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
                OR
      • 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.