Human gene therapy and congress.
Congress was the scene of conspicuous debate about human gene therapy during the 1980s. Congressional interest was sparked primarily by concerns about germ-line gene therapy expressed by clerics and public interest groups. The initial debate was provoked by Martin Cline's misadventures in 1980 and rekindled in 1983 by congressional resolution against germ-line intervention sponsored by Senator Mark Hatfield. The first hearing on gene therapy was held upon the release of the President's Commission report Splicing Life, in November, 1982, before a House subcommittee chaired by Congressman Albert Gore, Jr. Representative Gore later requested a report on gene therapy, which was released by the Office of Technology Assessment in December, 1984. He also sponsored the legislation that established the Biomedical Ethics Board and Biomedical Ethics Advisory Committee, Congress's abortive attempt to reestablish a federal bioethics commission. Implications of advances in human genetics, including gene therapy, were to be among the first topics addressed. Congress passed no substantive legislation affecting gene therapy research or clinical trials, but served principally as a national theater for debate. If and when germ-line gene therapy is contemplated, Congress will be faced with difficult choices, but will likely take no action to block trials that appear safe and are intended to produce clinical benefit for particular individuals.
Cook-Deegan
R M
RM
Kennedy Institute of Ethics, Georgetown University.
D026683:Advisory Committees; D002985:Clinical Protocols; D026724:Ethical Review; D004992:Ethics, Medical; D035082:Federal Government; D015316:Genetic Therapy / Q000331:legislation & jurisprudence*; D006076:Government; D033161:Government Regulation; D006801:Humans; D009316:National Institutes of Health (U.S.); D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration; D014491:United States Office of Technology Assessment