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The University of Pennsylvania School of Medicine, responding to a crisis in confidence in its genetic research practices, is about to unleash wholesale changes in the way it monitors human research studies at its campus.
Among the biggest changes: the formation of a new Office of Human Research to provide additional oversight of research studies.
Dr. Glen Gaulton, Penn medical school's vice dean for research, said the university is also planning to make greater use of outside contract research organizations (CROs) to oversee clinical trials of experimental treatments.
In addition, the university is placing new limits on the involvement of faculty members in drug studies who have an equity stake in companies sponsoring their research.
All the actions come a little more than two years after an Arizona teenager became the first patient in the nation to die while taking part in a gene therapy study, which was being conducted at Penn's Institute for Human Gene Therapy.
After the death of 18-year-old Jesse Gelsinger, the Food and Drug Administration halted all eight of the Institute's gene therapy trials. That suspension was never lifted by the FDA. According to a health system spokeswoman, Penn never requested that the hold be lifted and has no plans at this time to do so.
In May 2000, following the submission of a report by an independent panel that Penn brought in to review the monitoring of the Institute's clinical trials, Penn President Judith Rodin announced a series of steps the university intended to take to improve supervision of its human research studies.
The actions were not to be limited to gene therapy.
"Our feeling was any increase in the level of scrutiny should be applied to all individuals involved in human research," Gaulton said. "There is, a small minority of researchers who feel what we are doing is inappropriate, but institutionally we decided to do this. They can object, but this is the way it's going …