Regulatory issues for clinical gene therapy trials.
Gene therapy trials are among the most heavily regulated clinical trials. In this review, the basic tenets of human subject research are discussed in the context of the regulatory bodies which oversee this work. The challenges faced by academic research are outlined, including new and proposed regulations which impact human gene therapy investigators.
Cornetta
Kenneth
K
Departments of Medicine, Microbiology and Immunology, and Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN 46202, USA. kcornett@iupui.edu
Smith
Franklin O
FO
D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D015316:Genetic Therapy / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D009316:National Institutes of Health (U.S.); D014481:United States; D014486:United States Food and Drug Administration