Watching the Watchdogs: Negligence, Liability, And Research Ethics Boards‪.‬

Introduction Recent high profile incidents involving the death or injury of individuals participating in medical research projects have "shaken confidence in the protections afforded human subjects of biomedical research." (1) In 1999, 18 year old Jesse Gelsinger died while participating in a clinical trial conducted by the University of Pennsylvania Institute for Gene Therapy. Jesse suffered from a mild form of a rare metabolic disorder called ornithine transcarbamylase deficiency (OTC). The experiment involved the injection of genetic material into Jesse's bloodstream using a viral vector. This triggered multiple organ system failure, ultimately bringing about Jesse's untimely death. (2) It was later revealed that the investigator may have stood to benefit financially from this research. In the complaint filed by the Gelsinger family, it was alleged that the researchers involved had used a virus vector known to be more dangerous than other vectors, because they held patents on that particular virus. (3)