NIH Issues Final Policy on Use of Single IRB

On June 21, NIH published in the Federal Register the “Final NIH Policy on the Use of a Single Institutional Review Board for Multi–Site Research.”

The NIH found “no compelling reason” to narrow the essential scope of the final policy—it will cover all domestic sites of NIH-funded non-exempt multi-site studies as was proposed. However, the final policy clarifies the policy intent and modified several provisions.

The final policy will not take effect until May 25, 2017. In the interim, the NIH will issue guidance and provide resources to assist awardees in adapting to the shift.

The Policy

This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects at 45 CFR Part 46.

Scope

The policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.

Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy

Multi-site studies within ongoing, non-competing awards will not be expected to comply with the policy until a competing renewal application is submitted.

Process

Applicants/offerors will be expected to submit a plan identifying the sIRB that will serve as the IRB of record for all study sites in the applications/proposals they submit to the NIH. The NIH’s acceptance of the submitted plan will be incorporated as a term and condition in the Notice of Award or in the Contract Award.

It will be the responsibility of the applicant/offeror to assure that the sIRB is qualified to serve; the applicant’s plan will not be evaluated in peer review.

If, in delayed-onset research, an sIRB has not yet been identified, applications/proposals should include a statement that awardees will follow this Policy and communicate plans to use a registered IRB of record to the funding NIH Institute/Center prior to initiating a multi-site study.

The additional costs associated with sIRB review may be charged to grants or contracts as direct costs, provided that such costs are well-justified and consistently treated as either direct or indirect costs according to applicable cost principles in the NIH Grants Policy Statement and the Federal Acquisition Regulations (FAR) §§31.202 and 31.203.

Responsibility of Awardees

Awardees are responsible for ensuring that authorization agreements between IRBs (also called “reliance agreements”) are in place; copies of authorization agreements and other necessary documentation should be maintained in order to document compliance with this policy, as needed. As appropriate, awardees are responsible for ensuring that a mechanism for communication between the sIRB and participating sites is established.

Awardees may delegate the tasks associated with these responsibilities.

Responsibility of Funding Institute/Center

Funding ICs are responsible for management and oversight of the award, including communicating with the awardee regarding the implementation of its proposed plan to comply with the sIRB Policy. In the event that questions arise about the awardee’s plan, including the IRB that has been selected to serve as the sIRB, the funding IC will work with the awardee to resolve them.

Exceptions

Exceptions to the policy will be granted if the use of an sIRB is prohibited by federal, state, or tribal laws or regulations. NIH will also grant exceptions where the federal, state, or tribal prohibition on the use of an sIRB is established by policy. NIH  will consider granting an exception if a request is made and a compelling justification provided for why an exception is needed

 

The text of the publication may be accessed here. The actual policy begins on page 17 of the publication.