Abstract
The U.S. Food and Drug Administration (FDA) has begun proceedings that could disqualify gene therapy researcher James Wilson of the University of Pennsylvania in Philadelphia from conducting any future clinical trials. Wilson, who is head of the university9s Institute for Human Gene Therapy, oversaw the trial in which 18-year-old Jesse Gelsinger died after a genetically altered virus was injected into his liver. Disqualification is the harshest penalty the FDA can impose on an investigator.