The Final NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was published in the Federal Register on June 21, 2016. The effective date of the policy, originally May 25, 2017, has been extended to September 25, 2017. NIH has posted Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review as well as FAQson the policy. Additional related guidance and FAQs will be issued soon to the NIH Office of Science Policy website.
The policy applies to domestic NIH-funded multi-site studies carried out at more than one site “where each site will conduct the same protocol (emphasis added) involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.
It does not apply to career development, research training or fellowship awards.” Ongoing, non-competing awards will not be expected to comply until the grantee submits a competing renewal application.