The NIH “Points to Consider” and the Limits of Human Gene Therapy

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Abstract
In this essay, I examine the sources and reach of the NIH “Points to Consider.” These guidelines are based on normative considerations inherited from two sets of science policy deliberations that took place in the United States during the 1970s: the discussion of research with human subjects and the recombinant DNA debate. The combined lessons of those deliberations provide six criteria by which to evaluate human gene therapy proposals. While these criteria could be used to reject proposals to attempt germ-line gene therapy or enhancement engineering today, they provide no principled basis for publicly proscribing the development of these forms of genetic intervention. Instead, they will ultimately lead us to approach the moral limits of gene therapy as a professional policy question about the goals of medicine, rather than as a social policy question about the public good. The Points to Consider document (see Hum. Gene Ther. 1, 93–102, 185–189) was written in the mid 1980s to provide guidance in the review of human gene therapy clinical protocols. It has stood the test of time well. Juengst examines this document, and analyzes the historical roots that influenced its creation and content and the framework it provides in reviewing gene therapy protocols. He then reflects on the directions that policy/ethical discussions are likely to go.