution.

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sample
Year

Month

Day

Notification form regarding provision of existing samples and information to other research institutes
(Name of the head of the institution that provided it)
Reporter Affiliation:
Job
Mr

Name:
Name:

mark

Based on the "Rules for Conducting Medical Research for Humans" at this facility, we will maintain it at this facility.
We will provide the existing samples and information we have to other research institutes as follows (report / application).
To do.
Research plan at the institution to which it is provided
Attachment

Certificate of approval by the Ethics Review Board at the institution to which it is provided
Other (

)

1. Matters related to research

Research subject

Principal Investigator

Full name:
Affiliated research institute:

Described in the research plan

Year

Scheduled research period

Month

Day ~

Year

Month

Day

Samples and information to be provided
Item
Samples and information to be provided
Background of acquisition

How to provide
Name of research institute:
Institution to which it is provided
Job title of the person in charge:
Name of person in charge:

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2. Items to check
Received informed consent in writing
Orally receiving informed consent
A (A): Anonymized (By identifying a specific individual
Limited to those that cannot be used. )
A (B): When providing anonymously processed information or non-identified processed information
Consent of research subjects

A (c): Anonymized (in which research subject's sample / information

Acquisition status, etc.

Limited to those that have been processed or controlled so that it cannot be immediately determined whether they are present or not.
To )
B: If a cannot be done (opt-out and ethics review committee)
Examination required by the committee)
C: If it cannot be done by a or b, satisfy (*)
(Examination required by the Ethics Examination Committee)

Notification at the facility

Do not implement

Notify or publish
Or there is public implementation
Notification or disclosure + Guarantee of refusal opportunity (opt-out)
Unequal
Implement other appropriate measures
Yes (Administrator:
Whether to create a correspondence table
None

)(Management department:

)

Keep this application as a record
For providing samples and information
(Administrator:
)(Management department: )
Creating records related to
Send a separate form to the institution of the provider and keep the record at the institution of the provider
Storage method
Other (
)
(*) ① No invasiveness in conducting research
(2) Simplification of the consent procedure does not disadvantage the research subjects
③ If the procedure is not simplified, it will be difficult to carry out the research, and the value of the research will be significantly impaired.
④ It is recognized as a research of high social importance.
⑤ Take appropriate measures from any of the following
・ Regarding the purpose, content, method, etc. of collecting and using samples and information for the group including the research subjects, etc.
To publicize
・ Promptly give an ex post facto explanation to the research subjects, etc.
・ If samples / information are continuously collected or used for a long period of time, it will be reported to society.
Efforts will be made to publicize the actual situation, including the purpose and method of collecting or using the sample / information, and to make it known to society.
Mel

(* For facility management)
Examination by the Ethics Review Board

Unnecessary
Required (Date:
Permission (

Availability

Year

Month

Year

Month

Day)

acknowledgment(
Year

Month

Day)

Day)

Disallowed

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⑷ In case of conducting research by receiving existing samples and information based on the procedure of ⑶
Foamed outlet
Researchers, etc. will confirm the following matters and will be involved in the provision of the existing samples and information.
You must make a record.
The principal investigator is the date when the record created by the researcher, etc. is reported regarding the end of the research.
It must be stored for a period of up to 5 years from the beginning.
A. According to the contents of informed consent regarding the sample / information or the provisions of (3)
Details of the measures taken in providing the sample / information
B. Name, address and name of the head of another institution that provided the existing sample / information
C. Background of acquisition of the sample / information by another institution that provided the existing sample / information
In addition, when using existing samples and information that can identify a specific individual (researchers, etc.)
Except when receiving informed consent. ) Regarding the implementation of the research
4 As a general rule, the matters from ① to ⑥ should be disclosed and the research should be carried out.
It is necessary to guarantee the opportunity for the research subjects to withdraw their consent.
In addition, if you are provided under the provisions of (3) by falling under (3) a (c), you will be a researcher, etc.
Must disclose the matters from 4 ① to ④ regarding the implementation of the research.
1 The provisions of 12th 1 (4) are for conducting research with the provision of existing samples and information.
It stipulates the procedure for informed consent.
2 Regarding the method of "confirming the following matters" and "records regarding the provision of samples and information"
See the explanation of the twelfth 1 (1).
"A. According to the contents of informed consent regarding the sample / information or the provisions of (3).
Regarding "Details of measures taken in providing the sample / information", the provision of existing sample / information
If you receive the offer from a person who does only, the offer will be made appropriately in accordance with the regulations of the facility of the provider.
It is also desirable to confirm whether or not it has been damaged.
In addition, "a. Name, address and name of the head of another institution that provided the existing sample / information.
Name ”and“ C. Acquisition of the sample / information by another institution that provided the existing sample / information
The purpose of confirming "the background" is that the existing samples and information to be provided have been legally obtained.
The point is to prevent the use and distribution of the sample / information when it is suspected that the sample / information is not.
When it is suspected that the existing sample / information to be provided is not legally obtained.
For example, existing samples and information including personal information from private companies (data sales companies, etc.)
When purchasing or when receiving existing samples / information including personal information from a person overseas
It is assumed that there may be cases where the method of obtaining existing samples and information at the provider's institution is uncertain. this
The specific content of the "acquisition process" that should be confirmed in such cases depends on the mode of provision to a third party.
It may be different, but basically, it depends on the source of the existing sample / information (person, other institution, Iwayu).
Public information, etc.) and the mode of acquisition (whether it was acquired directly from the person or for a fee, so to speak.
It is necessary to confirm whether it was obtained from any public information, etc.).

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In addition, if you confirm the process of acquisition by the institution of the direct provider regarding the provision,
Sufficiently, it is obligatory to go back from there and confirm the acquisition process of the person who acquired it before the institution of the provider.
There is no.
3 Regarding "the opportunity for the research subjects to withdraw their consent must be guaranteed", the first
It is necessary to take the same measures as in 12 1 ⑴ a (a) ② (opt-out).
For "in principle", refer to the explanation of 12th 1 (2) A (c) (2).
<Reference> Inform of the institution of the provider and the institution of the provider in the transfer of existing samples and information
Relationship of procedures such as de outlet
(3) Provide existing samples and information(4) Institution that receives existing samples and information
organ
(The "research institute" of this guideline
(3) Provide existing samples and information
("Research institute" of this guideline or
Hit)
Procedures at the institution
"Only provide existing samples and information
Corresponds to "institution to perform")
Informed consent
Receive

Informed consent

Confirm the procedure of the provider

(Written or verbal)

＋ Creating a record of provision

＋ Creating a record of provision

A (A) Anonymization (a specific individualCreating a record of the offer
Cannot be identified)

Confirm the procedure of the provider

＋ Understanding the head of the institution ＋ Creating a record of provision

Creating a record of the offer
Confirm the procedure of the provider
A (B) Anonymously processed information or non-anonymous processing information
＋ Understanding the head of the institution ＋ Creating a record of provision
Identification processing information
(*)
(*)
A (c) Anonymization (which research subject
Creating a record of the offer
Is it the sample / information of the person?
＋ Notification or publication

Confirm the procedure of the provider
＋ Creating a record of provision

So that it cannot be identified immediately
＋ Understanding the head of the institution ＋ Notification or publication
Processed or controlled)

Opt out

Creating a record of the offer

Confirm the procedure of the provider

＋ Notification or publication

＋ Creation of records regarding provision ＋ Communication

＋ Guarantee of refusal opportunity (principle)
Knowledge or disclosure
＋ Submission to the Ethics Review Committee
＋ Guarantee of refusal opportunity (principle)
＋ Permission from the head of the institution

C. Has social importance

Creating a record of the offer

Confirm the procedure of the provider

＋ Appropriate measures

＋ Creating a record of provision

＋ Submission to the Ethics Review Committee
＋ Appropriate measures
＋ Permission from the head of the institution

(*) Comply with legal obligations regarding the handling of anonymously processed information or non-identified processed information

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2 Change of research plan
When a researcher, etc. changes the research plan and intends to carry out the research, the changed part
Therefore, as a general rule, do not perform informed consent procedures, etc. according to the provisions of 1.
Must be. However, changes approved by the director of the research institution in response to the opinion of the Ethics Review Committee
This does not apply to the location.
The twelfth provision is informed consent when attempting to change the research plan.
It stipulates the procedure for receiving the payment. In this case, info according to the twelfth 1 provision
As a general rule, carry out procedures such as mood outlets. Regarding the application of this principle,
Considering the content and the burden on the research subjects related to the procedure for informed consent, etc.
In a sense, the principal investigator will make a decision, describe it in the research plan, and examine its validity by the Ethics Review Committee.
To do. Explain the changes approved by the director of the research institution in response to the opinion of the Ethics Review Committee.
It can be omitted. For example, a collaborative research institute that plays a small role in research planning
A change in the principal investigator may be a part where the explanation is omitted. However, the explanation is omitted.
It was clarified that the parts were omitted, and at a later date, the research plan was requested at the request of the research subjects, etc.
It is necessary to give consideration such as making it possible to disclose.

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3 Explanation items
Matters to be explained to research subjects, etc. when receiving informed consent are the original
The rule is as follows. However, in response to the opinion of the Ethics Review Committee, the head of the research institution
This does not apply to the permitted matters.
(1) The name of the research and the permission of the director of the research institution for the implementation of the research
(2) Name of research institution and name of principal investigator (place to conduct research in collaboration with other research institutes)
In that case, the name of the joint research institution and the name of the principal investigator of the joint research institution are included. )
③ Purpose and significance of research
④ Research method (including the purpose of use of samples and information obtained from the research subjects) and period
⑤ Reason for being selected as a research subject
⑥ Burden on research subjects and expected risks and benefits
⑦ Even if you agree that the research will be conducted or continued, you can withdraw it at any time.
To that effect (it may be difficult to take measures according to the content of the withdrawal from the research subject, etc.
If so, and the reason)
⑧ By disagreeing with or withdrawing consent to conduct or continue research
That the research subjects will not be treated unfavorably
⑨ How to disclose information about research
⑩ Protection of personal information, etc. of other research subjects and the research concerned at the request of the research subjects, etc.
Includes research plans and materials related to research methods within the range that does not hinder the assurance of originality
The fact that it can be viewed by hand or the method of obtaining or viewing it
⑪ Handling of personal information (method of anonymization, anonymous processing information or non-identification processing)
When creating information, include that fact. )
⑫ How to store and dispose of samples and information
⑬ Research institutes such as research funding sources, conflicts of interest related to research by research institutes, personal profits, etc.
Situation regarding conflicts of interest related to research
⑭ Response to consultations, etc. from research subjects and related parties
⑮ If there is an economic burden or reward for the research subject, etc., that fact and its contents
⑯ Matters concerning other treatment methods, etc. in the case of research involving medical practice that exceeds normal medical care
⑰ In the case of research involving medical practice that exceeds normal medical care, after conducting the research to the research subjects
Correspondence about provision of medical care in
⑱ Regarding the health of the research subjects, genetic characteristics that can be inherited by offspring, etc. with the implementation of the research
If there is a possibility that important findings can be obtained, the research results (accidental) related to the research subject
Including findings. ) Handling
⑲ In the case of invasive research, whether or not there is compensation for health damage caused by the research
And its contents
⑳ When obtaining consent from the research subject, etc. regarding the samples and information obtained from the research subject, etc.
Possibility to be used for future research not specified in terms of points or provided to other research institutes
If there is a possibility of doing so, what is expected at the time of receiving consent to that effect
㉑ If the study involves invasion (excluding minor invasion) and involves intervention, the study

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For those engaged in monitoring and audits on the premise that the confidentiality of the target person is preserved
The person engaged and the ethics review committee will discuss the research subject to the extent necessary.
To browse samples / information
1 The twelfth and third provisions explain to the research subjects when receiving informed consent.
It defines the matters to be clarified. The contents to be explained are all matters from ① to ㉑ (⑮?
As a general rule, it should be (only when applicable). However, depending on the content of the research, etc.
May have some items that do not necessarily require explanation. Whether or not to omit a specific item is unique
The principal investigator decides, indicates the reason, and after examination by the Ethics Review Committee, it is appropriate.
It is necessary to receive the opinion and obtain the permission of the director of the research institution. For the content and degree of explanation,
Burdens of research subjects, etc. related to individual research contents and procedures for receiving informed consent, etc.
It is necessary for each research institution to make a decision after considering the above. However, when the explanation is omitted
It is necessary to describe the content and reason in the relevant item of the research plan. Items for which explanation is omitted
Regarding the place, the research plan can be disclosed at a later date at the request of the research subjects, etc.
It is necessary to consider such things as.
In addition to the matters listed here, the intellectual property rights and ownership of samples and information, etc.
Matters deemed necessary according to the content of the research will be added as appropriate at the discretion of each research institution.
It is desirable to add.
2 It is desirable to explain that the provisions of (1) have also been examined by the Ethics Examination Committee.
3 Regarding the provisions of ②, when conducting research in collaboration with other research institutes, the joint research institution
Including the name and the name of the principal investigator of the joint research institution, and then other than the research institution
If a person who provides existing samples / information is included, the name of the person and the institution to which the person belongs
It is desirable to include the name of (in the case of a large number, attributes related to the entire provider, etc.).
4 Regarding the provisions of (4), when the purpose of use includes providing samples and information to other institutions.
Needs to explain to that effect. For example, collecting samples / information from the samples / information used in the research
Dependence on databases, etc. to be provided to institutions for sale or for use in other research
When registering data, it is conceivable to explain to that effect.
When providing samples and information to persons overseas (including cases where they are provided by consignment), the first
In principle, it is necessary to obtain consent to that effect in accordance with the provisions of 12-9, but those who are overseas with the consent
If you provide it to, please explain to that effect as well.
In addition, regarding the method of creating records related to the provision of samples and information, trials that are considered inappropriate
Keep a record so that the distribution channel can be tracked after the fact when the distribution of fees and information occurs.
Therefore, it is not necessary to explain it to the research subjects.
5 Regarding the provisions of ⑪, personal information related to the research subject, etc. (for example, obtained from the research subject, etc.)
When providing samples / information that is not anonymized) to joint research institutes, provide it.

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Contents of personal information, etc., the name of the collaborative research institution to be provided, use at the collaborative research institution
Explanation including the name or name of the person responsible for the purpose and management of the personal information provided
There is a need to. Regarding the personal information provided to the joint research institute, from the research subjects, etc.
When a request is made pursuant to the provisions of 16th 2 (3), (4) or (9), the relevant personal information, etc. will be retained.
It may be necessary to take action at all joint research institutes.
6 Regarding the provisions of ⑭, from the perspective of protecting the personal information of other research subjects and the intellectual property rights of researchers.
If you cannot answer from, you need to explain to that effect.
7 Regarding the provisions of ⑯, "other treatment methods" that require explanation are, in principle, already established treatment methods.
However, participation in other research may be explained as necessary. Also of research
Depending on the content, explain options other than aggressive treatment (palliative care, follow-up, etc.)
It is included in the required "other treatment methods, etc."
8 Regarding the provisions of ⑳, there is a possibility of conducting research that is not specified at the time of obtaining consent in the future.
(Including the case of conducting another research and the case of changing the plan of the preceding research)
Can be used for future research in the procedure of informed consent related to the research to be conducted
As much as possible, explain the expected contents of at least ②, ③, ④, ⑥ and ⑬, including the possibility.
It shall be revealed. Based on this, the research subjects, etc. will use it for future research.
If consent is obtained, the information will be notified and disclosed to the research subjects in accordance with the 12th-5th provisions.
By guaranteeing the opportunity for refusal, it is necessary to take the procedure to receive informed consent again.
Absent. However, this is a general and vague form of mere "use for medical research".
It should be noted that it does not allow loose paper mandates. In addition, it is offered to those who are overseas
If there is a possibility of providing it, it is necessary to obtain consent to that effect in principle.
Regarding the 9 ㉑ provision, the investigation by the regulatory authority, etc. may confirm the information of the research subject at that time.
Inform because it is possible, but it is done in the event of a serious non-compliance with the guidelines
It is not uniformly required as an explanation when receiving a de-outlet.

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4 Matters to be notified or disclosed to the research subjects, etc.
In the provisions of 1 or 9, the matters to be notified or disclosed to the research subjects are as follows.
And.
(1) Purpose of use and method of use of samples / information (including the method if provided to other institutions)
(2) Items of samples and information to be used or provided
③ Scope of users
④ Name or name of the person responsible for the management of samples and information
⑤ Utilization of samples and information that identify the research subject at the request of the research subject or his / her agent.
To stop providing for use or to other research institutes.
⑥ How to accept the request of the research subject of ⑤ or its agent
1 "Notify the research subjects, etc." means to notify the research subjects, etc. directly, and the nature of the research.
And, depending on the handling status of samples and information, the content is rational and appropriate to be recognized by the research subjects, etc.
Must depend on the method.
Case 1) Notify by directly handing out documents such as leaflets.
Case 2) Inform by oral or automatic response device.
Case 3) Knowledge by sending by e-mail, fax, etc., or by sending a document by mail, etc.
To let.
2 “Public” means to inform the general public that the research will be conducted (unspecified number of people know).
(Announce so that you can do it), and when publishing it, the nature of the research and the sample / information
It must be done in a rational and appropriate manner according to the handling situation of the information.
Example 1) A place that can be reached from the top page of the homepage of a research institution with about one operation
Posting to the place
Case 2) Poster in a place where research subjects are expected to visit, such as medical institutions
Posting, pamphlets, etc.
3 "(1) Purpose of use and method of use of samples / information (including the method if provided to other institutions)
Mu. ) ”Includes an outline of the research (name, purpose, research period, etc.). Overview of research
When notifying or publishing, the scope of the research subjects in the research is clear from the perspective of a third party.
Be careful so that you can understand it accurately.
Which of the following is the case when providing it to a joint research institution or a person overseas, or when making it public to the general public.
To the extent necessary so that the research subjects can understand whether to provide or publish in such a way
Include laws (recording media, mail, electronic distribution, posting on the Internet, etc.).
4 "② Items of samples / information to be used or provided" means the samples / information to be used or provided.
Refers to common names (eg blood, hair, fluid, excrement, test data, medical records, etc.)
To the extent necessary, so that the research subjects can understand what kind of sample / information will be used.
Include the contents of.

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5 “③ Scope of users” means the names and research institutes of all joint research institutes that carry out the research.
Refers to the name of the person in charge of research. Includes those who provide existing samples and information other than research institutes
In that case, include the name of the person concerned and the name of the institution to which the person concerned belongs. However, of the user
If the number is large and it is difficult to list all of them individually and notify or publish them,
The following alternative methods can be used.
・ Notify or disclose the name of a representative research institution and the name of the principal investigator of that institution.
By notifying or disclosing the attributes, etc. related to the entire user, research
Clarify to the extent that the target person can determine to what institution it will be used in the future
・ If the range of users is announced on the websites of representative research institutes,
List and describe the site of
6 “④ Name or name of the person responsible for the management of samples / information” means research at your own facility.
In the case of doing, it refers to the name of the principal investigator. Also, when conducting joint research at multiple facilities
If there is, the name of one research institution representing all joint research institutes or belonging to that institution
Refers to the name of the principal investigator.
7 "⑤ Samples and information that identify the research subject at the request of the research subject or his / her agent.
"Stopping the use of or providing to other research institutes" means samples and information about the research subjects, etc.
The person himself / herself refuses to use the information for the research (including providing it to other research institutes).
It means to secure an opportunity.
"Agent" means a request to stop the use or provision of samples / information that identifies the research subject.
Refers to a delegated agent (including a voluntary guardian who has been granted proxy rights; the same shall apply hereinafter).
If the subject of the study is a minor, it means a parent or guardian of the minor. Research subject is dead
In this case as well, the basics are those who are considered to be able to represent the will and interests of the research subjects.
8 "Method of accepting the request of the research subject of ⑥ ⑤ or its agent" is, for example, as follows.
Such a method can be considered.
Case 1) Mail
Case 2) Sending an email
Case 3) Input to the designated form on the homepage
Case 4) Reception at the office window
Case 5) Telephone
9 When notifying or disclosing the research subjects, etc., the following matters based on the 16th provision shall also be taken into consideration.
It is conceivable to disclose it at the same time.
・ The fact that research plans and materials related to research methods can be obtained or viewed (other research subjects, etc.)
This includes the fact that it is limited to the extent that it does not interfere with the protection of personal information and intellectual property. ) And that
How to get and browse

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・ Procedures related to disclosure of personal information pursuant to the 16th provision (the amount of the fee pursuant to the 16th 2⑵ provision)
When stipulated, the amount of the fee is included. )
・ Notification of purpose of use pursuant to the provisions of 16th 1⑵, disclosure pursuant to the provisions of 16th 2⑴, or the same ⑸
If it is not possible to explain the reason according to the regulations, the matter and the reason
・ Information on how to respond to consultations, etc. from research subjects and related parties (see 8th ⑴⑭)

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5 Procedures for using samples and information for research that was not specified at the time of obtaining consent
Researchers, etc. are expected to use the samples and information at the time of obtaining consent from the research subjects, etc.
Etc. were explained as much as possible, and then the purpose of use, etc. was newly specified.
In some cases, after creating or changing the research plan, the newly specified purpose of use, etc.
As a general rule, information should be notified or disclosed to the research subjects, etc., and the research should be carried out.
Therefore, it is necessary to guarantee the opportunity for the research subjects to withdraw their consent.
1 The twelfth and fifth provisions are the use of samples and information for research that was not specified at the time of consent.
It stipulates the procedure of. The application of this provision is when consent is obtained from the research subjects, etc.
It is premised that the intended use, etc. that is expected in terms of points is explained as much as possible.
It should be noted that this is limited to cases where the purpose of use is newly specified within the scope of the explanation.
2 “Studies that were not identified at the time of consent” are, for example, prospective cohort studies.
In the case of acquiring follow-up information of research subjects, additional information is acquired for new research purposes.
Using the collected cells, tissues, and information in research on cases and treatments for specific diseases
Then, a study to analyze the relationship with another disease set after that can be considered. in this case,
After creating or changing the research plan for the research, the procedure will be carried out within the research institution.
There is a need. Regarding "We must guarantee the opportunity for research subjects to withdraw their consent"
For details, refer to the explanation of 12th 1 (1) (a) (2) (opt-out).
3 "In principle" includes the personal identification code for the samples and information used in the research.
It is necessary to handle it as personal information due to being confused, but it does not have the contact information of the person, etc.
Therefore, it is assumed that it is difficult to guarantee the opportunity for the research subjects to refuse.

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6 Handling of research in situations where the research subject is in an urgent and obvious life-threatening situation
Researchers, etc. must meet all of the following requirements, as stipulated in the research plan in advance.
If it is determined that this is the case, the research can be conducted without the consent of the research subjects, etc.
To However, if the research is conducted, the explanation items according to the provisions of 3 will be promptly stated.
Informed consent procedures must be carried out in accordance with the documents provided.
(1) There is an urgent and obvious life threat to the research subject.
(2) In the case of research that involves intervention, sufficient effects cannot be expected in normal medical care, and research is conducted.
It is recognized that there is a good possibility that the life threat of the research subject can be avoided.
(3) The burden and risk incurred by the research subjects as a result of conducting the research are the minimum necessary.
That.
④ It is not possible to immediately contact the substitute or the person who should be the substitute.
1 The 12th and 6th provisions apply to the situation where the research subject is in an urgent and obvious life-threatening situation.
It stipulates the handling of research. When performing this procedure, the contents of item 8 (1) and (7) shall be applied.
It is necessary to describe it in the research plan in advance.
2 ① "There is an urgent and obvious danger of life" is extremely urgent in terms of time.
I think that it is not possible to obtain proper consent not only from the research subjects themselves but also from their substitutes.
It has been determined, and for example, a severe head injury or a state of cardiac arrest can be considered.
3 ② "There is a good chance that the danger of life can be avoided" does not necessarily mean that the effectiveness has already been proved.
It is not limited to conducting the research that has been revealed.

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7 Simplification of informed consent procedures, etc.
(1) Researchers, etc. or those who provide existing samples and information meet all of the following requirements.
If you intend to carry out research, specify it in the research plan approved by the director of the research institution.
Thereby, a part of the procedure under the provisions of 1 and 2 can be simplified.
(1) Do not involve invasion (excluding minor invasion) in conducting research.
(2) Simplifying the procedures under the provisions of 1 and 2 does not disadvantage the research subjects.
thing.
③ It is difficult to carry out research, or it is difficult to carry out research unless the procedures under the provisions of 1 and 2 are simplified.
Significantly undermine the value of research.
(4) The research must be recognized as having high social importance.
(2) Researchers, etc., if the procedure under the provisions of 1 and 2 is simplified by the provision of (1),
Appropriate measures must be taken among the following.
(1) Purpose and content of collection and use of samples and information for a group including research subjects, etc.
To publicize (including methods).
(2) Promptly give ex post facto explanations (including those to the group) to the research subjects, etc.
thing.
③ If samples / information are continuously collected or used for a long period of time, the company
Publicize the actual situation to the association, including the purpose and method of collecting or using the sample / information.
And strive to be known to society.
1 The 12th-7th provisions stipulate the simplification of informed consent procedures.
Is. To simplify a part of the informed consent procedure, please refer to (1) to (4) of (1).
Regarding satisfying all the requirements, the reason is set as the content of 8 ⑴ ⑦, and the research total
It is necessary to specify it in the picture book.
As a study that can simplify the procedure, for example, a questionnaire conducted anonymously.
This is a survey, and by communicating the purpose of the survey in advance, the research results will be biased.
Research that may be frustrated is conceivable.
2 ⑴ ④ “Socially important research” means, for example, prevention and cure of diseases important for public health.
Samples and information related to medical treatment that have not been anonymized due to the systematic cooperation of society as a whole.
It is conceivable that it is necessary to utilize the information. Informed consent by this regulation
Protecting the rights and interests of the research subjects and the results of the research when simplifying the procedure of cents
From the perspective of comparative consideration with, the ethics review committee should judge the suitability. In addition, it should be noted.
When using samples obtained from the human body, the concept of protecting the rights and interests of research subjects, etc.
"About the ideal way of research and development using human tissues removed by surgery, etc." (Health Science Council)
Please refer to the report (December 16, 1998). Informed consent
Even if the procedure is simplified, the laws and regulations applicable to the protection of personal information (individuals)
Information Protection Law, Administrative Agency Personal Information Protection Law, Personal Information Protection Law such as Incorporated Administrative Agencies and Local Public Organizations
(Ordinances, etc. enacted in) must be observed. Consistency with laws and ordinances

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In the end, the principal investigator will make a primary decision, indicate the reason, and the ethics review committee will review and compromise.
It is necessary to obtain the permission of the head of the institution in response to the opinion that it is true.
3 ⑵ ① “Group including research subjects” means, for example, the place where the research subjects live.
Refers to a group of local residents when conducting an epidemiological survey on an area. This
As a method of public relations to the group, document circulation to all dwelling units, public notice at public halls, etc.
Posting on the group's homepage is conceivable.
4 ⑵ ③ "The actual situation" means, for example, receiving informed consent for a long period of time.
It is conceivable to weigh the necessity, importance, and danger of conducting the research without making a judgment.
Be done.

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8 Withdrawal of consent, etc.
Researchers, etc. may withdraw or refuse consent that falls under any of the following from the research subjects, etc.
If there is, we will take measures according to the contents of the withdrawal or refusal without delay, and
This must be explained to the research subjects, etc. However, take such measures
Hear the opinion of the Ethics Review Board about not taking such measures in difficult cases
This shall not apply when the director of the research institution approves it. In that case, the withdrawal or
Researchers, etc. are the subjects of the research regarding the fact that they will not take measures according to the content of the refusal and the reason.
We must try to gain understanding by explaining to others.
① Withdrawal of all or part of the consent given regarding the implementation or continuation of the research
(2) The research is carried out or continued based on the information notified or published about the research.
Refusal of all or part of what is done (including refusal of 13th 1 (1) (a) (2))
③ Research is conducted or continued in the procedure of informed consent pursuant to the provisions of 6.
Refusal of all or part of what is done
④ Informed consent from the research subject regarding the research for which the consenter has given consent
Refusal to carry out or continue the study in whole or in part in the procedure
1 The 12th-8th provisions stipulate the procedure in case of withdrawal or refusal of consent.
To Those who provide existing samples and information receive informed consent or research.
When notifying the research subject, etc. about the research or disclosing the information, existing samples / information
If the research subject, etc. withdraws or refuses the consent of the person who provides the information, the existing trial
The person who provides the fee / information promptly informs the researcher who provided the existing sample / information.
The fact that the consent has been withdrawn or refused and the details thereof shall be communicated.
2 No withdrawal or refusal of consent from the research subjects, etc. to carry out or continue the research.
If so, it is desirable that a written statement to that effect be given to researchers. On the other hand, the document
When requested, the research subjects may hesitate to withdraw or refuse their consent.
To prevent this, the principal investigator should take measures such as preparing a document form for withdrawal or refusal in advance.
Is appropriate. However, when the consent is verbally withdrawn or refused by the research subjects, etc.
In that case, you can flexibly deal with it by taking necessary measures promptly without waiting for a written manifestation of intention.
It is desirable to respond. In addition, when requesting withdrawal of consent or refusal, request the presentation of the reason.
Is suspected to be an adverse event because it may lead to atrophy of the offer.
It is not appropriate unless it is necessary, such as when it is necessary.
3 “Measures according to the content of the withdrawal or refusal” means, for example, the use of samples and information already obtained.
Suspension / disposal, suspension of provision of samples / information to other organizations, etc. are expected.
4 “When it is difficult to take measures” means, for example, a medical device implanted in the body by research.
Withdrawal of consent for research results and withdrawal of consent for research results that have already been published as a treatise
Be done. In such a case, the ethics review committee will not take such measures.

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If the director of the research institution approves after hearing the observation, do not take measures to withdraw or refuse the consent.
It is okay, but regarding the fact that the measures are not taken or cannot be taken and the reasons for that,
Please note that researchers must explain to the research subjects and try to gain their understanding.
There is a need.
5 When preparing a research plan, refusal of informed consent as the content of 8 ⑴ ⑦
Clarify the policy for responding to no or withdrawal, and receive informed consent
When making a request, fully explain the response to refusal or withdrawal as the content of 12th 3⑦.
You need to get consent. Specifically, it is possible to assume such a case even before the start of research.
Consent withdrawal regarding withdrawal of consent in the explanation in Informed Consent
It is desirable to explain what cannot be done or how difficult it is to take action.
In addition, in research involving invasiveness, when the consent of the research subject is withdrawn, the research institute concerned
It is generally said that discontinuing the investigation does not correspond to "when it is difficult to take such measures".
Conceivable.
6 ④ “Informed consent from the research subject regarding the research for which the consenter gave consent
"Procedures" means when research is conducted by receiving informed consent from a surrogate.
After that, the research subject can give informed consent by himself / herself.
Even after reaching the situation (for example, the situation specified in 13th 1 (3)), the research subject is still involved in the research.
When continued (based on the same research plan, continue to invade the research subject
It refers to cases where it is expected to accompany, intervene, or acquire new samples / information.
same as below. ) Etc., perform informed consent procedures from the research subject
It is supposed to be.
7 Implementation of studies that are not expected to have direct health benefits to the study subjects and are invasive.
At that time, the research subjects were observed in particular, and it seems that they were suffering unreasonable pain.
If you are injured, even if the research subject does not express your intention to withdraw your consent, the research subject will be notified.
It is appropriate to refrain from continuing research on this.

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9 Handling when providing samples and information to persons overseas
When providing samples / information used for research to persons overseas (of the samples / information)
This includes cases where all or part of the handling is outsourced to a person overseas. ) Indicates that the person concerned has personal information
Law Enforcement Regulations on Protection (2016 Personal Information Protection Commission Regulation No. 3; hereinafter "Personal Information"
It is called "Protection Law Enforcement Regulations". ) Or in the country specified in) or the Personal Information Protection Law Enforcement Regulations
If you have a system that meets the standards set forth in the above, or provide samples and information in accordance with the provisions of laws and regulations.
Regarding the provision of samples and information used for research to the person concerned, except when
Appropriate consent of the person to be investigated must be obtained.
In addition, except when providing samples / information pursuant to the provisions of laws and regulations, researchers, etc. are responsible for the samples / information.
A record of the provision of information must be made.
The principal investigator is three years from the date when the sample / information was provided for the record created by the researcher, etc.
Must be stored for a period of time up to the date when.
However, if it is difficult to obtain appropriate consent, one of the following (1) to (3)
When applicable, it is possible to provide samples and information used in the research to persons overseas.
Wear.
(1) Proposal of sample / information regarding the fact that the sample / information falls under any of the following
The head of the institution that provides the information should be able to understand the provision of the sample and information.
(1) Anonymized (limited to those that cannot identify a specific individual)
That.
(2) Must be anonymously processed information or non-identified processed information.
③ There is a particular reason for providing other relevant samples / information when using it for academic research.
If there is, and the matters from 4 ① to ④ are notified or made public to the research subjects, etc.
However, it is immediately possible to determine which research subject's sample / information is anonymized.
Limited to those that have been processed or controlled so that they cannot be separated. ).
⑵ If it does not correspond to ⑴, and when using it for academic research, other relevant samples / information
If there is a particular reason to provide it, it means that it meets the following requirements.
After hearing the opinions of the Ethics Review Committee, obtain the permission of the head of the organization that provides samples and information.
That you are.
(1) Regarding the implementation of the research and the provision of the sample / information to persons overseas, 4 (1) to (6)
Notify or disclose the above matters to the research subjects.
(2) As a general rule, keep an opportunity for research subjects to refuse to carry out research.
To hinder.
⑶ If it does not fall under either ⑴ or ⑵, it is recognized as a research of high social importance.
If this is the case, take appropriate measures from 7 (2) (1) to (3).
After hearing the opinion of the Ethics Review Committee, the head of the organization that provides samples and information
Have permission.

1 The 12th to 9th provisions apply to persons overseas (including businesses such as research institutes and inspection contractors).

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However, it stipulates the procedure for providing samples and information used in research. here
In order to outsource some of the research work (analysis of samples and information, etc.)
Please note that this includes cases where it is provided to a person. In addition, it is offered to those who are overseas other than consignment.
When providing, also comply with the provisions of 12th 1 (1) or (3).
2 "Law Enforcement Regulations on the Protection of Personal Information (2016 Personal Information Protection Commission Regulation No. 3).
Hereinafter referred to as "Personal Information Protection Law Enforcement Regulations". ) Is the country specified by the Personal Information Protection Commission.
See the rules.
As of March 2017, the countries stipulated in the Personal Information Protection Law Enforcement Regulations are:
Absent.
3 "A system that conforms to the standards stipulated in the Personal Information Protection Law Enforcement Regulations" is either (1) or (2) below.
If it meets the requirements and it is confirmed that such a system is secured, the relevant

It is not necessary to obtain the consent of the research subjects, etc. regarding the provision of samples and information to those overseas.
I. In this case, if it is provided to a joint research institution overseas other than by consignment, the 12th 1
Only ⑴ or ⑶ is applicable, and if it is provided by entrustment, it is not a research institution, so 12th 1
It is not necessary to apply the provisions of. We have confirmed that such a system is secured.
If so, specify that fact in the research plan.
(1) Receive the provision between the provider's institution and a person overseas who receives the sample / information.
Regarding the handling of the sample / information by a person who is a person, by an appropriate and rational method, an individual
Measures in line with the purpose of the provisions of Chapter 4, Section 1 of the Information Protection Law (or the provisions of Chapter 6 of this guideline)
Is ensured.
② Must be certified based on the international framework for handling personal information
The "appropriate and rational method" of (1) should be judged for each individual case.
What the personal information handling business operator in Japan should take for those who are overseas to whom the samples and information are provided
In a way that can ensure that measures equivalent to the alleged measures are taken continuously
There must be, for example, when entrusting the handling of samples and information to a person overseas,
This applies to contracts, confirmations, memorandums, etc. between the provider and the provider. In ①, "appropriate and correct
Measures equivalent to those in Japan by the method described in "reasonable method" (contract, confirmation, memorandum, etc.)
This applies when the implementation of is ensured by a practically appropriate and rational method.
(2) "Certification based on the international framework for handling personal information" means odors from international organizations, etc.
Approved by an authorized certification body, etc. based on the agreed discipline.
We will continue to take measures equivalent to the measures that the business operator handling personal information should take.
It needs to be something that can be done. This can be done by someone overseas who is providing APEC's CBPR.
Applicable to having obtained system certification.

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<Reference>
Guidelines for the Law Concerning the Protection of Personal Information (Provision to Third Parties in Foreign Countries)
(2016 Personal Information Protection Commission Notification No. 7)
4 “Receiving appropriate consent” means providing samples and information obtained from research subjects to persons overseas.
Recognizing the manifestation of the research subject's intention to consent to the provision, always
It is not necessary to give informed consent. For the provision when receiving consent
Regarding the explanation, the research subjects agree, depending on the nature of the business and the handling status of personal information.
Must be in a rational and appropriate manner deemed necessary to make such a judgment.
I. For details, refer to the explanation in 1 (1) of the twelfth.
Reasonable and appropriate way to obtain consent to provide to those overseas
For example, the following cases are applicable.
(Example 1)
"To be used in research to clarify the morbidity and causes of XX disease, the database of the △△ Society
Register your information in the business. It may be registered in an overseas database. "
(Example 2)
"To be used in research to clarify the morbidity and causes of XX disease, the database of the △△ Society
Register your information in the business. The data registered in this database is overseas
It may be used in
(Example 3)
"For research to clarify the morbidity and causes of XX disease, we will use it in the database business.
Register your information. In the database business, personal information should be used as a guideline.
Therefore, it will be managed properly. The same applies even when registering in an overseas database business
Will be treated as. "
5 "Create a record regarding the provision of the sample / information" and "Provide the sample / information with the record"
For "storage for a period from the date of the operation to the date when 3 years have passed", refer to the explanation in 1 (1) of the 12th.
To do.
6 “When it is difficult to obtain appropriate consent” means, for example, sample / information from the research subject.
Since a considerable number of years have passed since the acquisition, the research pair due to death, retirement, relocation, etc.
It may be difficult to contact the elephant.
7 ⑴ "The head of the institution that provides the sample / information can understand the provision of the sample / information.
As for "what you are doing", the head of the institution is overseas in advance, as in the case of 12-1 (3).
Provision of existing samples and information after establishing rules regarding handling and procedures when providing to persons in
To keep a record of the provision of samples and information based on the regulations, and to the head of the institution
A method such as making a report is conceivable.

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8 ⑴ “Anonymized ones (samples / information of which research subject can be immediately identified)
Limited to those that have been processed or controlled so that they do not exist. ) ”, Refer to the explanation of 1 (3) of the twelfth.
For the provisions of 9 (2), refer to the explanation of 12 (1) (3).
10 (3) “Socially important research” refers to, for example, prevention and treatment of diseases important to public health.
Samples and information that are not anonymized due to the systematic cooperation of society as a whole.
It is conceivable that it is necessary to utilize. According to this regulation, samples and information are overseas.
When providing to a person, the protection of the rights and interests of the research subject and the comparison with the results obtained in the research
In terms of quantity, the Ethics Review Board should determine suitability.
In addition, when providing based on this regulation, personal information applicable to each research institution is separately applied.
It is also necessary to consider the consistency with laws and ordinances related to the protection of information. Law
Regarding the consistency with the rules and ordinances, the principal investigator will uniquely judge and indicate the reason for the morality.
It is necessary to obtain the permission of the head of the institution after being examined by the Physical Examination Committee and receiving the opinion that it is appropriate.
thing.

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Procedures, etc. when receiving informed consent from the 13th surrogate, etc.

Procedures, etc. when receiving informed consent from the 13th surrogate, etc.
1 Requirements for proxy consent, etc.
(1) Researchers, etc. or those who provide existing samples / information should follow the procedures under the 12th provision.
When receiving informed consent from a surrogate, etc., the following requirements are not required.
This must also be met.
A. The following items must be stated in the research plan.
① Policy for selecting representatives, etc.
(2) If the research subject is a person who falls under (a) or (b), the matters to be explained to the substitute, etc.
Includes explanation about ③. )
(3) If a person who falls under (a) or (b) is the research subject, that person should be the research subject.
Why you need to
B. The research subject falls under any of the following.
(A) Being a minor. However, the research subject has completed a course such as junior high school.
Is a minor over the age of 16 and has sufficient judgment regarding the conduct of the study.
If it is judged that you have the ability to cut, the following matters are stated in the research plan.
After hearing the opinion of the Ethics Review Committee regarding the implementation of the research, the head of the research institution
Informed consent from the research subject, not by the surrogate
Shall be received.
① The fact that the research is not invasive
(2) Publicize information on the purpose of the research and the implementation of the research, including the handling of samples and information.
The parental authority of the research subject or the parental authority of the research subject regarding the opening and the implementation or continuation of the research.
Guarantees the opportunity for underage guardians to refuse
(B) Objectively judge that he is an adult and lacks the ability to give informed consent.
Being a person who is refused.
(C) Being dead. However, the fact that the research is carried out is explicit in its lifetime.
Except when it is against your will.
(2) Researchers, etc. or those who provide existing samples and information should follow the procedures under the 12th provision.
When receiving informed consent from a surrogate, etc., follow the selection policy of (1) a (1).
Therefore, a substitute, etc. is selected, and for the substitute, etc., in addition to the provisions of 12-3, (1) a (2)
Must be explained.
(3) Researchers, etc. or those who provide existing samples and information will give informed consent from their substitutes.
If you have received a cent, the research subject has completed a course such as junior high school, or 16
Minors over the age of and have sufficient judgment about conducting research
When it is judged that, informed consent is also received from the research subject.
I have to do it.
1 The 13th item is that researchers, etc. or those who receive existing samples / information are provided by substitutes, etc.
Requirements to be met and matters to be observed when receiving informed consent
It is a fixed one.

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2 (1) A. Regarding the "policy for selecting substitutes, etc." in (1), in general, those listed in (1) to (3) below
Basically, a substitute person, etc. is selected from among them.
① (When the research subject is a minor) Parent or guardian of a minor
(2) Spouse, parents, siblings, children / grandchildren, grandparents, relatives living together or their close relatives
Persons who are considered to be equivalent to those (excluding minors)
(3) Agent of the research subject (including a voluntary guardian who has been granted the right of representation)
However, instead of selecting uniformly, the situation in each research subject, for example, research
In addition to spiritual joint relationships such as partnerships and relationships of trust with the subject, in some cases research
It is possible to represent the will and interests of the research subject, taking into consideration the possibility of abuse of the subject.
It is desirable to select a person who is considered to be. Informed consent from substitutes, etc.
When receiving a cent, it is also important to keep a record showing the relationship between the person in charge and the research subject.
is there.
3 ⑴ (a) “It is objective if you are an adult and lack the ability to give informed consent.
In relation to "the person judged by", the opinion on the medical consent right by the adult guardian is among lawyers.
Medical practice for research purposes, especially medical care that goes beyond normal medical care, based on the fact that it has not been decided in
Actions that are carried out for research purposes or that are not expected to have direct health benefits to the research subject
For things that are not good (for example, blood sampling for the purpose of prevention, diagnosis and treatment of injuries, drug administration, etc.)
If an adult guardian, guardian, etc. is appointed as the research subject, a substitute person is selected from them.
It is considered that the appropriateness of the determination should be judged carefully.
4 Immediately informed consent only by the appointment of an adult guardian, guardian, etc.
It is not appropriate to judge that it lacks the ability to give cents, as well as the condition of individual study subjects.
Contents of research to be conducted or continued (burden on research subjects and expected risks and benefits
It is necessary to make a judgment based on the existence, content, etc.).
In addition, regardless of whether or not it is judged that it lacks the ability to give informed consent,
Those who have been appointed as adult guardians, guardians, etc. are usually in the first ⑥ "socially vulnerable position".
A person who is considered to be a "person" and carefully judges the appropriateness of being a research subject and gives special consideration.
Is required.
5 ⑴ A. ③ "Reason why it is necessary to make the person a research subject", inform yourself
Samples and information that can be sufficiently obtained from research subjects who can give de-outlets
It is not appropriate to obtain information from someone who lacks the ability to give informed consent.
It is based on the fact that it can be justified to receive informed consent from the surrogate.
Basically, for the group to be studied (for example, infants, people with intellectual disabilities, residents of facilities, etc.)
It should be noted that this is limited to studies that are primarily related to specific events that are seen.
6 After conducting research based on informed consent received from the research subject, the relevant

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When the research subject lacks the ability to give informed consent due to injury or illness, etc.
However, the research is continued by the research subject, or the trial already obtained from the research subject
When the handling of fees and information is about to be changed, it is appropriate according to the provisions of 13th 1 (1) and (2).
A person who gives informed consent will be selected and the procedure for receiving the informed consent will be carried out. Na
Oh, ⑴ A. Objectively if you lack the ability to give informed consent according to the provisions of ③.
The reason why it is necessary to continue to make the judged person the research subject is stated in the research plan in advance.
It is assumed that it is described, and the opinion of the Ethics Review Committee regarding the implementation of the study is heard.
It should be noted that this is only possible if the director of the research institution permits it.
7 ⑴ A “minor” in (a) must have been married under the age of 20 in accordance with the provisions of the Civil Code.
Refers to those who do not.
8 Regarding ⑴a (a) and ⑶ "Completed the course of junior high school, etc.", the course of junior high school, etc. in Japan
If you have completed a course at a foreign junior high school, etc., you are basically 16 years of age or older.
Is a requirement. "Junior high school, etc." includes special support schools equivalent to junior high school
Is done.
9 ⑴ B (a) and ⑶ “Judged to have sufficient judgment ability regarding conducting research
Regarding "Ru", for minors who have completed a junior high school course or are 16 years of age or older, they are healthy.
Basically, if the mental development and mental health are recognized, it is related to conducting the research.
It may be judged that the person has sufficient judgment ability. For research involving invasiveness, yes
It is not possible to give valid informed consent to the research subject alone, and the parental authority
After receiving informed consent from a person who consents to the research, etc., according to the provisions of (3), the research pair
It is also necessary to receive informed consent from the elephant.
When conducting research after receiving informed consent from a surrogate, and then
When the research subject completes a course such as junior high school or reaches the age of 16 and conducts research
Even after it is judged that the research subject has sufficient judgment ability, the research will be continued to the research subject.
When continuing, it is necessary to receive informed consent from the research subject.
In addition, based on the consent received from the substitute, the samples and information already obtained from the research subject
This does not apply when analyzing, etc. within the scope of the consent.
10 ⑴ (a) “It is objective if you are an adult and lack the ability to give informed consent.
As a typical example, "a person who is judged to be" is in an unconscious state due to injury or illness.
Patients, people in a coma, etc. are possible. In addition, diagnosis of dementia, schizophrenia, etc.
Immediately "lacking the ability to give informed consent" only by what is being done
It is not appropriate to judge that, in addition to the condition of individual research subjects, research to be conducted or continued
Based on the content of (the burden on the research subjects, the presence or absence of expected risks and benefits, the content, etc.)
It is necessary to judge. "Judged objectively" means not involved in conducting the study
It means that it is judged that way from the viewpoint of a person (not necessarily a doctor), for example, two or more people.

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Procedures, etc. when receiving informed consent from the 13th surrogate, etc.

Confirmation by the above medical / long-term care workers (preferably different occupations), and can be a substitute
Discussions with other people (family members, etc.), cooperation with local consultation support specialists, care support specialists, etc.
Conceivable. If there are guidelines, etc. presented by related academic societies, professional associations, etc.,
It is desirable to refer to it as appropriate and reflect it in the research plan.
(1) Receive informed consent from a surrogate as a person who falls under (a) and carry out research.
Even if it was given, the research subjects did not fall under (1) a (a) after that (inform).
Even after the situation where it was possible to give a de-outlet), the research was continued to the research subject.
When continuing, it is necessary to receive informed consent from the research subject.
As in the previous section, it has already been obtained from the research subject based on the consent received from the substitute.
This does not apply when analyzing samples / information within the scope of their consent.

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2 Procedures for obtaining informed consent, etc.
(1) A researcher or a person who provides existing samples / information gives informed consent from a substitute.
Even if you receive a cent, your intention is that the research subject will carry out the research.
When it is judged that the direction can be expressed, informed ascent is obtained.
I have to try. However, inform from the research subject according to the provisions of 1⑶
This does not apply when receiving a de outlet.
(2) The principal investigator is expected to perform informed consent procedures pursuant to the provisions of (1).
If you intend to carry out the research to be conducted, explain the matters and theories to the research subjects in advance.
The clear method must be stated in the research plan.
(3) Researchers and those who provide existing samples / information are informed according to the provisions of (1).
In Ascent's procedure, the subject of the study is either wholly or continues to carry out the study.
If you express your intention to refuse a part, you must try to respect that intention.
Not. However, by conducting or continuing the research, the research subjects will be directly affected by their health.
This is not the case when the interests of the company are expected and the substitute agrees with it.
1 The 13th-2 provisions are informed by researchers, etc. or those who provide existing samples and information.
If you need to try to get an ascent, get a researcher or existing sample / information
Those that stipulate matters to be observed when a person obtains informed consent
Is.
2 In other countries, "Acent" or "Informed Ascent" refers to children as research subjects.
This guideline is not limited to children, but is used by study subjects.
Prescribed even when informed consent cannot be given due to injury or illness, etc.
There is.
3 ⑴ “If it is judged that you can express your intention to carry out the research
"Ki" is a state in which you can understand the language and express your own intentions based on rational thinking.
It means that you are in a state, for example, when you study minors under 16 years old, you are individual.
It is desirable to deal with it according to the intellectual maturity of the research subjects.
Guidance on clinical trials of drugs in pediatric populations agreed upon by ICH
Q & A regarding Q & A (June 22, 2001, Administrative Contact, Examination and Management Division, Pharmaceutical Affairs Bureau, Ministry of Health, Labor and Welfare)
Now, let's take a look at the guidelines of the American Academy of Pediatrics regarding the age at which ascents are obtained from pediatric subjects.
For reference, the guideline is generally 7 years old or older (written ascents are generally junior high school students or older).
It may be used as a reference depending on the content of the research.
4 Research is conducted by receiving informed consent from the surrogate, and then the research subject
It was decided that he could express his intention to continue his research.
In some cases, when the research subject intends to continue the research, the researcher, etc.
Efforts should be made to obtain informed ascent from the research subject. Also, from the substitute

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Research is conducted by receiving informed consent, and then the research subject continues the research.
When it is judged that he / she can express his / her intention to be
When the handling of samples / information obtained from the research subject is to be changed, the researcher
Etc., regarding the change, the procedure for informed consent from the person concerned is renewed.
It is necessary to give informed consent from the research subject as well as to do so.
To
5 The matters to be explained to the research subjects in the procedure of informed consent should be described in the research plan.
Of the items specified as explanatory items when receiving an informed outlet, the research
We shall endeavor to explain what we believe the subject can understand.
In addition, regarding the method of explaining to research subjects in the procedure of informed consent, the Institute
In addition to using easy-to-understand words according to the comprehension of the research subject, use illustrations and documents with figures and tables.
It is desirable to consider things such as the time required for understanding.
6 When receiving informed consent from a substitute, the knowledge of individual research subjects
Implementation or continuation even when informed ascent is not given in view of maturity
It is desirable to explain any matters that you think you can understand about the research to be done.
Castanopsis.

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Chapter 6 Personal information and anonymously processed information
14th Basic Responsibilities Regarding Personal Information, etc.
1 Protection of personal information, etc.
(1) Researchers and heads of research institutes handle personal information, anonymously processed information and non-identified processed information.
In addition to the provisions of this guideline, the Personal Information Protection Law, the Administrative Agency Personal Information Protection Law, Germany
Comply with the Personal Information Protection Law of Incorporated Administrative Agencies and the ordinances enacted by local public bodies
There must be.
(2) Researchers and the heads of research institutes should consider the dead in consideration of the dignity of the dead and the feelings of the bereaved family.
Information that can identify a specific individual is the same as that for a living individual.
Therefore, it must be handled appropriately in accordance with the provisions of 2 and 15 and take necessary and appropriate measures.
We must also take appropriate measures in accordance with the 16th provision and strive to take necessary measures.
There must be.
1 The 14th provision is to comply with the provisions of applicable laws and regulations regarding the protection of personal information, and to the dead.
It also stipulates the application of this guideline regarding information that can identify a specific individual.
It is.
2 In the laws concerning the protection of personal information listed in 14-1 (1), the following are generally made.
The content is stipulated.
① Rules for acquiring and using personal information (restrictions depending on the purpose of use, proper acquisition, etc.)
(2) Appropriate and safe management (ensuring accuracy, safety management measures, supervision of employees and contractors, etc.)
③ Mechanism of personal involvement (notification of purpose of use, disclosure, correction, suspension of use, etc.)
④ Grievance handling system (establishment of grievance window, etc.)
⑤ Rules for creating and providing anonymously processed information
⑥ Effectiveness guarantee mechanism (collection / advice, recommendations / orders, etc. of reports by the Personal Information Protection Commission)
The mechanism for protecting personal information also aims at the effective and proper use and distribution of personal information.
Because of this, in addition to acquiring directly from the person himself, acquisition through a third party or provision to a third party is also possible.
It has been decided.
3 Regarding the protection of personal information listed in the 14th 2nd to 17th provisions and the 14th 1st ⑴
The correspondence with the provisions of various laws is as follows.

Medicine for people

Government agency personal information
Individualsprotection
such as incorporated administrative agencies
Ethics related to system researchPersonal Information Protection Law
Dharmapala
Information Protection Law
Guidelines
14th 2 (1)

14th 2 (2)

Article 17 (Proper acquisition)-

Article 5 (proper acquisition)

Article 3 (Protection of personalArticle
information
3 (Protection of personal information
Article 16 (for the purpose of use
Yes restrictions, etc.)
Yes restrictions, etc.)
Restrictions by)
Article 8 (Use and provision Article 9 (Use and provision
Limitation)

Limitation)

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15th 1
15th 2 (1)

Article 6 (Measures to ensure safety
Article 7 (Measures to ensure safety
Place)
Place)

−

Article 20 (Safety management Article
measures
6 (Measures to ensure safety
Article 7 (Measures to ensure safety
Place)

Place)

Place)

15th 1 (2)

Article 21 (Employee Supervision
−
Governor)

16th 1

Article 27 (Owned individual deArticle 11 (Personal InformationArticle 11 (Personal Information
Matters related to data
Creating a file book and
Creating a file book and
(Publication, etc.)
Published)
Published)

16th 2 (1), (5)

Article 28 (Disclosure)

Articles 12-25

Articles 12-25

16th 2 (2)

Article 33 (Fee)

Article 26 (Fee)

Article 26 (Fee)

16th 2 (3), (5)

Article 29 (correction, etc.)

Articles 27-35

Articles 27-35

16th 2 (4)-(7)

Article 30 (suspension of use, etc.) Articles 36-41

16th 2 (8), (9)

Article 47 (Disclosure Request, Article
etc.) 46 (Disclosure Request, etc.)
Article 32 (Request for Disclosure, etc.
To those who try
To those who try
Procedures for responding to requests, etc.)
(Provision of information, etc.) (Provision of information, etc.)

16th 1 (4), 2 (5),
(7)

(In Article 8 of the Administrative
(In Procedure
Article 8 ofAct
the Administrative Procedure Act
Article 31 (explanation of reason)
(Presentation of reason)
(Presentation of reason)

−

Articles 36-41

Articles 36-39 (anonymous
17th

Processing information handling−business operator
Etc.)

−

4 Article 76, Paragraph 1, Item 3 of the Personal Information Protection Law states that "universities and other institutions for the purpose of academic research"
Or groups or persons belonging to them handle personal information for the purpose of providing it for academic research.
In that case, it is stipulated that the provisions of Chapter 4 of the same law do not apply. However, Article 76, Paragraph 3 of the same law states.
Regarding the business operators handling personal information that are exempt from this application, "Safety of personal data or anonymously processed information"
Necessary and appropriate measures for all management, handling of complaints regarding the handling of personal information, etc.
Take the necessary measures to ensure the proper handling of personal information, etc., and the content of the measures
We must endeavor to make it public. " This guideline is based on the Personal Information Protection Law.
The head of a research institution that is not subject to some regulations and researchers belonging to that research institution must be on their own.
It also serves as a guideline for taking necessary measures.
5 Matters stipulated in Chapter 6 of this guideline are applicable to the protection of personal information.
You may respond in accordance with the personal information management system maintained by each research institution based on laws and regulations.
In medical research involving 6 people, not only living individuals but also dead people should be targeted.
There is also, "A guide for the proper handling of personal information by medical / long-term care related businesses.
Line ”(December 24, 2004, Medical Administration No. 1224001, Yaksik No. 1224002, Older No. 1224003
No. Director of Medical Affairs Bureau, Ministry of Health, Labor and Welfare, Director of Pharmaceutical and Food Safety Bureau, Director of Health and Welfare Bureau, revised on April 21, 2006, Heisei
Revised on September 17, 2010) and "Guidelines for Provision of Medical Information, etc." (September 12, 2003, issued by the Medical Association)
No. 0912001 (Notice of Director of Medical Affairs Bureau, Ministry of Health, Labor and Welfare) states that the same safety pipe is used even after the death of a patient or user.
It follows that it stipulates that legal measures should be taken and that medical information should be provided to the bereaved family.
Eh, the scope of personal information protection in this guideline is defined, and the provisions of 14th 1 (2)

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Shows the outline.
7 Both the 14th 2nd and 15th provisions can identify a specific individual with respect to the dead.
It stipulates "personal information, etc." including information such as information, regardless of the provisions of 14th 1 (2).
In addition, researchers and research on information that can identify a specific individual about the dead
The head of the institution shall handle it appropriately in accordance with the provisions of 14-2 and 15 and take necessary and appropriate measures.
It will be a mess.
8 The 16th provision is personal information acquired as a result of conducting research and is held by the research institution.
It stipulates measures such as disclosure of what is being done (personal information held), and death
For information that can identify a specific individual about a person, refer to the provisions of 14th 1 (2).
Therefore, "We must take appropriate measures in accordance with the 16th provision and strive to take necessary measures.
It stipulates that.
When the research subject dies after the research is conducted, or when the dead person is the research subject, etc.
It should be noted that the 16th provision applies mutatis mutandis as an obligation to make efforts.
In addition, some information may be information about multiple individuals at the same time, and it concerns the dead.
If the information is also information about a living individual such as a bereaved family, the living individual
As "personal information" related to the above, it is necessary to deal with the person, etc. in accordance with the 16th provision.

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2 Appropriate acquisition, etc.
(1) Researchers, etc. collect personal information, etc. by deception or other fraudulent means when conducting research.
Don't get it.
(2) As a general rule, researchers, etc. go beyond the scope of prior consent from the research subjects, etc.
Therefore, personal information, etc. acquired as a result of conducting research must not be handled.
1 The provisions of (1) are appropriate for researchers, etc. to acquire personal information, etc. in connection with the implementation of the research.
It stipulates that it should be done by the right means.
Even if you receive a offer from another person and acquire it, for example, fraud in the person who provides the offer
In the case of participating in or jointly implementing the means of, or directly participating in the illegal acquisition of individual personal information, etc.
Even if it is not done, the personal information etc. will be used and provided as a group as a whole and continuously.
If so, regarding personal information, etc. that is clearly obtained illegally or provided illegally
If you receive the offer, etc., it may be an illegal acquisition.
2 Regarding "False and other fraudulent means" in (1), "False" is an example of "False means" and "False".
In addition to "ri", illegal or improper methods and procedures are also included. For example, for the person
If you falsely acquire the fact that you are collecting personal information or the purpose of collecting it, or if you have a legitimate right
There may be cases where personal information managed by others is acquired without limit.
In addition, the person, etc. requests suspension of use of personal information, etc. acquired by fraudulent means.
In such cases, the provisions of 16th 2 (4) and (8) will be applied.
3 ⑵ stipulates the scope of prior consent from the research subjects, etc., except in certain cases.
Beyond that, by prohibiting the handling of personal information, etc. acquired in connection with the implementation of research,
Personal information etc. will be handled unnecessarily by unlimited use, and the rights and interests of the person will be infringed.
It is an attempt to prevent. In addition, if the consent of the person is obtained, the purpose of use
It is possible to add or change.
4 ⑵ "In principle" requires the consent of the research subjects, etc. under the 12th provision.
In some cases, it may not be necessary, or in some cases it may be difficult to obtain consent.
In such a case, it is not clear whether or not it is within the range of consent from the person, so
The purpose is to make an exception. Even in such a case, the range necessary to achieve the purpose of use
It is natural not to handle it beyond the limit, and when the person himself / herself requests suspension of use, etc., the 12th 8th
It is desirable to respond according to the 16th provisions of 2 (4) and (8), taking into account the provisions of.

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15th safety management

15th safety management
1 Proper handling
(1) Researchers, etc. are personal information, etc. acquired in connection with the implementation of research, and are the places of the researchers, etc.
Those owned by the research institution to which they belong (including cases where they are stored on consignment.
Personal information, etc. " ), Prevention of leakage, loss or damage, and other safety management
Therefore, it must be handled properly.
(2) The principal investigator will properly handle the personal information, etc. that he holds when conducting the research.
It is necessary for other researchers who handle the information in cooperation with the head of the research institution.
Guidance and management must be provided.
2 System development, supervision, etc. for safety management
(1) The head of the research institution holds personal information, etc. that it holds to prevent leakage, loss, or damage.
Necessary and appropriate measures must be taken for the security management of personal information.
(2) The head of a research institution is an individual possessed by researchers, etc. who are involved in conducting research at the research institution.
When trying to handle personal information, etc., establish the system and regulations necessary for the safety management.
In addition to being prepared, researchers, etc. will be able to manage the safety of their personal information, etc.
Necessary and appropriate supervision must be provided.
1 The 15th provision stipulates the safety management of personal information, etc. held by research institutes.
Not only the information used for research, but also personal information acquired as a result of conducting research.
Necessary and appropriate pipes owned by research institutes, not belonging to individual researchers, etc.
Basically, it is placed under the supervision of the director. Owned by researchers for the purpose of personal gain
In the case where personal information etc. is taken out and sold, the research institution to which the researcher belongs
If the supervisory obligation is not properly taken by the head of the research institute, the supervisory responsibility of the head of the research institution concerned
You may be asked to take charge. In addition, personal information, etc. held can be passed between research institutes.
It is considered that the safety management measures include the points to be noted when they are made.
In addition, we will try to identify a specific individual for anonymized samples and information without any reasonable reason.
Prohibition of acts is also considered to be included in safety management measures.
2 Recent research on the 15th 1 (1) and the 16th 1 (1) "including the case of consignment storage"
Business outsourcing is also actively carried out at institutions from the perspective of improving work efficiency.
However, even if we outsource the handling of personal information we hold (including safety management),
The principal investigator receives the content and consignment of the outsourced work in accordance with the provisions of 7th 1 (3) and 8 (1).
It is necessary to describe the supervision method for the person in the research plan. The head of the research institute is the 6th
Matters (including the contents of safety management) that the entrusted person should comply with in accordance with the provisions of 1 (4) of
In addition to concluding a written contract, necessary and appropriate supervision of the entrusted person
(For example, confirmation of compliance with safety management, etc.) is required.
3 2 ⑴ “Leakage” in “Leakage, loss or damage” refers to leakage to the outside. The same "destruction
"Loss" refers to the loss of part or all of the content. In addition, "damage" is intended by the content.

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It means that it is changed in a non-existent manner, or that it becomes unusable while maintaining its contents.
4 2 ⑴ Retention regarding "necessary and appropriate measures for the safety management of retained personal information, etc."
Depending on the nature of the personal information, etc., the following physical and technical technologies are under the responsibility of the director of the research institution.
Safety management measures shall be selected and implemented as appropriate. Specific methods of measures for safety management
For an example, see "(Attachment) Safety Management Measures to be Taken" in "Individual Information Law Guidelines (General Rules)".
"Contents", "Guidelines for measures for proper management of personal information held by government agencies" and "Germany"
Related to "Guidelines for measures for proper management of personal information held by incorporated administrative agencies, etc."
See guidelines.
○ "Physical safety management" means measures such as admission (room) management and prevention of theft of personal information held.
This refers to the following items.
① Management of areas that handle personal data Implementation of entrance / exit (room) management
② Prevention of theft of equipment and electronic media, etc.
③ Prevention of leakage when carrying electronic media, etc.
④ Deletion of personal data and disposal of equipment, electronic media, etc.
○ "Technical safety management" refers to personal information held and information systems that handle it.
Access control, anti-malware measures, information system monitoring, personal information held, etc.
Refers to technical safety management measures for the above, including the following items.
① Access control (access authority management, access records, etc.)
② Accessor identification and authentication
③ Prevention of unauthorized access from the outside (countermeasures against unauthorized software, etc.)
(4) Prevention of leaks due to the use of information systems (measures for transportation / communication, measures for operation check)
Measures, monitoring of information systems, etc.)
5 Regarding “Systems and Regulations Necessary for Safety Management” in 2⑵, referring to the guidelines listed in 4 above,
Depending on the nature of the personal information we hold, under the responsibility of the director of the research institution, the following organizational and organizational information
Human safety management measures shall be appropriately selected and implemented.
○ “Organizational safety management” clearly defines the responsibilities and authorities of researchers, etc. regarding safety management, and provides safety.
Develop and operate rules and procedure manuals (hereinafter referred to as "rules, etc.") related to all management, and implement them.
It refers to checking the situation and includes the following items.
① Improvement of organizational structure
(2) Operation in accordance with the rules regarding the handling of personal data (establishment of rules, etc. that determine safety management measures)
Operation in accordance with regulations, etc.)
③ Development of means to check the handling status of personal data
④ Establishing a system to respond to cases such as leaks (handling accidents or violations, etc.)
⑤ Grasp the handling status and review safety management measures (sufficient knowledge for information security measures)
Confirmation by the owner, etc.)

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○ "Personal safety management" defines the confidentiality obligation of personal information, etc. designated as confidential in business.
It refers to providing necessary education and training, and includes the following items.
① Confidentiality provisions when concluding employment contracts and consignment contracts
② Implementation of education and training for researchers, etc.

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16th Disclosure of retained personal information, etc.
1 Publication of matters related to personal information held
(1) The head of the research institution conducts research on personal information related to research subjects, etc., in accordance with the 12th provision.
Explain to the target person, etc., or provide information on the implementation of research, including the handling of personal information.
Obtained with the implementation of the research, except when notifying elephants, etc. or making it public.
Personal information held by the research institution (including cases where it is stored on consignment).
Hereinafter referred to as "retained personal information". ), Regarding the following matters, the personal information
Easily identified by a particular individual (hereinafter referred to as the "person") or its agent
Delayed at the request of a state that can be known (the person or his / her agent (hereinafter referred to as "the person, etc.")
Including the case of answering without. same as below. ) Must be placed.
① Name of research institution and name of head of research institution
(2) Regarding the purpose of using the personal information that we hold, if the information is used for research, please use it for research.
Used for research (including that fact when provided to other research institutes)
If the information is not available, its use
③ ⑵ or 2 ⑴, ⑶, ⑷ or ⑹ request (hereinafter referred to as “disclosure request”)
(If the amount of the fee is set according to the provisions of 2⑵, the amount of the fee will be changed.
Including. )
④ Contact point for consultation regarding the handling of personal information held
(2) The head of a research institution can identify the person among the personal information held by the person, etc.
If you are asked to notify us of the purpose of use of what you can do, the book that requested it
This must be notified to people, etc. (hereinafter referred to as the "claimant") without delay.
⑶ ⑴ ② and ⑵ do not apply if any of the following applies.
① To put the purpose of use in a state where it can be easily known or to notify the claimant
It may harm the life, body, property or other rights and interests of the research subject or a third party.
If there is
② To put the purpose of use in a state where it can be easily known or to notify the claimant
When there is a risk of harming the rights or legitimate interests of the research institution
(4) The head of the research institution will notify the notification of the purpose of use under the provisions of (2) according to the provisions of (3).
If it is decided not to do so, the claimant must be notified without delay.
Not. You must also explain the reason to the claimant and try to gain understanding.
Absent.
1 The 16th provision is from the viewpoint of ensuring transparency regarding the handling of personal information held.
For the head of a research institution, except in certain cases, the name of the research institution and the name of the head of the research institution,
Place the purpose of use of the retained personal information, procedures for responding to requests for disclosure, etc. in a state where the person, etc. can know
At the same time, the purpose of use of the personal information held about the person should be notified upon request.
Etc. are defined.
The "principal" is not only the research subject who conducted the research, but also, for example, through the research subject.
Informed consent from the family member or a surrogate when information such as family history is obtained.

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It also includes the person who has taken the procedure for the event.
2 ⑴ “Research including explanation to research subjects or handling of personal information in accordance with the 12th provision
Unless the research subject, etc. is notified of or disclosed information about the implementation of
Explained to research subjects, etc. in the procedure for informed consent, etc. pursuant to the 12th provision
Or, notify or disclose information about the conduct of research, including the handling of personal information.
If so, the personal information related to the research subject, etc. will be protected under the provisions of 16-1 (1).
The purpose is that it is not necessary to disclose the matters related to the personal information that the person has.
3 ⑴ "Personal information acquired as a result of conducting research and held by the research institution.
Regarding "no", for example, information such as family history (identifying a specific family) through the research subject
Information that can be obtained), etc., regarding personal information held in accordance with the provisions of 16th 1 (1)
It may be necessary to publicize such matters.
In addition, when using personal information acquired other than conducting research when conducting research,
It is not included in "Personal information acquired as a result of conducting research" and is retained in accordance with the 16-1 provisions.
It is not necessary to publish matters related to personal information, but it is related to the protection of personal information separately.
According to the provisions of various laws and regulations, it may be required to publish the prescribed matters.
4 ⑴ “Agent” refers to an agent who has been delegated to request disclosure, etc., and the research subject has not yet been submitted.
In the case of an adult, it refers to a parent or guardian of a minor. Even if the research subject is dead, the study
Basically, those who are considered to be able to represent the will and interests of the target person.
Of the matters related to the retained personal information that are subject to disclosure, etc. in 5 (1), especially (2)
"Purpose of use of retained personal information" is disclosed according to the provisions of 16-2 (1) and revised according to the provisions of (3).
Regarding the request for suspension of provision under the provisions of ⑹ and its implementation, such as suspension of use under the provisions of ⑷, etc.
This is important information. Even if the purpose of use is announced according to the provisions of (1), for example, the research
The content of the purpose of use may vary, such as when multiple studies are being conducted by an institution.
Therefore, it is not clear for what purpose the personal information held by the person is used.
In some cases, ⑵ provides for individual notifications in response to requests from the individual, etc.
ing.
6 ⑴ Regarding ② “information that is not used for research”, for example, consult with the research subject, etc.
Records when receiving informed consent, etc., and the relevant fee when receiving informed consent from a surrogate
The name, relationship, contact information, etc. of the consenter can be considered. Whether or not the information is used for research
Regardless, how long will it be retained when the matters related to the personal information held under the provisions of (1) are announced?
It is desirable to announce the fact that it will be done.
7 ⑴ ③ "Procedures for responding to requests for disclosure, etc." are considered to be in writing in many cases.
Regarding the request for notification of target (16th 1 (2)) and disclosure (16th 2 (1)), state the reason.

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Requesting or asking the claimant why it may hinder free demand.
Yes, it is inappropriate.
8 Regarding the notification of the purpose of use pursuant to the provisions of ⑵, the specific method of notification is particularly limited.
Not by the method that surely informs the claimant by referring to the explanation of the twelfth 4
Is fine. However, if there is a risk of future disputes with the claimant, only verbal
It is considered desirable to avoid notification by. Also, "without delay" has no reason.
The purpose is not to cause a stagnation.
9 ⑶ ① "To put the purpose of use in a state where it can be easily known or to notify the claimant
Therefore, there is a risk of harming the life, body, property or other rights and interests of the research subject or a third party.
For example, when a corporation that has a medical institution is a research institution,
By placing or notifying the purpose of use of the personal information that we have in a state where we can easily know it.
There may be cases where treatment is hindered or the patient may suffer mental distress.
The "third party" is the person who requested disclosure, etc. (requester) and the research institution that received the request.
It refers to a person other than, regardless of whether it is an individual, a corporation, or another organization.
10 ⑶ ② "To put the purpose of use in a state where it can be easily known or to notify the claimant
If there is a risk of harming the rights or legitimate interests of the research institution, for example,
Matters related to corporate secrets such as the contents of new products and services under research and development have been clarified
There may be cases where it ends up. Informed consent according to the 12th provision
In the procedure, etc., explain the information about the implementation of the research including the purpose of use to the research subjects, etc.
Or, if you notify or publish it, put it in a state where you can easily know it.
Harm the rights or legitimate interests of the research institution by notifying the claimant.
It is unlikely that there is a risk of doing so.
11 The provisions of ⑷ apply to ⑶ ① or ② when a notification of the purpose of use is requested pursuant to the provisions of ⑵.
If it is decided not to notify the purpose of use as applicable, notify the claimant to that effect.
Indicates to do. In addition, the request for notification of the purpose of use is for requests for future disclosure, etc. and complaints.
When notifying that the purpose of use is not notified because it is often made as a premise of an offer etc.
Claims as much as possible by explaining the reason and stipulating efforts to gain understanding
The purpose is to gain the understanding of others. In addition, the claimant is dissatisfied with the response of the research institution.
In this case, it is intended to make it easier to respond to subsequent complaints.
12 Regarding ⑷ "Explain the reason to the claimant", the method of explanation should be written or verbal.
It is not specified whether to do it, but it is necessary to show it as clearly as possible so that it can be accurately communicated to the claimant.
There is. Usually, it is reasonable to do it at the same time as the notification and in the same way.

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2 Responding to requests for disclosure, etc.
(1) The head of a research institution can identify the person among the personal information held by the person, etc.
Disclosure of what can be done (there is some personal information that identifies the person)
If not, it includes notifying that fact. same as below. ) Is requested
The relevant personal information must be disclosed to the applicant without delay. However, disclosure
If any of the following applies, all or part of it will be disclosed.
Can not be. In addition, the disclosure of personal information held is stipulated by the provisions of laws and regulations.
If there is, it shall be in accordance with the provisions of the relevant law.
(1) There is a risk of harming the life, body, property or other rights and interests of the research subject or a third party.
If there is
(2) When there is a risk of significant hindrance to the proper implementation of research work at a research institution
③ When it violates the law
(2) The head of the research institution requests notification of the purpose of use pursuant to the provisions of 1 (2) or disclosure pursuant to the provisions of (1).
If so, a fee may be collected for the implementation of the measure. However, that
In the case of, the amount of the fee shall be set within the range that is considered reasonable in consideration of the actual cost.
Must be determined.
1 The provisions of (1) apply to the person among the personal information held in response to the request for disclosure from the person, etc.
It is obligatory to disclose what is to be done except in certain cases, and the provisions of laws and regulations.
It also stipulates adjustments, etc. when the personal information held by the company is to be disclosed.
It is.
2 When disclosing the personal information held by the provisions of (1) regarding medical information (patients who died)
Including the case where the medical information of is applied mutatis mutandis. ), As a general rule, "related to the provision of medical information, etc."
Respond according to the guidelines.
3 ⑴ Regarding "when the provisions of laws and regulations stipulate the disclosure of retained personal information"
For example, if the research institution is an administrative agency or an incorporated administrative agency, each administrative agency's personal information
We will respond based on the provisions of the Information Protection Law and the Personal Information Protection Law of Incorporated Administrative Agencies.
4 ⑴ ① “May harm the life, body, property and other rights and interests of the research subject or a third party
Regarding "when there is", it is assumed that the disclosure may damage the rights and interests of a third party.
For example, the secret of a third party is described in the personal information about the person held by the research institution.
If the third party knows what the third party has described about the person, the third party
Is harmed to life or body, suffers mental distress, or impairs legitimate interests
It is possible that there is a risk of this.
5 ⑴ ② “When there is a risk of significant hindrance to the proper implementation of research work at a research institution”
Regarding, for example, the arrangement of bases constituting the DNA whose personal information is corresponding to the personal identification code.

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Immediately identify a specific individual because it is only a column and does not include name, date of birth, or other description.
When it takes a huge amount of money and time to identify the person because he / she cannot do it.
However, the judgment of whether or not there is such a possibility depends only on the viewpoint of researchers, etc.
Instead, we think that it should be done comprehensively, such as listening to the opinions of the Ethics Review Committee as necessary.
Be done.
6 ⑴ ③ "When it violates the law" includes, for example, the person who requested the disclosure.
The personal information that we hold and the secrets of others in the crime of secret disclosure under Article 134 of the Criminal Code are integrated.
It is possible that there is a case.
7 The provision of ⑵ states that notification of the purpose of use (16th 1⑵) or disclosure (16th 2nd ⑴) was required.
You can collect a fee for the implementation, and a place to collect a fee
In that case, the amount of the fee must be set within a range that is reasonably acceptable in consideration of the actual cost.
It stipulates what must be done. In addition, it is not obligatory to collect fees
Therefore, it is not necessary to collect a fee at the discretion of each research institution. Also, as a result, it is not open
Even if it is judged to be an indication, costs will be incurred in carrying out office work such as reception, examination of contents, notification, etc.
Therefore, a fee can be collected.
"Within a range that is reasonably acceptable in consideration of actual costs" is expensive beyond that range.
Notification of purpose of use (16th 1 (2)) and disclosure (16th 2) by setting a fee
The purpose is to prevent the request of (1) from being hindered, and the fee is charged according to the provisions of 16-2 (2).
When the amount is set, the person, etc. can easily include the amount of the fee according to the provisions of 16th 1 (1).
It is required to put it in a state where it can be known.

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(3) The head of a research institution can identify the person among the personal information held by the person, etc.
Regarding what can be done, correction of the content because the content is not true,
If you are requested to add or delete (hereinafter referred to as "correction, etc."), correct the content, etc.
Achievement of purpose of use unless special procedures are stipulated by laws and regulations regarding
To the extent necessary for the above, conduct the necessary investigation without delay, and based on the results, the relevant content
Must be corrected.
(4) The head of a research institution can identify the person among the personal information held by the person, etc.
Reasons that what can be done was acquired in violation of the provisions of 14th 2 (1)
Or because it is handled contrary to the provisions of the same ⑵, the relevant personal information
When requested to suspend or delete the use (hereinafter referred to as "suspension of use, etc.")
When the request is deemed appropriate, it is necessary to correct the violation of the provisions.
To the maximum extent, the use of the personal information must be suspended without delay. However,
When it is difficult to suspend the use of the personal information, the rights and interests of the person concerned
This shall not apply when taking alternative measures necessary for protection.
⑸ The head of the research institution concerned with all or part of the measures required by the provisions of ⑴.
If it is decided not to take measures, or the measures required by the provisions of (3) or (4)
If the measures are taken or not taken for all or part of
If the decision is made, the claimant will be notified without delay (if corrections are made, etc.).
Including its contents. ) Must be notified. In addition, according to the provisions of ⑴, ⑶ or ⑷
Notify that all or part of the measures requested by the person, etc. will not be taken.
In case of such a case, or in the case of notifying the claimant that a measure different from the said measure will be taken
You must explain the reason and try to gain understanding.
1 The provision of ⑶ requires correction, etc. because the content of the personal information held is not true.
If so, as a general rule, the personal information held within the scope necessary to achieve the purpose of use.
It stipulates that the content of the report should be corrected.
In addition, corrections, etc. are obligatory as long as the errors in the personal information held are corrected.
Therefore, incorrect research results, etc. based on the incorrect content (evaluation, judgment, consideration by researchers, etc.)
Etc. are included. same as below. ) Is derived, but for correction of the research results, etc.
Is outside the scope of the problem covered by this provision. Whether or not to correct incorrect research results, etc.
Appropriate judgment shall be made by the head of the research institution and the principal investigator.
2 ⑶ "Correction" of "Correction, addition or deletion" means to correct an error in information or to renew an old fact.
It refers to updating to the facts, and changes inaccurate information that is not clearly wrong to more accurate information.
It also includes getting. "Add" is to add the missing information when the information is incomplete.
It also includes issuing additional records. In addition, "deletion" means removing unnecessary information.
Point to. As a result of the investigation, it is a fact about the contents of the retained personal information that was requested to be corrected.
If it cannot be determined whether it is or not, take measures such as adding a note to that effect and using it.
Sometimes it is appropriate.

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3 ⑶ Handling of retained personal information regarding "within the range necessary to achieve the purpose of use"
The meaning and content of the information required for this depends on the purpose of use, and the timing of corrections, etc.
It is desirable to do this promptly so that incorrect information is not used as it is, but at the latest
Corrections, etc. need to be made before new use of the information begins.
4 When the content of the personal information held is corrected, and the one before the correction is another
Notify the institution of the provider that the correction, etc. has been made when it was provided to the research institution.
Although it does not directly stipulate that corrections, etc. should be made by the institution to which it is provided, the 20th
Based on the provisions of (1), it is necessary to take appropriate measures based on agreements between research institutes.
5 The provisions of ⑷ also apply to the personal information held by the individual, etc., in response to a request from the individual, etc.
Was obtained by fraudulent means, or with the prior consent of the research subject, etc.
If the personal information is handled beyond the scope of the above, the use will be suspended or the personal information will be deleted.
It is defined about.
6 "Suspension of use" of "Suspension or deletion of use" in ⑷ is based on the existence of personal information held.
Then, it means to stop the use completely or partially. "Erase" means the individual you own
It refers to erasing all or part of personal information from the recording medium, and refers to the personal information held by a specific individual.
This includes making people unidentifiable.
7 Regarding ⑷ "contrary to the provisions of 14th 2 (1)" and "contrary to the provisions of the same (2)", not necessarily
Not only intentionally, but also unintentionally, a situation that violates the provisions occurs.
For example, conducting research with the provision of existing samples and information that can identify a specific individual.
In that case, the procedure pursuant to the provisions of 12-1 (3) will be taken by the person who made the provision.
It is conceivable that it is not found after the fact. The fact that it violates the regulation is certain
If the request from the person, etc. is not deemed appropriate, such as when it cannot be confirmed, it is necessary to suspend the use, etc.
Absent.
8 ⑷ "When the request is deemed appropriate" is stated in Article 30, Paragraph 2 of the Personal Information Protection Law.
It has the same purpose as "when it turns out that there is a reason for the request" in the 14th-2.
Whether or not it violates the provisions of (1) or (2) is basically a factual relationship under the control of the research institution.
Since it is relatively easy to confirm, unlike the case of correction according to the provisions of (3), a special adjustment is made.
It is not specified that the inspection will be conducted. The decision is reasonably made under the responsibility of the head of the research institution.
The idea is that it should be done.
9 Regarding ⑷ "To the extent necessary to correct the violation of the relevant regulations", suspension of use
Such measures need only be taken to the extent necessary to correct the violation of the provisions.
Therefore, it is not always necessary to take all the measures required by the person himself / herself. For example,

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Even if you are asked to delete all of your personal information related to you, it is fraudulent.
It is against the regulation by erasing only the part acquired by means or suspending the use.
If it can be corrected, such measures may be taken.
10 ⑷ "When it is difficult to suspend the use of the personal information, the rights and interests of the person concerned

When taking the necessary alternative measures to protect the interests, for example, fraudulent hands
Distribute a large amount of research reports in the form of printed matter, etc., which includes some of the contents obtained by the stage.
If it takes a lot of money and effort to collect and reprint it, a modified version will be distributed separately.
It is conceivable to protect the rights and interests of the person by spreading the cloth. Appropriate alternative measures
If it is not possible to take the information, it is necessary to suspend the use of the personal information.
11 The provisions of ⑸ include disclosure under the provisions of ⑴, corrections under the provisions of ⑶, suspension of use under the provisions of ⑷, etc.
When we make a decision not to disclose the personal information we hold in relation to the request of
When you make a correction, etc. (including the content of the correction, etc.), when you suspend the use, etc.
If it is decided not to make corrections, etc., the fact will not be suspended or profits will be taken.
When it is decided to take measures to replace the suspension of use, etc., notify the claimant to that effect.
It is defined about. In addition, the requested measures should not be taken or should be replaced.
When notifying that measures will be taken, it is decided to explain the reason and try to gain understanding.
By doing so, we will try to gain the understanding of the claimant as much as possible, and the claimant will research.
If you are dissatisfied with the response of the institution, it will be easier to respond afterwards, such as filing a complaint.
In addition, disclosure, correction, etc., in response to the request from the requester for disclosure, correction, etc. or suspension of use, etc.
If you stop using the service, you do not need to explain the reason.
12 ⑸ "Explain the reason to the claimant" is explained in the same way as the provision of 16-1 ⑷.
It is not specified whether the method is written or verbal, but it should be communicated to the claimant accurately.
It needs to be as clear as possible. Usually it can be done at the same time as the notification and in the same way
It is rational.

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⑹ The head of the research institution should be the first sample / information that can identify a specific individual from the person himself / herself.
Provided to other research institutes (including joint research institutes; the same shall apply hereinafter) contrary to the provisions of 12.
I was asked to stop providing the sample / information to other research institutes because of this.
In some cases, if the request is deemed appropriate, the sample / information will be provided without delay.
Must be stopped from being provided to research institutes. However, other research on the sample / information
If it is difficult to stop providing to the institution, protect the rights and interests of the person concerned
Therefore, this does not apply when taking necessary alternative measures.
⑺ The head of the research institution must identify a specific individual who has been requested to suspend the provision under the provisions of ⑹.
A place where the provision of all or part of the available samples / information to other research institutes is stopped.
If it is decided not to suspend the provision to other research institutes, the requester will be notified.
You must notify us without delay. In addition, we stopped providing it to other research institutes.
When notifying that there is no such thing or taking measures different from the suspension of provision to other research institutes
If you do, you must explain the reason to the claimant and try to gain understanding.
Not.
⑻ The head of the research institution shall establish the following matters as a procedure for responding to requests for disclosure, etc.
Can be done. In that case, do not impose an excessive burden on the person, etc.
We must try to reduce the burden on. In addition, the person, etc. may disclose the information regardless of the procedure.
When making a request, inform the requester that it is difficult to respond to the request for disclosure, etc.
I can know.
① Request for disclosure, etc.
(2) Documents to be submitted when requesting disclosure, etc. (electronic method, magnetic method, and other human perceptions)
Includes records made in ways that some cannot recognize. ) Style and others
Method of requesting disclosure, etc.
③ How to confirm that the person requesting disclosure, etc. is the person himself / herself, etc.
④ If a fee is set according to the provisions of ⑵, the collection method
⑼ The head of the research institution will contact the requester when there is a request for disclosure, etc. from the person himself / herself.
By requesting the presentation of matters sufficient to identify the personal information held by the target.
Wear. In addition, the individual concerned can easily and accurately request disclosure, etc.
Providing information that contributes to the identification of personal information and other conveniences of the person, etc.
Care must be taken not to impose an excessive burden.
1 The provisions of ⑹ are samples / information that can identify a specific individual in response to a request from the person, etc.
However, informed consent according to the twelfth provision is provided for the person concerned.
Suspension of provision when it is provided to another research institution without taking the procedure to receive it
It defines what to do.
In addition, it does not include collecting what has already been provided to other research institutes, and new provision
However, in view of the provisions of 14th 2 (2), etc., the ones that have already been provided
If necessary, try to collect it, or stop using it at the research institution that received the offer.
It is considered that efforts should be made to take measures such as stopping (disposal, erasure, etc.).

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2 ⑹ "contrary to the twelfth provision" is not necessarily the case intentionally, but the result unintentionally.
It also includes cases where a situation that violates the 12th provision occurs. For example, collection / minutes of samples / information
Informed consent when existing samples and information are provided from the transferring institution to another research institution.
Since it was difficult to carry out the outlet procedure, the name, date of birth, address, etc. of the research subject should be entered.
It was deleted and provided, and opt-out procedures were not performed, but the identity of the person is sufficiently low.
It is conceivable that the number could not be reduced and the research subject could be identified.
In addition, the procedures for receiving informed consent, etc. pursuant to the 12th provision have been properly carried out.
Even if there is, if there is a withdrawal of consent under the provisions of 12-8, it will be sent to another research institution.
It is necessary to take measures in accordance with the withdrawal of the consent as much as possible, including the suspension of provision.
3 ⑹ "When it is difficult to stop providing the sample / information to other research institutes,
Regarding "when taking necessary alternative measures to protect the rights and interests of the person concerned"
(4) Similar to the proviso, if a large amount of cost is required due to the suspension of the provision, the proposal will be made.
Appropriate considering the degree of risk of infringement of rights and interests by not suspending the service
If there is a serious alternative, it is permissible to deal with it. Take appropriate alternative measures
If this is not possible, it is necessary to stop providing the sample / information to other research institutes.
4 The provision of ⑺ can identify a specific individual related to the request for suspension of provision under the provision of ⑹.
When the provision of the sample / information is suspended, the provision will be suspended.
If there is no decision or it is decided to take measures to replace the suspension of the provision, a request to that effect is made.
It stipulates that the person should be notified. In addition, the provision will not be suspended or the provision will be made.
Explain the reason and gain understanding when notifying that we will take measures to replace the suspension of provision.
By stipulating that we will endeavor to do so, we will try to obtain the understanding of the claimant as much as possible.
In addition, if the claimant is dissatisfied with the response of the research institution, he / she will take further action such as filing a complaint.
It makes it easier to do. Suspension of provision in full response to the request from the claimant to suspend provision
If you do, you do not need to explain the reason.
5 Regarding ⑺ "Explain the reason to the claimant", write the method of explanation in the same way as the provision of ⑸.
It is not specified whether it is face-to-face or verbal, but it can be communicated accurately to the claimant.
It needs to be clearly shown. It is usually reasonable to do it at the same time as the notification and in the same way.
is there.
6 The provisions of ⑻ and ⑼ stipulate the necessary procedures, etc. regarding the request for disclosure, etc.
In deciding the procedure, etc., care should be taken not to impose an excessive burden on the person, etc.
It is defined about. Confirm that you are the person, etc. when receiving a request for disclosure, etc.
This is extremely important, but unnecessarily requesting the presentation of a huge amount of certificates, etc., and setting up complicated procedures
It is necessary to prevent excessive things such as kicking, and the reception desk is unreasonably restricted.
Therefore, it is necessary not to install it in an inconvenient place that is difficult to understand.

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17th Handling of anonymously processed information

17th Handling of anonymously processed information
(1) Researchers, etc. (universities subject to the Personal Information Protection Law and other institutions for academic research)
Or an organization or a person belonging to them, who handles personal information or anonymously processed information.
Limited to those whose purpose is to be used for academic research in whole or in part. Below this 17th
It's the same. ) Is anonymously processed information (anonymously processed information database, etc. (information including anonymously processed information)
It is a collection of information, and specific anonymously processed information can be searched using a computer.
You can easily search for information that is systematically configured and other specific anonymously processed information.
It is a systematic structure. ) Consists of. same as below. ) Create
When doing so, identify a specific individual and restore the personal information used to create it.
The personal information must be processed according to the standards necessary to prevent it from being done.
I.
(2) When researchers, etc. create anonymously processed information, they delete it from the personal information used to create it.
Leakage of information regarding the description, personal identification code, and processing method performed according to the provisions of (1)
A safeguard for this information, in accordance with the standards set as necessary to prevent swelling.
We must take steps for reason.
(3) When researchers, etc. create anonymously processed information, they are concerned with the individuals included in the anonymously processed information.
The item of information to be made must be published.
(4) Researchers, etc. will create anonymously processed information and provide the anonymously processed information to other research institutes.
Information about individuals included in anonymously processed information provided to other research institutes in advance.
In addition to disclosing the items of the information and the method of providing it, to the other research institutes concerned
It must be clearly stated that the information related to the provision is anonymously processed information.
⑸ Researchers, etc., when creating anonymously processed information and handling the anonymously processed information by themselves.
In order to identify the person related to the personal information used to create the anonymously processed information,
Anonymously processed information must not be collated with other information.
⑹ When researchers, etc. create anonymously processed information, for the purpose of safety management of the anonymously processed information.
Necessary and appropriate measures, handling of complaints regarding the creation and other handling of the anonymously processed information
Take necessary measures to ensure the proper handling of other anonymously processed information, and
We must endeavor to publicize the details of the measures.
⑺ Researchers, etc. are anonymously processed information (excluding those created by processing personal information by themselves. Hereinafter, this
Same in 17th. ) To other research institutes in advance
Items of personal information included in the anonymously processed information provided and the method of providing it
The information related to the provision is anonymously processed to the other research institutes.
It must be clearly stated that it is information.
⑻ Researchers, etc. who have been provided with anonymously processed information should handle the anonymously processed information.
In order to identify the person related to the personal information used to create the anonymously processed information,
It is done according to the description etc. deleted from personal information, personal identification code or the provisions of (1)
Do not obtain information about the processing method or collate the anonymous processing information with other information.
Not.
⑼ Researchers, etc. who have been provided with anonymously processed information are required for the safety management of the anonymously processed information.

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17th Handling of anonymously processed information

Appropriate measures, handling of complaints regarding the handling of anonymously processed information and other appropriateness of anonymously processed information
Take necessary measures to ensure proper handling, and publicize the details of the measures
I have to try.
1 Regarding item 17, if it falls under Article 76, Paragraph 1, Item 3 of the Personal Information Protection Law (universities and other academic fields)
Eyes used for academic research by institutions or organizations for the purpose of surgical research or those who belong to them
(When handling personal information in a targeted manner), the provisions of Chapter 4 of the Act do not apply, so in Chapter 4 of the Act
The legal provisions regarding the handling of "anonymously processed information" that are stipulated do not apply. This guideline
In, a unified route is used to facilitate the exchange of anonymously processed information at all institutions.
Handling of anonymously processed information in cases that fall under Article 76, Paragraph 1, Item 3 of the same law
It is stipulated in the same way as Chapter 4 of the same law.
<Reference>
Guidelines for Law Concerning Protection of Personal Information (Anonymously Processed Information) (2016)
Personal Information Protection Commission Notification No. 9)
In addition, the scent of the Personal Information Protection Law of administrative agencies, the Personal Information Law of Incorporated Administrative Agencies, and local public organizations
Institutions to which the ordinances enacted in the above are applied, comply with the handling stipulated in each law.
There is a need.
Regarding 2 ⑻, the organization (private business operator) to which the Personal Information Protection Law is applied is anonymously processed information or ignorant
If you receive additional processing information, you will be required to comply with the obligations stipulated in the law.
In addition, personal information of institutions (administrative agencies) to which the Personal Information Law of Administrative Agencies is applied and independent administrative agencies, etc.
Ordinances, etc. enacted by organizations (incorporated administrative agencies) and local public bodies to which the protection law is applied
Applicable organizations (local public bodies) are also anonymously processed information or non-identified according to the procedure stipulated in ⑺.
You can receive processing information. However, the anonymously processed information or ignorance provided
Separately processed information cannot be treated as anonymous processed information and is subject to the laws and regulations applicable to the relevant organization.
If the information provided in the above is judged to be personal information or not, and if it is personal information
Must be treated as personal information.

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18th Response to Serious Adverse Events

Chapter 7 Response to Serious Adverse Events
18th Response to Serious Adverse Events
1 Correspondence of researchers, etc.
When researchers become aware of the occurrence of serious adverse events in conducting invasive research
Will take necessary measures such as explanations to the research subjects, etc., in accordance with the procedure manual, etc. pursuant to the provisions of 3 (1).
At the same time, it is necessary to promptly report to the principal investigator.
1 The 18th provision is that when a serious adverse event occurs in a research subject as a result of conducting a research,
It stipulates the responsibilities that researchers must perform. Conduct invasive research
If a serious adverse event occurs during the course, it depends on whether there is a causal relationship with the study.
However, the intent is to report all serious adverse events.
2 “Procedures, etc.” include research plans and instructions from the directors of research institutes.
3 Preparation of procedure manuals for dealing with adverse events that are not serious, and reporting at the time of occurrence
The order, etc. will be determined by each research institution.
4 In research using drugs or medical devices, due to side effects, defects, etc. of the drugs, etc.
For reports of side effects, etc. when the occurrence of suspected cases, etc. is known, please refer to Pharmaceuticals and Medical Devices, etc.
It is necessary to pay attention to the provisions of the law and take appropriate measures.

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18th Response to Serious Adverse Events

2 Correspondence of the principal investigator
(1) When the principal investigator becomes aware of the occurrence of a serious adverse event in conducting an invasive study
Promptly report to the head of the research institution and follow the procedure in 3 ⑴.
Appropriate measures must be taken in accordance with the documents. In addition, promptly carry out the research
Information on the occurrence of the adverse event must be shared with the researchers involved.
I.
(2) The principal investigator is serious in conducting invasive research conducted jointly with other research institutes.
If you become aware of the occurrence of an adverse event, the research institute of the joint research institute will promptly carry out the research.
Information regarding the occurrence of the adverse event must be shared with the investigator.
1 The 18th-2 provisions are made by the principal investigator when the research subject becomes aware of the occurrence of a serious adverse event.
It defines the responsibilities that must be fulfilled.
2 In addition to the review by the Ethics Review Committee, the principal investigator evaluates adverse events, etc. and accompanies them.
Established an efficacy and safety evaluation committee to discuss the appropriateness of continuing research and changes in research.
Can be placed.
3 The Efficacy and Safety Evaluation Committee puts research progress, safety data and important evaluation items at appropriate intervals.
The purpose is to make a recommendation to the principal investigator to continue, suspend or discontinue the research, or change the research plan.
Can be set up by the principal investigator. The Effectiveness and Safety Evaluation Committee is the principal investigator and the research institute.
Conducting the research in order to make it a committee independent of the persons involved in the research and the ethics review committee
Those who are involved in the research, members of the ethics review committee that reviews the research, and the head of the research institution are effective.
It is not desirable to be a member of the integrity evaluation committee.
4 The Effectiveness and Safety Evaluation Committee acts when the Ethics Review Committee meets all of the following conditions.
Of these, (1) the suitability of continuing research and (2) changes in the plan associated with the evaluation of adverse events, etc., will be evaluated.
It can be done, and the evaluation result can be replaced with the evaluation of the Ethics Review Board.
It should be possible.
(A) Appropriately describe the composition, function and procedures of the Effectiveness and Safety Evaluation Committee in the research plan.
It is stipulated, and the content has been reviewed and approved by the Ethics Review Committee.
When.
(B) Take action based on the evaluation results of the Effectiveness and Safety Evaluation Committee, and include the results as well.
Report the content of the evaluation from the Effectiveness and Safety Evaluation Committee to the Ethics Review Committee.
5 Regarding the provisions of ⑵, the principal investigator adversely affects the safety of the research subject and affects the conduct of the research.
Information that may affect or change the approval of the Ethics Review Board regarding research continuity,
It is necessary to inform or report to all the principal investigators and the heads of research institutes involved in the research.
6 Regarding the provisions of (2), the principal investigator (general manager) who supervises the principal investigator of each joint research institution

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18th Response to Serious Adverse Events

If you have, the principal investigator of the research institution where the event occurred is serious to the principal investigator.
Others report the occurrence of adverse events and through the principal investigator or the person engaged in the relevant administrative procedures, etc.
You can contact the principal investigator of the joint research institution. However, in that case, research in advance
It is necessary to describe the corresponding method in the plan.

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18th Response to Serious Adverse Events

3 Correspondence of the head of the research institution
(1) The head of a research institution should be serious in advance when attempting to carry out research that involves invasiveness.
Create a procedure manual for matters to be implemented by researchers, etc. when an adverse event occurs.
Necessary measures must be taken to ensure proper and smooth response in accordance with the procedure manual.
Absent.
(2) The head of the research institution should discuss the occurrence of serious adverse events from the principal investigator according to the provisions of 2 (1).
If a report is made, we will promptly take necessary measures in accordance with the procedure manual and take the necessary measures.
The Ethics Review Board must hear the opinions of adverse events and take necessary measures.
I.
(3) Preliminary research involving invasion (excluding minor invasion) that involves intervention
A place where an unmeasurable serious adverse event occurs and a direct causal relationship with the study cannot be ruled out.
In that case, the head of the research institution where the adverse event occurred promptly reports to the Minister of Health, Labor and Welfare.
At the same time, the status and results of the response pursuant to the provisions of (2) must be announced.
1 The 18th to 3rd provisions apply to researchers and themselves when a serious adverse event occurs in a research subject.
Must be done by the head of the research institution, such as prescribing procedures so that
It stipulates no responsibilities.
2 ⑴ “Necessary measures to ensure proper and smooth response in accordance with the relevant procedure manual” includes research
It also includes the necessary system development for proper and smooth implementation.
3 Regarding the provisions of (3), the format for reporting to the Minister of Health, Labor and Welfare is as follows. Published
For the method, refer to the explanation of 6-4.

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18th Response to Serious Adverse Events

(Style)
FAX: 03-3503-0595
Report of serious adverse events that cannot be predicted
Heisei Year Month Day
Minister of Health, Labor and Welfare
We report the following serious adverse events related to the following studies:
1. Research institute information
(1) Name of research institution, job title and name of its head:
(2) Name of principal investigator:
(3) Research project name:
(4) Research registration ID:
(* Registration ID given from the pre-registered research plan public database, etc., to identify the research
Enter a valid number, etc. The same number should be used for reports related to the research at all related research institutes.
When. )

(5) Contact:

TEL:

FAX:

e-mail:
2. Report content
(1) Originating institution: □ Own facility □ Other joint research institute (institution name:

)

(2) Name and course of serious adverse events
(Concisely describe the date of occurrence, the reason for determining that it is serious, the content and causal relationship of the invasion / intervention, the course, the outcome, etc.)

(3) Measures for serious adverse events
(Suspension of new registration, revision of explanatory consent document, re-consent with other research subjects, etc.)

(4) Examination date by the Ethics Examination Committee, outline of examination contents, results, necessary measures, etc.
(5) Dissemination to joint research institutes:
Joint research institute

□ No

organ)
□ Yes (total number of institutions (including own
facility)

Whether or not the information is known□□Yes
None
Well-known method:
(6) Publication of results
(URLs that have been published or will be published, etc.)

that's all

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19th Conflict of Interest Management

Chapter 8 Ensuring Research Reliability
19th Conflict of Interest Management
(1) When conducting a research, researchers, etc. are concerned with conflicts of interest related to the research, such as personal profits.
Report the situation to the principal investigator and take appropriate measures to ensure transparency.
I have to respond.
(2) The principal investigator is a commercial activity such as research on the efficacy or safety of pharmaceuticals or medical devices.
When conducting research that may be related to, grasp the situation regarding conflicts of interest related to the research.
However, it must be stated in the research plan.
(3) Researchers, etc. shall be aware of the situation regarding conflicts of interest described in the research plan pursuant to the provisions of (2).
Explain to research subjects, etc. in the procedure for receiving informed consent as stipulated in 12.
Must.
1 The 19th provision requires that researchers, etc. and the principal investigator make conflicts of interest related to research.
It stipulates the procedures and responsibilities that must be taken.
For guidelines and guidelines regarding the concept of conflicts of interest, refer to the explanation in item 8 (1).
Teru.
2 Regarding the provisions of (1), researchers, etc. are based on the regulations regarding conflicts of interest established by the institution to which they belong.
Next, it is necessary to report the situation regarding the conflict of interest to the principal investigator.
3 Regarding the provisions of (2), the principal investigator is a researcher, etc. regarding the situation regarding conflicts of interest of the research institution.
In addition to the report from, the situation regarding conflicts of interest related to research by research institutes such as funding sources for the research is also included.
It is necessary to grasp it and describe it in the research plan.
4 Even when conducting research in collaboration with other research institutes, for research that the principal investigator grasps
The situation regarding the conflict of interest refers to the situation regarding the conflict of interest related to the research of the research institution.
It is not always necessary to understand the situation regarding conflicts of interest related to research at joint research institutes.
It's not something to blame.
5 In institutions that have a Conflict of Interest Committee, the head of the research institution received from the principal investigator.
It is advisable to seek the opinion of the Conflict of Interest Committee on the situation regarding conflicts of interest. Conflict of interest
The committee will discuss the situation regarding conflicts of interest related to the research (self-reports, etc. may be used).
If the researcher is judged to be in a conflict of interest after evaluation, a summary or written opinion will be provided by the research institution.
It is advisable to report to the Chief and the Ethics Review Board.

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Storage of samples and information related to the 20th research

Storage of samples and information related to the 20th research
(1) Researchers, etc. should use the information used in the research and the materials related to the information (tests used in the research).
Includes records regarding the provision of fees and information. Hereinafter referred to as "information, etc." ) To be accurate
Must be.
(2) When storing samples and information obtained from the human body, the principal investigator shall comply with the provisions of (3).
Based on the procedure manual, the method is described in the research plan, and researchers, etc. provide information, etc.
Leakage of samples and information obtained from the human body by instructing and managing to make the information accurate.
Necessary management must be carried out to prevent mixing, theft, loss, etc.
(3) The head of the research institution prepares a procedure manual for storing samples and information obtained from the human body.
However, in accordance with the procedure manual, the test obtained from the human body related to the research conducted by the research institution.
Necessary supervision must be carried out so that fees and information are properly stored.
(4) The principal investigator shall follow the procedure manual under the provisions of (3) and follow the management status under the provisions of (2).
Must be reported to the head of the research institution.
⑸ The head of the research institution will keep the information of the research institution for as long as possible.
Intervention is a study that involves invasiveness (excluding minor invasion).
If doing so, at least 5 from the date reported the end of the study
Three years from the date of the lapse of years or the date of the final publication of the results of the study.
Do not perform the necessary supervision to ensure proper storage for the period until the later of the elapsed days.
Must be. In addition, the research institution holds a correspondence table for anonymized information.
If so, the same shall apply to the storage of the correspondence table. Also, regarding the provision of samples and information
Regarding records, when samples and information are provided, from the date of provision to the date when three years have passed.
From the date when the end of the research is reported, if samples and information are provided during the period of
Necessary supervision must be provided for proper storage until the day after 5 years
Absent.

⑹ The head of the research institution can identify a specific individual when disposing of samples, information, etc.
You have to do the necessary supervision to take appropriate steps to prevent it from happening.
It doesn't become.
1 The 20th provision is for the principal investigator and the research institute regarding the storage of samples and information used in research.
It stipulates the actions and responsibilities that the head of the research institution must take.
2 ⑴ “Materials related to the information” contains records related to the provision of samples and information used in research.
In addition, case report forms, records created by the study subjects, revision history (including date and name), 12th
It also includes records regarding the provision of samples and information created in accordance with the regulations. (1) Correction of information, etc.
When doing so, it is hoped that not only the correction history (including date and name) but also the reason will be recorded.
Good.
3 Of the "information, etc." in (1), personal information related to the research is necessary to achieve the purpose of use.
It is desirable to keep the latest contents (address change, etc.) within the range.

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Storage of samples and information related to the 20th research

4 ⑴ “Accuracy” includes information that researchers and others do not create (records created by research subjects).
It also includes confirming that etc. were created correctly.
5 Regarding the provisions of (2), the principal investigator should appropriately and appropriately use the samples and information obtained from the human body.
It is necessary to manage it in an orderly manner so as to contribute to the confirmation of research results. In addition, the storage of information etc. is information etc.
The name, storage location, consent obtained from the research subject, etc. should be understood.
It is necessary.
6 Regarding the provisions of (3), the storage of information, etc. will be delegated to a person appointed by the head of the research institution.
(Including the appointment of a manager) In addition, based on a written contract including necessary safety management, etc.
You may outsource it to others.
7 Regarding the provisions of (3), the head of the research institution changes the management status of information, etc. from the principal investigator according to the procedure manual.
Receive reports on this, give appropriate guidance when necessary, and store items and their items.
It is necessary to establish the relevant procedure manual in consideration of the person in charge, storage location, storage method, etc.
8 If the storage under the provisions of (3) is data recorded on an electronic medium, etc., store the data appropriately.
In order to maintain the security system, back up the data, etc., as well as data
It is necessary to keep in mind that it is necessary to maintain the authenticity, storability, and readability of the.
9 Regarding the provisions of ⑸, the head of the research institution and the principal investigator are required to keep this information, etc.
Necessary so that it will not be lost or discarded in the meantime and can be presented upon request
Take measures.
10 Regarding the provisions of ⑸, even the head of an institution that provides existing samples and information other than research institutes
It is advisable to endeavor to store the information provided for as long as possible.
11 ⑹ “Appropriate measures” means, for example, autoclaving of samples obtained from the human body.
In terms of information, if it is saved on paper, it is shredded and saved as data.
If this happens, the data may be deleted.

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21st Monitoring and Audit

21st Monitoring and Audit
(1) The principal investigator must endeavor to ensure the reliability of the research and invade (exclude minor invasion).
Ku. ) When conducting research that involves intervention, permission from the director of the research institution
According to the research plan received, monitoring and auditing as necessary
Must be given.
(2) The principal investigator is appropriate as stipulated in the research plan approved by the director of the research institution.
Engaged in monitoring and auditing so that monitoring and auditing can be carried out
Necessary guidance and management must be provided to those who do.
(3) The principal investigator shall follow the persons involved in the implementation of the research subject to audit and their monitoring.
Do not let the person doing the audit perform the audit.
(4) Persons engaged in monitoring must report the results of the monitoring to the principal investigator.
Must be. In addition, the person engaged in the audit shall check the result of the audit by the principal investigator and the research machine.
I have to report to the chief of Seki.
(5) Persons engaged in monitoring and those engaged in audits should correct the information that they have learned in the course of their work.
Do not leak without good reason. The same shall apply even after he / she is no longer engaged in the work.
⑹ The head of the research institution will cooperate with the implementation of monitoring and audits pursuant to the provisions of ⑴.
In addition, the necessary measures must be taken for the implementation.
1 The 21st provision is for those who are engaged in research and its work that are subject to monitoring and auditing.
It is a fixed one.
2 Regarding the provisions of (1), the implementation system that should be stipulated in the research plan for monitoring and auditing
As for matters related to the implementation procedure, the person in charge engaged in monitoring and auditing and the relevant work
When outsourcing, the outsourcee, etc. can be considered.
In addition, the principal investigator should prepare a procedure manual for monitoring and a procedure manual for auditing.
The implementation procedure can be replaced with this. At that time, according to the provisions of 8th ⑴㉕
As with the research plan, the procedure manual needs to be submitted to the Ethics Review Committee.
Regarding the necessity of auditing, the social and academic significance of research, the burden on research subjects, and
Comprehensive evaluation from the perspective of ensuring the quality and transparency of research, taking into account the expected risks and benefits.
It is worthwhile, and primarily the principal investigator makes a decision when preparing a research plan, including the validity of that decision.
It is necessary to be examined by the Ethics Examination Committee.
3 Regarding the provisions of ⑵, the monitoring method is not uniform and individual research
It is required to be carried out appropriately and efficiently depending on the purpose and nature of the above.
Regarding the monitoring method, for example, the source material etc. should be obtained by a predetermined method.
In addition to direct confirmation, EDC (Electronic Data Capture) is used for multicenter joint research.
It is conceivable to centrally manage and evaluate the data by the method using
In a sense, the implementation system and implementation procedure are described in the research plan prepared by the principal investigator, and the compromise is achieved.
It is necessary to undergo an examination by the Ethics Examination Committee, including the appropriateness.

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21st Monitoring and Audit

4 Regarding the provisions of (2), the principal investigator is the person engaged in monitoring in addition to the monitoring method.
Determine the appropriate scope and method of monitoring in the study, such as responsibilities and evaluation items, and study
It is necessary to specify in the plan.
5 Regarding the provisions of (2), the principal investigator is the person engaged in monitoring and the person engaged in auditing.
Those who have the ethics related to research and the knowledge necessary for monitoring and conducting audits.
It is appropriate to specify.
6 Regarding the provisions of (3), those engaged in audits shall be engaged in the relevant research and monitoring.
Anyone other than the one in the research institution may be used.
7 Regarding the provisions of ⑷, the results reported by those engaged in monitoring are based on the monitoring method.
It may change depending on the date, but includes the date, place of implementation, name of the person in charge, summary of monitoring results, etc.
Get caught.
8 Regarding the provisions of ⑷, those engaged in monitoring and those engaged in audits shall be the joint research machines.
If there is a principal investigator (general manager) who supervises the principal investigator of Seki, the principal investigator
It is desirable to share the contents of each report.
9 Regarding the provisions of ⑷, the results reported by those engaged in audits include the date, place of implementation, and the person in charge.
Includes name, audit target, summary of audit results, etc.
10 Regarding the provisions of (4), those engaged in audits should be audited not only by the principal investigator but also by the head of the research institution.
You need to report the results.
11 Regarding the provisions of ⑹, the head of the research institution shall be assigned to those engaged in monitoring and those engaged in auditing.
On the other hand, it is necessary to cooperate in browsing information.

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<Reference> Laws and Regulations Concerning the Protection of Personal Information
○ Law Concerning Protection of Personal Information
http://www.ppc.go.jp/personal/legal/
○ Law Enforcement Ordinance / Enforcement Regulations on the Protection of Personal Information
http://www.ppc.go.jp/personal/preparation/
○ Guidelines for the Law Concerning the Protection of Personal Information
・ General rules
http://www.ppc.go.jp/files/pdf/guidelines01.pdf
・ Provision to third parties in foreign countries
http://www.ppc.go.jp/files/pdf/guidelines02.pdf
・ Confirmation / recording obligation when provided to a third party
http://www.ppc.go.jp/files/pdf/guidelines03.pdf
・ Anonymous processing information
http://www.ppc.go.jp/files/pdf/guidelines04.pdf
○ "Guidelines for the Law Concerning the Protection of Personal Information" and "Leakage of Personal Data, etc."
Q & A about "What to do if an incident occurs"
https://www.ppc.go.jp/files/pdf/kojouhouQA.pdf
○ Law concerning the protection of personal information held by government agencies
http://law.e-gov.go.jp/htmldata/H15/H15HO058.html
○ Guidelines for the law concerning the protection of personal information held by government agencies (administrative agency ignorance)
Separate processing information)
https://www.ppc.go.jp/files/pdf/guidelines05.pdf
○ Law Concerning the Protection of Personal Information Held by Independent Administrative Institutions, etc.
http://law.e-gov.go.jp/htmldata/H15/H15HO059.html
○ Guidelines for the Act on the Protection of Personal Information Held by Incorporated Administrative Agencies (Incorporated Administrative Agencies)
Non-identification processing information for government corporations, etc.)
https://www.ppc.go.jp/files/pdf/guidelines06.pdf

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