• Overview
• Program Contacts
• Inter-institutional Alignments
  • Reciprocal Common IRB Reliance Agreement
• Research Participants and Communities
  • Research Subject Advocacy (RSA)
• Investigational Drugs and Devices (IND/IDE)
• Quality Assurance/Quality Improvement (QA/QI)

Reciprocal Common IRB Reliance Agreement

The institutional review boards (IRBs) of nine Harvard Catalyst-participating institutions have come together to create a framework that will smooth the review of proposed multicenter human studies, including clinical research, social or behavioral studies, or research using human tissues. Called a Reciprocal Common IRB Reliance Agreement, the framework provides a way for investigators proposing multicenter studies to request "ceded review" - that is, to request that the IRBs on a multicenter study rely on the review of one IRB - and for the IRBs at the participating institutions to elect to do so on a protocol-by-protocol basis.

This agreement applies not only to new protocols, but can also be used if an investigator wishes to add a new site to an existing protocol. While not all studies will be eligible for single IRB review, the hope is that this reliance agreement can reduce duplicative IRB review and in that way promote, even accelerate, collaborative research efforts among investigators at the participating institutions.

The following institutions have signed the agreement:

• Beth Israel Deaconess Medical Center
• Brigham and Women's Hospital
• Children's Hospital Boston
• Dana-Farber Cancer Institute
• Harvard Medical School (HMS)
• Harvard School of Public Health
• Harvard University Faculty of Arts and Sciences (FAS)
• Joslin Diabetes Center
• Massachusetts General Hospital
The Harvard School of Dental Medicine (which comes under the auspices of the HMS IRB) and the University's non-medical professional schools (all of which receive regulatory coverage from the FAS IRB) are also participating in the agreement.

For investigators, a significant practical outcome of the reliance agreement is the ability to request ceded IRB review for multicenter studies before submitting a full IRB application. Investigators may request ceded IRB review via the IRB Ceded Review Request form. While the form developed out of the Reciprocal Common Reliance Agreement, it may be used for any multisite studies that involve at least one Harvard Catalyst-participating institution. The IRBs will review the request and work together to determine whether the proposed research warrants individual regulatory reviews by each institution's IRB, or if review by a single IRB will be sufficient.

For more information about the Harvard Catalyst Reciprocal Common IRB Reliance Agreement or to request a reference copy, please contact:

Director, Regulatory Affairs Operations
Sabune J. Winkler, JD
Harvard Catalyst
E-mail
617-432-7811