5 
RAC in the "moral" areas. Cr. Harris said this is because RAC has restricted 
its scope of responsibility; RAC has generally declined to consider explicitly 
ethical and social issues in its deliberations. She felt that social goals 
ard oversight can be achieved within the existing structure (RAC, IBCs, and 
IRBs). She said she personally was biased against separating ethical considera- 
tions from scientific considerations; issues must be evaluated within a context, 
and the context in genetic engineering discussions is a scientific one. 
Dr. Miller of the FDA questioned whether a "blurring" between oversight and 
regulation was occurring in RAC. He pointed out that regulation was FDA's 
domain. Dr. Harris replied that aspects of a proposal such as Dr. Martin's 
might appropriately be evaluated by FDA, but she felt the public might have 
fears which would be more appropriately dealt with by a committee such as RAC. 
Dr. Gottesman said the difficult ethical issues are just beginning to arise. 
She asked Dr. Walters if the system in place is adequate to handle really 
difficult issues. Dr. Walters replied that a case-by-case review approach would 
of necessity be followed. He did not perceive a need for an additional over- 
sight body at this time. He felt, however, that more research in the ethical 
and social questions was needed. Dr. Gottesman agreed that, in a practical 
sense, a case-by-case evaluation system would arise and that this was appro- 
priate. She questioned whether everyone would accept the report "Splicing 
Life" as a standard. She suggested RAC might consider the adequacy of the 
report. Is this report consistent with the general view? Is it adequate to 
cover most questions? 
Cr. Nightingale presented her view that two committees are necessary. She 
agreed that RAC might oversee human genetic engineering but pointed out that 
other topical issues, such as use of reproductive technologies, mood control 
technology etc., are not part of RAC's mandate. RAC, on the other hand, is and 
has been dealing with issues far afield frcm human applications, e.g., engineer- 
ing of plants. Dr. Nightingale expressed her belief that RAC and a second 
commission could interact in the area of overlapping responsibility. 
Dr. John Fletcher of the NIH Clinical Center felt RAC cannot reassure the public 
on all the issues associated with applications of novel biomedical technologies. 
He agreed that RAC has tremendous credibility in the scientific camminity and 
felt RAC should continue to review specific proposals with scientific applica- 
tions. He felt, however, that RAC was not an appropriate body for overseeing 
the social implications of applied genetics. He thought RAC, as an advisory 
group of the largest funder of biomedical research, would be vulnerable to 
charges of favoring the scientific community or of wanting to move quickly. 
He said a presidential commission would report to the President and Congress 
and would not be vulnerable to these charges. 
Dr. Harvin disagreed. He thought the scientists performing the work should 
have some responsibility in overseeing it. He did not think total responsi- 
bility should be assigned to individuals who do not deal with the science. He 
said RAC need not be located in the NIH. Dr. Miller felt RAC gained frcm its 
association with the NIH. 
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