6 
Mr. Mitchell said that if RAC is criticized, it is criticized for what it has 
not done (i.e., review proposals in an explicitly ethical context). What RAC 
has done, it has done well. He agreed that the scientists who perform the 
research must have confidence in the oversight group. If they do not, the 
public in time will learn of this, and public confidence in the oversight group 
will be eroded. 
Dr. Gottesman noted that RAC will be faced in the near future with a proposal 
involving human gene therapy and must react to that. She pointed out that 
RAC's expertise and experience are not relevant to other issues such as over- 
seeing use of reproductive technologies. RAC's experience is, however, relevant 
to consideration of human genetic engineering. If RAC is going to expand its 
purview to evaluate ethical considerations, she suggested several questions 
should be considered. These include: (1) What is the definition of "recombi- 
nant DNA?" She pointed out that had Dr. Cline cut the gene out of the vector, 
his proposal would not have been covered by the NIH Guidelines as currently 
written. Such a distinction may be specious, however. RAC could ask to evaluate 
all proposals involving human genetic engineering in which recombinant ENA 
technology is being applied. (2) Dr. Gottesman said that with four or five 
groups currently overseeing sane aspect of human genetic engineering (RAC, 
IRBs, IBCs, OPPR, and OREA) sane confusion will occur. Sane ordering of review 
procedures might be considered. (3) Finally, Dr. Gottesman suggested RAC 
must be explicit in stating its responsibilities, what it will consider, and 
how its decisions are reached. 
Dr. Gartland said same proposal's may involve proprietary information. Will 
RAC maintain its credibility if, on occasion, it functions in closed session? 
Dr. Martin thought it would, if its composition is credible. Mr. Mitchell 
thought RAC could publish the reasons for the decisions it might make in closed 
session, without disclosing proprietary information. Dr. Martin added that he 
cannot imagine a company wanting to develop gene therapy; there is no market 
for specific gene therapies at the present time. 
Dr. Harris said the establishment of a body to evaluate biomedical issues is 
not precluded by RAC evaluating social and ethical issues involved in human 
genetic engineering. She wondered whether RAC should address questions involv- 
ing the organization of an oversight commission. 
Dr. Nightingale suggested that a new oversight commission might be an "expert 
group" vhich could have technical panels. RAC might serve as a technical 
panel for the expert group. In that capacity, RAC could review issues on a 
case-by-case basis. The IRBs could also be "a technical panel" to the expert 
body. As certain IRB and IBC oversight issues overlap, a broad linkage to an 
"expert body" could clarify oversight responsibilities. Dr. Nightingale also 
suggested that when RAC renders a decision on a case-by-case basis, RAC could 
indicate what technical and safety issues it had evaluated; the questions which 
remain might then be evaluated by the "expert body" or by its other technical 
panels . 
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