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Human Genome / Gene Analysis Research
Rinri finger needle

March 29, 2001
(All revised on December 28, 2004)
(Partially revised on June 29, 2005)
(Partially revised on December 1, 2008)
(Revised on February 8, 2013)
(Partially revised on November 25, 2014)

Ministry of education
Ministry of Health, Labor and Welfare
Ministry of Economy, Trade and Industry

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table of contents
preamble

1

1st basic idea
1 Basic policy

2

2 Scope of application of this guideline

2

Responsibilities of the second researcher, etc.
3 Basic responsibilities of all researchers, etc.

3

4 Obligation of the head of the research institution

4

5 Responsibilities of the principal investigator

7

6 Joint research with overseas

Ten

Basic attitude toward the third provider
7 Informed consent

11

8 Disclosure of genetic information

16

9 Genetic counseling

19

4th Ethics Review Committee
10 Obligations and composition of the Ethics Review Board

20

Fifth handling of samples and information, etc.
11 Provision of samples and information to institutions conducting other research, etc.

twenty two

12 Handling of anonymized information

twenty three

13 Storage and disposal of samples and information

twenty four

14 Utilization of existing samples and information from research institutions

twenty four

15 Utilization of existing samples and information from external organizations

twenty five

6th protection of personal information
16 Personal information to be protected

26

17 Safety management measures

26

18 Handling of personal information

28

19 Disclosure of personal information, etc.

31

20 Obligation of personal information manager

34

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Definition of 7th term
21 Definition of terms

35

(1) Sample / information

35

(2) Medical information

36

(3) Human genome / gene analysis research

36

(4) Genetic information

37

(5) Anonymization

37

(6) Personal information manager

37

(7) Informed consent

37

(8) Substitutes, etc.

38

(9) Institution that conducts research

38

(10) Institutions that provide samples and information

38

(11) An organization that collects and sells samples and information

38

(12) Joint research institute

39

(13) External organization

39

(14) Ethics Review Committee

39

(15) Researchers, etc.

39

(16) Principal Investigator

39

(17) Researcher

40

(18) Provider

40

(19) Genetic counseling

40

(20) Existing sample / information

40

8th review
22 Review

40

9th Bylaw
23 Bylaws

41

10th enforcement date
24 Enforcement date

41

11th transitional measure
25 Transitional measures

41

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preamble
Promotion of scientific research is important for realizing a society where people can live a healthy and enriched life.
This is an important issue. Among them, human genome / gene analysis research started in the latter half of the 20th century
Contributes greatly to the progress of life science and health science, and develops human health and welfare.
It plays an important role in fostering new industries.
On the other hand, human genome / gene analysis research relies heavily on research targeting individuals.
In addition, the genetic information obtained in the course of the research is provided by the donor (human genome / gene analysis research).
Clarify the genetic predisposition of the person who provides the sample / information for) and its relatives, and its
Depending on the treatment, it may lead to various ethical, legal or social problems.
There is a side. Therefore, respect human dignity and human rights, obtain the understanding and cooperation of society, and be appropriate.
It is essential to carry out the research exactly. Also, the Declaration of Helsinki by the World Medical Association
Based on the ethical norms shown in the above, the guarantee of the human rights of individual providers is scientific or social.
In addition to having to be prioritized for profit, this aspect is sufficient for society
It is required to give an explanation and carry out research based on that understanding.
Based on these circumstances, this guideline is generally applied to human genome / gene analysis research.
Jointly produced by the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labor and Welfare and the Ministry of Economy, Trade and Industry as ethical guidelines to be taken
It is made and presented to society. In addition, various forms for human genome / gene analysis research
In consideration of the state, this guideline will show the basic principles of researchers.
Etc. make a research plan, and the Ethics Review Committee decides whether or not it is appropriate.
Based on this principle, it is necessary to make an appropriate decision according to the content of each research plan.
It can be found.
Regarding the protection of personal information, at institutions that conduct human genome / gene analysis research,
For protection of personal information applied according to the classification of private companies, administrative agencies, independent administrative agencies, etc.
Law Concerning (Law No. 57 of 2003), Protection of Personal Information Held by Administrative Organizations
Regarding the protection of personal information held by the law (Law No. 58 of 2003), independent administrative agencies, etc.
The purpose of Article 11, Paragraph 1 of the Law (Law No. 59 of 2003) and the Law Concerning the Protection of Personal Information
Keep in mind that it is necessary to comply with the ordinances enacted by local governments based on this.
There must be.

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1st basic idea
1 Basic policy
This guideline follows the characteristics of human genome / gene analysis such as obtaining genetic information.
Before, it is applied to all human genome / gene analysis research and is observed in the research field.
It was formulated as an ethical guideline to be followed. This guideline is the dignity of human beings
Human rights are respected, and research is properly promoted with the understanding and cooperation of society.
The basic policy is to:
(1) Respect for human dignity
(2) Sufficient explanation in advance and free will consent (informed consent)
G)
(3) Thorough protection of personal information
(4) Implementation of socially beneficial research that contributes to the intellectual foundation, health and welfare of humankind
(5) Prioritization of the guarantee of individual human rights over scientific or social interests
(6) Preparation and compliance of research plans based on this guideline, and morality from an independent standpoint
Ensuring the appropriateness of research through prior examination and approval by the Physical Examination Committee
(7) Through on-site surveys of research implementation status by a third party and publication of research results
Ensuring research transparency
(8) People and society through educational activities related to human genome / gene analysis research
Dialogue with the public based on the promotion of understanding and research content

<Note>
In this guideline, the genetic information obtained in the course of research reveals the genetic predisposition of donors and relatives.
Depending on the research content, the provider belongs to the problem of the individual provider.
It is said that it may raise various problems because it may characterize the nature of the group.
Based on the characteristics of the human genome / gene analysis research, it should be the subject of this guideline in the 7th 21 (3).
The definition and scope of research are defined.

2 Scope of application of this guideline
This guideline targets human genome / gene analysis research and is involved in that research.
It requires researchers to comply. For proper research, research
The efforts of each person, etc. are important, and the institution conducting the research also has personal feelings.
Establishing the organizational structure and environment necessary to protect information and take appropriate ethical responses
It is important to be prepared.

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In addition, it is carried out in medical treatment, and the analysis result is medical treatment of the provider and its relatives.
Clinical tests that are medically established to be directly utilized in and similar
Human genome / gene analysis will be carefully examined in the future as a medical matter.
This is an issue to be discussed and is not subject to this guideline.
However, doctors who provide medical care for these human genome / gene analysis
Responsible for medical / long-term care based on the Act on the Protection of Personal Information
Follow the guidelines for the proper handling of personal information by the trader, and have a relationship
Appropriate based on the purpose of this guideline with reference to the guideline prepared by academic societies, etc.
It is desirable to take appropriate measures.

<Note>
In this guideline, "human genome / gene analysis research" is defined in the 7th 21 (3).
And the range is defined.

Responsibilities of the second researcher, etc.
3 Basic responsibilities of all researchers, etc.
(1) All researchers, etc. are those who elucidate life phenomena, prevent diseases, diagnose and treat.
Human genome / gene analysis research for the purpose of improving law and improving health
Must be carried out.

(2) All researchers confirm the social benefit of human genome / gene analysis research
Acknowledge and prioritize the protection of individual human rights over scientific or social interests
Must be considered.

(3) All researchers, etc. are informed consents such as providers or substitutes.
Basically, we will carry out human genome / gene analysis research.
Must be.

(4) All researchers, etc. leak personal information that they have learned in the course of their duties without a justifiable reason.
must not. The same shall apply even after resigning from that position.

(5) All researchers, etc. should protect personal information and handle personal information.
We must respond in good faith to complaints about illness.

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(6) All researchers, etc., have the human rights of the providers, etc., such as unexpected leakage of personal information.
An institution that promptly conducts research when serious concerns arise from the perspective of security.
Must be reported to the head of the research and the principal investigator.

(7) All researchers, etc. are the institutions that conduct research with the approval of the Ethics Review Committee.
Comply with this guideline, such as conducting research in accordance with the research plan approved by the director.
Protect, respect human dignity and human rights, and properly analyze the human genome and genes
The study must be carried out.

(8) All researchers, etc. should ensure proper procedures for conducting research, and externally.
Targets for field surveys by experts and inquiries about the progress of research from providers, etc.
It is necessary to ensure the transparency of research, such as accurate response and publication of research results.
Absent.

(9) All researchers, etc. must provide samples and information in good faith.
Appropriately store and utilize the samples and information already provided.
By doing so, we strive to minimize the provision of samples and information from people.
I have to get it.

(10) All researchers, etc., are required to carry out human genome / gene analysis research.
Do not obtain personal information and samples / information by deception or other fraudulent means
Absent.

(11) All researchers, etc., prior to conducting the human genome / gene analysis research,
Ethics on human genome / gene analysis research Other human genome / gene analysis
You must receive education and training on the knowledge necessary to carry out the research.

4 Obligation of the head of the research institution
(1) The head of the institution conducting the research is the Institute for Human Genome and Genetic Analysis at that institution.
The principal investigator and the person in charge of research have the ultimate responsibility for conducting the research.
It must be supervised to carry out the research properly according to the research plan. So
At that time, the head of the research institution should guarantee the human rights of the providers as much as possible.
And there is no detrimental action such as disciplinary action in case of violation of this guideline, research plan, etc.

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It is necessary to thoroughly inform the researchers of the institution about what can be done.
Must be.

(2) The head of the institution conducting the research shall be stipulated in this guideline in accordance with the regulations established by the institution.
Authority or affairs may be delegated to an appropriate person within the institution.

<Detailed rules regarding authority or delegation of office work stipulated in this guideline>
1. 1. The head of the research institution is responsible for the smooth and agile implementation of human genome / gene analysis research.
To appoint and delegate a person who has overall responsibility for all or part of the authority or affairs stipulated in the guidelines.
Can be done.
2. 2. The person who has the overall responsibility is the person in charge of research, who gives the necessary supervision orders and the research institute of the institution.
It supervises the overall research, for example, as follows.
・ In the case of a hospital attached to a university, etc., the hospital director
・ In the case of a health center, the director of the health center
・ In the case of university medical school, the director of medical school
・ In the case of a research institute attached to a company, etc., the director of the research institute
3. 3. If research and samples / information are provided within the same corporation or government agency, each business
A person who has overall responsibility can be appointed and delegated for each task.

(3) The head of the research institution should ask whether or not to carry out human genome / gene analysis research.
An ethics review committee must be set up as an advisory body to review
Must be.
However, due to the small size of the institution that provides samples and information, etc.
If it is difficult to establish an ethics review committee or if there is any other need
Established by joint research institutes, general incorporated associations, general incorporated foundations, or academic societies
To replace this by requesting the ethics review committee to review
Can be done.

<Detailed rules regarding the establishment of an ethics review committee>
1. 1. A similar committee already established in the research institution has been reorganized into an ethics review committee that conforms to this guideline.
If you organize it, it doesn't matter what the name is.
2. 2. If it is possible to request an ethics review committee established at a joint research institution, etc., the following
It will be a cage.
(1) An ethics review committee cannot be established within the research institution due to the small size of the research institution.
If
(2) It is a joint research and is exclusively engaged in the accumulation of information (excluding genetic information) used for research.
If you are a subordinate research institute

(4) The head of the research institution shall be ethical regarding all research plans or changes thereof.
We must respect the opinions of the review committee and decide whether or not to allow it.

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I. In this case, the study for which the Ethics Review Board submitted a disapproval opinion
Do not permit its implementation.

(5) If the head of the institution conducting the research conducts joint research in Japan,
At the ethics review committee established in each research institution, etc.
Status of approval of research plans at joint research institutes, informed consent
The research plan must be approved after showing the status of the research project and the status of anonymization.
It doesn't become.
However, the main research will be conducted in joint research in which multiple institutions participate.
If the institution is responsible for promoting and managing the entire research, the opportunity to carry out the main research
In Seki, the ethics review committee established at the relevant institution covers the entire research plan.
The examination will be conducted, and at other joint research institutes, follow the 4th 10 (5).
In addition, it is possible to carry out a rapid examination of the implementation of the research plan.

<Note>
In the second 4 (5), the "ethics review committee established in the research institution, etc." is the second 4
Established by joint research institutes, general incorporated associations, general incorporated foundations, or academic societies based on the proviso of (3)
When requesting an ethics review committee, it means the ethics review committee.

(6) The head of the institution conducting the research is asked by the principal investigator about the implementation status of the research for one year.
In addition to receiving regular reports at least once in Japan, regular fruits by outside experts
The fruit of human genome / gene analysis research, such as conducting a land survey at least once a year
Keep track of the status of the procedure and change the study as needed or by the Ethics Review Board.
If you give an opinion of cancellation, change or cancel it based on that opinion
I have to order.

<Detailed rules regarding field surveys by outside experts>
1. 1. The head of the research institution is responsible for the implementation of informed consent procedures and the protection of personal information.
The situation, etc. shall be investigated on-site to see if it is properly implemented in accordance with the research plan.
2. 2. The head of the institution conducting the research will have the principal investigator and the person in charge of the research cooperate in the field survey.
3. 3. External investigators must not divulge any information obtained during the field survey without good reason.
The same shall apply even after resigning from that position.

(7) The head of the institution conducting the research informs the Ethics Review Committee about the implementation status of the research.
Send a copy of the regular report and a copy of the field survey results by outside experts
Must be attached.

(8) Prior to conducting the human genome / gene analysis research, the head of the research institution should

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Researchers, etc. ethics of human genome / gene analysis research Other human genome / heredity
Make sure to receive education and training on the knowledge necessary to carry out child analysis research
The necessary measures must be taken to maintain it.

5 Responsibilities of the principal investigator
(1) The principal investigator is responsible for conducting the human genome / gene analysis research.
You have to prepare an Ecklonia cava research plan and ask the head of the research institution for permission.
It doesn't become. The same applies when attempting to change the research plan.

<Detailed rules regarding changes to the research plan>
If the research plan is changed, including the purpose of the research, after obtaining informed consent, before the change
The fifth 14 applies to the samples and information provided for use in the study.

(2) The principal investigator is trying to prepare the research plan.
Various effects expected on donors, etc. due to research on genome and gene analysis
Based on this, the necessity of research, research methods to prevent disadvantages of providers, etc.
Must be fully considered.

<Detailed rules regarding cases where the provider has a mental disorder, intellectual disability, etc.>
The donor is a monogenic disease for which a treatment or prevention method has not been established, and is a mental disorder or intellectual disability.
If you have something with harm or serious disability, the need for research, medical for the donor
The principal investigator carefully considers the psychological effects and the pros and cons of research methods that take them into consideration.
In addition, the Ethics Review Board will conduct a particularly careful review.

(3) Principal Investigator (excluding the principal investigator of the institution that collects and sells samples and information)
Created a research plan with due consideration given to the characteristics of human genome / gene analysis research
Must be done. In particular, informed consent procedures and
Method, method of protecting personal information, way of thinking about disclosure of genetic information, sample
Information storage and use methods, other human genome / gene analysis research in the future
Possibility of being used for, provision of samples and information to institutions conducting other research, and
The concept of genetic counseling must be clearly stated
I.

<Detailed rules regarding matters to be stated in the research plan>
The items to be stated in the research plan are generally as follows, but can be changed according to the research content.
To
・ Policy to select a provider (specific method to understand that the provider is rationally selected, the provider is ill or drug

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In the case of having a reactive abnormality, etc., a method of notifying the disease name or a state image corresponding thereto, etc. )
・ Significance, purpose, method, duration of research, expected results and dangers, method of protecting personal information (anonymization)
Including handling when not. )
・ Types and amounts of samples and information
・ Name of joint research institute
・ Name of the principal investigator, etc.
・ Procedures and methods for informed consent
・ Explanatory documents and consent documents for receiving informed consent
・ If it is difficult to receive informed consent from the provider, the importance of the research and
Select the reason why the research cannot be completed without receiving the sample and information from the provider, and the substitutes, etc.
Way of thinking
・ Concept of disclosure of genetic information (including the method of accepting requests for disclosure as necessary)
・ Presence / absence of consent when using existing samples / information, content, timing of provision, conformity with this guideline
・ Informed consent related to the sample / information when receiving the sample / information from an external organization
Contents of
・ Anonymization methods when providing samples / information to external institutions or when outsourcing part of research
Item (including the contents of the contract)
・ How to store samples and information and their necessity (to that effect when using for other research)
・ Safety management method of genetic information
・ If samples and information are provided to institutions conducting other research after the research is completed and used for other research,
To the effect
・ How to dispose of samples and information and how to anonymize them
・ Necessity of genetic counseling and its system
・ How to raise research funds, possible conflicts of interest, and relationships with related organizations such as researchers

(4) The principal investigator of the institution that collects and sells samples and information is the human genome and remains.
Research related to the collection and sale of samples and information, giving due consideration to the characteristics of gene analysis research
You have to make a plan. Informed consent in particular
How to check the contents of, the contents of protection of personal information, storage of samples and information
And the quality control method must be clearly stated.

<Detailed rules regarding matters to be stated in the research plan for collection and sale of samples and information>
The items that should be stated in the research plan for collecting and selling samples and information are generally as follows.
However, it can be changed according to the contents of collection / sale of samples / information.
・ Significance, purpose, method, period of collecting and selling samples and information, and method of protecting personal information (anonymization)
Including handling when not available. )
・ Types of samples and information to be collected and sold
・ Name of the institution that receives the sample and information
・ Names of the principal investigator (responsible for collecting and selling samples and information)
・ Method for confirming the contents of informed consent of samples and information
・ To confirm the conformity with this guideline at the institution that receives the sample / information and the institution to which it is sold.
the method of
・ Anonymization method when distributing samples / information to other research institutions
・ Methods for storage and quality control of samples and information
・ Safety management method of genetic information

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・ Handling of samples and information after the end of the plan
・ How to raise research funds, possible conflicts of interest, and relationships with related organizations such as researchers

(5) The principal investigator shall take all matters included in the approved research plan.
Properly human genome / gene solution by the researcher, such as making the researcher comply
It must be supervised to carry out the analysis study.

(6) The principal investigator will discuss the implementation status of the human genome / gene analysis research.

Must be regularly documented to the head of the research institution at least once a year
Not.

<Detailed rules regarding report items>
In general, the items to be regularly reported on the status of research conducted by the principal investigator to the head of the institution conducting the research are as follows.
It is as follows, but it can be changed according to the research content.
・ How to store samples and information
・ Status of provision of samples and information to external organizations
・ Number of samples / information for which human genome / gene analysis research was conducted
・ Research results, research progress
・ Whether or not a problem has occurred

(7) The principal investigator is a group of people with certain characteristics, such as local residents, who live in the area.
When conducting research that may reveal the genetic characteristics of the people, etc.
Research by holding briefing sessions for local residents before conducting research
To explain the content and significance of the research and try to gain an understanding of the research.
In both cases, to provide information on research even during research.
We must strive for more continuous dialogue with local residents.

(8) As a general rule, the principal investigator is a human being, using anonymized samples and information.
Genome / gene analysis research must be carried out.
However, the provider or substitute, etc. agrees and the ethics review committee approves.
Recognized in the research plan approved by the head of the research institution
If so, it is possible not to anonymize the sample / information.

(9) In principle, the principal investigator is an external machine using non-anonymized samples and information.
Do not provide to Seki.
However, the provider or proxy will provide it to an external institution without anonymization.
An institution that agrees to the above and conducts research with the approval of the Ethics Review Committee.
Anonymized if permitted in the research plan approved by the head of the

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It is possible to provide samples and information that have not been released to external organizations.

(10) The principal investigator entrusts a part of the work of human genome / gene analysis research.
If so, get approval from the Ethics Review Board and get permission from the head of the research institution.
It shall be done on a single digit and shall be indicated to the trustee in writing to that effect.

(11) The principal investigator entrusts a part of the work of human genome / gene analysis research.
In some cases, when providing the sample / information to the trustee, in principle, the sample / information
Information must be anonymized.
However, the provider or substitute, etc. agrees and the ethics review committee approves.
Recognized in the research plan approved by the head of the research institution
If so, the sample / information can be provided without anonymization.

(12) The principal investigator is the progress and results of the human genome / gene analysis research.
Must be explained or published on a regular basis and at the request of the provider, etc.
Must be.
However, the part necessary for guaranteeing the human rights of providers and protecting intellectual property rights
However, this is not the case.

6 Joint research with overseas
(1) When an institution conducting research in Japan conducts joint research with an overseas research institution,
Providing samples and information, as well as the human genome and remains, even in the partner countries where joint research is conducted
Sufficiently respecting human dignity and human rights in gene analysis research
It must be done with care.

(2) When an institution conducting research in Japan conducts joint research with an overseas research institution,
In principle, while complying with the laws and guidelines established by the partner country in which the joint research is conducted.
The research shall be conducted in accordance with this guideline.
However, in the following cases, provision of samples and information in the partner country and
Regarding the handling of samples and information, follow the standards such as laws and guidelines set by the partner country.
Can be done.
A. If this guideline is stricter than the standard in the partner country, and then
When all of the listed requirements are met
(A) It is difficult to apply this guideline in the partner country.

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(B) Regarding the appropriate measures taken by the matters stipulated in the bylaws, Japan
With the approval of the ethics review committee of the institution conducting the research, the head of the institution concerned
Judging that it is appropriate.
B. When the standards in the partner country are stricter than this guideline

<Detailed rules for conducting joint research with overseas research institutes>
1. 1. The matters stipulated in the second 6 (2) a (b) shall be as follows.
(1) Obtaining informed consent
(2) Appropriate measures should be taken to protect the personal information of the provider.
(3) The scientific and ethical validity of the research plan must be approved by the partner country, or the partner country must
Ethics review committee within the organization of the partner country or an organization equivalent thereto based on the stipulated laws and guidelines
Approved by the head of the research institution in the partner country
2. 2. In the case of the second 6 (2) a, the research must be conducted in accordance with the standards of the partner country.

Basic attitude toward the third provider
7 Informed consent
(1) Principal Investigator (Samples / Information from an external institution or another department within the institution conducting the research
Persons who carry out research by receiving information and collect and sell samples and information
Excludes those who do. The same applies to the third 7 below. ) Is the provision of samples and information
The person receiving the request must not be selected in an unreasonable, unreasonable or unfair manner.

(2) The person who receives the request for the provision of samples / information has a disease or abnormal drug responsiveness.
If, and if there is a possibility of them, the person is the name of the disease or its phase.
You must have been notified of the relevant state image, etc.

(3) The principal investigator shall inform the provider in advance of the significance, purpose, and direction of the research.
Laws, expected results, disadvantages that providers may suffer, disclosure of genetic information
The policy shown, how to store and use samples and information, and other human genomes in the future.
Sufficient about the possibility of being used for genetic analysis research and the procedure in that case
Written consent based on free will (inform)
You must receive the sample and information from the outlet.
However, for the protection of human life or body, urgently personal information or samples
Informed consent if information needs to be provided
You don't need to receive it.

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(4) The principal investigator is false when receiving informed consent.
Do not use any other improper means.
Also, when receiving samples and information, make the provider feel uneasy.
Care must be taken not to happen.

<Detailed rules regarding considerations when receiving informed consent>
Matters to be considered when receiving informed consent should be exposed to the information provided by the provider more than necessary.
This is to prevent things from happening.

(5) The principal investigator should give informed consent.
Notify the provider or proxy of the purpose of use of the sample / information, or publicize it
By doing so, the life, body, property and other rights and interests of the provider or a third party
Don't hurt.

(6) The principal investigator is required to receive informed consent.
Institution where samples and information are provided if
Fully understand the content and significance of research among the researchers of
Have a person perform all or part of the work under the guidance and supervision of the principal investigator.
Can be

(7) The principal investigator is a person other than the researchers belonging to the institution (hereinafter referred to as "performance assistance").
Person ". ) Concludes a contract to clarify the scope and responsibilities of business
By doing so, the informed consent is received from the performance assistant.
Give the necessary explanations and receive other informed consent
You can have them do some of the work you need to do.
In this case, the principal investigator shall state that fact in the research plan and at the same time.
If necessary, training opportunities for the performance assistant must be secured.

<Detailed rules regarding informed consent performance assistants>
1. 1. The principal investigator of the institution that provides the sample / information belongs to the institution that provides the sample / information.
When giving informed consent to a person other than the person who gives informed consent, a performance assistant is required.
Describe the placement and training methods, etc. in the research plan as necessary, and the research plan is a sample.
Approved by the ethics review committee of the institution where the information is provided, and the sample and information are provided.
The permission of the head of the institution shall be obtained.
2. 2. Performance assistance when the consent is included from the provider of the sample / information or the consenter, etc.
The person must be a person who is prohibited from leaking secrets that he / she has learned in the course of business under the law or contract.
Not.

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(8) The principal investigator must receive informed consent from the provider.
If it is difficult, the research you are trying to carry out is very important.
One, research cannot be completed without the provision of samples and information from that person.
Only when approved by the Ethics Review Board and approved by the head of the research institution.
Informed consent can be received from the provider's consenter, etc.
To

<Detailed rules 1 (Detailed rules regarding handling when receiving informed consent from a surrogate, etc.)>
It is difficult to receive informed consent from the provider, and info from the consenter, etc.
When it is possible to use a mud outlet and how to handle it, it is as follows, and in any case
In that case, the principal investigator will be able to complete the research unless he / she receives the importance of the research and the sample / information provided by the provider.
The reason for not having it and the idea of ​selecting a substitute, etc. are described in the research plan, and the research plan is written by the Ethics Review Board.
It shall be approved by the committee and approved by the head of the institution conducting the research.
・ Objective that the provider cannot give effective informed consent due to dementia, etc.
When judged
・ For minors. However, even in this case, the principal investigator will use words that are easy for the provider to understand.
Give sufficient explanation and try to gain understanding (so-called informed ascent)
And. In addition, if the provider is 16 years old or older, the inform from the provider together with the substitute
I will also receive a de outlet.
・ When the donor is dead and does not violate the explicit intention of his / her life

<Detailed rules 2 (Detailed rules regarding the basic concept of selecting a substitute)>
The principal investigator, in general, refers to the donor's family structure and the following persons.
A person who is considered to be able to represent the provider's presumed intentions and interests is selected in consideration of the situation etc.
It is necessary to describe the concept of selecting a substitute in the research plan based on the fact that it is determined.
1. 1. If a guardian, guardian, guardian or guardian is determined, that person
2. 2. Donor's spouse, adult child, parent, adult sibling or grandchild, grandparent, cohabiting relative or so
Those who are considered to be similar to their close relatives

<Detailed rules 3 (Detailed rules regarding the basic concept of selecting a bereaved family)>
The principal investigator is generally the family of the donor who died from the following persons regarding the bereaved family.
Considering the composition, situation, customs, etc., we think that we can represent the inferred intention of the provider during his lifetime.
It is necessary to describe the idea of ​selecting a bereaved family in the research plan on the basis that the person to be selected is selected.
is there.
・ Spouse of deceased donor, adult child, parent, adult sibling or grandchild, grandparent, parent living together
A person who is considered to be similar to a tribe or their close relatives

(9) The provider or surrogate does not give informed consent at any time.
It can be withdrawn in writing without benefit.

(10) The principal investigator is informed consent from the provider or substitute.

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If there is a withdrawal, in principle, the sample / information related to the provider will be provided.
Anonymize and dispose of it, and do not notify the provider or substitute in writing to that effect.
Must be. In addition, the provider or the substitute person wishes to take measures other than disposal.
In that case, unless there is a specific reason, this must be dealt with.
However, if any of the following requirements are met, the sample / information will be abolished.
Can not be abandoned.
A. When the sample / information cannot be linked and is anonymized
B. There is very little risk that personal information will be revealed by not discarding it.
Do not dispose of due to circumstances such as excessive disposal work.
Approved by the Ethics Review Board and approved by the head of the research institution
If

<Detailed rules regarding the handling of samples and information related to providers who have withdrawn informed consent>
If it is difficult for the principal investigator to determine the range of samples and information to be discarded, the research manager will conduct research.
You must report to the head of the institution that does this.
In this case, the head of the research institution should dispose of the sample / information, including consideration of the following matters in particular.
Request the opinion of the Ethics Review Committee regarding the scope of the report, and based on the results, the samples and information to be discarded
We will make a decision about the range.
・ Impact on providers and substitutes
・ In the explanation about withdrawal of informed consent at the time of informed consent
Yong
・ Impact on proper implementation of research work

(11) The principal investigator of the institution that provides the sample / information is the provider or the surrogate.
When receiving informed consent from, etc., the provider or consent
Documents that describe necessary matters so that people, etc. can fully understand
It must be delivered and explained.
<Detailed rules regarding the description of explanatory documents>
The matters to be stated in the explanatory document for the provider or the substitute, etc. are generally as follows.
It can be changed according to the research content.
・ Provision of samples and information is voluntary, and the person who receives the request for provision is not allowed by disagreeing with the provision.
Do not receive profitable response
・ Providers or surrogate persons are always disadvantaged with respect to the informed consent given by them.
Can be withdrawn in writing without benefit (received request for withdrawal if necessary)
Including how to attach. )
・ Reason for being selected as a provider
・ Name and job title of the principal investigator
・ Significance, purpose and method, period of research
・ Trial for future human genome / gene analysis research that is not specified at the time of receiving samples / information
If there is a possibility that the fee / information will be used, that fact (the sample / information will be used for other human genome / remains).
When using it for gene analysis research, the method of stipulating the use of existing samples and information of the institution conducting the 5th 14th research

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Follow the continuation)
・ At the time of providing the sample / information to other research institutions and receiving the sample / information from the provider
Places where samples and information may be used for future unspecified human genome / gene analysis research
In that case (the sample / information will be provided and used for other human genome / gene analysis research.
In that case, follow the procedure prescribed in the use of existing samples and information from the 5th 15th external organizations)
・ When personal information is used jointly with other institutions in joint research, that fact and joint use will be used.
Items of personal information to be used, the purpose of use of the user, and management of the personal information.
・ Predicted research results and predicted dangers and disadvantages to providers (social discrimination, etc.)
Including the disadvantages of life. )
・ To protect the personal information of other providers and ensure the originality of research at the request of providers and substitutes.
You can obtain or browse materials on research plans and research methods within the range that does not cause any problems.
To be able to
-Separation of connectable anonymization or non-linkable anonymization of samples and information, and specific methods of anonymization.
If you cannot anonymize, that fact and the reason
・ When there is a possibility of providing samples / information to an external institution or outsourcing a part of the research
To that effect and the handling of the sample / information, etc.
・ Matters concerning disclosure of genetic information (If not disclosed, the reason and the provider or substitute are inherited
If you agree not to disclose all or part of the information, it may not be disclosed.
Including that there is. )
・ Matters concerning disclosure of personal information (receptionist, acceptance method, provider or surrogate, etc.
Confirmation method, if a fee is incurred for disclosure, include that fact. )
・ If there is a possibility that the results of research will generate intellectual property rights such as patent rights in the future, that fact and assumptions
Attribution
・ How to store and use samples and information
・ How to dispose of samples and information
・ Information on the use of genetic counseling (in the case of monogenic diseases, the need for research and the remains
(Transmission counseling is available, etc.)
・ How to raise research funds, possible conflicts of interest, and relationships with related organizations such as researchers
・ Providing samples and information is free of charge
・ Information on inquiries (correction of personal information, withdrawal of consent, etc.), contact information for complaints, etc.
・ Other necessary matters

(12) The principal investigator is the human genome before conducting genetic analysis research.
Provided assuming use for genetic analysis research or related medical research
When receiving informed consent from a person or a surrogate, etc.
In addition to clarifying the specific research objectives expected at the time of
How personal information is managed and protected, including the possibility of anonymization
You must explain what is done and get an understanding.

(13) The head of the institution where the sample / information is provided is obtained from the provider or the surrogate.
Regarding the consent form for informed consent, samples and information will be provided.
Persons who can strictly manage such as the research manager of the institution and the personal information manager
Must be managed.

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8 Disclosure of genetic information
(1) The principal investigator is the human genome, in which the genetic information of each donor is clarified.
Provider wants to disclose his / her genetic information regarding genetic analysis research
In that case, it must be disclosed in principle.
However, by providing the genetic information, the life of the provider or a third party
Risk of harming life, body, property or other rights and interests, or opportunity to conduct the research
There is a risk of significant hindrance to the proper implementation of Seki's research work, and
Receiving informed consent from the provider regarding not disclosing
If so, all or part of it may not be disclosed.
If not disclosed, the reason for not disclosing the genetic information to the provider
Must be explained.

<Detailed rules regarding disclosure of genetic information>
1. 1. The principal investigator, when requested by the provider to disclose his / her genetic information, will be responsible for the genetic information.
If all or part of the information is disclosed, that is the case, and if the genetic information is not disclosed, that fact and the reason.
The reason must be reported to the head of the research institution.
2. 2. The life, body, or property of a provider or third party who may not disclose all or part of the genetic information
Written for the risk of harming industry or other rights and interests, or for the proper implementation of research work by the institution conducting the research.
Specific cases that may cause problems are as follows, but application to individual cases
It is necessary to make an individual, concrete, objective and careful judgment.
・ The accuracy and certainty of the genetic information as information for evaluating the health condition of the person is sufficient.
Instead, disclosure may impose a mental burden on the donor or relatives or cause misunderstanding.
If there is
・ Institutions conducting the research, including those whose accuracy and certainty as information are not sufficient
When there is a risk that disclosing all of the transmitted information will significantly hinder the implementation of the research.
3. 3. When the principal investigator can be a mental burden on the provider by notifying the reason for not disclosing it.
Etc., it may not always be appropriate to give an explanation, so carefully inspect according to the reason.
After discussion, we will respond.
4. The principal investigator will disclose if the minor donor wishes to disclose his or her genetic information.
It can be disclosed to the minor after giving due consideration to the psychological effects of such cases. However
However, if a minor is under the age of 16, he / she must confirm and respect the intentions of his / her substitute.
Not.
In addition, the principal investigator will hurt the donor by disclosing the genetic information of minors.
Conduct research if you are concerned about discrimination against donors, refusal to raise children, or adverse effects on treatment
You must report to the head of the institution. The head of the research institution should, if necessary, morale before disclosure.
After asking for the opinion of the Physical Examination Committee and discussions between minors and their substitutes, whether or not to disclose it and its
The content and method will be decided.
5. If we decide not to disclose the genetic information, we will inform the provider who requested the disclosure in writing.
I will notify you.
6. The method of disclosing the genetic information shall be the method agreed by the person who issued the document or requested the disclosure.

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And.

(2) The principal investigator is the human genome / gene analysis research to be carried out and the research.
Based on the characteristics of the genetic information obtained by the study,
Establish a policy regarding disclosure of genetic information to providers, and provide or substitute
When receiving informed consent from, etc., explain the policy and explain it.
You have to get an understanding. Consider the following when deciding on a policy
Must.
A. The genetic information serves as information for evaluating the health condition of the provider.
Whether it has accuracy and certainty
B. The genetic information indicates important facts for the health of the provider.
Whether or not
C. Disclosure of the genetic information will significantly hinder the proper implementation of research work.
Whether there is a fear

<Detailed rules regarding policy regarding disclosure of accidental findings>
The principal investigator is a provider who was not initially envisioned in the process of human genome / gene analysis research.
And when incidental findings that have a significant impact on the life of relatives are discovered
We will also consider the policy regarding the disclosure of genetic information in
When receiving a mood outlet, explain the policy and try to gain understanding.

(3) When the principal investigator discloses genetic information, the genetic information is the provider.
Has accuracy and certainty as information for evaluating the health condition of
We will try to explain as much as possible, and the donors and relatives
We will endeavor not to be misleading.

(4) The principal investigator is the human genome, in which the genetic information of each donor is clarified.
Provider wants to disclose his / her genetic information regarding genetic analysis research
If not, do not disclose.

<Detailed rules regarding non-disclosure of genetic information>
The principal investigator is responsible for the genetic information, even if the donor does not wish to disclose his or her genetic information.
Information has been found to have a significant impact on the lives of donors and relatives, and there are effective remedies.
In some cases, report to the head of the institution conducting the research.
The head of the research institution may or may not disclose the information, including consideration of the following matters, and its contents and contents.
We seek the opinion of the Ethics Review Committee on the method, and based on that, we are in charge of medical treatment of the principal investigator and the provider.
Consult with the doctor and the head of the medical institution to which the doctor belongs. Research based on the results
The person in charge confirms the intention of the provider after giving a sufficient explanation to the provider, and still wishes to disclose it.
If not, it shall not be disclosed.

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・ Impact on the lives of donors and relatives
・ Existence of effective treatment and health condition of donor
・ The possibility that relatives are suffering from the same disease, etc.
・ Explanation regarding disclosure of research results for informed consent

(5) The principal investigator will provide the genetic information of the donor without the consent of the donor.
In principle, it must not be disclosed to anyone other than the provider.

<Detailed rules regarding disclosure to persons other than the provider>
1. 1. If the surrogate (excluding those in 2 and 3) wishes to disclose the genetic information of the provider, the surrogate
After showing the reason or necessity for the consenter to request disclosure to the Ethics Review Committee, based on the opinion of the committee.
The head of the institution conducting the research must decide what to do. In making this decision, the following
Make sure that you meet one of the requirements.
1) Obtain the consent of the provider when it is necessary for the protection of human life, body or property.
Is difficult
2) It is difficult to obtain the consent of the provider even when it is particularly necessary to improve public health.
thing
2. 2. If the bereaved family (relatives) wishes to disclose the genetic information of the donor, the bereaved family (relatives) will disclose it.
After showing the ethics review committee the reason or necessity for requesting the above, conduct research based on the opinion of the committee.
The head of the institution will decide the response.
3. 3. If the donor is a minor, the principal investigator will inherit the minor's inheritance from the minor's substitute.
When requested to disclose information, it may be disclosed to the person concerned. However,
If a minor is 16 years of age or older, he / she must confirm his / her intention and respect it. Also,
By disclosing the genetic information of minors, the principal investigator discriminates against donors and refuses to raise children.
No, if you are concerned about adverse effects on treatment, you should report it to the head of the research institution.
Prior to disclosure, the head of the research institution should discuss the propriety of disclosure and its content and method as necessary.
We will seek the opinions of the Ethics Review Board and discussions between minors and their substitutes.
4. The principal investigator may not wish to disclose his genetic information to relatives, even if the donor does not wish to disclose it to relatives.
If all of the following requirements are met, the donor's relatives will be derived from the donor's genetic information.
Can convey information about diseases with a genetic predisposition and drug responsiveness.
1) The genetic information of the donor is likely to have a significant impact on the lives of the donor's relatives.
It turns out that there is an effective countermeasure
2) The head of the institution conducting the research who received the report of 1) from the principal investigator, especially regarding the following matters
Request the opinion of the Ethics Review Board regarding the propriety of disclosure including consideration and its content and method.
Based on this, it is concluded that the necessary information should be provided to relatives in consultation with the principal investigator.
When
a Relatives may be suffering from the same disease
b Impact on the life of relatives
c Presence or absence of effective treatment and health status of relatives
d Explanation of disclosure of research results for informed consent
3) Based on the conclusion of 2), the principal investigator seeks the understanding of the donor again and is necessary for relatives.
Strive to obtain consent for the provision of information
4) Confirm the intention to provide information after giving sufficient explanation to the relatives of the provider.
thing

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(6) The principal investigator is a single-gene disease, etc. (multifactorial disease with clear related genes)
Including. ), Medically or precisely
In close cooperation with the doctor in charge of medical treatment, giving due consideration to divine influences, etc.
In addition to disclosing it, we must provide opportunities for genetic counseling as necessary.
Must be.

<Note>
The meaning of the genetic information to be disclosed largely belongs to the medical treatment, and the doctor in charge of the medical treatment
Close cooperation with teachers, especially doctors specializing in medical genetics, is required. Therefore, take charge of medical treatment
As part of the medical treatment, the doctor may disclose it at the request of the principal investigator or study under the doctor's instructions.
It is conceivable that the person in charge of research will disclose it.

9 Genetic counseling
(1) Genetic counseling in human genome / gene analysis research involves dialogue
Through, provide accurate information to the provider and his / her family or relatives and ask questions
Answer appropriately, deepen the understanding of the person's hereditary diseases, etc., and the human genome
By responding to anxieties or worries about genetic analysis research and hereditary diseases
So, we support you to make your own choices and actions for your future life.
Or the purpose is to help.

(2) Genetic counseling has sufficient knowledge about medical genetics and genetic counseling.
Unless doctors, medical professionals, etc. who are proficient in counseling cooperate
It doesn't become.

<Note>
Matters concerning the establishment of a genetic counseling system for the head of the institution where samples and information are provided
And the matters concerning the provision of opportunities for genetic counseling are described in the third 9 (3), genetics in the research plan.
Matters concerning the description of the concept of counseling can be found in the second 5 (3), informed consent.
For the explanation when receiving the genetic information, see the third 7 (11), which provides an opportunity for genetic counseling when disclosing genetic information.
Matters concerning provision are stipulated in the third 8 (6), respectively.

(3) The head of the institution that provides the sample / information provides the sample / information from the provider.
If necessary, establish an appropriate genetic counseling system
Explanation of equipment or genetic counseling and introduction of appropriate facilities, etc.
Allows donors and their families or relatives to receive genetic counseling
Care must be taken to ensure that. In particular, the donor is a monogenic disease, etc.
Includes multifactorial diseases with well-defined linkage genes. ), Providing samples and information

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Informed consent is given to the principal investigator of the institution where
At that time, I would like to explain including information on the use of genetic counseling.
In addition, we must provide opportunities for genetic counseling as needed.
I.

<Detailed rules regarding introduction of genetic counseling facilities>
When the genetic counseling system is not established at the institution where the samples and information are provided.
When there is a request for genetic counseling from the donor and his / her family or relatives, therefore
We will introduce the appropriate facilities of.

4th Ethics Review Committee
10 Obligations and composition of the Ethics Review Board
(1) The Ethics Review Committee will determine the appropriateness of implementing the research plan based on this guideline.
Institutions that conduct research by examining and conducting research from an ethical perspective as well as a scientific perspective
You must give your opinion in writing to the chief.

(2) The Ethics Review Committee will inform the head of the research institution about the research being conducted.
Then, state the opinion that the research plan is changed, canceled, or otherwise deemed necessary.
Can be done.

(3) Members of the Ethics Review Committee leak information that they have learned in the course of their duties without a justifiable reason.
should not be done. The same shall apply even after resigning from that position.

(4) Is the Ethics Review Board an interdisciplinary and multidimensional perspective from an independent standpoint?

The committee members from various standpoints can conduct fair and neutral examinations.
It must be properly configured and operated.

<Detailed Regulations 1 (Detailed Regulations on the Composition of the Ethics Review Committee)>
・ From humanities and social science experts including ethics and law, natural science experts, and general people
Need to be done.
・ It is necessary to have multiple external committee members, including those who are experts in the humanities and social sciences and those in general positions.
To
・ It must be composed of both sexes.

<Detailed Regulations 2 (Detailed Regulations on the Operation of the Ethics Review Committee)>
・ At the time of deliberation or voting, at least one member from the humanities / social sciences or general position must attend.

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is there.
・ The head of the institution conducting the research, the principal investigator of the research to be examined, and the person in charge of the research shall deliberate or adopt the research.
Do not participate in the decision. However, at the request of the Ethics Review Board, attend and explain at the meeting.
Can be
-The head of the research institution cannot be a member of the Ethics Review Board.

<Detailed rules 3 (Detailed rules regarding operating rules)>
Operating rules regarding the following matters must be established.
・ How to appoint a chairperson
・ Requirements for establishing a meeting
・ Voting method
・ Retention period of examination records
・ Matters concerning disclosure

(5) The Ethics Review Committee is a committee nominated in advance by the chairman based on the decision.
A rapid examination procedure can be established by a member or its subordinate organization. Quick trial
Regarding the result of the inspection, all the members other than the member who conducted the examination or the upper part
It must be reported to the organization, the Ethics Review Board.

<Detailed rules regarding rapid examination procedures>
1. 1. The matters that can be entrusted to the examination by the accelerated examination procedure are generally as follows.
・ Examination of minor changes in the research plan
・ Collaborative research that has already been approved by the Ethics Review Committee at the institution that conducts the main research
Examination of research plans when other joint research institutes intend to implement the plan
・ Minimal danger to donors and substitutes (physical problems in daily life and daily medical examinations)
Some types of danger that do not exceed the limits of the potential for psychological and social harm and are socially acceptable.
To say. Examination of research plans that do not include risks exceeding)
2. 2. Upon receiving the report of the result of the accelerated examination, the committee member gives a reason to the chairperson and then discusses the matter.
Therefore, the ethics review committee can request another review. In this case, the chairman
If we find that there is a good reason, we will promptly hold an ethics review committee to discuss the matter.
Must be examined.

(6) The Ethics Review Committee publishes matters related to the organization and rules regarding its operation.
At the same time, the content of the proceedings must be disclosed in principle.
I.

<Detailed rules 1 (Detailed rules regarding disclosure of matters related to the organization)>
Matters to be disclosed regarding the organization are as follows.
・ Composition of the Ethics Review Committee (including subordinate organizations)
・ Name, affiliation and position of committee members

<Detailed rules 2 (Detailed rules regarding disclosure of minutes)>
1. 1. The content of the proceedings needs to be disclosed so that it becomes clear.
2. 2. It will hinder the human rights of providers, originality of research, protection of intellectual property rights, and preservation of competitive position.

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Some parts of it may be kept private by the decision of the Ethics Review Board. In this case, Rin
The review committee needs to disclose the reason for keeping it private.

(7) The founder of the Ethics Review Committee is responsible for the education and training of the members of the Ethics Review Committee.
I have to make an effort.

Fifth handling of samples and information, etc.
11 Provision of samples and information to institutions conducting other research, etc.
(1) The head of the research institution provides samples and information to other research institutes.
In that case, do not notify the contents of informed consent in writing.
Must be.

(2) The head of the institution that provides the sample / information is the sample / information (existing sample / information).
Excludes information. ) To an external institution, in principle, provide samples and information.
Must be anonymized.
In addition, human genome / gene analysis within the institution where samples and information are provided.
Research department conducting research (hereinafter referred to as "institutions where samples and information are provided"
Research department ". ), As a general rule, anonymity when providing samples and information
Must be converted.
However, if all of the following requirements are met, do not anonymize.
Can provide samples and information.
A. The provider or the surrogate, etc. does not anonymize the external organization or sample / information.
Agree to provide to the research department at the institution where the information is provided
Being.
B. Research approved by the ethics review committee and approved by the head of the research institution
Providing external organizations or samples / information without anonymization in the plan
Approved to provide to the research department at the institution where the service is provided
thing.

<Note>
The fifth 11 (2) provision is the head of the institution where samples and information are provided within the scope of the research plan.
Provides samples / information to research departments at external institutions or institutions where samples / information are provided.
It stipulates the criteria for anonymization, and samples and information must not be provided beyond the scope of consent.

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(3) The principal investigator who receives the sample / information from an external organization is the sample / information.
The contents of informed consent regarding information from the external organization concerned
It must be confirmed by the document etc.

12 Handling of anonymized information
(1) The head of the research institution collects anonymized information that does not correspond to personal information.
When handling the information, it is important for researchers to manage the information appropriately.
Thorough dissemination, management of relevant information (including response to accidents, etc.), clarification of responsibilities, research
Do not take appropriate measures such as preventing the handling of the information by persons other than researchers.
Must be.

<Detailed rules regarding the handling of anonymized information>
When handling anonymized information that does not correspond to personal information, distinguish between connectable and unlinkable
And take appropriate measures. Linkable When dealing with anonymized information, pair
Appropriate measures shall be taken for the safety management of the response table.

<Detailed rules regarding the handling of anonymized genetic information>
When handling anonymized genetic information that does not correspond to personal information, leakage of the handled information,
Appropriate security management measures must be taken to prevent loss or damage and to manage the security of information.
The general safety management measures to be taken regarding the handling of anonymized genetic information that does not correspond to personal information
It is as follows, but it can be changed according to the amount and nature of the genetic information to be handled. Also, the laboratory
Before having researchers handle anonymized genetic information that does not correspond to personal information,
Take appropriate measures such as presenting a policy for disclosure or sharing of the information according to the amount and nature of the information.
I will squeeze.
・ Clarification of responsibility and authority for the safety management of genetic information
・ Preparation of procedure manuals, etc. that define safety management measures for genetic information and operation in accordance with them
・ Dealing with accidents, etc.
・ Implementation of education on the handling of genetic information for researchers, etc.
・ Implementation of entrance / exit (room) management, prevention of theft, etc.
・ Access control of genetic information and information systems that handle it, countermeasures against malicious software, monitoring, etc.

(2) The head of the research institution is the individual involved in the work of human genome / gene analysis research.
Entrust all or part of the handling of anonymized information that does not correspond to personal information
If so, it has been anonymized and does not correspond to the personal information entrusted with its handling.
Matters to be observed by the outsourced person so that information can be handled appropriately
Is secured by contract and necessary for those who have been entrusted with
And appropriate supervision must be provided.

<Detailed rules regarding matters to be secured by contract when outsourcing>
As for the matters that the entrusted person should comply with, the matters that should be secured by the contract are generally as follows.

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However, other items can be added depending on the content of the outsourced work.
・ Matters concerning the handling of anonymized information of entrusted persons
・ Prohibition of use beyond the scope of entrustment
・ Prohibition of providing samples and information to anyone other than those who have been entrusted
・ Confidentiality of information obtained in business
・ Matters concerning the disposal / return of samples / information after the contract ends

<Detailed rules regarding supervision of contracted persons>
Necessary and appropriate supervision of the entrusted person is determined by the entrustor, for example, in the entrustment contract.
Explicitly specify the content of safety management measures and confirm that the content is being observed.
That is.

13 Storage and disposal of samples and information
(1) The principal investigator, when storing samples and information within the institution conducting the research,
The method specified in the research plan, observing the consent of the provider or the surrogate
Must obey.

(2) The principal investigator should save the samples and information by himself / herself according to the research plan.
Unless provided to an institution conducting other research, the retention period of samples and information will be researched.
If the period specified in the research plan has passed, the consent of the provider or the substitute, etc.
Must be obeyed, anonymized and discarded.

14 Utilization of existing samples and information from research institutions
The principal investigator is a human being who uses existing samples and information stored at his / her institution.
When used for genome / gene analysis research (a place to collect and sell samples / information)
Excludes cases. ) Regarding the use of existing samples and information from providers or surrogate persons, etc.
In principle, we will receive your consent and make a record of that consent. Ta
However, if the consent cannot be obtained, it falls under any of the following.
With the approval of the Ethics Review Board, permission from the head of the institution conducting the research
The existing sample / information can be used only when the information is received.
A. The existing sample / information cannot be linked and is anonymized.
B. If the existing sample / information does not correspond to a, the existing sample / information
If the information is concatenable and anonymized and does not have a correspondence table, the relevant information is available.
About the implementation of Togenome / gene analysis research Purpose of use of existing samples / information
Notify the provider, etc. of the information including it, or make it public.
C. If the existing sample / information does not correspond to a and b, the existing test

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When providing fees and information, it is clear that they will be used in the human genome / gene analysis research.
If only consent for a study not shown is given, then
Meet the listed requirements.
(A) Existing samples and information regarding the implementation of the human genome / gene analysis research
Notify or disclose information including the purpose of use to the provider.
(B) The consent is considerably related to the purpose of the human genome / gene analysis research.
Be reasonably recognized as having sex.
D. If the existing sample / information does not correspond to a to c, then
Must meet all of the listed requirements or be compliant with laws and regulations.
(A) Dangers and disadvantages to providers, etc. due to the human genome / gene analysis research
There is very little risk of this.
(B) Public human genome / gene analysis research using the existing samples / information
When it is necessary to improve hygiene.
(C) In other methods, in effect, the human genome / gene analysis research is carried out.
Is impossible.
(D) Disclosure of information on the implementation status of the human genome / gene analysis research
At the same time, inquire the provider or the surrogate, etc. and research the sample / information.
Measures have been taken to ensure the opportunity to refuse to use
thing.
(E) It is difficult to obtain the consent of the provider or the substitute.

15 Utilization of existing samples and information from external organizations
(1) The principal investigator conducts research by receiving existing samples and information from an external institution.
If you intend to implement it (excluding cases where samples and information are collected and sold),
Research plan on the contents of existing samples and information to be provided and the necessity of receiving the provision
Permission from the head of the institution conducting the research, written in writing and approved by the Ethics Review Board
Must receive.

(2) Those who provide existing samples and information should send the human genome to other research institutions.
When providing existing samples and information for use in genetic analysis research,
For the provision of samples and information from the provider or the surrogate, etc. and the research concerned by the time of delivery
Obtain consent for use and create a record of such consent
In principle. However, if the consent cannot be obtained,
Conduct other research on existing samples and information only when any of the following applies

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Can be provided to institutions.
A. The existing sample / information cannot be linked and is anonymized.
B. If the existing sample / information does not correspond to a, the existing sample / information
If the information is concatenable and anonymized and the correspondence table is not provided, the relevant information is available.
Implementation and provision of genome / gene analysis research
Notifying or disclosing information including the purpose of use to providers, etc.
With the approval of the Ethics Review Board and the permission of the head of the institution
thing.

6th protection of personal information
16 Personal information to be protected
(1) "Personal information" is information about living individuals, and is included in the information.
Identifying a specific individual by the included name, date of birth, or other description.
What can be done (can be collated with other information, thereby a specific individual
Includes those that will be able to identify a person. ).

(2) Personal information cannot be linked Anonymized information does not correspond to personal information. Individual
Personal information can be linked Anonymized information is the individual information at the research institution.
A new code or code that can connect the individual related to personal information and the information.
Does not correspond to personal information if it does not have a correspondence table such as numbers.

<Detailed rules regarding the handling of linkable and anonymized information>
When handling anonymized information that can be linked in the same corporation or research department within an administrative agency,
The research department is anonymized outside the research department, and the correspondence table for the anonymization information is strict.
It is sufficient for the institution as a whole, such as establishing appropriate measures in consideration of the circumstances such as being managed by
Safety management measures can be established to ensure safety management.

(3) Information handled in human genome / gene analysis research corresponds to personal information.
Even if there is no information, genetic information, medical information, etc. that show individual characteristics and constitution
Information must be handled appropriately based on the 5th 12 (1) and (2) of this guideline.
Must be.

17 Safety management measures

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(1) The head of the research institution leaks, loses, or damages the personal information it handles.
Organizational, human, physical and for the prevention of loss and other security management of personal information
Technical safety control measures must be taken.
In addition, when making researchers handle personal information, the personal information concerned
Necessary and appropriate supervision of the researcher, etc. so that the safety of the information can be managed.
I have to do the governing.

<Detailed rules regarding safety management measures>
Organizational, human, physical and technical security measures are necessary and appropriate depending on the nature of the information handled.
It calls for urgent measures.
At that time, if the head of the research institution leaks, loses, or damages personal information, he / she himself / herself.
Record the nature of the research, the handling status of personal information, and personal information, considering the magnitude of infringement of rights and interests suffered by
Necessary and appropriate measures shall be taken according to the risks caused by the nature of the medium.

1. 1. Organizational safety management measures
Organizational safety management measures clearly define the responsibilities and authorities of researchers, etc. regarding safety management, and are used for safety management.
To maintain and operate the regulations and procedure manuals (hereinafter referred to as "regulations, etc.") and check the implementation status.
Say. Organizational safety management measures include the following:
(1) Establishing an organizational system to take security management measures for personal information
(2) Development of rules, etc. that determine security management measures for personal information and operation in accordance with the rules, etc.
③ Development of means to list the handling status of personal information
④ Evaluation, review and improvement of security management measures for personal information
⑤ Dealing with accidents or violations

2. 2. Human safety management measures
Personal safety management measures are contracts for non-disclosure of personal information designated as confidential in business to researchers, etc.
It means to conclude, educate, and train. Human safety management measures include the following items.
① Conclusion of non-disclosure contract at the time of employment contract and consignment contract
② Implementation of education and training for researchers, etc.

3. 3. Physical safety management measures
Physical safety management measures refer to measures such as management of entrance / exit (room) and prevention of theft of personal information. Physics
Safety management measures include the following items.
① Implementation of entrance / exit (room) management
② Prevention of theft, etc.
③ Physical protection of equipment / devices, etc.

4. Technical safety management measures
Technical security management measures include access control of personal information and information systems that handle it, and fraudulent operations.
It refers to technical security management measures for personal information such as security measures and information system monitoring. Technology
Safety management measures include the following items.
① Identification and authentication in accessing personal information
② Access control of personal information
③ Management of access authority to personal information

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④ Access record of personal information
⑤ Countermeasures against malicious software for information systems that handle personal information
⑥ Measures for transfer and communication of personal information
⑦ Measures to be taken when checking the operation of an information system that handles personal information
⑧ Monitoring of information systems that handle personal information

(2) The head of the research institution says that personal information about the dead is respected as a dead person.
Survival in view of the common feelings and genetic information of the bereaved family and relatives
As well as personal information about the dead, personal information about the dead is safe
Organizational, human, physical and technical safety management measures must be taken for management
Must be.

18 Handling of personal information
(1) The head of the research institution is the individual involved in the work of human genome / gene analysis research.
When entrusting all or part of the handling of personal information, entrust the handling
The person entrusted with the information should comply with it so that the personal information can be safely managed.
Matters are secured by contract, and for those who have been entrusted
Necessary and appropriate supervision must be provided.

<Detailed rules regarding matters to be secured by contract when outsourcing>
Regarding the matters that the entrusted person should comply with, the matters that should be secured by the contract are generally as follows.
However, it can be added according to the content of the outsourced work.
・ Matters concerning the handling of personal information of the person who has been entrusted
・ Prohibition of use beyond the scope of entrustment
・ Prohibition of providing samples and information to anyone other than those who have been entrusted
・ Confidentiality of information obtained in business
・ Matters concerning the disposal / return of samples / information after the contract ends

<Detailed rules regarding supervision of contracted persons>
Necessary and appropriate supervision of the entrusted person is determined by the entrustor, for example, in the entrustment contract.
Explicitly specify the content of safety management measures and confirm that the content is being observed.
That is.

(2) The head of the research institution is personal in the human genome / gene analysis research.
When handling information, a personal information manager is appointed to protect personal information.
There must be.
In addition, if necessary, after clarifying responsibilities, authority, and chain of command,
A person who divides the duties of a personal information manager (hereinafter referred to as "shared manager")

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Or perform the actual work under the supervision of the personal information manager or the division manager
An assistant can be placed.

<Detailed rules regarding requirements for personal information managers>
Personal information managers and shared managers are the Criminal Code (Act No. 45 of 1890), Article 134, and the National Civil Service Law (Akira).
Japanese Law No. 120) Article 100 Other laws prohibit the leakage of secrets that have been learned in business.
Person (doctor, pharmacist, etc.).
In addition, the personal information manager and the sharing manager use the sample and information provided by the personal information manager and the human genome and heredity.
Principal Investigator or Principal Investigator conducting child analysis research (excluding provision or collection / sales of samples / information)
Cannot be combined with.

(3) The head of the research institution should make a copy of the approved research plan and the status of research implementation.
A copy of the regular report on and the results of the field survey by outside experts
A copy must be sent to the personal information manager.

(4) The head of the research institution uses personal information when handling it.
The purpose of (hereinafter referred to as "purpose of use") must be specified as much as possible.
Absent. In addition, the head of the research institution changes when changing the purpose of use.
Exceeding the range reasonably recognized as having a considerable relevance to the purpose of use before the renewal
Don't go.

(5) The head of the research institution does not obtain the consent of the provider in advance, and the sixth
Individuals beyond the scope necessary to achieve the purpose of use specified in 18 (4)
Do not handle information.

(6) The head of the research institution is the institution that conducts other research due to a merger or other reasons.
If personal information is obtained as a result of taking over the research from
For the purpose of using the personal information before the succession without obtaining the consent of the provider
The personal information must not be handled beyond the scope necessary for achievement.

(7) When the head of the research institution obtains personal information, the head of the research institution should know it in advance.
Promptly provide the purpose of use, except when the purpose of use is announced.
Must be notified or made public.

<Detailed rules regarding publication of purpose of use>
Announcement of the purpose of use means to announce the contents to the general public, and generally it is as follows.
It can be changed to a rational and appropriate method according to the nature of the research and the handling situation of personal information.
・ Posting to a place that can be reached from the top page of the homepage with about one operation
・ Posting and provision of documents at the window of the research institution

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・ Description and distribution in pamphlets, etc.

(8) If the head of the research institution changes the purpose of use, the changed use
The provider must be notified or made public about the purpose.

(9) The head of the research institution shall be individual within the range necessary to achieve the purpose of use.
We must strive to keep personal information accurate and up-to-date.

(10) The head of the institution conducting the research will provide it in advance, except in the following cases.
Personal information must not be provided to a third party without the consent of the person.
A. When required by law
B. When there is a particular need to improve public health, the same as the provider
When it is difficult to get the motivation
A national institution or a local public body or a person entrusted with it is required by law.
When it is necessary to cooperate in carrying out the affairs
Obtaining the consent of the provider may hinder the performance of the relevant affairs.
When there is
In addition, in the following cases, the person who receives the personal information is the first
It shall not correspond to the three parties.
A. All handling of personal information within the scope necessary to achieve the purpose of use
When outsourcing a part
B. Personal information will be provided as a result of the succession of research due to a merger or other reasons.
If
C. When personal information is shared with a specific person,
The purpose and items of personal information used jointly, of those who use it jointly
Responsible for the scope, purpose of use of the user and management of the personal information
Notify the provider in advance of the name or name of the owner, and
Is in a state that the provider can easily know
Regarding the purpose of use of the user or the management of personal information specified in c.
If you change the name or name of the person who is responsible
Notification to the provider in advance, or a letter that the provider can easily know
Must be put in a state.

<Note>
Existing samples / information can be linked If the correspondence table is not provided because it is anonymized, the fifth 15 (2) rule
Based on the rules, the existing sample / information can be provided to a third party.

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(11) The head of the research institution shall make the following matters regarding the personal information held.
About the state that the provider can know (answer without delay at the request of the provider
Including the case. ) Must be placed.
A. Name of the institution conducting the research
B. Purpose of use of all personal information held (6th 18 (12) a to c
Except when applicable to. )
C. 6th 18 (12) or 6th 19 (1), (2), (3) or (4)
Procedures for responding to requests (when the amount of the fee is set, the amount of the fee is included
Mu. )
D. Where to file complaints regarding the handling of personal information we hold

(12) The head of the institution conducting the research is identified by the provider from the provider or the surrogate.
When requested to notify the purpose of use of the retained personal information, the provider
Alternatively, this must be notified to the surrogate, etc. without delay.
However, this does not apply if any of the following applies.
A. To notify the provider or the surrogate, etc. of the purpose of use, or to announce it
Harm the life, body, property and other rights and interests of the provider or a third party
When there is a risk
B. To notify or publicize the purpose of use to the provider or the surrogate
When there is a risk of harming the rights or legitimate interests of the institution conducting more research
For national institutions or local public bodies to carry out affairs stipulated by laws and regulations
If it is necessary to cooperate with the provider or substitute for the purpose of use
Notifying or publicizing the consenting party will hinder the performance of the relevant affairs.
When there is a risk of spilling
If it is decided not to notify the purpose of use, the provider or consent
Persons, etc. must be notified to that effect without delay.

19 Disclosure of personal information, etc.
(1) The head of the institution conducting the research is identified by the provider from the provider or the surrogate.
Disclosure of retained personal information (individuals retained by which the provider is identified
Includes notifying when information does not exist. ) Was asked
In some cases, request the provider or the surrogate, etc. to deliver or disclose the document.
We will disclose the personal information we hold without delay by the method agreed by the person.

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There must be.
However, if the disclosure falls under any of the following, all of them
Part or part may not be disclosed.
A. Harm to the life, body, property or other rights and interests of the provider or a third party
If it is
B. It will significantly hinder the proper implementation of research work of the research institution.
If there is
C. When it violates the law
Decision not to disclose all or part of the personal information held
If you do, notify the provider or the surrogate, etc. without delay.
There must be.

<Note>
Disclosure of genetic information is the responsibility of the principal investigator in Section 3-8.
I will do it.

(2) The head of the institution conducting the research is identified by the provider from the provider or the surrogate.
The protection is due to the fact that the content of the personal information held is not true.
Correction, addition or deletion of the content of personal information held (hereinafter referred to as "correction, etc.")
When requested, the provisions of other laws and regulations regarding correction of the contents, etc.
Except when special procedures are stipulated, the range necessary to achieve the purpose of use
In the siege, we will conduct the necessary investigation without delay, and based on the result, the relevant insurance
You must correct the content of your personal information.
In addition, corrections, etc. of all or part of the content of personal information held
When it is done, or when it is decided not to make corrections, etc., the provider or
To that effect (if any corrections are made, the contents of the corrections, etc.) without delay to the substitutes, etc.
including. ) Must be notified.

(3) The head of the institution conducting the research is identified by the provider from the provider or the surrogate.
The personal information held is taken in violation of the sixth 18 (5) or (6).
Also acquired because it is being treated or in violation of the second 3 (10)
Suspension of use of the personal information held or due to the reason
Erasing (hereinafter referred to as "suspension of use, etc." in this section and 6th 19 (5))
When it turns out that there is a reason for the request
Is the individual in possession, without delay, to the extent necessary to correct the breach.
The use of information must be suspended.

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However, a place where a large amount of money is required to suspend the use of the personal information held.
In cases where it is difficult to suspend the use, etc., the rights of the provider
When taking alternative measures necessary to protect interests, this
Not limited.

(4) The head of the institution conducting the research is identified by the provider from the provider or the surrogate.
The retained personal information is provided to a third party in violation of the sixth 18 (10).
Providing the personal information held to a third party because of the reason
If you were asked to stop, it turned out that there was a reason for that request
In some cases, do not stop providing the personal information held to a third party without delay.
Must be.
However, it costs a lot of money to stop providing the personal information that we hold to a third party.
When it is difficult to stop providing to other third parties
Therefore, the alternative measures necessary to protect the rights and interests of the provider
This is not the case when picking.

(5) The head of the institution conducting the research shall hold the research as required based on the sixth 19 (3).
When the use of all or part of personal information is suspended or
When it is decided not to suspend the use, etc., or based on the 6th 19 (4)
To a third party about all or part of the requested personal information
When the provision is stopped or it is decided not to stop the provision to a third party
In that case, the provider or the surrogate must be notified to that effect without delay.
Must be.

(6) The head of the institution conducting the research is the 6th 18 (12) or the 6th 19 (1), (2) young.
Or all the measures requested by the provider or the surrogate, etc. according to (5).
In some cases, when notifying that the measures will not be taken or with the measures
When notifying the provider or a substitute, etc. that different measures will be taken,
You must try to explain the reason for this.

(7) The head of the institution conducting the research is the 6th 18 (12) or the 6th 19 (1), (2), (3).
Or accept the request according to (4) (hereinafter referred to as "request for disclosure, etc.")
The following matters can be specified as a method of checking. In this case
Therefore, the provider or the surrogate, etc. requests disclosure, etc. in accordance with the relevant method.
There must be.
A. Request for disclosure, etc.
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B. Documents to be submitted when requesting disclosure, etc. (electronic method, magnetic method, etc.)
A record made in a way that cannot be recognized by the perception of others
including. ) Form and other methods of requesting disclosure, etc.
C. Confirmation that the person requesting disclosure, etc. is the provider or the surrogate
Law
D. How to collect fees

(8) The head of the research institution requests disclosure, etc. from the provider or the surrogate.
Presentation of matters sufficient to identify the personal information held by the subject
Can be sought. In this case, the head of the institution conducting the research
The provider or the substitute can easily and accurately request disclosure, etc.
U, provision of information that contributes to the identification of the personal information held, or other providers
Appropriate measures must be taken in consideration of the convenience of the substitute.

(9) The head of the research institution shall disclose, etc. based on the 6th 19 (7) and (8).
In deciding the procedure to respond to the request, it is excessive to the provider or the substitute
Care must be taken not to impose a burden.

(10) The head of the institution conducting the research shall be notified of the purpose of use by the 6th 18 (12) or the 1st.
When disclosure is requested according to 6-19 (1), regarding the implementation of the measures.
Fees can be collected.
In that case, it should be within the range that is considered reasonable in consideration of the actual cost.
The amount of the fee must be determined.

(11) The head of the research institution should set up a contact point for complaints, etc.
We must respond appropriately and promptly to complaints and inquiries.
For the head of the research institution, the contact point for complaints, etc. is beneficial to the provider, etc.
Consideration should be given to the placement of personnel, usage procedures, etc. so that it is easy to use.
There must be.

20 Obligation of personal information manager
(1) Personal information manager (including shared manager. The same shall apply hereinafter in the sixth 20).
As a general rule, based on the research plan, at the request of the principal investigator
Samples and information must be anonymized before conducting human genome / gene analysis research

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It doesn't become.
However, the provider or substitute, etc. agrees and the ethics review committee approves.
Recognized in the research plan approved by the head of the research institution
If so, it is possible not to anonymize the sample / information.

(2) In principle, the personal information manager uses the personal information removed during anonymization as a general rule.
To the research departments of external institutions and institutions that provide samples and information
Do not provide.
However, the provider or substitute, etc. agrees and the ethics review committee approves.
Recognized in the research plan approved by the head of the research institution
If so, personal information will be provided to external organizations and samples / information.
It can be provided to the research department of the institution.

(3) In addition to the anonymization work, the personal information manager is responsible for the anonymization work.
Appropriately manage and dispose of the created correspondence table, etc., and include personal information
Information must be strictly controlled so that it will not be leaked.

Definition of 7th term
21 Definition of terms
(1) Sample / information
Blood, tissues, cells, and body to be used for human genome / gene analysis research
Liquids, excrement and parts of the human body such as human DNA extracted from them
Provider's medical information, genetic information and other information used for research (related to the dead)
Including things. ).
However, the academic value has been determined, and it has been fully recognized as a research achievement, and the research has been conducted.
Widely used and commonly available tissues, cells, and body fluids for research
And excrement and human DNA extracted from these are not included.

<Note 1>
Samples from people who were determined to be brain dead based on the Act on Transplantation of Organs (Act No. 104 of 1997)
Regarding the provision of information, the removal of organs causes the heart to stop beating, respiratory arrest, and dilated pupils.
It is premised that it is sufficient to receive samples and information after reaching the state of "three signs".

<Note 2>

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The purpose of this guideline is to carry out research with the donation of fertilized eggs, embryos, foets, ES cells, etc.
However, it is necessary to carefully consider from an ethical point of view, etc., and this guideline
It does not mean that it is appropriate to carry out those studies just because they satisfy.

(2) Medical information
Information such as disease names, medication names, test results, etc. obtained through diagnosis and treatment
Say.

(3) Human genome / gene analysis research
Common to the cells that make up the donor's individual and inherited by its offspring
Clarify the possible human genome and gene structure or function using samples and information
A study that tries to be clear. Providing samples and information used in this research
It also includes cases where collection and sale are carried out.
Law Concerning Ensuring Quality, Effectiveness and Safety of Pharmaceuticals, Medical Devices, etc.
Pharmaceuticals, medical devices or regeneration implemented based on (Act No. 145 of 1960)
Clinical trials of medical products and post-marketing surveys and tests (reexamination and reexamination)
Limited to those related to evaluation and use-results evaluation. ) Is based on the same law
Already, the Ministerial Ordinance on Standards for Conducting Clinical Trials of Pharmaceuticals (Ministry of Health, Labor and Welfare 1997)
Ordinance No. 28), regarding standards for conducting post-marketing surveillance and testing of pharmaceutical products
Ministerial Ordinance (2004 Ministry of Health, Labor and Welfare Ordinance No. 171), the basis for conducting clinical trials of medical devices
Ministerial Ordinance on Associates (2005 Ministry of Health, Labor and Welfare Ordinance No. 36), Manufacture and sale of medical equipment
Ministerial Ordinance on Standards for Conducting Subsequent Surveys and Examinations (2005 Ministry of Health, Labor and Welfare Ordinance No. 3)
No. 8), Ministerial Ordinance on Standards for Conducting Clinical Trials of Products such as Regenerative Medicine (2014)
Ministry of Health, Labor and Welfare Ordinance No. 89) and post-marketing surveys and tests of products such as regenerative medicine
Regulated by the Ministerial Ordinance on Standards for Implementation (2014 Ministry of Health, Labor and Welfare Ordinance No. 90)
It is not covered by this guideline.

<Detailed rules regarding the scope of human genome / gene analysis research covered by this guideline>
1. 1. The human genome / gene analysis research covered by this guideline uses tissues such as leukocytes of the donor.
It analyzes the structure or function of complementary DNA made from DNA or mRNA, such as the base sequence.
Yes, the main ones are so-called germline mutations or polymorphisms
There is research to analyze polymorphism). On the other hand, in diseases such as cancer, only the lesion site is acquired.
Research on genome or gene mutations that appear in the future and are not inherited by the next generation (Iwayu)
A study that analyzes somatic mutations in normal tissues to confirm mutations.
Including the case of analysis. ), Research on gene expression and research on protein structure or function
As a general rule, research is not covered by this guideline. However, even in such studies, the child
Research is conducted to reveal information about the genome or genes that can be passed on to grandchildren.
In some cases, it is subject to this guideline. These somatic mutations and genes that are not covered by this guideline
Appropriate for research on expression and protein structure or function, based on the purpose of this guideline

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It is desirable to take appropriate measures.
2.1. In the process of conducting research that is not covered by this guideline shown in, genetic information (genetic information) for accidental reasons
Includes samples and information used to obtain information. ) Is obtained, the human genome / heredity
Use for child analysis research purposes, appropriate management (safety management measures if applicable to personal information, personal information
Appropriate handling of anonymized information that does not correspond to), storage, anonymization and disposal, etc.
The handling of information shall be decided after consulting with the Ethics Review Committee by the head of the research institution.
3. 3. The main content is not the human genome / gene analysis research, but in some cases the human genome / gene solution
Includes research in which analysis research is carried out and research in which samples and information obtained in clinical practice are secondarily used.
4. Heredity carried out for gene regions with known structures and functions, such as biological training conducted for educational purposes
For child structure analysis training in which samples / information and analysis results are not used for purposes other than the training purpose.
Therefore, it is not covered by this guideline. However, even when performing gene analysis for these purposes,
Appropriate measures based on the purpose of this guideline are desired.

(4) Genetic information
The process of human genome / gene analysis research conducted using samples and information
Can be obtained through or inherited by descendants who are already associated with the sample / information
Information that indicates the genetic characteristics and constitution of an individual.

(5) Anonymization
The personal information of the provider is leaked to the outside contrary to the law, this guideline or the research plan.
Take all or part of the personally identifiable information from the personal information so as not to
Exclude, instead give a code or number unrelated to the provider
Say. Of the information that accompanies the sample / information, only certain information can be used to identify a specific person.
Even if the information cannot be identified, it is combined with information that can be obtained from other lists such as various lists.
If the provider can be identified by matching, it is necessary for the combination.
Remove all or part of the required information so that the provider cannot be identified
To say. Anonymization includes the following.
A. Linkable anonymization
Newly attached to the provider so that the provider can be identified when necessary
Anonymization by leaving a correspondence table of codes or numbers
B. Anonymization that cannot be connected
A method that does not leave a correspondence table like the above a so that the provider cannot be identified
Anonymization by

(6) Personal information manager
Research that handles personal information, including institutions that provide samples and information
At the institution that conducts the information, the personal information of the provider, etc.
Manage personal information and anonymize it so that it will not be leaked to the outside of the institution

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Responsible person.

(7) Informed consent
The person who is requested to provide samples and information is asked to provide human resources in advance by the principal investigator.
After receiving a sufficient explanation about the gene analysis research, the significance and purpose of the research,
Understand the method, expected results and disadvantages, and give it freely
Consent regarding the provision of samples / information and the handling of samples / information. This guideline
Is required to be in writing.

(8) Substitutes, etc.
If the provider does not have the ability to give informed consent,
A person who gives informed consent on behalf of the provider. Proposal
If the donor is dead, it means the bereaved family.
When used without including the bereaved family, it is called a "substitute".

<Note>
From the perspective of protecting the human rights of the provider, the proxy, etc., provides samples and information on behalf of the provider, etc.
The person who decides whether or not to agree with the above, and considers a separate response regarding the genetic problems of the substitutes, etc.
You need to be careful.

(9) Institution that conducts research
Institutions and sole proprietors conducting human genome / gene analysis research (samples /
Including institutions that provide information and institutions that collect and sell samples and information
Mu. ).

<Detailed rules regarding research institutions>
Institutions that carry out human genome / gene analysis research are corporations and government agencies (individuals owned by government agencies).
It is an administrative agency stipulated in Article 2 of the Information Protection Law).

(10) Institutions that provide samples and information
Among the institutions that conduct research, samples from people, such as medical institutions and health centers
An institution where information is provided.

<Detailed rules regarding institutions that provide samples and information>
When there is a department that conducts research and a department that provides samples and information within the same corporation, such as a university.
Is an institution that provides samples and information.

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(11) An organization that collects and sells samples and information
Among the institutions conducting research, we receive and provide samples and information from other institutions.
The collected samples and information will be used as resources for human genome and gene analysis research.
To carry out quality control and provide it to other research institutes (in this guideline)
These acts are called "collection / sale". ) Refers to an institution.

(12) Joint research institute
Jointly conduct human genome / gene analysis research described in the research plan
An institution that conducts research. An institution that conducts a certain research is a sample / information other than that institution
When receiving samples / information from the institution that provides the information,
Includes institutions that provide samples and information.

<Detailed rules regarding the handling of personal information between joint research institutes>
When personal information is shared between joint research institutes listed in the research plan, that fact
Also, regarding the items of personal information used jointly, the purpose of use of the user, and the management of the personal information.
The provider must be notified in advance or placed in a state that the provider can easily know.

(13) External organization
A machine for conducting research to which researchers conducting human genome / gene analysis research belong
An institution that conducts research other than Seki.

(14) Ethics Review Committee
Suggestions regarding the suitability of conducting human genome / gene analysis research and other matters
Investigative trial including scientific viewpoint as well as ethical viewpoint such as guarantee of human rights of donors
A collegial opportunity set up as an advisory body to the head of the research institution for discussion
Seki.

(15) Researchers, etc.
At the institution conducting the research, the principal investigator and the person in charge of research (providing samples and information)
Persons who carry out the work of receiving services and those who carry out the work of collecting and selling samples and information
Including. ), Persons who carry out genetic counseling, and work to protect personal information
Involved in human genome / gene analysis research
Refers to the person concerned.

(16) Principal Investigator
Usefulness of human genome / gene analysis research in institutions conducting individual research

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A researcher with sufficient knowledge of sex and marginalities and bioethics
To carry out human genome / gene analysis research and to develop the research plan
A person who supervises the relevant business.

(17) Researcher
Conduct human genome / gene analysis research according to the instructions and consignment of the principal investigator
Researchers who have the necessary knowledge and skills according to the content of their work,
Refers to doctors, pharmacists, nurses, clinical laboratory technicians, etc.

(18) Provider
A person who provides samples and information for human genome / gene analysis research.
In addition, in the genetic information of the donor, such as the donor's family, relatives, substitutes, etc.
When including people who are considered to be involved, it is called "provider, etc."

(19) Genetic counseling
Dialogue and sentiment using medical genetics knowledge and counseling techniques
Medical or psychological consequences of hereditary disorders, with repeated reporting
It means to support or assist with the aim of solving or alleviating various problems.

(20) Existing sample / information
Refers to samples / information that fall under any of the following.
Already existed by the time the research plan for the human genome / gene analysis research was created
Samples and information to be used
Collected after the preparation of the research plan for human genome / gene analysis research
Samples / information, and at the time of collection, the relevant human genome / gene solution
Those that were not intended to be used in analysis research

8th review
22 Review
This guideline is based on changes in social conditions, progress in human genome / gene analysis research, etc.
Based on changes in the situation, if necessary, or within 5 years after the enforcement, all of them
It shall be reviewed after considering the general matters.

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9th Bylaw
23 Bylaws
In addition to what is stipulated in this guideline, necessary matters regarding the enforcement of this guideline are not included.
Determine.

10th enforcement date
24 Enforcement date
This guideline will come into effect on April 1, 2013.

11th transitional measure
25th transitional measure
In the human genome / gene analysis research currently underway at the time of enforcement of this guideline
Regarding the application of ethical guidelines for human genome / gene analysis research,
According to the previous example.
However, regarding the human genome / gene analysis research, after the enforcement of this guideline
This guideline applies when changing the research plan.

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