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RESEARCH SAFETY New Post Adds Vigor to Biological SafetyPosition a Response to Rise in Number of Gene Transfer Studies As the latest move in a comprehensive effort to strengthen protections for patients, research subjects, and workers across the Harvard medical community, HMS has appointed Andrew Braun to a newly created position as associate director for biological safety in the Office of Research Subject Protection.
As associate director for biological safety, Andrew Braun will work to ensure the safety of research involving microbes or recombinant DNA at Harvard and the affiliated hospitals. —Pam Murray Coming most recently from a similar role at Partners HealthCare, Braun serves as coordinator for the University's Committee on Microbiological Safety (COMS), working with investigators and administrators at HMS, affiliated hospitals, and other Harvard schools to ensure the safety of all research involving microbiological agents or recombinant DNA. A preliminary version of the new COMS website is at www.hms.harvard.edu/coms. Until Braun came on board in early September, COMS was run by the Environmental Health and Safety Office. But the rise of gene transfer studies over the past five years—and with it, COMS's increasing responsibilities—demanded professional management for the committee, said Andrew Onderdonk, COMS chairman and professor of pathology at Brigham and Women's Hospital. "We really needed someone to interface at a high level with the heads of IRBs, with the committee itself, and with the FDA and NIH, to make sure the procedures we're following keep in compliance with all their guidelines," and to maintain clear lines of communication on biosafety issues within the Harvard community, Onderdonk said. Susanne Churchill, HMS associate dean for research, said, "This was truly a collaborative effort at all levels—each of the hospitals and other Harvard schools were fully engaged and willing to contribute to a strengthened compliance effort. And we couldn't have asked for a better implementation team, including Ron Morales, our superb facilitator from Environmental Health and Safety, along with Andy Braun, Andy Onderdonk, and Mason Freeman, the new gene transfer subcommittee chair." A Harvard HistoryBraun certainly knows his way around Harvard. After receiving undergraduate degrees from Middlebury College and MIT, he came to the Harvard School of Public Health for masters and doctoral degrees. He was a member of the HMS faculty in radiation therapy, then from 1993 to 1995 was biosafety manager in the University's Environmental Health and Safety Office where, he said, "many of the policies developed during my stay remain in force." From June 1995 until September 2000 he was the biosafety officer at Partners.Optimizing interactions between COMS and the hospitals' IRBs, biosafety officers, and departments of environmental and occupational health will be key, Braun said, adding, "We need to ensure that activities are not unnecessarily duplicated—but that nothing falls through the cracks," COMS has also assumed the functions of the University's Committee on Regulation of Hazardous Biological Agents, which was based at the main campus in Cambridge and traces its roots back to concerns over possible dangers of laboratory research related to recombinant DNA. As gene-splicing labs established a safe track record over the past few decades, the need for oversight seemed less urgent and the Cambridge committee had less work. With the coming of human gene therapy studies, oversight of recombinant DNA research shifted to the Longwood medical area. "The number of clinical studies requiring examination by this committee has been rising very quickly and, in fact, that has now become its dominant activity," Braun said. Folding the Cambridge committee's members and activities into COMS has made them part of a more active body (although that committee maintains a separate existence to meet Cambridge city regulations). At the same time, changes to the federal Recombinant DNA Advisory Committee (RAC) have made local oversight of gene manipulation studies more crucial. The RAC, which originally had the power to veto NIH-funded gene transfer studies, was abolished by NIH director Harold Varmus in 1997, only to be resurrected months later in a more limited advisory role. This October, in a move catalyzed by last year's gene therapy death at the University of Pennsylvania, the government again beefed up RAC's role, so institutional review boards now must hold off approving any gene transfer study until RAC either passes it on to the FDA or—usually for studies with novel aspects—takes it up for full deliberation. Degrees of ChangeDespite increased federal and public concern over gene therapy oversight, Braun emphasized that Harvard already had good safeguards in place and that NIH officials "went away very satisfied" after a visit last summer. "I'm not here to fix a broken system," he said, "but to expand an effective system."Due to a recent FDA mandate that university biosafety committees oversee animal–human transplants, COMS now has a subcommittee on xenotransplantation in addition to the one on gene transfer. In addition to scientists from each institution, COMS has four community representatives from Boston, Brookline, and Cambridge. Braun said these members "are a real asset" to the committee, lending an independent perspective and making sure, for example, that informed consent forms are clearly understandable. Braun said he will "work hand-in-hand" with Carolyn Connelly, director of the Office for Research Subject Protection. That office handles the Medical School's own IRB and oversees the use of animals in research. (see Focus, April 21, 2000). —Tom Reynolds |
