NIH Single IRB Policy

On June 21, 2016, the National Institutes of Health (NIH) issued a policy on the use of a single Institutional Review Board (sIRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.

The NIH Single IRB Policy applies to 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. The policy applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after January 25, 2017.

More Background

• Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research: NOT-OD-16-094
• Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research: NOT-OD-18-004
• Guidance on Exceptions to the NIH Single IRB Policy: NOT-OD-18-003
• Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research: NOT-OD-16-109
• NIH Single IRB Policy FAQs for Extramural Community on Implementation of sIRB Policy
• NIH Single IRB Policy FAQs for Multi-Site Research Costs