Gene therapy in the post-Gelsinger era.
As gene therapy research races to a first cure of a genetic-based disease, the research community has struggled with the aftermath of the well-publicized death of Jesse Gelsinger from complications of an experimental treatment. In a wrongful death lawsuit against the University of Pennsylvania and its researchers, Jesse Gelsinger's family alleged violations of federal regulations and research ethics. This article reviews gene therapy research, examines the role of the key players in this tragedy, and provides suggestions for preventing future misfortunes.
Smith
Lynn
L
University of Central Florida, School of Nursing, Orlando 32816, USA. lcsmith@mail.ucf.edu
Byers
Jacqueline Fowler
JF
D000293:Adolescent; D028744:Ethics Committees, Research; D015316:Genetic Therapy / Q000009:adverse effects / Q000941:ethics* / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006708:Homicide; D006801:Humans; D007258:Informed Consent; D015143:Philadelphia; D036302:Therapeutic Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D014481:United States