title: Debates, divisions, and decisions: recombinant DNA advisory committee (RAC) authorization of the first human gene transfer experiments.
abstract: Possibly the most far-reaching, controversial research currently being conducted in the international biological science community involves human gene therapy experimentation. In this paper, I report the dynamics of the political process which ultimately found the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health approving for the first time protocols of this genre. A full appreciation of the policy-making dialogue shows that significant participants perceived the process from very different vantage points regarding the way in which the American political system works and the way in which it ought to work. I argue that, if we are to understand how the RAC should proceed in orchestrating a human gene therapy policy agenda, then we must flesh out and critically analyze these competing vantage points. To that end, I postulate seven possible "action models" for characterizing how protocol assessments of the type at issue might be developed given the nature of our politics, reaching the conclusion that one of these models holds out the most promise for synthesizing efficaciously the key factors involved. In conclusion, I discuss how the RAC might profitably employ this preferred strategy in these and other cases.
authors.affiliation: Department of Political Science, University of Illinois, Urbana 61801-3696.
authors.forename: I H
authors.initials: IH
authors.lastname: Carmen
mesh_terms: D026683:Advisory Committees; D035843:Biomedical Research; D032921:Consensus; D018864:Cultural Diversity; D004274:DNA, Recombinant; D026724:Ethical Review; D004992:Ethics, Medical; D035082:Federal Government; D030342:Genetic Diseases, Inborn; D015316:Genetic Therapy / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D033183:Interdisciplinary Communication; D033222:Judicial Role; D009316:National Institutes of Health (U.S.); D033281:Nontherapeutic Human Experimentation; D018570:Risk Assessment; D012926:Social Control, Formal; D012941:Social Responsibility; D012945:Social Values; D036302:Therapeutic Human Experimentation; D014162:Transfection; D014481:United States
chemical_list: D004274:DNA, Recombinant