The FDA's proposal for public disclosure of adverse events in gene therapy trials.
In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials.
Department of Philosophy, Kent State University, P.O. Box 5190, Kent, OH 44242-0001, USA. dbarnbau@kent.edu
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D000818:Animals; D002986:Clinical Trials as Topic / Q000009:adverse effects* / Q000331:legislation & jurisprudence*; D003256:Community Participation; D030881:Disclosure / Q000592:standards*; D005190:Family; D030661:Genetic Privacy; D036281:Genetic Research / Q000941:ethics; D015316:Genetic Therapy / Q000009:adverse effects* / Q000331:legislation & jurisprudence*; D005854:Germ Cells; D033161:Government Regulation; D006126:Group Processes; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D011634:Public Health; D012306:Risk; D014183:Transplantation, Heterologous / Q000009:adverse effects* / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration