Medical genetics : a legal frontier / by Lori B. Andrews.

  • Lori Andrews
Date:
1987
Catalogue details

Licence: Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)

Credit: Medical genetics : a legal frontier / by Lori B. Andrews. Source: Wellcome Collection.

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    277 Splicing Life, resulted from a two-year process of public deliberations and hearings; upon release of that report, a House subcommittee held three days of public hearings with witnesses from a wide range of fields from the biomedical and social sciences to theology, philosophy, and law. In December 1984, the Office of Technology Assessment released a background paper. Human Gene Therapy, which brought these earlier documents up-to-date. As the latter report concluded: Civic, religious, scientific, and medical groups have all accepted, in principle, the appropriateness of gene therapy of somatic cells in humans for specific genetic diseases. Somatic cell gene therapy is seen as an extension of present methods of therapy that might be preferable to other technologies. (9) Concurring with this judgment, the RAC and its working group are prepared to consider for approval somatic-cell therapy protocols, provided that the design of such experiments offers adequate assurance that their consequences will not go beyond their purpose, which is the same as the traditional рифозе of all clinical investigations, namely, to benefit the health and well- being of the individual being treated while at the same time gathering generalizable knowledge. (10) Two possible undesirable consequences of somatic-cell therapy would be unintentional ( 1 ) vertical transmission of genetic changes from an individual to his or her offspring or (2) horizontal transmission of viral infection to other persons with whom the individual comes in contact Accordingly, this document requests information that will enable the RAC and its working group to assess the likelihood that the proposed somatic-cell therapy will inadvertently affect reproductive cells or lead to infection of other people (e.g., treatment personnel or relatives). (11) In recognition of the social concern that surrounds the general discussion of human gene therapy, the working group will continue to consider the possible long-range effects of applying knowledge gained from these and related experiments. While research in molecular biology could lead to the development of techniques for germ line intervention or for the use of genetic means to enhance human capabilities rather than to correct defects in patients, the working group does not believe that these effects will follow immediately or inevitably from experiments with somatic-cell gene therapy. The working group will cooperate with other groups in assessing the possible long-term consequences of somatic-cell gene therapy and related laboratory and animal experiments in order to define appropriate human applications of this emerging technology. (12) Responses to the questions raised in these Points to Consider should be provided in the form of either written answers or references to specific sec¬ tions of the protocol or its appendices.
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