Applications for non-exempt human subjects research (including clinical trials) with multi-sites submitted for due dates on or after January 25, 2018, are expected to use a single Institutional Review Board (sIRB) to conduct the ethical review required for the protection of human research subjects.
- The sIRB policy applies to domestic sites of wholly or partially NIH-funded multi-site studies where each site will conduct the same protocol.
- The sIRB policy does not apply to:
- Foreign sites.
- Career development (K), research training (T), or fellowship (F) awards.
If applicable, a single IRB plan is required as an attachment to the Human Subjects & Clinical Trials Information form. The sIRB plan should include:
- A description of compliance with the NIH sIRB policy.
- The name of the IRB that will serve as the sIRB of record.
- An indication that all identified participating sites have agreed to rely on the proposed sIRB and that any sites added after award will rely on the sIRB.
- A brief description of how communication between sites and the sIRB will be handled.
- An indication that all participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.
- Stipulation of which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.
The means of document reliance among the participating institutions will be determined by the sIRB.
Resources: https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm.
16 March 2018