Cmte. calls for increased oversight

Researchers working with human subjects are affected by the preliminary recommendations. Midway through its ongoing review process, a provost-led committee investigating Penn's human research protocols will submit to University President Judith Rodin today a list of procedural, interim recommendations aimed at more closely monitoring Penn's human research. In addition, the committee requested that a group from Penn's Center for Bioethics do a closer review of the University's Institutional Review Board system and that current Penn researchers be surveyed to provide the committee with feedback on the current review systems. The five recommendations include implementing external reviews of independent clinical research trials and the creation of an overarching formal code of standard operating procedures for all human research at the University. "I see these as mainly recommendations that will help us get to our conclusions," said Provost Robert Barchi, who chairs the 10-member internal committee of top administrators and faculty. "We are looking to receive the highest standards anywhere." Rodin, who is expected to approve the recommendations, charged the committee in January with reviewing Penn's procedures for using human test subjects as the scandal surrounding a controversial death in Penn's gene therapy program began to mushroom. The committee, which has been meeting regularly over the past few months, initially anticipated submitting its final recommendations by the end of this semester. But Barchi now says the committee needs more time to complete its investigation before releasing its findings, now slated to occur next fall. The internal University committee has been working in parallel with an external committee of experts charged with reviewing the research practices of Penn's Institute for Human Gene Therapy. That group was formed by Rodin after the U.S. Food and Drug Administration put on hold all Penn gene therapy experiments four months after the highly publicized death of 18-year-old Jesse Gelsinger, who was participating in an IHGT clinical study. The FDA claims that IHGT researchers violated various research protocols during the trial. Penn officials said, however, that the internal committee was not formed as a direct result of Gelsinger's death but as part of a regular review of Penn's research practices. Of the committee's five recommendations, the most substantial one calls for providing an external review group to oversee the clinical drug trials that Penn sponsors independently. About 15 percent of Penn's clinical drug trials -- including the study in which Gelsinger participated -- are sponsored mainly by the University itself, leaving no formal external oversight. The remaining 85 percent of Penn's pharmaceutical research is sponsored by drug companies or the National Institutes of Health. NIH-funded studies require their own review committees to ensure that the investigators follow separate, strict protocols. The committee also recommended that members of the Center for Bioethics conduct a formal review of the University's Institutional Review Board system -- a series of internal committees that must approve all research involving human subjects before actual experiments start. Using a site-based benchmark study, developed by Penn's Center for Bioethics and used by large research organizations like the RAND Corporation, the group will compare how Penn's research procedures stack up to peer institutions. The committee also called for Penn to develop a code of standard operating procedures, formally stating protocol that University investigators have traditionally followed. The procedures will provide general guidelines for human research, such as rules for obtaining informed consent. It also recommended that Penn investigators be required to formally disclose any proprietary interest in a product or procedure on all research proposals to the IRB. This would serve as an extension of the practice currently overseen by University department chairmen and deans. The final recommendation will primarily serve to aid the internal committee in its investigation. A Web-based survey will be conducted among all Penn investigators involved in human research, providing the committee with feedback about how to improve the IRB and the human-subject protocol review process. "The committee has decided that it better get more information from the investigator's point-of-view," said School of Arts and Sciences Dean Samuel Preston, a member of the committee. The external review committee investigating the IHGT -- headed by William Danforth, chancellor emeritus at Washington University in St. Louis -- has come to campus several times to interview administrators and researchers. It is expected to submit a final report within the next month.