Chapter 24 - IRB Reliance Mechanisms

Background

Relevant guidance from OHRP states that multiple institutions engaged in the same non-exempt human participant research may enter into joint review arrangements, rely upon the review of another qualified IRB, or make similar arrangements to avoid duplication of effort. Similarly, FDA regulations permit a sponsor to utilize a single, central IRB for review of multicenter clinical trials.  

The purpose of this policy is to define the procedures and standards the University of Pittsburgh Human Research Protection Office (HRPO) follows for determining when to accept the review of another IRB for non-exempt human-participant research in which University of Pittsburgh faculty, staff or students are engaged, and when to permit another institution or an unaffiliated researcher to rely upon the review of a non-exempt human-participant protocol by the University of Pittsburgh IRB.

Policy Statement

When non-exempt human participant research is being conducted in collaboration with other institutions or with collaborating individual investigators, each collaborating institution and/or collaborating individual investigator engaged in the research must obtain IRB approval from an appropriately authorized IRB. The OHRP guidance document, Guidance on Engagement of Institutions in Human Subjects Research will be used as the basis for determining whether the duties contemplated by an investigator constitute engagement in human participant research. Such determinations will be made in collaboration and consultation with authorized representatives of the collaborating institution and/or the collaborating individual investigators, as applicable.

In an effort to streamline IRB reviews for multicenter trials, HRPO will consider requests to either rely on another institution’s IRB or to serve as the central IRB for other collaborating sites engaged in the trial under the conditions set forth in this policy.   The Institutional Official (IO), in consultation with Office of General Counsel and HRPO representatives, has the authority to execute Institutional Authorization Agreements (IAAs) or Reliance Agreements (RAs) on behalf of the University of Pittsburgh.   All determinations to rely upon, or to permit another institution to rely upon the University of Pittsburgh IRB, shall be documented in an IAA or RA.