JOHN C. FLETCHER 
ETHICAL ISSUES IN AND BEYOND PROSPECTIVE 
CLINICAL TRIALS OF HUMAN GENE THERAPY 
ABSTRACT. A* the potential for the First human trials of somatic cell gene 
therapy nears, two ethical issues are examined: (1) problems of moral choice for 
members of institutional review boards who consider the first protocols, for 
parents, and for the clinical researchers, and the special protections that may be 
required for the infants and children to be involved, and (2) ethical objections 
to somatic cell therapy made by those concerned about a putative inevitable 
progression of genetic knowledge from therapy to mass genetic engineering in 
human reproduction. The author's viewpoint is that a consensus exists on the 
required moral approach to somatic cell therapy, but that no moral approach 
yet exists for experiments beyond this level, especially in the germline cells of 
human beings. 
Key Words: gene therapy, somatic cells, germ cells, institutional review boards, 
genetic engineering. 
This paper concentrates on two ethical issues in prospective human 
trials of gene therapy: 
(1) Problems of moral choice in the first human trials of somatic 
cell gene therapy, and 
(2) Ethical objections to human gene therapy and to some of its 
implications. 
BACKGROUND 
Protocols for trials of human gene therapy will likely be considered 
within the next year by institutional review boards (IRBs) and a 
nationally-situated review body of the Recombinant Advisory Com- 
mittee (RAC) of the National Institutes of Health (NIH) (Fox, 1984; 
John C Fletcher, Ph.D., Assistant for Bioethics, Warren C. Magnuson, Clinical Center, 
National Institutes of Health, Bethesda, HD 2020S, U.S.A. 
The Journal of Hedicine and Philosophy 10 (1985) 293—309. 0360—5310/85.10 
C 1985 by D. Reidel Publishing Company. 
Recombinant DNA Research, Volume 12 
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