Operational Procedures of RERF Institutional Review Board (8.2)

Radiation Effects Research Foundation
Operational Procedures of RERF Institutional Review Board

1.

Objectives
These operational procedures set forth the composition and operation of theInstitutional Review Board (hereinafter referred to as “IRB”), which has been
established in accordance with the RERF Regulations for Protection of Study
Subjects and Standing Committee Establishment Procedures.

2. Composition of the IRB(1) The IRB shall have at least five members who are appointed by the RERF
Chairman. However, the RERF Chairman may not appoint him/herself as an IRBmember.
(2) The IRB membership shall be composed to meet all of the following requirements.
(With regard to 1)-3) below, the same person may not meet multiplerequirements.)
1) The IRB shall include experts in natural science, such as specialists in medicalscience/medical treatment.
2) The IRB shall include experts in humanities/social science, such as specialistsin ethics/legal science.
3) The IRB shall include those who express opinions from the perspective of thegeneral public, such as study subjects.
4) The IRB shall include more than one individuals who are not affiliated withRERF. One of such individuals shall not be a spouse, child, parent, sibling orother relative who shares living expenses with a person who is affiliated withRERF.
5) The IRB shall include members of both genders.
(3) In appointing committee members, due consideration shall be given to thecomposition of the IRB to maintain balance among all RERF research
departments/secretariat.
(4) The IRB shall have a Chairperson and Vice Chairperson, to be appointed by theRERF Chairman from among the members of the IRB.
(5) The term of office for IRB members shall be two years, with reappointment
possible. In the case of replacement in the middle of a term, the term of office for
the IRB member appointed to fill the vacancy shall be the remainder of thepredecessor’s term of office.
(6) The IRB shall have an executive secretary (ies), to be appointed by the RERF
Chairman. The executive secretary (ies)’s term of office shall be two years, withreappointment possible.
(7) IRB members and executive secretary (ies) shall not disclose information obtainedin the course of their board duties without justifiable reason. The same applies
after the members and executive secretary (ies) leave their IRB posts.
(8) The RERF Chairman shall take all measures necessary to ensure that IRB
members and the executive secretary (ies) receive education and training forreviews and the related work of the committee.
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Operational Procedures of RERF Institutional Review Board (8.2)

3. Convening of the IRB and decision(1) Convening of the IRB
1) The IRB Chairperson shall convene the IRB.
2) The IRB may not convene unless a simple majority of the committee members
are in attendance. Furthermore, attendance must fulfill the requirements forcommittee composition set forth above in 2.(2).
3) The committee members shall participate in IRB reviews and decisions from afair and neutral standpoint, without consideration paid to their own interests or
the interests of their organizations or departments.
4) Investigators and others engaged in conducting a study to be reviewed shallnot participate in the IRB’s deliberation and decision-making processes.
However, such individuals may attend the meeting to present explanations
about the study upon the committee’s request.
5) The IRB Chairperson may ask for experts’ opinions in relation to the contentsof a study to be reviewed.
6) When reviewing a research protocol that involves study subjects for whom
special consideration is required, the IRB shall ask for opinions from those
who have expertise about these subjects.
(2) Decision
1) The IRB shall endeavor to reach a unanimous decision.
2) If unanimity cannot be achieved, decisions by the IRB shall require theconsensus of at least two-thirds of the members in attendance.
4. Functions of the IRB(1) In response to a request from the RERF Chairman for an opinion about whether aspecific study involving human subjects should be approved or disapproved, theIRB shall conduct reviews in a neutral and fair manner, from both ethical andscientific perspectives, in compliance with all domestic/applicable foreign laws,
regulations, and guidelines for protection of study subjects in the relevant study.
The IRB will also consider information about possible conflicts of interest
involving RERF, its investigators or others, and provide its opinions in writing tothe RERF Chairman.
(2) The IRB will investigate existing research protocols involving human subjects onan as-needed basis, from both ethical and scientific perspectives, and provide theRERF Chairman with recommendations concerning these protocols, including
suggestions for modifications or termination.
(3) The IRB may review research protocols involving human subjects upon requestfrom other research institutes. Such reviews shall be predicated on sufficientunderstanding of the system for conducting research at the relevant research
institute.
5. IRB review of research protocols and progress(1) The IRB review of research protocols and progress shall be conducted in either ofthe following formats.
1) Regular review (reviews by the IRB in accordance with the provisions of 3.(1)2(8.2)

Operational Procedures of RERF Institutional Review Board (8.2)

of these operational procedures)2) Expedited review
a. Regardless of the provisions of 3. (1), the IRB may conduct a review
through the IRB Chairperson or through at least one experienced
committee member appointed by the IRB Chairperson.
b. The IRB may conduct an expedited review after confirming that theresearch protocol in question meets the requirements for expedited review
stipulated by domestic/applicable foreign laws, regulations, and guidelines
for protection of study subjects (Attachment 1).
c. Expedited review results shall be presented as the IRB’s view andannounced to the committee members.
d. Committee members notified of expedited review results have the right torequest, upon submission of justification for the action, that the IRB
Chairperson convene the committee to review the item concerned once
again. In such cases, when the IRB Chairperson finds reasonable grounds,
he/she must convene the committee to re-review the item concerned.
(2) Matters to be reviewed
The IRB review of research protocols and progress shall be conducted in any of thefollowing circumstances:
1) Review of new research proposals (procedures shown in Attachment 2)2) Review of proposals to modify existing research protocols (procedures shownin Attachment 2)3) Continuing review of progress of existing research proposals (proceduresshown in Attachment 3)
a. All ongoing research protocols involving human subjects shall be subject
to at least one continuing review by the IRB each year. The frequency ofsuch reviews shall be determined by the IRB at the first review, based on
the degree of the risk.
b. In addition to the continuing reviews set forth above in a., all ongoing
human genome/gene analysis research protocols shall be subject to annual,
continuing reviews by a qualified external individual, and the review
results shall be announced to the committee members.
c. A principal investigator (hereinafter referred to as “PI”) shall prepare
documents required for reviews stipulated above in a. and b., and submit
them to the IRB.
d. As part of a continuing review, the IRB may interview the PI and others incharge of the relevant study. To confirm that no material changes in theresearch protocol have occurred since the previous review, the IRB may
also obtain information from sources other than the PI on an as-neededbasis for verification.
4) Review of adverse event reports (procedures shown in Attachment 4)
a. When an investigator or other concerned party finds a case described inany of the following categories or is concerned that a relevant case hasoccurred, the investigator shall take necessary measures in a timely manner,in accordance with predetermined procedures, and make a report to the PI.
i. An adverse event that has occurred to study subjects
ii. Problems that are not anticipated in a research protocol
iii. Noncompliance with laws, regulations or guidelines for protection of3(8.2)

Operational Procedures of RERF Institutional Review Board (8.2)

b.

c.

study subjects, or with determinations of the IRB
In response to the report stipulated above in a., the PI shall confirm thepresence/absence of the relevant case without delay. When the case isconfirmed, he/she shall take all measures necessary, including managing
any adverse event that has occurred to study subjects and reporting to theChief of the Department/Secretariat to which he/she belongs as well as theChairman, and submit an adverse event report to the IRB.
It is necessary to ensure that the person who made such a report set forth
above in a. and b. will not receive any disadvantageous treatment byreason of having made the relevant report.

6.

Preparation for IRB review and disclosure of records and information
The IRB executive secretary (ies) shall perform the following duties with
instructions and/or approval from the IRB Chairperson.
(1) Preparation for IRB review
1) Acquisition of review-related materials and prior confirmation
2) Issuance of acceptance numbers
3) Provision of IRB meeting notification to committee members(2) Provision of IRB review results, preparation of minutes of IRB meetings, andretention of documents
1) The executive secretary (ies) shall announce review results to PIs.
2) The executive secretary (ies) shall summarize the proceedings and prepareminutes.
3) In addition to the aforementioned minutes of IRB meetings, the executive
secretary (ies) shall retain documents received by or dispatched from the IRB.
(3) Disclosure of IRB-related information
1) Regulations concerning the organization and operation of the IRB and a list ofIRB members, identified by name, shall be disclosed on RERF’s external
website and through the Health, Labour and Welfare Ministry’s (MHLW’s)
IRB reporting system.
2) Meeting dates for the IRB and review outlines shall be disclosed on the RERF
external website and through MHLW’s IRB reporting system not less thanonce a year.
7. Retention period for IRB review materials and disposal procedures(1) Materials pertaining to the review of research protocols shall be retained for atleast five years after the completion of research is reported.
(2) Records shall be retained in an appropriate storage area to prevent damage or loss.
(3) When the retention period for records has expired, they shall be disposed of inaccordance with procedures set forth in the RERF regulations.
8.

Revision of these operational procedures
These operational procedures shall be revised on an as-needed basis orapproximately five years after the date of enforcement, based on a review of theentire contents.

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Operational Procedures of RERF Institutional Review Board (8.2)

Supplementary Provision
These operational procedures shall take effect from April 1, 2016.
Supplementary Provision
These procedures will be partially revised with effect from July 1, 2019.

5(8.2)