Ethical Issues in Gene Therapy 
more informative about whether or not human DNA sequences 
would be affected by a retroviral vector. 
The second objection proceeds from a social premise rather than 
from concern for the safety and welfare of the first subjects of re- 
search in gene therapy. Rifkin (1983) views gene therapy as the first 
in a series of what he sees as inevitable steps that will end in indis- 
criminate future genetic manipulation of human characteristics. 
Guidelines for institutional review of federally-supported research 
(Protection of Human Subjects, 1983, 46: 1 1 1(a) (2)) discourage the 
assessment of long-range effects of applying knowledge gained in 
the research under review. The guidelines apply to the role of the 
IRB itself but should not restrain 1RB members themselves from 
study of long-range implications of encouraging research in human 
gene therapy. Somatic cell therapy may open the possibility to treat 
genetic disease by altering the sex cells that transmit genetic dis- 
orders, or to knowledge of how to alter or enhance a feature of 
human physiology, such as short stature or the aging process. In light 
of potentially undesirable consequences of genetic manipulation 
(President’s Commission, 1982, p. 53), a rational response is needed 
to an argument that dangers exist because it would be impossible to 
'draw moral lines’ between medical and non-medical uses of genetic 
knowledge. 
PROBLEMS Or CHOICE IN HUMAN 
TRIALS OF GENE THERAPY 
A strong consensus in favor of somatic cell therapy exists within 
medicine and among authorities in religious and philosophical ethics 
(Friedmann, 1983, p. 114; U.S. Congress, 1982, p. 301; U.S. Con- 
gress, Office of Technology Assessment, 1984). Great human suffer- 
ing might be at least partially relieved and many benefits enjoyed by 
patients and their families, in the United States, about one in ten 
persons, more than twenty million persons, have genetic disorders. 
Between 25 and 30 percent of admissions to children’s hospitals 
are for treatment for genetic disorders (National Institute of Child 
Health and Human Development, 1982, p. v— 39). However, the same 
ethical principles that support gene therapy, beneficence and non- 
maleficence, are involved in considerations of the safety and efficacy 
of the first human trials. Possible conflicts between the interests of 
science, society, ind the research subjects pose problems of moral 
choice. 
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