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