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Forum to focus on ethical concerns in human medical trials

Eighteen-year-old Jesse Gelsinger's death in September 1999 during a gene therapy trial sent shock waves through the medical research community and launched an intense scrutiny of human medical trials across the country.

Conflicts of interest and other ethical concerns prompted a temporary shutdown of research programs at several universities, including the University of Pennsylvania's Institute for Human Gene Therapy where Gelsinger died.

Paul Gelsinger, Jesse's father, and lawyer Alan Milstein will be the featured speakers at a School of Law "Forum on Research Ethics" April 3 (see below) in the law school's Strom Thurmond Auditorium.

"The Gelsinger tragedy brought to the forefront a lot of issues that need to be raised about oversight at the institutional and federal levels," Milstein said. "Scientists should not be conducting any research on a non-therapeutic basis in which there is any greater than minimal risk for the patients."

In addition to Gelsinger and Milstein, other speakers at the forum will be Tommy Coggins, interim director of Sponsored Programs and Research and director of USC's Office of Research Compliance; George Khushf, an assistant professor in the Department of Philosophy and a bioethicist; and Robert Best, an associate professor in the medical school's Department of Obstetrics and Gynecology. The forum will be moderated by Robin Fretwell Wilson, an assistant professor in the School of Law who also organized the program.

Much of the recent discussion about human medical trials has centered on the role of institutional review boards (IRBs), which are responsible for reviewing research proposals that involve human subjects. Critics contend that most IRBs are ill-equipped to effectively monitor ongoing research and researchers increasingly have a financial interest in the outcome of their research, which creates conflict of interest.

Human medical trials by USC professors and clinicians are carried out under the auspices of Palmetto Richland Hospital and Dorn V.A. Hospital, whose IRBs, in conjunction with USC's IRB, work cooperatively.

"It is very difficult for IRBs, which are staffed by faculty volunteers, to act as reviewers, policemen, and enforcers," Coggins said. "Ultimately, the principal investigator is the one responsible for conducting the research in an ethical manner."

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