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Guidelines for clinical research such as gene therapy

August 12, 2015
(Partially revised on April 7, 2017)

Ministry of Health, Labor and Welfare

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table of contents
Chapter 1 General Rules
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First purpose
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Definition of the second term
1
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Third scope of application
3
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Requirements for clinical research such as gene therapy ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
3
Fifth efficacy and safety
3
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No. 6 Confirmation of quality,
etc.
3
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Prohibition of genetic modification of 7th germ cells,
etc.
Four
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Eighth: Securing informed consent based on appropriate explanations
Four
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Ninth Public Health Safety
Four
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Disclosure of tenth information
Four
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Eleventh subject selection
Four
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Chapter 2 Obligations of researchers,‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
etc.
Four
12th Basic Responsibilities of Researchers,‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
etc.
Four
13th Responsibilities of the principal ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
investigator
Five
14th Responsibilities of the general manager
6
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Fifteenth research institute‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
7
Responsibilities of the Director of the Sixteenth
Research Institute
7
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Chapter 3 Research Plan
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17th Procedure for Research Plan
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Items to be stated in the 18th research plan‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
Ten
Nineteenth Research Registration / Publication
11
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Chapter 4 Ethics Review Committee
12
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Establishment of the 20th Ethics Review Committee,
etc.
12
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21 Roles and responsibilities of the Ethics Review Committee,
etc.
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Chapter 5 Informed consent, etc.
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22. Procedures for receiving informed consent, etc.
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Procedures, etc. when receiving informed consent from the 23rd surrogate
16
Chapter 6 Opinions of the Minister of Health,
Labor and Welfare
17
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Opinion of the Minister of Health, Labor and
Welfare
17
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Twenty-five Opinions of the Minister of Health, Labor and Welfare regarding
serious adverse events,17
etc.
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26th Survey by the Minister of Health, Labor‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
and Welfare, etc.
17
Chapter 7 Personal information and anonymously ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
processed information
18
27 Basic responsibilities related to personal information,
etc.
18
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28th Safety Management ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
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29. Disclosure of retained personal information, etc.
18
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30th Handling of anonymously processed information
Chapter 8 Response to Serious Adverse Events
twenty one
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31 Response to serious adverse events
twenty one
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Chapter 9 Ensuring the reliability of‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
research
twenty one
32. Management of Conflicts of Interest
twenty two
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33 Storage of samples and information related to research ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
twenty two
34 Monitoring and audit
twenty two
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Chapter 10 Miscellaneous
Rules
twenty three
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35 Enlightenment dissemination
twenty three
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36th enforcement date
twenty three
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37 transitional measures ‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
twenty three
Supplementary
provisions
27
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Chapter 1 General Rules
First purpose
This guideline is referred to as clinical research such as gene therapy (hereinafter referred to as "clinical research such as gene therapy".
U. ), And medically clinical research such as gene therapy
Aiming to ensure usefulness and ethics, and to ensure proper implementation in a form open to society
Target.
Definition of the second term
(I) In this guideline, "gene therapy, etc." is used for the purpose of treating or preventing diseases.
It refers to the administration of a gene or cells into which a gene has been introduced into the human body.
(Ii) In this guideline, "subject" means heredity in clinical research such as gene therapy.
A person who is the target of child treatment.
(Iii) In this guideline, "researcher" refers to a person who conducts clinical research such as gene therapy.
Say.
(Iv) In this guideline, the term "research director" means gene therapy, etc. at a research institution.
In addition to giving necessary instructions to researchers conducting clinical research, clinical research such as gene therapy
A researcher who is in a position to supervise.
(V) In this guideline, the "general manager" shall be implemented in collaboration with other research institutes.
Give necessary instructions to researchers and principal investigators in clinical research such as gene therapy
In addition, it refers to the principal investigator who oversees the work related to clinical research such as gene therapy.
(Vi) In this guideline, "research institute" means a method for conducting clinical research such as gene therapy.
Refers to people, government agencies and sole proprietors.
(Vii) In this guideline, "the head of a research institution" refers to conducting clinical research such as gene therapy.
Refers to the representative of a corporation, the head of an administrative agency, and the sole proprietor.
(Viii) In this guideline, "joint research institute" means genetic control based on the research plan.
A research institution that jointly conducts clinical research such as medical treatment.
9. In this guideline, the "ethics review committee" refers to the implementation of clinical research such as gene therapy.
Or, regarding the suitability of continuation and other necessary matters regarding clinical research such as gene therapy,
A collegial body established to investigate and deliberate from a scientific and scientific point of view.
U.
Boil
10. In this guideline, "sample" means blood, body fluid, tissue, cells, excrement and this.
DNA extracted from them, which is a part of the human body and used for research
(Including those related to the dead).
11 In this guideline, "information used for research" means diagnosis and treatment of subjects.
For human health, such as the name of injury or illness obtained through medical treatment, medication content, test or measurement results, etc.
Information related to other information used for research (related to the dead)
Including. ).
Twelve In this guideline, "sample / information" means information used for samples and research.
To say.
13. In this guideline, "informed consent" means the subject or the subject.
Heredity that a person who substitutes for (hereinafter referred to as "subject, etc.") intends to carry out or continue
Regarding clinical research such as child therapy, the purpose and significance of the clinical research such as gene therapy
Methods, burdens on subjects, expected outcomes (including risks and benefits)
After receiving sufficient explanations about such matters and understanding them, we will study based on our free will.
Researcher, etc. (Researcher who is a researcher or a doctor who has been instructed by the researcher
Say. same as below. ), Clinical research such as gene therapy (sample / information)
Including the handling of. ) Consent to implement or continue.

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(14) In this guideline, the "substitute" can represent the will and interests of the subject.
The subject is given informed consent.
If it is objectively determined that the subject lacks the ability to do so, the research responsibility will be taken on behalf of the subject.
A person who can give informed consent to a person in charge.
15. In this guideline, "informed ascend" means informed.
・ Performed or performed by a subject who is objectively judged to lack the ability to give an outlet
Regarding clinical research such as gene therapy that is about to be continued, the amount according to the understanding
Receive explanations in easy-to-understand words and carry out or continue clinical research such as gene therapy
It means to understand and express your support.
16. In this guideline, the "final product" is the final product to be administered to the subject.
DNA in which a gene for the treatment or prevention of a disease has been integrated or contains this
It refers to viruses and other particles (hereinafter referred to as "recombinant genes, etc.").
17 In this guideline, "personal information" is information about living individuals.
Anything that falls under any of the following.
(1) Name, date of birth, and other descriptions contained in the information (documents, drawings, etc.
Is an electromagnetic record (electromagnetic method (electronic method, magnetic method or other human perception)
Is a method that cannot be recognized. Same for 18②. )
A record to be recorded. ) Described or recorded, or voice, action
Any matter expressed using other methods (excluding personal identification code).
same as below. ) Can identify a specific individual (with other information)
Being able to collate and thereby identify a particular individual
Including those that become. )
② Those that include a personal identification code
18 In this guideline, "personal identification code" corresponds to any of the following:
Ordinance for Enforcement of the Law Concerning the Protection of Personal Information Of Letters, Numbers, Symbols and Other Codes
(Cabinet Order No. 507 of 2003) Refers to those stipulated in Article 1.
① Convert the characteristics of a part of the body of a specific individual to use for a computer
Characters, numbers, symbols and other codes that identify the specific individual.
What can be done
② Regarding the use of services provided to individuals or the purchase of products sold to individuals
Assigned or issued to a person on a card or other document, young
Or letters, numbers, symbols or other codes recorded by electromagnetic means.
It will be different for each user or purchaser or the person who receives the issue.
By being assigned, described, or recorded to
Can identify specific users or purchasers or those who receive the issue
thing
19 In this guideline, "personal information, etc." refers to the dead in addition to personal information.
It means information that can identify a specific individual.
Twenty In this guideline, "anonymization" means a specific individual (including the dead; the same shall apply hereinafter.
) Can be identified (including personal identification code)
Deletion of part or part (involvement of all or part of the description, etc. with the individual
Includes replacement with a description without. ).
21 In this guideline, the "correspondence table" is a necessary place from anonymized information.
Replaced when anonymizing with the subject so that the subject can be identified
A table that allows you to collate with the obtained description, etc.
Say something.
22 In this guideline, "anonymously processed information" means the following personal information (individual).

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Limited to personal information stipulated in the Information Protection Law (Law No. 57 of 2003).
The same shall apply hereinafter in these twenty-two. ), The following measures are taken
Obtained by processing personal information so that it is not possible to identify a specific individual
It is information about an individual who is not able to recover the personal information.
Sea urchin (limited to those subject to the provisions of the law).
(1) Personal information corresponding to (1) 18 (1) Part of the description, etc. contained in the personal information is deleted.
Excluding (there is no regularity that can restore the part of the description, etc.
Includes replacement with other descriptions by the method. ).
(2) Personal information corresponding to (2) 18 (2) All personal identification codes included in the personal information
Delete the part (has regularity that can restore the personal identification code
Includes replacement with other descriptions, etc. by a method that does not. ).
23 In this guideline, "non-identifying processed information" means the following personal information.
(Act on the Protection of Personal Information Held by Administrative Organizations (Act No. 58 of 2003)
Or the Act on the Protection of Personal Information Held by Incorporated Administrative Agencies (Act 2003)
Personal information that is subject to processing related to non-identification processing information pursuant to the provisions of No. 59)
Limited to information. The same shall apply hereinafter in these twenty-three. ) Next, respectively
Personal information is added so that a specific individual cannot be identified by taking measures to prevent it.
It is information about an individual obtained by work, and it is possible to restore the personal information.
Things that cannot be done (Administrative Agency Personal Information Protection Law or Incorporated Administrative Agencies, etc. Individuals
Limited to those subject to the provisions of the Information Protection Law. ).
(1) Personal information corresponding to (1) 18 (1) Part of the description, etc. contained in the personal information is deleted.
Excluding (there is no regularity that can restore the part of the description, etc.
Includes replacement with other descriptions by the method. ).
(2) Personal information corresponding to (2) 18 (2) All personal identification codes included in the personal information
Delete the part (has regularity that can restore the personal identification code
Includes replacement with other descriptions, etc. by a method that does not. )
24 In this guideline, "adverse event" means the clinical research institute for gene therapy, etc.
All unfavorable youth that occurred in the subject, with or without a causal relationship with the study
Refers to unintended injury or illness or its signs (including abnormal laboratory test values).
25 In this guideline, "serious adverse events" are listed below among adverse events.
Anything that falls under any of the above.
① Things that lead to death
② Life-threatening things
③ Those that require hospitalization for treatment or extension of hospitalization period
④ Permanent or significant disability / dysfunction
⑤ Those that cause birth defects in descendants
26 In this guideline, "monitoring" is appropriate for clinical research such as gene therapy.
How much progress has been made in clinical research such as gene therapy to ensure that it is done correctly
And whether it is done in accordance with this guideline and research plan
A survey conducted by a person designated by the principal investigator.
27 In this guideline, "audit" means trust in the results of clinical research such as gene therapy.
In order to ensure sex, clinical research such as gene therapy follows this guideline and research plan.
This is a survey conducted by a person designated by the principal investigator as to whether or not the research was conducted.
Third scope of application
1 Applicable research
This guideline is implemented by Japanese research institutes or is actually implemented in Japan.

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The target is clinical research such as gene therapy to be given.
However, the provisions from 12th to 35th are the quality of pharmaceuticals, medical devices, etc.
The cure stipulated in the Act on Securing Effectiveness and Safety (Act No. 145 of 1960)
Clinical research such as gene therapy corresponding to the test and cells into which genes have been introduced into the human body
It does not apply to clinical studies such as gene therapy to be administered.
(Ii) Research conducted outside Japan
1 Japanese research institutes carry out clinical research such as gene therapy outside Japan
Case (when conducting clinical research such as gene therapy in collaboration with overseas research institutes
Including. ) Follows this guideline and complies with the standards such as the laws and regulations of the place of implementation.
You have to protect it. However, compared to the provisions of this guideline, the laws and regulations of the place of implementation
, If the provisions of standards such as guidelines are strict, the actual situation will be replaced with the provisions of these guidelines.
Conduct clinical research such as gene therapy in accordance with the regulations of the site, guidelines, etc.
Shall be.
2 The provisions of this guideline are the provisions of standards such as laws and guidelines at implementation sites outside Japan.
It is stricter, and clinical research such as gene therapy will be conducted according to the provisions of this guideline.
If it is difficult to do so, the following matters will be stated in the research plan.
We listened to the opinions of the Ethics Review Committee regarding the implementation of clinical research such as gene therapy.
When the head of a national research institution approves, the actual fact will be replaced with the provisions of this guideline.
Conduct clinical research such as gene therapy in accordance with the regulations of the site, guidelines, etc.
It shall be possible.
① Appropriate measures will be taken for informed consent
(2) For protection of personal information, etc. acquired in connection with the implementation of clinical research such as gene therapy
Appropriate measures will be taken
Requirements for clinical research such as gene therapy
The subjects of clinical research such as gene therapy are limited to those that meet all of the following requirements.
1 The therapeutic / preventive effect of clinical research such as gene therapy is compared with other currently available methods.
It should be sufficiently predicted that they are equal to or better than each other.
2 The benefits obtained from clinical research such as gene therapy for the subjects are more disadvantageous.
It is expected to turn around. In addition, the clinical research institute for gene therapy, etc.
If research is aimed at prevention, it is well predicted that the benefits will far outweigh the disadvantages.
It must be measured.
Fifth efficacy and safety
Sufficient scientific knowledge that clinical research such as gene therapy is effective and safe
Limited to those that are predicted based on what you see.
No. 6 Confirmation of quality, etc.
Genes used in clinical research such as gene therapy and other substances administered to humans
In addition, the Ministerial Ordinance on Standards for Conducting Clinical Trials of Pharmaceuticals (Ministry of Health and Welfare Ordinance No. 28, 1997)
No.) Article 17 or Ministerial Ordinance on Standards for Conducting Clinical Trials of Products such as Regenerative Medicine
2014 Ministry of Health, Labor and Welfare Ordinance No. 89) Facilities that have reached the standards required by Article 25
Or, Article 2 of the Act on Ensuring the Safety of Regenerative Medicine (Act No. 85 of 2013)
The manufacturer of the specified cell processed product in Paragraph 8 has the permission under Article 35, Paragraph 1 of the same law or the same law.
Cell culture that has been certified under Article 39, Paragraph 1 or has been notified pursuant to the provisions of Article 40, Paragraph 1.
Manufactured in a nutrient processing facility and confirmed for its quality, effectiveness and safety
Limited to things.

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Prohibition of genetic modification of 7th germ cells, etc.
Human germ cells or embryos (one cell or group of cells, as they are, of humans or animals
It may grow into a single individual through the process of development in the womb.
Of these, those before the placenta begins to form. same as below. ) Genetic modification
Clinical research such as gene therapy for the purpose of genetic modification of human germ cells or embryos
Do not conduct clinical research such as gene therapy that may cause damage.
Eighth: Securing informed consent based on appropriate explanations
Informed consent based on appropriate explanation for clinical research such as gene therapy
Must be ensured and implemented.
Ninth Public Health Safety
Clinical research such as gene therapy must be carried out with sufficient public health safety.
Must be.
Disclosure of tenth information
Clinical research such as gene therapy is registered in the database specified in 19th.
The information must be published appropriately and accurately.
Eleventh subject selection
When selecting subjects, from the perspective of protecting human rights, medical conditions, age, consent ability, etc.
Must be considered and carefully considered.
Chapter 2 Obligations of researchers, etc.
12th Basic Responsibilities of Researchers, etc.
A researcher must perform the following tasks.
1 Consideration for subjects, etc.
(1) Researchers respect the life, health and human rights of subjects, and conduct gene therapy, etc.
Floor studies must be conducted.
⑵ Researchers should be careful when conducting clinical research such as gene therapy.
Informed consent must be given.
(3) Researchers are consultants, inquiries, complaints, etc. from subjects and related parties (hereinafter
Below is called "consultation, etc." ) Must be dealt with appropriately and promptly.
(4) Researchers can use the information they have learned in conducting clinical research such as gene therapy.
Do not leak without good reason. Involved in conducting clinical research such as gene therapy
The same shall apply even after the straw is gone.
⑸ Researchers are subjects such as leakage of information related to clinical research such as gene therapy.
From the perspective of respecting human rights such as, or from the perspective of conducting clinical research such as gene therapy
If a serious concern arises, promptly contact the director of the research institution and the principal investigator.
I have to report.
2 Ensuring ethical validity and scientific rationality of clinical research such as gene therapy
(1) Researchers comply with laws and regulations, guidelines, etc., and the Ethics Review Committee and the Minister of Health, Labor and Welfare
Respect the opinions of the research institute and properly follow the research plan approved by the director of the research institution.
The study must be carried out.
(2) The researcher assists the principal investigator and is involved in the research plan of clinical research such as gene therapy.
It is necessary for the principal investigator to implement the plan as well as prepare the materials to be used.

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You must make the necessary reports.
(3) Researchers are ethical validity or scientific rationalization of clinical research such as gene therapy.
When we obtain facts or information that impairs sexuality or information that may impair (4)
Except when applicable to. ) Must be promptly reported to the principal investigator
Not.
(4) Researchers are responsible for the appropriateness of conducting clinical research such as gene therapy or the results of research.
When we obtain facts or information that damages trust or information that may damage trust
Must promptly report to the principal investigator or the head of the research institution.
3 Education / Training
Researchers should conduct clinical research on gene therapy, etc. prior to conducting clinical research on gene therapy, etc.
Ethics related to research and knowledge necessary for conducting clinical research such as gene therapy
You must receive education and training on technology. Also suitable during the research period
You must continue to receive education and training.
(Ii) Researchers have the specialized knowledge necessary to properly carry out clinical research such as gene therapy.
Those who have knowledge or clinical experience.
13th Responsibilities of the principal investigator
(I) The principal investigator shall perform the following tasks.
1 Preparation of research plan and thorough compliance with researchers
(1) The principal investigator obtains domestic and overseas information regarding the implementation of clinical research such as gene therapy.
Based on the materials and information obtained, the medical usefulness of clinical research such as gene therapy
And ethics will be examined, and based on the results of the examination, gene therapy
Prepare a system necessary for conducting clinical research and prepare a research plan in advance
However, we must seek the permission of the director of the research institute. Change the research plan
The same shall apply when
(2) The principal investigator occurred in the subject in connection with the clinical research such as gene therapy.
In order to compensate for health damage, take out insurance in advance, etc.
The necessary measures must be taken appropriately.
(3) The principal investigator shall, pursuant to the nineteenth provision, outline the research and other gene therapies.
Appropriately register information on clinical research such as gene therapy
The results of the study must be published.
(4) The principal investigator will properly carry out clinical research such as gene therapy according to the research plan.
In order to ensure the reliability of the results, the gene therapy, etc.
Researchers involved in conducting research must be instructed and managed.
2 Management and supervision of progress of clinical research such as gene therapy and grasp of adverse events, etc.
report
(1) The principal investigator collects necessary information regarding the implementation of clinical research such as gene therapy.
Proper implementation of clinical research such as gene therapy and reliability of research results
We must try to secure it.
(2) The principal investigator is the ethical validity or scientific of clinical research such as gene therapy.
Facts or information that impair rationality or information that may impair
A place where we obtained something that is thought to affect the continuation of clinical research such as gene therapy
In that case (excluding cases that fall under (3)), promptly the head of the research institution and the total
Report to the person in charge and stop clinical research such as gene therapy if necessary
Or discontinue, or change the research plan.
(3) The principal investigator is the appropriateness of conducting clinical research such as gene therapy or the conclusion of the research.
Obtained facts or information that undermines the credibility of the fruit or information that may undermine it

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In case, promptly report to the head of the research institution and the general manager, and if necessary
To stop or stop clinical research such as gene therapy, or research plan
Must be changed.
(4) The principal investigator is responsible for the gene cure in conducting clinical research such as gene therapy.
It is judged that the risk predicted is higher than the expected benefit from clinical research such as medical treatment.
Sufficient results can be obtained by refusal or clinical research such as gene therapy.
Or if it is judged that sufficient results cannot be obtained, the relevant gene
Clinical research such as treatment must be discontinued.
⑸ The principal investigator is clinically responsible for gene therapy, etc., as stipulated in the research plan.
Occurrence of adverse events associated with the progress of research and the implementation of clinical research such as gene therapy
Report the situation in writing to the head of the research institution, the general manager, and the ethics review committee.
Must. In this case, the progress is at least
Also, report at least once a year.
(6) The principal investigator has completed (including the case of discontinuation) of clinical research such as gene therapy.
Same as below. ), The matters necessary for the head of the research institution and the general manager
I have to report.
⑺ The principal investigator conducts clinical research such as gene therapy in collaboration with other research institutes.
In that case, the chief investigator of the joint research institute will be asked to the clinical research institute for gene therapy, etc.
You must share the necessary information related to your research.
3 Response to subjects after conducting clinical research such as gene therapy
(1) The principal investigator is the subject even after conducting clinical research such as gene therapy.
The best necessary prevention, diagnosis and cure including the results of clinical research such as gene therapy
You must try to get medical treatment.
(2) The principal investigator is responsible for safety even after conducting clinical research such as gene therapy.
And from the viewpoint of ensuring effectiveness, regarding the effects and side effects of gene therapy, etc.
And try to take appropriate follow-up surveys and other necessary measures.
Must be. Regarding the results, the head of the research institution and the general manager
Must be reported to.
4 In addition to the ones specified in 1 to 3, the principal investigator is assigned to his / her own research institution.
Take necessary measures to summarize clinical research such as gene therapy
Must be.
(Ii) The principal investigator is one per research institution for one clinical study such as gene therapy.
The name shall be a person who can properly carry out the work listed in 1.
14th Responsibilities of the general manager
(I) The general manager shall perform the following duties.
1 The general manager can obtain domestic and foreign information regarding the implementation of clinical research such as gene therapy.
Medical usefulness and ethics of clinical research such as gene therapy based on the materials and information
Study reason, and based on the result of the study, research in advance
You have to make a plan and ask for permission from the head of the research institution to which you belong.
Absent. The same applies when changing the research plan.
2 The general manager supervises clinical research such as gene therapy and is necessary for other research managers.
In addition to giving appropriate instructions, provide education and training to other principal investigators as appropriate.
It must be made.
3 When the general manager receives a report pursuant to the provisions of 13-12 (2) or (3)
Promptly informs the head of the research institution to which he belongs and all the principal investigators.
, I must report to that effect.

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4 In addition to the ones specified in 1 to 3, the general manager is the Clinical Research Institute for Gene Therapy, etc.
Necessary measures must be taken in summarizing the investigation.
(Ii) General responsibility in clinical research such as gene therapy conducted in collaboration with other research institutes
One person will be assigned to each clinical study such as gene therapy, and the research responsibility of each research institution will be assigned.
Only one person shall be appointed from among the persons.
(Iii) The general manager shall carry out the duties of the research manager and rely on other research managers.
Registration of research outline, etc. of clinical research such as gene therapy according to the requested 19th rule
Can be done on behalf of. In this case, conduct clinical research such as gene therapy.
Information about all the research institutes to be conducted must also be registered.
Fifteenth research institute
Research institutes must meet all of the following requirements:
Sufficient clinical observation and testing and analysis and evaluation of these results
Must have the human ability and facility functions that can be used.
(Ii) Human ability and facility equipment that can take necessary measures according to the medical condition of the subject
Must be capable.
Responsibilities of the Director of the Sixteenth Research Institute
The head of the research institution must perform the following tasks.
Overall supervision of a study
1 The head of the research institution is appropriate for clinical research such as gene therapy that has been approved.
With the necessary supervision and ultimate responsibility
To do.
2 The head of the research institution leaves the researcher with respect for the life, health and human rights of the subject.
It is necessary to make it known that clinical research such as gene treatment will be carried out.
3 The head of a research institution should not leak information that he has learned in the course of his work without a justifiable reason.
It doesn't become. The same shall apply even after he / she is no longer engaged in the work.
4 The head of the research institution entrusts a part of the work related to clinical research such as gene therapy.
In that case, a written contract is made regarding the matters that the entrusted person should comply with.
Do not conclude and provide necessary and appropriate supervision to those who have been entrusted.
Must be.
(Ii) Establishment of systems and regulations for conducting clinical research such as gene therapy
1 The head of a research institution is necessary to properly carry out clinical research such as gene therapy.
Systems and regulations must be put in place.
2 The head of the research institution is related to clinical research such as gene therapy conducted by the research institution.
If the subject suffers a health hazard, compensation or other necessary measures will be taken.
It must be ensured that the placement is properly taken.
3 The head of the research institution is suitable for information on clinical research such as gene therapy, such as research results.
We must ensure that it is published urgently.
4 The head of the research institution is in charge of clinical research such as gene therapy at the research institution.
If necessary, inspect and evaluate the suitability of the needle by yourself.
Appropriate measures must be taken based on the results.
5 The head of the research institution is responsible for ethics related to clinical research such as gene therapy and gene therapy.
Education and training on knowledge and technology necessary for conducting clinical research
Measures must be taken to ensure that Seki researchers receive it.
In addition, they must also receive these educations and trainings themselves.
6 The head of a research institution shall use this finger in accordance with the regulations established by the research institution.

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The authority or affairs specified in the needle can be delegated to an appropriate person within the research institution.
Wear.
(3) Research permission, etc.
1 The head of the research institution shall carry out clinical research such as gene therapy from the principal investigator or
Ethical review when requested permission for significant changes in clinical research such as gene therapy
To the Committee and the Minister of Health, Labor and Welfare, other changes in clinical research such as gene therapy
When asked for permission, ask the Ethics Review Board for their opinions and respect those opinions.
, The permission or disapproval and other necessary measures for research must be decided.
Must be. In addition, clinical research institutes such as gene therapy conducted in collaboration with other research institutes
When asking the Minister of Health, Labor and Welfare for opinions on research, ask for opinions in a lump sum.
be able to.
2 The head of the research institute is thought to affect the continuation of clinical research such as gene therapy.
Ethical review as necessary when receiving reports of facts or information
Ask the committee for their opinions, respect their opinions, and promptly as necessary.
In addition, take appropriate measures such as stopping clinical research such as gene therapy and investigating the cause.
Must be. Before hearing the opinion of the Ethics Review Committee, the head of the research institution should
If necessary, the principal investigator is asked to discontinue or provisionally carry out clinical research such as gene therapy.
Can be instructed to take appropriate measures.
3 The heads of research institutes cooperate with the investigation conducted by the Ethics Review Committee and the Minister of Health, Labor and Welfare.
There must be.
4 The head of the research institution is responsible for the appropriateness of conducting clinical research such as gene therapy or the conclusion of the research.
Facts or information that undermines the credibility of the fruit or information that may undermine it
Upon receipt of the report, the necessary measures must be taken promptly.
5 The head of the research institution is told by the principal investigator about the end of clinical research such as gene therapy.
When the report was received, Rin conducted a review on clinical research such as the gene therapy.
You must report to the Physical Examination Committee on the necessary matters.
(Iv) Report to the Minister of Health, Labor and Welfare, etc.
1 The head of the research institution will discuss the progress and research results of clinical research such as gene therapy.
Then, receive a report or opinion from the principal investigator or the Ethics Review Committee, and if necessary
, To give instructions to the principal investigator regarding the points to be noted, items to be improved, etc.
We must also report to the Minister of Health, Labor and Welfare.
2 The head of the research institution promptly makes a copy of the general report received from the principal investigator.
Must be submitted to the Minister of Health, Labor and Welfare.
3 The head of the research institution is the 12th 1-12 ⑸ or the 13th 1-2 ⑵ or ⑶.
If you receive a report according to the regulations, it will affect the continuation of clinical research such as gene therapy.
Promptly report to the Minister of Health, Labor and Welfare regarding facts or information that may be obtained.
There must be.
4 The head of the research institution is the genetics carried out by the research institution or carried out in the past.
If you learn that clinical research such as child treatment does not conform to this guideline
We will promptly listen to the opinions of the Ethics Review Committee and take necessary measures.
, If the degree of nonconformity is serious, we will inform you of the status and results of the response.
It must be reported to the Minister of Labor and made public.
Chapter 3 Research Plan
17th Procedure for Research Plan
(1) Creation / change of research plan
1 The principal investigator conducts clinical research such as gene therapy (changes the research plan)

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Including the case of The same shall apply hereinafter except for 24-1. ) When trying
A research plan must be prepared in advance and permission from the director of the research institution must be obtained.
Absent.
2 The principal investigator conducts clinical research such as gene therapy in collaboration with other research institutes.
When trying, clarify the roles and responsibilities of the principal investigator of each joint research institution.
The research plan prepared by the general manager in accordance with the provisions of 14-11
A research plan must be prepared based on the book.
3 The principal investigator is gene therapy at the research institution to which the principal investigator belongs.
If you intend to outsource a part of the work related to clinical research, etc.
A research plan must be prepared after defining the contents of the commissioned work.
(Ii) Submission to the Ethics Review Committee

(Ii) Submission to the Ethics Review Committee
1 The head of the research institution is from the principal investigator, gene therapy, etc. at the research institution.
When asked for permission to carry out clinical research, the relevant gene therapy, etc.
The Ethics Review Board must be heard on the suitability of the implementation.
2 The head of the research institute is a clinical research institute for gene therapy, etc., which is conducted in collaboration with other research institutes.
When listening to the opinions of the Ethics Review Committee regarding research, please contact the joint research institute.
Permission to conduct clinical research such as gene therapy, review conclusion by other ethics review committees
Information necessary for reviewing the results and the status of progress in clinical research such as gene therapy
The information must also be provided to the Ethics Review Board.
3 The heads of research institutes are clinical research institutes such as gene therapy conducted in collaboration with other research institutes.
Collective review of research plans related to research by a single ethics review committee
Can be sought.
Permission from the heads of three research institutes
The head of the research institute respects the opinions of the Ethics Review Committee and the Minister of Health, Labor and Welfare, and inherits
Permit or disapproval of clinical research such as child treatment Other clinical research such as gene therapy
You have to decide what you need to do. In this case, of the research institution
The head is inappropriate for conducting research by the Ethics Review Board or the Minister of Health, Labor and Welfare
When you give an opinion to that effect, you must not permit the conduct of the research.
(Iv) Procedures under study
1 The principal investigator is the Clinical Research Institute for Gene Therapy, etc., as stipulated in the research plan.
Progress of research and occurrence of adverse events associated with the implementation of clinical research such as gene therapy
Etc. should be reported in writing to the head of the research institution, the general manager, and the ethics review committee.
Must be. In this case, the progress will be at least once a year.
This is the above report.
2 The head of the research institution is responsible for the progress of clinical research such as gene therapy and the progress of gene therapy.
Regarding the occurrence of adverse events associated with the implementation of floor research, the principal investigator or ethics
Receive reports or opinions from the review committee, and if necessary, send them to the principal investigator.
Give instructions on points to note, improvements, etc., and contact the Minister of Health, Labor and Welfare
I have to make a report.
(5) Response after the end of research
1 The principal investigator shall state the following items immediately after the completion of clinical research such as gene therapy.
Prepare a general report and promptly appoint the head of the research institution (when a general manager is appointed)
In that case, the head of the research institution and the general manager. ) Must be reported.
① Name of clinical research such as gene therapy
(2) Principal Investigator and other researchers (conduct research in collaboration with other research institutes)
In the case of this, the general manager and the research manager of the joint research institution are included. )of
Full name

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③ Names and locations of research institutes and joint research institutes
④ Purpose and significance of clinical research such as gene therapy
⑤ Implementation method and period of clinical research such as gene therapy
⑥ Results and consideration of clinical research such as gene therapy
⑦ Other necessary matters
2 When the head of the research institution receives a report from the principal investigator under the provisions of 1,
Inheritance to the Ethics Review Committee, which reviewed clinical research such as gene therapy
Document the completion of clinical research such as child treatment and a summary of the results
At the same time, a copy of the summary report must be promptly submitted to the Minister of Health, Labor and Welfare.
Not.
Items to be stated in the 18th research plan
(I) The following matters shall be stated in the research plan of 17th 1-1.
① Name of clinical research such as gene therapy
(2) Principal Investigator and other researchers (conduct research in collaboration with other research institutes)
In this case, the general manager and the research manager of the joint research institution are included. ) Name
And the role played in clinical research such as gene therapy
③ Names and locations of research institutes and joint research institutes
④ Purpose and significance of clinical research such as gene therapy
⑤ Implementation method and period of clinical research such as gene therapy
⑥ Target diseases and reasons for their selection
⑦ Subject selection policy
⑧ Gene to be introduced and method of gene transfer
⑴ Development process
⑵ Gene to be introduced
(3) Gene transfer method
(4) Composition of the final product to be administered to the subject
⑨ Characteristic analysis and quality test
⑩ Special equipment and medical materials used for administration to subjects
⑪ Evaluation of safety and efficacy in non-clinical studies
(1) Studies to predict clinical efficacy
⑵ Biodistribution
(3) Evaluation of safety in non-clinical studies
(4) Summary of non-clinical study results
⑫ Reasons for determining that clinical research such as gene therapy can be conducted
⑬ Procedures for receiving informed consent pursuant to the provisions of Article 22 (same as above)
Includes matters related to explanation and consent by regulation. )
⑭ Handling of personal information (including the method when anonymizing)
⑮ Burden on the subject and expected risks and benefits, these comprehensive
Evaluation and measures to minimize the burden and risk
⑯ Storage and abolition of samples and information (including materials related to information used in research)
How to abandon
⑰ Contents and method of reporting to the head of the research institution and the ethics review committee
⑱ Conflicts of interest related to clinical research such as gene therapy of research institutes such as research funding sources
Conflicts of interest related to clinical research such as gene therapy of researchers such as personal profits
Situation
⑲ Method of disclosing information on clinical research such as gene therapy

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⑳ Response to consultations from subjects and related parties
㉑ When receiving informed consent from a substitute, the 23rd
Procedures according to regulations (similar to the policy for selecting a substitute under the provisions of 22 and 23)
Also includes matters related to explanation and consent. )
㉒ Procedures pursuant to the provisions of 23 when obtaining informed consent
(Including matters related to explanation.)
㉓ If the subject has an economic burden or reward, that fact and its contents
㉔ Response when a serious adverse event occurs
㉕ Whether or not there is compensation for health damage caused by clinical research such as gene therapy
Its contents
㉖ Regarding the provision of medical care after conducting clinical research such as gene therapy to subjects
Correspondence
㉗ With the implementation of clinical research such as gene therapy, the health of the subjects and inheritance to offspring
When there is a possibility that important findings regarding the genetic characteristics to be obtained may be obtained,
Handling of research results (including accidental findings) related to subjects
㉘ When outsourcing a part of clinical research such as gene therapy, the business concerned
Duties and supervision method of contractor
㉙ Obtain consent from subjects, etc. regarding samples and information obtained from subjects
May be used for future studies not specified at the time or other studies
If there is a possibility of providing it to the institution, at the time of obtaining consent to that effect
Expected content
㉚ Implementation system and procedure for monitoring and auditing pursuant to the provisions of 34
㉛ Other necessary matters
The following materials shall be attached to the 21 research plan.
① Biography and research achievements of researchers
② Status of facilities and equipment of research institutes
(3) Suggest the effectiveness of clinical research such as gene therapy at research institutes
If there are results of research on testing and safety,
Achievement
④ Domestic and overseas research status other than research institutes related to clinical research such as gene therapy
⑤ Form of explanatory document and consent document for informed consent
⑥ Other necessary materials
(Iii) In the research plan, a summary that describes the outline in as simple terms as possible.
Must be attached.
Nineteenth Research Registration / Publication
I. Outline of research and registration of results
Principal Investigator (Place for clinical research such as gene therapy conducted in collaboration with other research institutes
In that case, the general manager or research manager. ) For clinical research such as gene therapy
Therefore, the National University Hospital Directors' Meeting, Japan Pharmaceutical Information Center, or
In the public database set up by the Japan Medical Association, the relevant gene cure
The outline of clinical research such as medical treatment is registered prior to its implementation, and the research plan is changed and remains.
It must be updated as appropriate according to the progress of clinical research such as gene treatment, and heredity.
When the clinical research such as child treatment is completed, the clinical research such as gene therapy is completed without delay.
The result of must be registered. However, the human rights of subjects and their related parties
Or it is necessary to keep it private to protect the rights and interests of researchers and their related parties.
The contents are approved by the director of the research institution in response to the opinion of the Ethics Review Committee.

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This does not apply to.
(Ii) Publication of research results
When the principal investigator completes clinical research such as gene therapy, he / she will take the test without delay.
Protecting the human rights of persons and their related parties or the rights and interests of researchers and their related parties
Do not publish the results of clinical research such as gene therapy after taking necessary measures.
Must be. In addition, when the final publication of the results was made, the research machine was released without delay.
I have to report to the chief of Seki.
Chapter 4 Ethics Review Committee
Establishment of the 20th Ethics Review Committee, etc.
(I) Requirements for establishing an ethics review committee
The founder of the Ethics Review Board must meet the following requirements:
I.
(1) Have the ability to carry out the affairs related to the examination accurately.
(2) Have the ability to continuously operate the Ethics Review Committee.
(3) Have the ability to operate the Ethics Review Committee in a neutral and fair manner.
(Ii) Obligations of the founder of the Ethics Review Board
1 The person who establishes the ethics review committee is concerned with the organization and operation of the ethics review committee.
Regulations are established, and according to the regulations, the members of the Ethics Review Committee and their affairs are followed.
You have to let the person doing the work do the work.
2 The founder of the ethics review committee is the gene examined by the ethics review committee.
Examination materials related to clinical research such as treatment will be submitted to the end of clinical research such as gene therapy.
Must be properly stored from the date it was reported until the day 10 years have passed.
I.
3. The person who establishes the ethics review committee shall start the operation of the ethics review committee.
Therefore, the composition, organization and operation of the ethics review committee, as well as public disclosure and other genetic control
Established rules regarding procedures required for examination of clinical research such as medical treatment, and ethics examination committee bulletin
Must be published in the notification system.
In addition, the ethics review committee is established at least once a year by the ethics review committee.
About the holding situation and the outline of the examination, in the ethics examination committee reporting system
Must be published. However, in the outline of the examination, the subjects, etc. and their
Private to protect the human rights of related parties or the rights and interests of researchers and their related parties
For what the Ethics Review Committee has determined to be necessary to do,
This is not the case.
4 The founder of the ethics review committee shall be a member of the ethics review committee and its affairs.
Ensuring that those engaged will receive education and training related to examination and related work
The necessary measures must be taken to maintain it.
5 The establishment of the ethics review committee is the organization and operation of the ethics review committee.
Minister of Health, Labor and Welfare or a person entrusted by the Minister of Health, Labor and Welfare for conforming to the guidelines
Must cooperate with the investigation conducted by.
21 Roles and responsibilities of the Ethics Review Committee, etc.
Role / responsibility
1 The Ethics Review Committee is suitable for conducting clinical research such as gene therapy from the head of the research institution.
When asked for an opinion on denial, etc., based on this guideline, an ethical point of view
And from a scientific point of view, including information on conflicts of interest between research institutes and researchers
The examination must be conducted in a neutral and fair manner, and opinions must be expressed in writing.

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2 The Ethics Review Board is free and independent of its activities so that the review can be conducted fairly.
Must be guaranteed.
3 The Ethics Review Committee conducted clinical research on gene therapy, etc., which was reviewed in accordance with the provisions of 1.
From an ethical and scientific point of view, we will conduct necessary research on
For the chief, change of research plan, discontinuation of clinical research such as gene therapy, etc.
Can state necessary opinions regarding clinical research such as gene therapy.
4 The Ethics Review Committee conducted clinical research on gene therapy, etc., which was reviewed in accordance with the provisions of 1.
Appropriateness of conducting clinical research such as gene therapy and reliability of research results
Conduct the necessary research to ensure sexuality, and ask the head of the research institution for a research plan.
Changes to the book, discontinuation of clinical research on the gene therapy, etc. Other clinical studies on the gene therapy, etc.
Be able to give the necessary opinions regarding the research.
5 Members of the Ethics Review Committee and those engaged in their affairs should know in their work.
Information should not be leaked without good reason. Stop engaging in the business
The same shall apply thereafter.
6 Members of the Ethics Review Committee and those engaged in their affairs shall be examined pursuant to the provisions of 1.
Leakage of information related to clinical research such as gene therapy that was investigated, etc.
From the perspective of respecting human rights and from the perspective of conducting clinical research such as gene therapy
Promptly if there is a significant concern in terms of review neutrality or fairness
Must be reported to the founder of the Ethics Review Board.
7. The members of the Ethics Examination Committee and those engaged in their affairs shall be examined and related.
Prior to work, learn the knowledge necessary for examination from an ethical and scientific perspective.
You must receive education and training to obtain it. Also, after that, as appropriate
You must continue to receive education and training.
(Ii) Composition and requirements for establishing a meeting, etc.
1 The composition of the Ethics Review Committee can appropriately carry out operations such as review of research plans.
All of the following requirements must be met, from ① to ③
Each of the listed persons cannot serve as the other at the same time. Also,
The same requirements apply to the establishment of a meeting.
① Experts in molecular biology, cell biology, genetics, clinical pharmacology, pathology, etc.
Includes clinicians involved in diseases that are the subject of clinical research such as gene therapy
thing.
(2) Appropriate for expressing opinions on legal experts and bioethics
It must be composed of those who have insight.
③ Someone who can express an opinion from a general standpoint, including the subject's point of view
Must be included.
④ There are several people who do not belong to the institution to which the ethics review committee is established.
That.
⑤ Must be composed of both men and women.
⑥ There must be 5 or more people.
2 Researchers involved in conducting clinical research such as gene therapy to be examined are ethical.
You must not be present at the review committee's deliberations and decision-making. However, the relevant ethics
At the request of the Physical Examination Committee, attend the meeting and clinically apply the gene therapy, etc.
I can give an explanation about the research.
3 The head of the research institution that requested the examination deliberates and decides the opinion of the Ethics Examination Committee.
Do not participate in. However, the content of the examination by the Ethics Examination Committee
If necessary to understand, with the consent of the relevant ethics review committee
, You can attend the meeting.

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4 The Ethics Review Committee seeks opinions from experts according to the subject and content of the review.
be able to.
5 The Ethics Review Committee is a research plan for those who require special consideration.
When reviewing the book and expressing opinions, knowledge about these persons as necessary
We must seek opinions from those who have a view.
6 The opinion of the Ethics Review Committee must be unanimously decided.
It doesn't become.
3 Rapid examination
The Ethics Review Board will determine the ethics of any of the following reviews.
Examination by members appointed by the Physical Examination Committee (hereinafter referred to as "rapid examination")
I can express my opinion. The result of the accelerated examination is the opinion of the Ethics Examination Committee.
The examination result must be reported to all committee members.
Absent.
(1) Clinical research such as gene therapy conducted in collaboration with other research institutes, and has already been conducted.
Ethics trial at a joint research institute for the entire clinical research such as gene therapy
It has been examined by the inspection committee and has obtained the opinion that it is appropriate for its implementation.
Case examination
(2) Examination of minor changes to the research plan
(Iv) Examination of research conducted by other research institutes
1 The head of a research institution consults with an ethics review committee established outside the research institution.
When requesting an inspection, the ethics review committee will be responsible for clinical research such as gene therapy.
It is necessary to fully understand the implementation system, conduct an examination, and express an opinion.
Absent.
2 The Ethics Review Committee conducts clinical research such as gene therapy conducted by other research institutes.
After conducting the examination, the director of the research institution will continue to provide the gene therapy, etc.
If you are asked to review floor research, you must review it and give your opinion.
Must be.
Chapter 5 Informed consent, etc.
22. Procedures for receiving informed consent, etc.
(I) Procedures for receiving informed consent, etc.
When the principal investigator, etc. intends to carry out clinical research such as gene therapy, the research machine
According to the research plan with the permission of the head of Seki,
Informed consent is provided by a document that describes the matters to be explained according to the regulations.
have to receive.
In addition, researchers and other related parties involved in the implementation of research (hereinafter referred to as "researchers, etc.""
U. ), When providing samples and information used for research to joint research institutes,
A record of the offer must be made. The principal investigator is created by researchers, etc.
From the date when the sample / information was provided to the date when three years have passed.
Must be stored for a period of time.
In addition, when receiving samples and information used for research from other research institutes
For researchers, etc., appropriate procedures should be taken by the person who provides the sample / information.
Confirm that the sample / information has been provided, and record the provision of the sample / information.
Must be created. The principal investigator shall keep the record created by the researcher, etc.
, 5 years from the date when the end of the study was reported
Must be tubed.

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(Ii) Changes to the research plan
The principal investigator, etc. should change the research plan and carry out clinical research such as gene therapy.
If you try, as a general rule, the changed part will be renewed according to one provision.
You must carry out procedures such as informal outlets. However, ethics
In response to the opinion of the review committee, the head of the research institution renewed the info according to one provision.
Regarding the changes permitted for not requiring procedures for mud outlets, etc.
However, this is not the case.
Three explanations
Matters to be explained to subjects when receiving informed consent
Is as follows in principle. However, the Ethics Review Committee and the Ministry of Health, Labor and Welfare
This does not apply to matters approved by the director of the research institution in response to the opinion of the Minister.
I.
(1) Name of clinical research such as gene therapy and implementation of clinical research such as gene therapy
And have obtained the permission of the director of the research institution
(2) Name of research institution and name of principal investigator (gene in collaboration with other research institutes)
When conducting clinical research such as treatment, the name of the joint research institution and the joint research machine
Includes the name of the principal investigator of Seki and the name of the general manager. )
③ Purpose and significance of clinical research such as gene therapy
④ Method of clinical research such as gene therapy (use of samples and information obtained from subjects)
Including purpose. ) And period
⑤ Reason for being selected as a subject
⑥ Burden on the subject and expected risks and benefits
⑦ If you agree to carry out or continue clinical research such as gene therapy.
However, it is possible to withdraw this at any time (measures according to the content of the withdrawal from the subject etc.
If it may be difficult to take, to that effect and the reason. )
⑧ Do not agree to carry out or continue clinical research such as gene therapy
To the effect that subjects, etc. will not be treated unfavorably by withdrawing their consent
⑨ Method of disclosing information on clinical research such as gene therapy
⑩ Protection of personal information, etc. of other subjects, etc. and the relevant remains at the request of the subjects, etc.
Research plans and research plans within the range that does not interfere with ensuring the originality of clinical research such as gene treatment
The fact that materials related to clinical research methods such as gene therapy can be obtained or viewed, and
How to get or browse
⑪ Handling of personal information (including the method when anonymizing)
⑫ How to store and dispose of samples and information
⑬ Conflicts of interest related to clinical research such as gene therapy of research institutes such as research funding sources
Conflicts of interest related to clinical research such as gene therapy of researchers such as personal profits
Situation
⑭ Response to consultations from subjects and related parties
⑮ If the subject, etc. has an economic burden or reward, that fact and its contents
⑯ Matters concerning other treatment methods, etc.
⑰ Regarding the provision of medical care after conducting clinical research such as gene therapy to subjects
Correspondence
⑱ With the implementation of clinical research such as gene therapy, the health of the subjects and their inheritance to offspring
When there is a possibility that important findings regarding the genetic characteristics to be obtained may be obtained,
Handling of research results (including accidental findings) related to subjects
⑲ Whether or not there is compensation for health damage caused by clinical research such as gene therapy
Contents

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⑳ Obtain the consent of the subjects regarding the samples and information obtained from the subjects.
May be used for future research or other research that is not specified at any given time
If there is a possibility of providing it to a research institution, at the time of obtaining consent to that effect
What is expected
㉑ Engage in monitoring on the premise that the subject's confidentiality is preserved
Persons and persons engaged in audits, the Ethics Review Board, and the Minister of Health, Labor and Welfare are required.
To browse samples and information about the subject within the range
(Iv) Procedures for using samples and information for research that was not specified at the time of obtaining consent
The principal investigator, etc., is expected to have samples and information at the time of obtaining consent from the subjects, etc.
When the purpose of use, etc. is explained as much as possible, and then the purpose of use
When a new research plan is created or changed, a new research plan is created.
Notify or disclose information about the specified purpose of use, etc. to the subjects, etc.
Do not guarantee the opportunity for subjects, etc. to withdraw their consent for the investigation to be carried out.
Must be.
(V) Withdrawal of consent, etc.
The principal investigator, etc. withdraws the consent corresponding to any of the following from the subjects, etc.
Or, if there is a refusal, take measures according to the content of the withdrawal or refusal without delay.
It is necessary to take measures and explain to the subject, etc. to that effect. Ta
However, if it is difficult to take such measures, do not take such measures.
When the director of the research institution approves after hearing the opinion of the Ethics Review Committee
Is not limited to this. In that case, measures according to the content of the withdrawal or refusal
The principal investigator, etc. explained to the subjects, etc. about the fact that the placement was not taken and the reason for it.
You must try to gain understanding.
(1) Consent given regarding the implementation or continuation of clinical research such as gene therapy
Withdrawal of all or part
(2) Regarding clinical research such as gene therapy for which the consenter gave consent,
Clinical research such as gene therapy in the procedure of informal outlet
Refusal to implement or continue in whole or in part
(Vi) Handling when providing samples and information to persons overseas
When providing samples and information used for research to persons overseas (the test)
This includes cases where all or part of the handling of fees and information is outsourced to a person overseas. ) Is
, The person concerned is the Law Enforcement Regulations on the Protection of Personal Information (2016 Personal Information Protection Commission)
Meeting rule No. 3. Hereinafter referred to as "Personal Information Protection Law Enforcement Regulations". ) To the country
Establish a system that meets the standards stipulated in certain cases or the Enforcement Regulations of the Personal Information Protection Law
Provide samples and information used for research to the person concerned, except when doing so.
Appropriate consent of the subjects, etc. must be obtained.
In addition, researchers, etc. must create a record regarding the provision of the sample / information.
Not.
The principal investigator provided the sample and information on the record created by the researcher, etc.
It must be stored for a period of 3 years from the date.
However, if it is difficult to obtain appropriate consent, the following ⑴ or ⑵
When satisfying those requirements, the samples and information used for the research are available overseas.
Can be provided to the person.
(1) The sample / information corresponds to any of the following.
① Anonymous (things that cannot identify a specific individual)
Limited to. ).
(2) Must be anonymously processed information or non-identified processed information.

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(2) Provide other existing samples and information when using for academic research.
There is a particular reason, and the matters from a to d are passed on to the subjects, etc.
Anything that is known or made public and is anonymized (which)
Processed or tube so that it cannot be immediately determined whether the sample / information is the subject's sample / information.
Limited to what is reasoned. ).
A. Purpose of use and method of use of samples / information (those who provide to persons overseas)
Including the law. )
B. Items of samples and information to be provided
C. Range of users
D. Name or name of the person responsible for the management of samples and information
⑵ If it does not correspond to ⑴, and it is used for academic research, other cases
There is a special reason for providing the sample / information, and from a to f
Notify or disclose the matters to the subjects, etc., and submit them to the relevant person overseas.
Ethical review of ensuring the opportunity to refuse to offer
After listening to the opinions of the committee, the permission of the director of the research institution must be obtained.
A. Purpose of use and method of use of samples / information (those who provide to persons overseas)
Including the law. )
B. Items of samples and information to be provided
C. Range of users
D. Name or name of the person responsible for the management of samples and information
E. Research subjects are identified at the request of the subject or his / her agent.
Stop providing samples and information.
How to accept requests from mosquito subjects or their agents
Procedures, etc. when receiving informed consent from the 23rd surrogate
Requirements for consent, etc.
(1) The principal investigator, etc., will be informed by the substitute in the procedure pursuant to the provisions of Article 22.
All of the following requirements are met when receiving a warmed outlet
Must have been.
(1) The following items must be stated in the research plan.
① Policy for selecting a substitute
(2) Items to be explained to the substitute (including explanations regarding (3))
③ ⑵ Reasons why it is necessary to have a person who falls under ① or ② as a subject
(2) The subject must fall under any of the following.
① Being a minor.
② If you are an adult and lack the ability to give informed consent
Being an objective judge.
(2) The principal investigator, etc., will be informed by the substitute in the procedure pursuant to the provisions of Article 22.
If you want to receive an outlet, accept it according to the selection policy of 1 ⑴ ①.
Select a person, and for the person who substitutes, in addition to the provisions of 22-3, 1 ⑴ ②
Must be explained.
3 When the principal investigator receives informed consent from a surrogate
And the subject has completed a course such as junior high school or is a minor 16 years or older
Sufficiently related to conducting clinical research such as gene therapy
When it is judged that the subject has judgment ability, the subject also informs
You must receive a de outlet.
(Ii) Procedures for obtaining informed consent, etc.

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1 When the principal investigator receives informed consent from a surrogate
And the subject himself about conducting clinical research such as gene therapy
Informed consent when it is judged that the intention of
You must try to get cents. However, it is subject to the provisions of 1-3.
This does not apply when receiving informed consent from the examiner.
2 The principal investigator performs informed consent procedures pursuant to the provisions of 1.
If you are going to carry out clinical research such as gene therapy that is expected to be
It is necessary to describe the explanation items and explanation methods for the Ecklonia cava subjects in the research plan.
It doesn't become.
3 The principal investigator, etc., should follow the procedure for informed consent pursuant to the provisions of 1.
All that the subject conducts or continues clinical research such as gene therapy
Or, if you express your intention to refuse a part, respect that intention.
I have to make an effort. However, clinical research such as the gene therapy is carried out or succeeded.
Continuing is expected to have a direct health benefit to the subject and is a surrogate
If you agree with it, this is not the case.
Chapter 6 Opinions of the Minister of Health, Labor and Welfare
Opinion of the Minister of Health, Labor and Welfare
(I) The Minister of Health, Labor and Welfare will provide gene therapy, etc. in advance at the request of the director of the research institution.
Express opinions on the implementation of floor research or significant changes in clinical research such as gene therapy
Shall be.
(Ii) The head of the research institution gives an opinion to the Minister of Health, Labor and Welfare based on the provisions of 16-3-1.
In order to request, the following documents must be submitted.
① Research plan and materials attached to the research plan
(2) Documents showing the process and results of the examination by the Ethics Examination Committee
③ Rules stipulated in 20-2-3
(Iii) The Minister of Health, Labor and Welfare may have more than one when requested for opinions based on the provisions of (ii).
Based on the opinions of experts in the above, the following items are not included in the clinical research such as gene therapy.
When it is judged that it corresponds to the deviation, the medical treatment of clinical research such as the gene therapy concerned
We shall hear the opinions of the Health Science Council on its usefulness and ethics.
(1) It is a recombinant gene and is used when introducing the gene into cells.
You are using a new or new gene administration method.
(2) Targeting new diseases.
(3) Using a new method such as gene therapy (corresponding to (1) or (2))
except for. ).
(4) It must include other matters that require individual examination.
(Iv) The Minister of Health, Labor and Welfare needs to hear opinions from the Health Science Council pursuant to the provisions of (3).
If it is determined that there is no such gene, within 30 days from the date when the opinion was requested.
Opinions shall be expressed regarding the implementation of clinical research such as treatment.
Twenty-five Opinions of the Minister of Health, Labor and Welfare regarding serious adverse events, etc.
The Minister of Health, Labor and Welfare conducted research based on the provisions of 16-4-3 and 31-4-3.
If you receive a report from the head of the institution, if necessary, you will be involved in clinical research such as gene therapy.
And give an opinion.
26th Survey by the Minister of Health, Labor and Welfare, etc.
The Minister of Health, Labor and Welfare shall state his / her opinion based on the provisions of 24-1 or 25.

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When it is deemed necessary, the director of the research institution shall be stipulated in 24-2.
Request the submission of materials other than the above documents, and obtain the consent of the director of the research institution.
Surveys of the research institute and other necessary surveys shall be conducted.
Chapter 7 Personal information and anonymously processed information
27 Basic responsibilities related to personal information, etc.
(I) Protection of personal information, etc.
1 Researchers and heads of research institutes are responsible for personal information, anonymous processing information, and non-identification processing information.
Regarding the handling of information, in addition to the provisions of this guideline, the Act on the Protection of Personal Information
Ritsu, the Act on the Protection of Personal Information Held by Administrative Agencies, Incorporated Administrative Agencies, etc.
Enacted by the Law Concerning Protection of Personal Information and Local Public Organizations
Must comply with the ordinances.
2 Researchers and heads of research institutes are dead in view of the dignity of the dead and feelings of the bereaved family.
A surviving individual, even with respect to information that can identify a particular individual
As with humans, handle properly in accordance with the provisions of paragraph (2) and twenty-eighth,
Necessary and appropriate measures must be taken, and in accordance with the provisions of 29
We must take appropriate measures and take necessary measures.
(Ii) Appropriate acquisition, etc.
1 Researchers are false or other fraudulent in conducting clinical research such as gene therapy.
Personal information, etc. must not be obtained by means.
2 As a general rule, researchers should cover the range in which the consent of the subjects, etc. has been obtained in advance.
Beyond that, we collect personal information, etc. acquired in connection with the implementation of clinical research such as gene therapy.
Do not handle.
28th Safety Management
Proper handling
1 Researchers can obtain personal information, etc. in connection with the implementation of clinical research such as gene therapy.
Those owned by the research institution to which the researcher belongs (consigned maintenance)
Including the case of pipe. Hereinafter referred to as "retained personal information, etc." ), Leakage
It must be handled properly for the prevention of damage, loss or damage and other safety management.
Must be.
2 The principal investigator has personal information when conducting clinical research such as gene therapy.
In cooperation with the head of the research institution, the information will be provided so that the information will be handled appropriately.
Necessary guidance and management must be provided to other researchers who handle it.
(Ii) System development, supervision, etc. for safety management
1 The head of the research institution should prevent the leakage, loss or damage of the personal information that he holds.
Do not take necessary and appropriate measures for the safety management of other personal information held by others.
Must be.
2 The head of the research institution is responsible for conducting clinical research such as gene therapy at the research institution.
If you want the researchers involved to handle the personal information you hold,
In addition to establishing the systems and regulations necessary for safety management,
Perform necessary and appropriate supervision so that the personal information held can be managed safely.
There must be.
29. Disclosure of retained personal information, etc.
(I) Publication of matters related to personal information held
(1) The head of the research institution shall comply with the provisions of Article 22 regarding personal information relating to subjects, etc.

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Clinical research on gene therapy, etc., including explanations to subjects, etc., or handling of personal information
When notifying or disclosing information about the implementation of the research to the subjects, etc.
Except for, personal information obtained in connection with the implementation of clinical research such as gene therapy.
Those owned by the research institution (including cases where they are stored on consignment)
It is called "retained personal information". ), The following matters
A specific individual identified by personal information (hereinafter referred to as "the person") or that
A state that can be easily known by the agent of the person (the person or his / her agent (hereinafter referred to as "the person, etc.")
Say. ) Is included in response to the request without delay. same as below. )
Must be done.
① Name of research institution and name of head of research institution
(2) Regarding the purpose of using the retained personal information, it is used for clinical research such as gene therapy.
The information provided will be used for clinical research such as gene therapy (other research)
If provided to an institution, include that fact. ), Clinical research such as gene therapy
If the information is not used for
③ Request according to the provisions of 2 or 2-1, 3, 4 or 6 (hereinafter referred to as "disclosure, etc."
Ask. " ) Procedures (determine the amount of fees according to the provisions of 2-2)
If so, the amount of the fee is included. )
④ Contact point for consultation regarding the handling of personal information held
2 The head of the research institution identifies the person among the personal information held by the person, etc.
When requested to notify the purpose of use of what can be done
To the person who made the request (hereinafter referred to as the "claimant") without delay
, Must notify this.
3 The provisions of 2 and 2 of 1 apply when any of the following applies:
Absent.
① Place the purpose of use in a state where it can be easily known or notify the claimant
By doing so, the life, body, property and other rights and interests of the subject, etc. or a third party
When there is a risk of harming profits
② Place the purpose of use in a state where it can be easily known or notify the claimant.
This may harm the rights or legitimate interests of the research institution.
If
4 The head of the research institution has set the notification of the purpose of use according to the provisions of 2 to the provisions of 3.
If it is decided not to notify the claimant, the requester will be notified without delay.
You must notify that. Also, explain the reason to the claimant and explain it to the claimant.
You must try to gain understanding.

(Ii) Responding to requests for disclosure, etc.
1 The head of the research institution identifies the person among the personal information held by the person, etc.
Disclosure of what can be done (the person himself / herself knows the personal information he / she holds
Includes notifying that if there is nothing to be separated. Same below
Ji. ) Is requested to the claimant without delay.
The information must be disclosed. However, by disclosing it,
If any of the deviations apply, all or part of them may not be disclosed.
In addition, where there is a stipulation regarding the disclosure of personal information held by laws and regulations.
In that case, it shall be in accordance with the provisions of the relevant law.
① Harm the life, body, property or other rights and interests of the subject, etc. or a third party
If it is
(2) There is a risk of significantly hindering the proper implementation of research work at research institutes.
If

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③ When it violates the law
2 The head of the research institution shall comply with the notification of the purpose of use pursuant to the provisions of 1-2 or the provisions of 1.
When requested to disclose the information, a fee will be collected for the implementation of the measures.
Can be done. However, in that case, it is considered reasonable in consideration of the actual cost.
Within the range, the amount of the fee must be determined.
3 The head of the research institution identifies the person among the personal information held by the person, etc.
For what you can do, because the content is not true
Therefore, you will be asked to correct, add or delete the content (hereinafter referred to as "correction, etc.").
In that case, special procedures will be taken according to the provisions of laws and regulations regarding correction of the contents.
Unless otherwise specified, it is delayed within the range necessary to achieve the purpose of use.
Conduct necessary investigations without delay, and do not correct the contents based on the results.
Must be.
4 The head of the research institution identifies the person among the personal information held by the person, etc.
What can be obtained, contrary to the provisions of 27-2-1
It is said that it is handled because it is a product or contrary to the provisions of the same 2
Suspension or deletion of the use of applicable personal information for some reason (hereinafter referred to as "suspension of use")
Stop, etc. " ) Is requested, and the request is recognized as appropriate
If so, it will be delayed to the extent necessary to correct the violation of the relevant provisions.
The use of the personal information must be suspended without delay. However, this
When it is difficult to suspend the use of the personal information, the right of the person concerned
This is the limit when taking alternative measures necessary to protect interests.
Not.
5 The head of the research institution shall cover all or part of the measures required by the provisions of 1.
If it is decided not to take such measures, or in the provisions of 3 or 4
If you take all or part of the more requested measures
If it is decided not to take such measures, the claimant will be delayed.
No notification to that effect (including the content of any corrections made)
Must be. In addition, according to the provisions of 1, 3 or 4, requested by the person, etc.
When notifying that all or part of the measures taken will not be taken
If you notify the claimant that you will take a different measure than that,
You must explain the reason for this and try to gain understanding.
6 The head of the research institution is a sample that can identify a specific individual from the person, etc.
・ Information is contrary to the provisions of 22. Other research institutes (including joint research institutes)
Same as below. ), Others of the sample / information
When requested to stop providing to research institutes, the request is deemed appropriate
When it is found, stop providing the sample / information to other research institutes without delay.
I have to stop. However, provision of the sample / information to other research institutes
Protecting the rights and interests of the person concerned even when it is difficult to suspend
This shall not apply when taking necessary alternative measures.
7 The head of the research institution may refer to a specific individual who is requested to stop providing the information under the provisions of 6.
Other research institutes for all or part of the identifiable samples / information
Decision not to stop providing to other research institutes
If you do, you must notify the claimant without delay.
Absent. In addition, when notifying that the provision to other research institutes will not be stopped, or other
If you want to notify us that you will take measures different from the suspension of provision to research institutes,
You must explain the reason to the applicant and try to gain their understanding.
8 The head of the research institution shall carry out the following matters as a procedure for responding to requests for disclosure, etc.

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Can be determined. In that case, it may impose an excessive burden on the person, etc.
We must try to reduce the burden so that it does not become a problem. Also, the person himself
When a request for disclosure, etc. is made without following the relevant procedure, the requester is opened.
It is possible to notify that it is difficult to respond to requests such as indications.
① Request for disclosure, etc.
(2) Documents to be submitted when requesting disclosure, etc. (electronic method, magnetic method)
Including records made in a way that cannot be recognized by the perception of others
Mu. ) Form and other methods of requesting disclosure, etc.
③ How to confirm that the person requesting disclosure, etc. is the person himself / herself, etc.
④ If a fee is set according to the provisions of 2, the collection method
9 The head of the research institution makes a request when there is a request for disclosure, etc. from the person himself / herself.
Proposal of matters sufficient to identify the personal information held by the person
You can ask for an indication. In addition, the person, etc. can easily and accurately request disclosure, etc.
Provision of information that contributes to the identification of the personal information so that it can be done Other books
Considering the convenience of people, etc., and imposing an excessive burden on the person, etc.
Care must be taken not to.
30th Handling of anonymously processed information
(I) Researchers, etc. (for the purpose of university and other academic research subject to the Personal Information Protection Law)
Institutions or organizations that do so, or those who belong to them, and their personal information or concealment
The purpose of handling name processing information is to use all or part of it for academic research.
Limited to those who The same shall apply hereinafter in this thirty. ) Is anonymous processing information (anonymous processing)
Information database, etc. (A collection of information including anonymously processed information, which is a specific secret
Systematically configured so that name processing information can be searched using a computer
Body so that you can easily search for other specific anonymously processed information
It is a systematic structure. ) Consists of. same as below. ) Create
When doing so, identify a specific individual and restore the personal information used to create it.
The personal information will be provided in accordance with the standards necessary to prevent it from being rehabilitated.
Must be processed.
(Ii) When researchers, etc. create anonymously processed information, the personal information used to create it
The description, etc. deleted from, the personal identification code, and the processing method performed according to the provisions of?
To the standards set as necessary to prevent the leakage of information about
Therefore, measures must be taken to ensure the security of this information.
(Iii) When a researcher, etc. creates anonymously processed information, it is included in the anonymously processed information.
The item of information about the individual must be published.
(Iv) Researchers, etc. create anonymously processed information and transfer the anonymously processed information to other research institutes.
When providing it, it should be included in the anonymously processed information provided to other research institutes in advance.
The items of information about individuals and the method of providing them will be announced.
In addition, the information related to the provision to the other research institute is anonymously processed information.
It must be clearly stated.
(V) Researchers, etc., create anonymously processed information and handle the anonymously processed information by themselves.
In doing so, we will know the person who is related to the personal information used to create the anonymously processed information.
To separate, the anonymously processed information must not be collated with other information.
(Vi) When researchers, etc. create anonymously processed information, they are responsible for the safety of the anonymously processed information.
For necessary and appropriate measures for reason, creation of the anonymously processed information and other handling
To ensure proper handling of complaints and other anonymously processed information
You must take the necessary measures yourself and make an effort to publicize the contents of the measures.

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Must be.
(Vii) Researchers, etc. exclude anonymously processed information (excluding information created by processing personal information by themselves.
The same shall apply hereinafter in this thirty. ) To other research institutes
Information about individuals contained in anonymously processed information provided to other research institutes
We will announce the items and the method of providing them, and inform the other research institutes concerned.
On the other hand, it must be clearly stated that the information related to the provision is anonymously processed information.
Absent.
(Viii) Researchers, etc. who have been provided with anonymously processed information should handle the anonymously processed information.
In doing so, we will know the person who is related to the personal information used to create the anonymously processed information.
In order to separate, the description etc. deleted from the personal information or the personal identification code
Obtain information about the processing method performed according to the provisions of?
The name processing information must not be collated with other information.
9. Researchers, etc. who have been provided with anonymously processed information are responsible for the safety management of the anonymously processed information.
Necessary and appropriate measures for handling complaints regarding the handling of anonymously processed information
Take the necessary measures to ensure the proper handling of other anonymously processed information,
At the same time, efforts must be made to publicize the details of the measures.
Chapter 8 Response to Serious Adverse Events
31 Response to serious adverse events
Correspondence of one researcher
Researchers have reported the occurrence of serious adverse events in the implementation of clinical studies such as gene therapy.
If you know it, follow the procedure manual, etc. according to the provisions of 4-1 and explain it to the subjects, etc.
, Take necessary measures and promptly report to the principal investigator
Absent.
(Ii) Response of the principal investigator
The principal investigator is responsible for the occurrence of serious adverse events in the implementation of clinical research such as gene therapy.
If you learn about the life, promptly inform the director of the research institution and the general manager.
In addition to making a notification, do not take appropriate measures in accordance with the procedure manual, etc. pursuant to the provisions of 4-1.
Must be. In addition, promptly engage in the implementation of clinical research such as gene therapy.
Information regarding the occurrence of the adverse event must be shared with researchers.
Response of the general manager
If the general manager receives a report pursuant to the second provision, the general manager shall be responsible for the research to which he / she belongs.
You must promptly report to the head of the institution and all principal investigators.
It doesn't become.
(Iv) Correspondence of the head of the research institution
1 When the head of a research institution intends to carry out clinical research such as gene therapy,
Regarding matters to be implemented by researchers in the event of a serious adverse event in advance
Create a procedure manual to be used, and respond appropriately and smoothly according to the procedure manual.
The necessary measures must be taken.
2 The head of the research institution has a serious adverse event from the principal investigator pursuant to the second provision.
If a report is made, take necessary measures promptly according to the procedure manual.
It is necessary to listen to the opinions of the Ethics Review Board regarding the adverse event.
Must be taken. The head of the research institute is the Ethics Review Committee.
Before listening to the opinions of the above, if necessary, ask the principal investigator to the clinical research institute for gene therapy, etc.
You can instruct them to stop the investigation or take provisional measures.
3 The head of the research institution promptly reports to the Minister of Health, Labor and Welfare about serious adverse events.
I have to tell you.

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Chapter 9 Ensuring the reliability of research
32. Management of Conflicts of Interest
(I) When conducting clinical research such as gene therapy, a researcher shall be concerned with personal profits, etc.
Regarding the situation regarding conflicts of interest related to clinical research such as gene therapy, we will study the situation.
You must report to the investigator and take appropriate action to ensure transparency.
(Ii) When conducting clinical research such as gene therapy, the principal investigator shall be responsible for the gene therapy.
It is necessary to grasp the situation regarding conflicts of interest related to clinical research and describe it in the research plan.
Must be.
(Iii) The researcher shall be in the situation regarding the conflict of interest stated in the research plan pursuant to the second provision.
In the procedure for receiving informed consent prescribed in 22.
It must be explained to the subjects.
33 Storage of samples and information related to research
(I) Researchers use information used in clinical research such as gene therapy and resources related to the information.
Fees (including records related to the provision of samples and information used in research. Information, etc.
". ) Must be accurate.
(Ii) When the principal investigator stores samples, information, etc. obtained from subjects, etc.
, Based on the procedure manual according to the third provision, the method will be described in the research plan.
In addition, the researcher will instruct and manage the information so that it will be accurate, and will take it from the subjects.
It is essential to prevent leakage, mixing, theft, loss, etc. of the obtained samples and information.
You have to do the necessary management.
The heads of the three research institutes are concerned with the storage of samples and information obtained from subjects, etc.
Create a procedure manual and follow the procedure manual for gene therapy performed by the research institution.
Samples and information obtained from subjects involved in clinical research are properly stored.
You have to do the necessary supervision.
(Iv) The principal investigator shall follow the procedure manual under the third provision and manage the condition under the second provision.
The situation must be reported to the head of the research institute.
(V) The principal investigator shall be responsible for the cause when the subject is newly infected with a pathogen in the future.
The end product to clarify whether is due to clinical research such as gene therapy
Serum before and after administration of the final product to the subject while storing for a certain period of time
Report to the head of the research institution and the general manager for the samples and information
It shall be stored for the required period of at least 10 years from the date of submission.
In addition, the head of the research institution needs to properly store the final products during the period.
Must be supervised. In addition, regarding the anonymized information, the relevant research institute
When the research institution keeps the correspondence table, the same applies to the storage of the correspondence table.
In addition, when providing samples and information, from the date of provision to the date when three years have passed.
If samples and information are provided during the period, the end of the research will be reported.
Supervision necessary for proper storage for the period from the date of date to the date of 5 years
It must be made.
(Vi) When the head of a research institution discards samples, information, etc. obtained from subjects, etc.
Has appropriate measures to prevent the identification of a particular individual
The necessary supervision must be provided so that it can be taken.
34 Monitoring and audit
(1) The principal investigator must endeavor to ensure the reliability of clinical research such as gene therapy.
Instead, monitor as stipulated in the research plan with the permission of the director of the research institution.

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The ring and audits shall be conducted as necessary.
(Ii) The principal investigator shall be as stipulated in the research plan approved by the director of the research institution.
Engage in monitoring for better monitoring and auditing
Necessary guidance and management must be provided to persons and persons engaged in audits.
(Iii) The principal investigator is a person who is involved in the implementation of clinical research such as gene therapy that is subject to audit.
And those engaged in its monitoring shall not be allowed to perform audits.
(Iv) Persons engaged in monitoring report the results of the monitoring to the principal investigator.
I have to tell you. In addition, those engaged in audits study the results of the audits.
It must be reported to the responsible person and the head of the research institution.
(V) Persons engaged in monitoring and persons engaged in audits have learned in the course of their work.
Information must not be leaked without good reason. After not engaging in the work
The same applies to.
(Vi) The head of the research institution cooperates in the implementation of monitoring and audits pursuant to the provisions of (1).
At the same time, the necessary measures must be taken for the implementation.
Chapter 10 Miscellaneous Rules
35 Enlightenment dissemination
Researchers take every opportunity to provide information on clinical research such as gene therapy.
We shall endeavor to raise awareness and disseminate information.
36th enforcement date
This guideline will come into effect on October 1, 2007.
37 transitional measures
Before the enforcement of this guideline, the guideline for clinical research on gene therapy before abolition (2004 text)
In procedures and other acts pursuant to the provisions of the Ministry of Education, Culture, Sports, Science and Technology / Ministry of Health, Labor and Welfare Notification No. 2)
If there is a considerable provision in this guideline, it depends on the considerable provision in this guideline.
It is considered to have been done.

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Supplementary provisions
(April 7, 2017 Ministry of Health, Labor and Welfare Notification No. 174)
1 This notification applies to specific individuals in the Act on the Protection of Personal Information and administrative procedures.
Date of enforcement of the law to partially revise the law regarding the use of identification numbers, etc.
It will come into effect on May 30, 2009). However, the provisions of Paragraph 2 of the Supplementary Provisions shall be on the day of promulgation.
Enforce from.
2 Guidelines for clinical research such as gene therapy after revision by this notification (hereinafter referred to as "new gene"
It is called "guideline". ) The principal investigator and other related parties prescribed in the second four shall be in this notification.
Even before the date of enforcement (hereinafter referred to as the "date of enforcement"), the provisions of the new genetic guidelines will apply.
Can prepare, change, and perform other necessary preparatory actions such as creating a research plan.
3 Personal information of the person made before the enforcement date (Individual specified in New Gene Guideline No. 27)
Information. ), If there is consent, that consent is the new gene
Agree to consent to allow the provision of personal information to persons overseas according to the guideline 22-6
If it is applicable, it is considered that the consent has been given.

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