Protecting human research subjects.

In early November, little more than a year after 18-year-old Jesse Gelsinger died in a gene-transfer trial at the University of Pennsylvania, his family reached an unspecified settlement with the research team and institutions involved in the experiment. Although the settlement with the university brought closure to the lawsuit, Gelsinger's death raised lingering concerns about the risks of clinical trials involving human subjects. Government investigations and hearings in the wake of the tragedy have led to greater scrutiny of how organizations conduct clinical trials and efforts to strengthen protections of human subjects. This well-intended scrutiny comes at a time when clinical trials are growing dramatically in number and complexity. This article outlines some of the emerging issues concerning human subject research as well as possible procedures for handling the associated risks.