Research Policy Analysis and Coordination
NIH Single IRB Policy
In an effort to streamline the IRB review process for multisite human subject research, 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 of non-exempt human subjects research protocols funded by NIH and carried out at more than one site in the United States. Similarly, on January 19, 2017, the Department of Health and Human Services (HHS) and 15 other federal departments issued the final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") that mandates that any institution in the U.S. engaged in cooperative research must rely upon approval of a single IRB for the portion of the research conducted in the U.S.
Effective January 25, 2018, all domestic multi-site non-exempt human subject studies, where each site will conduct the same protocol, are expected to use a sIRB to conduct the ethical review for new, renewal, revision, or resubmission of all competing grant applications and contracts solicitations funded by NIH.
While January 19, 2018 has been set at the implementation date for the majority of revisions, on October 7, 2017, the Office of Management and Budget (OMB) received a proposal from HHS that seeks a “Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year.” To date, no formal delay has been published as final rulemaking; therefore, January 19, 2018 is still anticipated as the implementation of most Common Rule revisions.
- Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research: NOT-OD-16-094
- 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