HRP recently sought clarification from NIH and OHRP regarding the process for organizations to request exceptions from the revised Common Rule requirement for single IRB for cooperative research.
While NIH was previously able to grant exceptions from its own single IRB policy, it is unable to grant exceptions to the revised Common Rule requirement. HHS interprets the regulatory text (see excerpt below) to mean that exceptions not based in law may only be granted at the Department or Agency Head level.
45 CFR 46.114(b)(2) The following research is not subject to this provision:
(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
(ii) Research for which any 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.
Requests for exceptions for HHS agencies and offices are managed by OHRP while the decisions are made at the Department Head level (i.e., the Office of the Secretary). A listing of HHS agencies and offices is available here: https://www.hhs.gov/about/agencies/hhs-agencies-and-offices/index.html. At this time, requests for HHS exceptions may be emailed to OHRP at OHRP@HHS.gov. OHRP anticipates that few exceptions will be granted. It is unclear whether SACHRP’s 2018 recommendations on the topic will be taken into consideration.
Decisions regarding single IRB exceptions for other Common Rule Departments or Agencies (see list below) must also be made at the department or agency head level. Organizations seeking such exceptions should reach out to the department or agency supporting the research for guidance on the process.
- Department of Homeland Security
- Department of Agriculture
- Department of Energy
- Department of Commerce
- Social Security Administration
- Agency for International Development
- Department of Housing and Urban Development
- Department of Labor
- Department of Defense
- Department of Education
- Department of Veterans Affairs
- Environmental Protection Agency
- National Science Foundation
- Department of Transportation
- Office of the Director of National Intelligence
- Central Intelligence Agency
- Consumer Product Safety Commission