News

New regulatory reliance agreement for multicenter human studies signed

Posted October 29, 2009

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.

While individual institutions have had reciprocal agreements in place for some time, each required negotiation, institutional review and signature, and significant resources. This new agreement should help facilitate and even minimize negotiation and review between the nine participating IRBs as long as the institutions on a given protocol agree that a ceded review is appropriate.

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.

“In general, investigators who want to conduct a multicenter trial must submit a separate application to each institution’s IRB,” according to Barbara Bierer, MD, senior vice president for research at Brigham and Women’s Hospital and the director of the Harvard Catalyst Regulatory Knowledge and Support Program. “With this reliance agreement in place, we hope we can reduce duplicative IRB review and in that way promote, even accelerate, collaborative research efforts among investigators at the participating institutions. “Not all studies will be eligible for review by only one IRB,” Bierer noted, “but all will be considered as long as the principal investigator requests it.” 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.

“This is an important moment for translational research at Harvard,” said Lee Nadler, MD, dean of clinical and translational research at Harvard Medical School and director of Harvard Catalyst. “For such research to be effective, investigators must be able to recruit as many patients, or accrue as many samples, as necessary, which often means that studies need to be conducted across multiple institutions. Facilitating regulatory review multicenter research is critical, and is one of Harvard Catalyst’s primary goals.”

Bierer added, “The agreement illustrates what can happen when people from multiple institutions and backgrounds come together. The IRBs, regulatory offices, and legal offices of the participating institutions worked tirelessly to bring this mechanism about, and will continue to work together to make sure that it really works for the Harvard research community.”

For investigators, a significant practical outcome of the reliance agreement will be the ability to request ceded IRB review for multicenter studies before submitting a full IRB application. To request ceded IRB review, a common form called a “Cede Review Form” will soon be made available on the websites of Harvard Catalyst and the participating IRBs. Through a series of check boxes, the investigator will give a preview of the proposed study and detail the activities that will take place at the participating institutions. The IRBs will 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.

Until that form is available, to request ceded review, or to find out more about the Reciprocal Common IRB Reliance Agreement and how it applies both to your institution specifically, and to multicenter research at Harvard in general, contact your home institution’s IRB office:

Beth Israel Deaconess Medical Center:  Mary Williams, Committee on Clinical Investigations (E-mail, 617-667-0476)

Brigham and Women’s Hospital:  Rosalyn Gray, Partners Human Research Office (E-mail, 617-424-4100)

Children’s Hospital Boston:  Susan Kornetsky, Office of Clinical Investigation (E-mail, 617-355-7052)

Dana-Farber Cancer Institute:  Sara Harnish, Office for Human Research Studies (E-mail, 617-632-5457)

Harvard Medical School and Harvard School of Dental Medicine:  Pamela Richmond, Office of Research Subject Protection (E-mail, 617-432-2597)

Harvard School of Public Health:  Julie Kaberry, Office of Human Research Administration (E-mail, 617-384-8547)

Harvard University-area/Harvard University Faculty of Arts and Sciences (FAS) IRB*:  Elizabeth Bowie, Committee on the Use of Human Subjects in Research (E-mail, 617-496-6087)

Joslin Diabetes Center: Leigh Read, Committee on Human Studies (E-mail, 617-732-2543,

Massachusetts General Hospital: Rosalyn Gray, Partners Human Research Office (E-mail, 617-424-4100)

Harvard Catalyst | The Harvard Clinical and Translational Science Center: Sabune Winkler, Harvard Catalyst Regulatory Knowledge and Support Program (E-mail, 617-432-7811)

* The Harvard University FAS IRB is also the IRB for:

  • Harvard Business School
  • Harvard Divinity School
  • Harvard Graduate School of Design
  • Harvard Graduate School of Education
  • Harvard Law School
  • Harvard School of Engineering and Applied Sciences
  • Harvard University Health Services
  • Harvard Kennedy School of Government
  • Radcliffe Institute for Advanced Study