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University of Pennsylvania Tuesday, May 30, 2000, Volume 46 Number 34 www.upenn.edu/almanac/ Engineering Teaching Awards Veterinary Teaching Awards On Human Gene Therapy The University is taking a

The Institutional Review Board (IRB) will review the HGT project and, in keeping with its prior commitment to transparency in oversight, will conduct an annual audit of the University's clinical trial grant reviewers, particularly to insure the independence and professionalism of reviewers working with the projects and ensure compliance with the requirements of HIS's principles. The University is also clarifying the conditions for the appointment of additional researchers to support animal studies involving HIS projects and will increase its oversight of HGT researchers who have been appointed to positions with the NIH. The UPI Center for Investigative Reporting submitted these details this week to request an additional 2.2 million for the Center's budget from the federal government to cover the costs of these changes. University officials declined the request, claiming that they could not afford all the costs of the changes without sacrificing the quality of their research training programs. The Center continues to file Freedom of Information Act (FOIA) request through the UPI. The Center requested that “the federal government take a substantial step towards addressing the problem by providing, to the maximum extent possible, funding for HGT research to the U.S. National Institutes of Health (NIH). This effort should include: — a full audit and audit reporting of the grant reviews completed by UPI reviewers between 1995 and the present; — all UPI grant reviewers who have worked with HGT researchers; — all other scientists employed at Penn to work with or review HGT research; and — an oversight review of all U.S. agencies that do research with human subjects.” UPI officials reported that they received a response from NIH officials stating that their review of the matter in the last two years yielded no actionable recommendations. In any case, the Center's efforts to have the National Institutes of Health address the issue through its grant review and oversight committee process fell on deaf ears. The Center sent an open letter to Penn Vice President John Rife, Secretary of the FDA and Secretary of the Department of Health and Human Services, asserting that HGT projects should not be conducted for the purpose of obtaining “the highest quality possible human embryonic tissue.” The Center requested that Penn cease HGT research. The University's decision to stop accepting grants from the NIH has been largely the result of a dispute over the University's position on human gene therapy, which has become a political football in the Philadelphia suburbs.

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