Determination of Exception to the Required Use of a Single IRB for Certain HHS Cooperative Research that is Subject to the 2018 Requirements

The Office for Human Research Protections (OHRP) in the Office of the Assistant Secretary for Health of the Department of Health and Human Services (HHS) has announced its determination of exception for two categories of research from the required use of a single institutional review board (IRB) to review cooperative research under the HHS regulations for the protection of human subjects.  This determination is specific to research conducted or supported by HHS.  The announcement with the OHRP determination of exception has been put on public display by the Office of the Federal Register and can be accessed at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-25358.pdf.  The determination of exception can also be accessed on OHRP’s website at: https://www.hhs.gov/ohrp/regulations-and-policy/index.html.

OHRP determined that for HHS cooperative research subject to the revised Common Rule (also referred to as the 2018 Requirements), and for purposes of 45 CFR 46.114(b)(2)(ii), an institution may continue to use multiple IRBs, in lieu of a single IRB, for the following research:

(1) Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB initially approved the research before January 20, 2020.

(2)  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.

Note that this determination is only made for purposes of section 46.114(b)(2)(ii) – namely, for determining whether certain cooperative research may be excepted from the single IRB mandate.  This determination does not prevent, nor should it be viewed as discouraging, the voluntary use of a single IRB in cooperative research subject to the 2018 Requirements that would fall within the above two categories.  Further, note that category (2)(b), above, applies for the duration of NIH’s exception from its policy for the particular research study; categories (1) and (2)(a) apply for the duration of the research.