The death of University of Pennsylvania gene therapy patient Jesse Gelsinger continues to have implications for Penn's Institute for Human Gene Therapy (IHGT) and for Health and Human Services (HHS) policy in general. Based on recommendations of a six-member independent panel led by William H. Danforth, chancellor emeritus of Washington University in St. Louis, Penn recently announced a restructuring of the IHGT. A day earlier, HHS Secretary Donna E. Shalala had announced new protections for human subjects.
Among the changes at Penn: a new special gene therapy institutional review board (IRB), a review of the IRB system, review by a contract research firm of all current clinical trials at Penn that have no external sponsorship, and a review of conflict-of-interest issues related to researchers' ties to industry. Perhaps the biggest planned change will be a shift of the institute's focus to preclinical animal experiments and molecular and cellular work. To ...
