Abstract

Pressure is mounting to hold researchers and research institutions accountable for the protection of human subjects. When subjects or their family members believe they have been injured, they are increasingly willing to file lawsuits. Recent cases indicate that institutional review boards and their members may be pulled more and more into the legal fray.On September 17, 1999, 18-year-old Jesse Gelsinger died while participating in research conducted by the University of Pennsylvania's Institute for Gene Therapy. Gelsinger was involved in a Phase I clinical trial testing a new approach to treatment of ornithine transcarbamylase deficiency, a rare metabolic disorder. Although infants affected by the severe form of OTC die shortly after birth, Gelsinger suffered from a relatively mild form. It appears undisputed that the cause of Gelsinger's death was not the disorder itself, but multiple organ system failure triggered by the virus used to carry new genetic material into his system.