Author: Eva Pastor
Date: 12-23-09 20:55
Source: FOCUS - News from Harvard Medical, Dental & PH Sch
URL: http://focus.hms.harvard.edu/2009/120409/irb_traffic.shtml
Date published: December 4th 2009
Smoothing the Road for IRB Traffic
Nine Harvard-linked Institutions Agree to New Plan for Approving Multicenter Human Studies
Through Harvard Catalyst, nine Harvard schools and HMS-affiliated institutions have created a framework that will smooth the regulatory review process for multicenter human studies, including clinical, human tissue and social or behavioral research. This new Reciprocal Common IRB Reliance Agreement gives investigators a way to request that the institutional review boards (IRBs) with jurisdiction over a proposed multicenter study rely on the review of one IRB, and for the IRBs to decide, on a protocol-by-protocol basis, whether a “ceded review” is appropriate.
Barbara Bierer, who directs Harvard Catalyst’s regulatory arm, praises the efforts of regulatory and legal officials across the Harvard medical community for streamlining the review process for human studies.
The reliance agreement—which covers Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Children’s Hospital Boston, Dana-Farber Cancer Institute, HMS, HSPH, the Harvard Faculty of Arts and Sciences (FAS), Joslin Diabetes Center and Massachusetts General Hospital—applies to new studies and to the addition of sites to existing studies.
HSDM and the University’s nonmedical professional schools are also participating via the HMS and FAS IRBs.
“With this reliance agreement in place, we hope we can reduce duplicative IRB review and promote, even accelerate, collaborative research efforts among investigators at the participating institutions,” said Barbara Bierer, senior vice president for research at BWH and director of Harvard Catalyst’s Regulatory Knowledge and Support Program. “Not all studies will be eligible for ceded review, but all will be considered as long as the principal investigator requests it.”
To help investigators apply for ceded IRB review, Harvard Catalyst and the nine IRBs will launch a “Cede Review” form. Investigators will be able to use it to give the IRBs a snapshot of their proposed studies and detail the activities that will take place at each institution. The IRBs will work together to determine whether the proposed research warrants individual review by each or if review by one IRB will suffice. The form will be available on the websites of Harvard Catalyst and the nine IRBs in December.
Bierer noted that “the agreement illustrates what can happen when people from multiple institutions and backgrounds come together. The IRBs and regulatory and legal offices of the participating institutions worked tirelessly to bring this mechanism about and will continue to do so to make sure that it really works for the Harvard research community.”
—Thomas Ulrich
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