During a three-day expanded session of the US National Institutes of Health (NIH; Bethesda, MD) Recombinant DNA Advisory Committee (NIHRAC) in December, committee members and officials of NIH and the US Food and Drug Administration (FDA; Rockville, MD) seemed unable to resolve differences in adverse event reporting requirements with which gene therapy researchers are being asked to comply. This seemingly minor impasse belies more fundamental and far-reaching disagreements between some gene therapy researchers and federal officials overseeing this field—an unease that intensified following the death last September of 18-year old Jesse Gelsinger (Nature Biotechnol . 17, 1153). He was participating in a phase I gene therapy clinical trial at the University of Pennsylvania (Philadelphia, PA) to test an engineered version of an adenovirus vector carrying a gene intended to correct for the inherited disorder known as ornithine transcarbamylase deficiency. James Wilson and other members of the University of Pennsylvania team attribute Gelsinger's death to an acute respiratory system collapse and subsequent multiorgan failure.