Single IRB (sIRB) Requirements – 2018 Common Rule
|There are new requirements for documenting and managing sIRB review. The requirements have different compliance dates as noted below.|
- Required as of January 21, 2019 for institutions that rely on an IRB outside of their own local IRB:
- The relying institution and the reviewing IRB must enter into a “reliance” agreement to document the reliance activity.
- The reliance agreement must include the specific responsibilities of both the relying institution and the reviewing IRB.
- Both the relying institution and the reviewing IRB remain responsible for
- Safeguarding the rights and welfare of human subjects
- Complying with the regulatory requirements of the 2018 Common Rule
- Required as of January 20, 2020 to use a single IRB model for cooperative research
- A cooperative research project is one that is covered under the 2018 Common Rule that involves more than one institution.
- Applicable to any institution located in the United States that is engaged in cooperative research
- Includes research where different activities will be conducted at each participating site.
- The reviewing IRB is identified by
- The Federal department or agency supporting or conducting the research
- Proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.
Remember that the NIH requirement for use of a sIRB model in multi-site research is in effect already and still applies if the research is funded or supported by the NIH.