9 
Review Board (IRB) to review research involving human subjects; this would 
include any research that might involve human genetic manipulations. 
Dr. McCarthy said IMIS is discussing reestablishing an ethics advisory 
board. Such a board existed from 1978 to 1980 and was advisory to the 
Secretary, DHEW (now CUHS). If reestablished, that board might review issues 
such as those discussed in the President's Commission report. Alternatively, 
RAC might be expanded or some interrelationship between an ethics board 
and RAC established. Dr. McCarthy added that Senator Kennedy said he 
would introduce legislation to reestablish a President's Commission. 
Dr. Nightingale informed the RAC that the Institute of Medicine of the 
National Academy of Sciences will be holding a meeting on June 2, 1983, to 
discuss the need for a new group to replace the President's Commission for 
the study of Ethical Problems in Medicine and Biomedical and Behavioral 
Research . 
Dr. Nightingale said ethical issues must be discussed in their proper 
context. In genetic engineering, the context is a technical context; the 
technical issues must be understood before the ethical issues can be discussed. 
She said the concept of two separate entities evaluating this issue was, 
therefore, troubling to her. She suggested that if two separate groups 
were instituted to provide oversight, these groups might be linked in 
some way. Dr. Harris concurred with Or. Nightingale's view. She favored 
having one group address all the issues; on the other hand, deliberative 
and regulatory functions are difficult to incorporate into one group. 
Dr. Miller of the Food & Drug Administration (FDA) argued that it is not 
necessary to establish a new regulatory entity. The RAC with its balance 
of scientific expertise and public representation has admirably met the 
challenges on the national level. The Institutional Biosafety Committees 
(IBCs) execute the dictums of the Guidelines at the local level. He pointed 
out that the IRBs have extensive experience with experimental protocols 
involving humans, and the ethics attendant to such studies. In addition, 
an array of regulatory agencies mandated by statute deal with both the 
process and the products of recombinant DNA experiments. The FDA, for 
example, will probably regulate the products and process of human gene 
therapy. Dr. Nightingale asked if Dr. Miller's statement was the official 
FDA position. Dr. Miller replied that the issue was discussed at the 
FDA National Center for Drugs and Biologies. 
Dr. Martin responded that ethical considerations in genetic engineering 
will not be limited to human issues. Agricultural and industrial issues 
will indirectly but quite profoundly affect human society. 
Dr. Gottesman felt the major issue facing RAC was to formulate an appro- 
priate response to the President's Commission report. She suggested two 
possible responses. As the PHS will publish the Commission's report for 
public comment, RAC members might comment individually. A second possibility 
is that RAC reply as a group. She suggested an informal poll might gauge 
RAC's sentiment on these two possibilities. If RAC decides to respond as 
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