Multi-site research studies funded by the National Institutes of Health (NIH) are required to use a single IRB of record for all participating sites. This policy applies to non-exempt human subjects research conducted under the same protocol. The policy is effective as of January 25, 2018.
Why the Change?
The purpose of the change is to streamline the IRB review process, remove redundant hurdles to the initiation of studies and eliminate duplicative IRB review. This change also aims to reduce unnecessary administrative burdens while still maintaining appropriate human subject protection standards.
How Does this Impact You?
If you are applying for an NIH grant application or contract proposal, you will be required to identify the reviewing IRB for your multi-site study. Multi-site studies are defined as two or more sites. Every site must be operating under the same research protocol to fall under this requirement. “Same research protocol” means protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes.
Which IRBs can Serve as the Single IRB?
Institutional based IRBs, as well as commercial/independent IRBs, can serve as the reviewing IRB under this policy. Review costs for all research sites should be contemplated in your grant application or contract proposal.
Will the MHRI IRB Serve as the Reviewing IRB?
Please contact the IRB office BEFORE submitting your grant application or contract proposal to discuss IRB review options at MHRI-ORIHelpDesk@MedStar.net.
