Single IRB (sIRB) Policy for Multi-site Research
Single IRB Policy: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html
Frequently Asked Questions on Use of a Single IRB for Multi-Site Research Costs: https://osp.od.nih.gov/clinical-research/nih-policy-on-the-use-of-a-single-irb-for-multi-site-research-faqs-on-costs/
Frequently Asked Questions on Implementation of the Single IRB Policy: https://osp.od.nih.gov/clinical-research/implementation-of-the-sirb-policy/
For applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human subjects.
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. It does not apply to career development, research training or fellowship awards. Implementation of the NIH sIRB policy is expected to reduce unnecessary administrative burdens and systemic inefficiencies while maintaining appropriate human subjects protections.
Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).
The NIH single IRB 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.
The NIH single IRB policy does not apply to studies conducted under career development, research training or fellowship awards. Under the policy, “multi-site” is defined as two or more sites. Foreign sites participating in NIH- funded, multi-site studies will not be expected to follow this policy.
The NIH single IRB policy applies to multi-site human subjects research regardless of the funding mechanism (e.g., grants, cooperative agreements, contracts or other mechanisms such as Cooperative Research and Development Agreements (CRADAs), and Interagency Agreements (IAA)). The policy applies whether the sites are subawards to a primary award recipient or separate awards are made for participating sites. The NIH Single IRB policy does not apply to Other Transaction Agreements (OTAs).
** Please note that information listed here is subject to change based on additional guidance by NIH. Please continue to monitor this page for additional/updated guidance from NIH.**