The Institute for Human Gene Therapy at the University of Pennsylvania will no longer conduct gene therapy trials on patients, officials announced at a news conference last week. Dr Judith Rodin, president of the university, said it will also strengthen oversight of gene therapy research and other clinical trials, and review its policies on conflict of interest.
The gene therapy researchers came under scrutiny following the death of 18 year-old Jesse Gelsinger during a clinical trial last September. Following the tragedy, the Food and Drug Administration (FDA) suspended all human gene therapy trials at the institute, so the latest move will have no immediate effect.
Dr James M Wilson, director of the institute, founded a company - Genovo - in 1992, which had exclusive commercial rights to any discoveries made by his team. An external review board investigating the death concluded that similar financial relationships may be ill-advised. 'We think that Dr Wilson was overloaded with regard to responsibility' said Dr Rodin at the press conference.
Wilson will remain as the institute's director, where his team will focus on basic research and animal experiments. The university will continue to conduct gene therapy trials, subject to FDA approval, but they will not be done by the institute. Wilson may help design such experiments, but he will not participate in them, said Rodin.
The US government intends to issue new guidelines and regulations designed to protect people who participate in clinical trials, reports this week's Science. The Health and Human Services department is planning to appoint a 'czar' who will coordinate the efforts of 17 agencies to protect human research subjects.
Sources and References
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HHS plans to overhaul clinical research rules
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Institute restricted after gene therapy death
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Penn ends gene trials on humans
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Penn gene therapy lab to stop performing research on humans
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