Radiation Effects Research Foundation
Regulations for Protection of Study Subjects(Objective)
Article 1 - The objective of these regulations is to provide for the protection of study
subjects at the Radiation Effects Research Foundation (hereafter referred to as “thisjuristic person”), in accordance with Paragraph 2 of Article 66, Articles ofIncorporation.
(Employees’ responsibilities)
Article 2 - Individuals stipulated in Article 2 of the Rules of Employment, as well as all
individuals engaged in activities at this juristic person by this juristic person’s
direction and order (hereafter referred to as “employees”), in conducting research
involving human subjects, pledge to strive for the protection of study subjects, inline with their roles in such research, giving due attention to the following basicmatters:(1) Compliance with applicable domestic and foreign laws and guidelines
concerning the protection of study subjects in such research;(2) Ensuring the appropriateness of research by developing and complying withresearch protocols, and by preliminary review and approval of such research
protocols by an institutional review board;(3) Protection of personal information of study subjects;(4) Provision of sufficient prior explanation to study subjects and securing theirconsent of their own free will (informed consent), in cases in which such efforts
are required;(5) Reporting to the persons, the institutional review board, and the Director(s) incharge of such research when a problem related to the protection of study
subjects has occurred.
(Compliance with laws and guidelines)
Article 3 - Laws and guidelines applicable to this juristic person’s research in Item 1 ofParagraph 1 of the preceding Article are as follows:(1) Research on the atomic bomb survivors and their children
1) Japanese ethical guidelines for medical research: Ethical Guidelines for
Life-Science and Medical Research Involving Human Subjects
2) The U.S. ethical guidelines for medical research: The U.S. Code ofFederal Regulations: Title 45 Public Welfare Part 46 Protection of HumanSubjects(2) Research on human subjects other than (1) above
1) Japanese ethical guidelines for medical research: Ethical Guidelines for
Life-Science and Medical Research Involving Human Subjects(Institutional review board)
Article 4 - This juristic person shall establish an institutional review board (IRB) toperform ethical and scientific review of its research. Duties of the IRB shalltypically be the following:(1) Advance review of research protocols; approval or other such decisions on said

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research protocols;(2) Periodic review of ongoing research programs; submission of modification,cancellation, or other such opinions on said research programs;(3) Items separately prescribed as necessary in addition to the preceding items.
RERF Chairman must determine the approval or disapproval of all research
protocols or proposals for changes with due respect to the decision of the IRB. Any
research not approved by the IRB will not be allowed to be implemented.
The IRB must be appropriately composed and operated in order to pursue impartial
and neutral reviews, in accordance with domestic and applicable foreign laws andguidelines related to protection of study subjects in each research program
conducted by this juristic person.
Members of the IRB must not reveal any information obtained from theperformance of their duties without reasonable justification. This shall also apply
after resignation from their positions.
Matters pertaining to the operation of the IRB will be determined separately.

(Education and training programs concerning protection of study subjects)
Article 5 - The Chairman shall be responsible for taking necessary measures to ensurethat employees receive education and training programs concerning the protectionof study subjects.
(Punishment)
Article 6 - If an employee violates Article 2 and/or Paragraph 4 of Article 4, he or she
will be disciplined in accordance with the provisions of the Rules of Employment
or his or her contract.
(Revision and abolition of the regulations)
Article 7 - Revision and abolition of these regulations will be implemented by decisionof the Board of Directors.

Supplementary Provision
These regulations shall take effect on the date of approval by the Board of Directors(June 4, 2014).
Supplementary Provision
These regulations shall take effect on the date of approval by the Board of Directors(March 4, 2016) and be implemented from April 1, 2016.
Supplementary Provision
These regulations shall take effect on the date of approval by the Board of Directors(June 3, 2021) and be implemented from June 30, 2021.

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