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The National Institutes of Health (NIH) has released a new policy, effective in 2017, to align with the proposed Common Rule changes in regards to the use of a single institutional review board (IRB) for multi-site studies. The goal of this policy is to enhance and streamline the IRB review process such that multi-site research can proceed as effectively and expeditiously as possible.
This 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, or contracts. All sites participating in a multi-site study are expected to rely on a single IRB of record. Participating sites continue to be responsible for meeting other regulatory requirements such as obtaining informed consent, overseeing the implementation of the protocol, and reporting unanticipated problems and study progress to the IRB. The single IRB may also act as a privacy board, as applicable, to fulfill the HIPAA requirements for use or disclosure of protected health information for research purposes. This policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017. For contracts, the policy applies to all solicitations issued on or after May 25, 2017.
Guidance on scenarios illustrating the use of direct and indirect costs for single IRB review under the policy are now available.
We encourage investigators to contact the MHRI IRB/ORI through MHRI-ORIHelpDesk@MedStar.net as soon as they learn they will be participating in a project that requires a central IRB, that a reliance agreement can be completed and assist the investigator with the entire process.