New Office Further Promotes Safety of Clinical Trials

UR Improves Program that’s Already a National Model

December 11, 2002

The University of Rochester Medical Center is leading a trend by establishing a new Office for Human Subject Protection (OHSP), which will oversee research involving human volunteers at the UR, including Strong Memorial Hospital and Highland Hospital. For the last several years, the UR Medical Center has been a national leader among institutions that conduct clinical research, having written a training manual that was recommended by the Secretary of Health and Human Services for physician investigators and scientists. The new OHSP and other improvements, effective immediately, expect to provide even greater protection of people participating in research trials here. OHSP will expand its audit function, for example, and plans to extend its educational program beyond doctors, nurses and scientists to patients and local residents who may have questions about the safety of clinical trials and what to expect upon enrollment. “This community has traditionally been very supportive of medical research,” says Gary L. Chadwick, who has been appointed Director of the Office for Human Subject Protection. “Our objective is to design a program that thoroughly explains the process to anyone who’s interested. For physicians and scientists, the educational component has always been aimed at raising awareness of ethical issues.” The more sophisticated program will also help the UR maintain its leadership status as it pursues more industry-sponsored drug trials and federal research grants, Chadwick adds. “We’re riding the crest of a new movement. In the future, the most important grants will go to institutions that can best ensure that human subjects are adequately protected.” Chadwick, Pharm.D., M.P.H., previously was director of the Medical Center’s Research Subjects Review Board (RSRB), the reviewing body in place since the 1970s to ensure the safety of medical research projects. Chadwick is also co-author of the 1999 training manual used widely by researchers, which has sold 75,000 copies. A second edition was published in October 2002. Chadwick came to the Medical Center in 1996 from the U.S. Food and Drug Administration, and serves in key roles on several national organizations concerned with boosting the safety of clinical trials and promoting education. Chadwick will report to Jeanine Arden-Ornt, UR General Counsel. Mary Adams has been appointed director of the RSRB. Adams came to the university in 1997, when she began managing the UR’s institutional review boards. Prior to 1997 Adams was the administrator for a research subjects review board at a community hospital in Texas. She is a certified IRB professional, through the Applied Research Ethics National Association. Under its new structure, the OHSP will conduct three main activities: oversight of the RSRB, education, and auditing. The auditing function was added to spot check approved research projects as they proceed through their normal course, and to focus on quality improvements. Timothy Hackett has been named manager of quality assurance. In addition, Bill Kelvie has been named director of research education. Clinical trials are a vital part of academic medical institutions. The gold standard for new treatment often emerges from scientifically rigorous programs in which people volunteer to test an experimental drug or other therapy. Today at the UR Medical Center, four separate boards and a contract board monitor 1,800 research projects at any given time. The projects range from telephone surveys classified as having a low risk for participants, to cancer trials testing drugs not yet approved by the FDA. # # #

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