SAMPLE COOPERATIVE AMENDMENT LANGUAGE

For use between MPA institutions
or as OPRR may otherwise find to be appropriate

BACKGROUND

There are occasions when the Institutional Review Board (IRB) of one institution may wish to defer to the review of another institution. Section 45 CFR 46.114 allows for such reliance so long as the reliance is approved by the Office for Protection from Research Risks (OPRR) on behalf of the Department of Health and Human Services (DHHS). OPRR employs an administrative device which is called a Cooperative Amendment (CA) for use between institutions with OPRR-approved Multiple Project Assurances (MPAs) or under other circumstances, on a case-by-case basis. CAs may be unrestricted in nature or limited, such as for a particular research activity or type of circumstance.

Circumstances that may prompt consideration of a CA might include shared accrual of subjects at more than one institution for the same research activity or when the institution under whose auspices the activity would occur is not the institution at which the subjects would be accrued. Therefore, a CA may be considered where past experience or future prospects portend the routine or frequent interrelationships of this nature between institutions. IRBs of each institution would need to be suitably composed to do equal justice in protection of the rights and welfare of subjects at either institution, when called upon. Consideration of a CA is elective on the part of institutions but does require OPRR approval where a DHHS MPA or other basis of OPRR jurisdiction is involved.

The purpose of a CA is to establish a written understanding that defines which IRB will perform reviews and under what circumstances. In a CA, each institution must attest to the adequacy of IRB membership to satisfactorily fulfill that responsibility for either institution. Supplementation of existing IRB membership(s) may be necessary to ensure familiarity with institutional constraints and populations across institutions. IRB composition may be supplemented with at least nonvoting consultant input, when necessary. OPRR need not be informed of compositional changes unless voting membership is involved. IRB minutes will serve to document consultant attendance for initial and all subsequent continuing reviews of a research activity. Each institution must acknowledge and endorse their respective responsibilities to ensure, cooperate with, and abide by the performance of effective IRB reviews and related functions. Disapprovals of the IRB may not be overturned, IRB requests for additional information may not be denied, reporting to the IRB will occur as required, and the reviewing IRB must ensure that copies of its relevant minutes are made available to both institutions.

Sample language has been prepared for the convenience of institutions that may wish to consider election of a CA (see attached). The sample language assumes that reliance on each other's IRB will automatically occur in the prescribed manner for any human subject research activity for which both institutions participate (i.e., "unrestricted"). There may be other more restrictive circumstances for which reliance may be considered. Specialized language may be adapted from the sample for such circumstances.

(11-29-93)

COOPERATIVE AMENDMENT

Sample Language
(this wording assumes unrestricted reliance)

The officials having signed below commit their respective institutions to the following binding cooperative amendment with regard to reliance upon each others Institutional Review Boards (IRBs). Unless a review by the relied upon IRB is denied by either of the institutions, in writing, any time all of the human subjects (HSs) of a research activity will be exclusively accrued at only one of the institutions, the IRB of that institution will review for both participating institutions. Any time HSs will be seen at both institutions, IRB Chairs shall confer and have the authority to decide which shall review for both. Their decision shall be in writing and provided to the appropriate committing official of each institution. Each institution reserves the right to insist on review by its own IRB regardless of this amendment, so long as that preference is in writing and provided to the Chairs of both IRBs. IRB reviews shall occur with voting membership and/or consultant supplementation appropriate to any given activity. Changes in voting membership shall be reported to the Office for Protection from Research Risks (OPRR) as they occur. The cooperating institutions agree that the reviewing IRB shall be adequately supported in its function, cooperate with reporting requirements and requests for additional information, and abide with IRB decisions. Disapprovals may not be administratively overruled by either cooperating institution. Relevant minutes of IRB meetings shall be made available to both cooperating institutions.

Signatures:

Institutional Official "A" ______________________________

Institutional Official "B" ______________________________

Only for OPRR Use

DHHS APPROVING OFFICIAL

(10-10-95)

Policy | Assurances | OHRP Home Page

If you have questions about human subject research, click   ohrp@osophs.dhhs.gov
If you have questions/suggestions about this web page, click  Webmaster
Updated June 23, 2000