Beginning January 20, 2020, the Federal Policy for the Protection of Human Subjects (the “Common Rule”) will require the use of a Single IRB (sIRB) when more than one institution is involved in a research project funded by a Common Rule agency*.
What is an sIRB?
An sIRB is the IRB of record, selected on a study-by-study basis, which provides the ethical review and related administrative coordination for all sites participating in a multi-site study and assumes responsibility for all human participant research compliance.
Who will this impact?
Federally-funded studies, with very few exceptions, are required to use an sIRB for review and approval of cooperative studies conducted in the United States. This applies to all cooperative research applications and contract proposals submitted on or after January 20, 2020.
If you are conducting an NIH-funded study, a version of the sIRB requirement has been in effect since January 25, 2018. For NIH-funded studies, all multi-site projects with non-exempt human participant research (clinical and non-clinical) where the same research protocol is conducted at more than one domestic site are required to use an sIRB. Applicants are required to include an sIRB Plan in their NIH proposal, identifying which IRB has agreed to serve in this role. Note: other federal funders may require a similar sIRB plan be submitted with proposals, going forward.
What happens next?
The Cornell IRB is currently not equipped to serve as the sIRB, but will comply with the requirements for a participating IRB when another institution serves as the IRB of record. Researchers should speak with the Cornell IRB office prior to submitting a proposal to NIH or any other federal agency for a multi-site project. The IRB staff will assist PIs with identifying a suitable partner to act as the sIRB, including other institutions involved in the project or a commercial sIRB provider.
*The following federal agencies follow the revised (2018) Common Rule:
- Agency for International Development
- Central Intelligence Agency
- Consumer Product Safety Commission
- Department of Agriculture
- Department of Commerce
- Department of Defense
- Department of Education
- Department of Energy
- Department of Health and Human Services (excluding FDA, which has different regulations)
- Department of Homeland Security
- Department of Housing and Urban Development
- Department of Justice
- Department of Labor
- Department of Transportation
- Department of Veterans Affairs
- Environmental Protection Agency
- National Aeronautics and Space Administration
- National Science Foundation
- Office of the Director of National Intelligence
- Social Security Administration