The revised Federal Policy for the Protection of Human Subjects (the “Common Rule”) collaborative (multi-site) research provision requires that U.S. institutions engaged in cooperative research conducted or supported by a Common Rule agency must rely on a single IRB (sIRB) to review and approve that research conducted at domestic sites [45 CFR 46.114(b)]. The compliance date for this collaborative research provision was January 20, 2020. The reviewing IRB must be identified by the funding department or agency or proposed by the lead institution.
Will your investigation be affected by this requirement?
This is a big question now and a confusing one to answer. The answer depends on a couple things, namely your funding source and the regulatory agency that oversees your study.
Is your study regulated by FDA or DHHS Office for Human Research Protections (OHRP)?
- If your study is funded by National Institutes of Health (NIH), the single IRB requirement went into effect 25 January of last year.
- If you are receiving any other federal funding, the OHRP requirement of single IRB review for federally funded multi-site research goes into effect January 20, 2020.
However, on November 21, 2019, OHRP issued an exception into the federal register related to sIRB review for collaborative research.
OHRP exception to sIRB review for collaborative research
OHRP’s notice allows an exception from the collaborative research provision under 45 CFR 46.114(b) for projects approved by an IRB before January 20, 2020 in the following circumstances:
- Cooperative research conducted or supported by HHS agencies other than the NIH, if an IRB initially approved the research before January 20, 2020.
- Cooperative research conducted or supported by NIH if either:
a. the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020; or,
b. NIH excepted the research from its single IRB policy before January 20, 2020.
This exception applies only to HHS-conducted or supported research. Other Federal agencies that have adopted the revised Common Rule have not yet issued this same exception.
At the present time, there is no existing or pending FDA regulation requiring single IRB review of FDA regulated multi-site research. Per 21 CFR 56.114, “institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.” The key word there is ‘may’. If you would like to implement this requirement for FDA regulated studies, you can, but you are not required to.