U. reviews research procedures

Provost Barchi will head a new committee to study Penn's use of human subjects in research trials. A special committee chaired by Provost Robert Barchi was appointed last week to review Penn's procedures for using human subjects in research trials. The announcement comes four months after the highly publicized and controversial death of an 18-year-old man who was a subject in a gene-therapy experiment at Penn's Institute for Human Gene Therapy. The 10-member committee is designed to ensure that Penn's human research is of the "absolutely highest standards," Barchi said. Barchi said the formation of the new committee is not a direct result of Jesse Gelsinger's death last September, though he acknowledged that the incident showed the risks involved with human testing. "Jesse's death, of course, is a tremendous concern to us," he said. "This is something we would have been undertaking in any event." Various federal agencies are investigating Gelsinger's death. The Penn researchers behind the study have denied that they acted improperly. Barchi, a professor of neuroscience and neurology, said the University needs to examine its research practices. "We have an obligation to make sure that our research structure keeps up with our research enterprise," he said. Penn, like all universities that receive federal funds, is required to have an Institutional Review Board that must approve any human experiments before they begin. The University recently reviewed its procedures for testing on animals, Barchi noted, calling the human-subject review "a natural extension of that." He said the committee is not designed to find fault with past research at the University, but rather to evaluate how research is currently conducted and how procedures could be improved to meet the changing demands of scientific research in future years. "This is not an investigative committee," Barchi said. "It's a committee looking at how we operate right now." Vice Provost for Research Ralph Amado, a physics professor and committee member, said now is an "opportune time" to review the "remarkable growth of research at Penn." Amado said he was unaware of any such review of human testing at Penn in recent years, though he added that similar reviews have recently been conducted by other universities. Amado noted that Duke University had its new grants for medical research suspended by the federal government last year after investigators questioned the school's system of oversight for testing involving humans. He said Penn wanted to avoid the possibility that similar objections could be raised here in the future. Gelsinger's death is still under investigation by the University and federal authorities. Officials at the U.S. Food and Drug Administration have alleged that the Penn research team, led by IHGT Director James M. Wilson, committed serious misconduct by ignoring test results and reactions in early study participants and by withholding information from government regulators. The Penn research team has denied the government's allegation that human error caused Gelsinger's death. The Tucson, Ariz., native died several days after being injected with a high dosage of genes in an attempt to correct a disorder that prevented his body from properly ridding itself of ammonia. However, researchers have admitted some lapses in their work and publicly apologized for failing to properly communicate with government authorities. Nursing Professor and committee member Linda Aiken said the University is "thinking about things for the future" as a result of the tremendous growth of research funding and the "changing nature of science" in recent years. And Infectious Diseases Professor Harvey Friedman, another committee member, said it is an appropriate time for the University to conduct a review of human-subject research. "There's a tremendous amount of research support, from government and other research agencies, on campus," he said. "The complexities of patient research are such that it's always wise to review where we are and see if we can do things differently or better." Friedman said Gelsinger's death in the gene-therapy experiment last year was an "appropriate incentive" for the University to look at research procedures, but not the only reason for a review. "I think it made the University think about this issue in detail," he said, noting that investigating gene-therapy trials "is not the goal of this committee." Barchi said he hopes the group would complete its evaluation by the end of the current semester. The committee will then issue a report to University President Judith Rodin.