Reliance Agreement 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