Chapter 24 - IRB Reliance Mechanisms
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 an external 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.
Effective January 25, 2018, the National Institutes of Health (NIH) mandated the use of single IRBs as a contingency for funding of multi-site studies. The NIH issued this policy to establish the expectation that a single IRB of Record will be used in the ethical review of non-exempt human subject research projects funded by the NIH that are carried out at more than one site within the United States.
Effective January 20, 2020, the U.S. Department of Health & Human Services requires all domestic multi-site research projects supported by Federal funding to utilize a sIRB mechanism, regardless of specific funding agency, under the Revised Common Rule.
The purpose of this policy is to define the procedures and standards University of Pittsburgh Human Research Protections (Pitt HRP) follows for determining when to accept the review of an external IRB for a human subject research project in which University of Pittsburgh faculty, staff or students are engaged, and when to permit a domestic external institution or an unaffiliated researcher to rely upon the review of the University of Pittsburgh IRB (Pitt IRB) for a non-exempt human subject research project.
When a non-exempt human subject research project is being conducted in collaboration with domestic external institutions or 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, Pitt HRP will consider requests to either rely on an external institution’s IRB or to serve as the central IRB for external collaborating sites engaged in the trial under the conditions set forth in this policy. The Institutional Official (IO) or his designee, in consultation with the Office of University Counsel and Pitt HRP 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 an external institution to rely upon the Pitt IRB, shall be documented in an IAA or RA.