The January 20, 2020 compliance date for the single IRB requirement for cooperative research at §46.114(b) of the revised Common Rule is only a few short days away.  While it is HRP’s understanding that OHRP intends to issue guidance about this provision, that guidance is not anticipated before January 20th.

Here are a few key points for human research protection professionals to keep in mind:

  • The scope of the revised Common Rule provision is broader than NIH’s sIRB policy which excludes certain award types
  • The definition of “cooperative research” in the revised Common Rule is not the same as “multi-site study” in the NIH policy (see below), there is no reference to use of the same protocol.
    • Revised Common Rule: “Cooperative research projects are those projects covered by this policy that involve more than one institution”
    • NIH Policy: “A multi-site study uses the same protocol to conduct non-exempt human subjects research at more than one site”
  • The revised Common Rule provision does not apply to:
    • Cooperative research subject to the “pre-2018” version of the Common Rule
    • Cooperative research for which more than single IRB review is required by law (including tribal law)
    • Cooperative research when the Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context
    • Institutions located outside of the United States
    • Research conducted outside of the United States (but, the requirement would apply to any portions of such research conducted inside of the United States)
  • In accordance with the 3rd bullet above, OHRP has published the following date-based exceptions from the single IRB requirement for HHS conducted or supported research. Cooperative research:
    • Initially approved by at least 1 IRB between January 21, 2019 and January 20, 2020
    • Initially approved by at least 1 IRB before January 21, 2019 and which was voluntarily transitioned to comply with the revised Common Rule
    • For which an NIH exception determination was issued on or before January 20, 2020
  • Importantly, the HHS exceptions noted above do not apply to research conducted or supported by the other Common Rule departments and agencies. Institutions with support from these depts/agencies for non-exempt research that was IRB-approved between January 21, 2019 and January 20, 2020 may want to consult with them regarding the applicability of the provision.  As a reminder, these include:
    • of Homeland Security
    • of Agriculture
    • of Energy
    • NASA
    • of Commerce
    • Social Security Administration
    • Agency for International Development
    • of Housing and Urban Development
    • of Labor
    • of Defense
    • of Education
    • of Veterans Affairs
    • Environmental Protection Agency
    • National Science Foundation
    • of Transportation
    • Office of the Director of National Intelligence
    • Central Intelligence Agency
    • Consumer Product Safety Commission