Extension of the Effective Date of the Single IRB Policy for NIH Studies

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As announced in the July edition of Focus, the National Institutes of Health (NIH) has released a new policy on 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 so that multi-site research can proceed as effectively and expeditiously as possible.

Originally scheduled for May 2017, this policy will now take effect September 25, 2017. Any competing grant applications (including contracts) for NIH-funded, multi-site studies with receipt dates on or after September 25, 2017, will need to adhere to this policy. All sites participating in a multi-site study are expected to rely on a single IRB. The single IRB may also act as the privacy board for that study

NIH has released additional guidance, in the form of FAQs, on the handling of the costs associated with the implementation of the policy. 

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.

The NIH policy on IRB review can be viewed on their website. The notice of extension can be viewed here.