5 
5. Are there areas of biotechnology which RAC should review, but for which 
the Guidelines as written do not mandate review? Could and should the RAC 
mandate be expanded? 
6. Can a "checklist" of issues be developed for these types of experiments? 
7. What types of consequences should be the primary emphasis of the review? 
8. Does RAC as it is currently constituted have sufficient credibility to 
perform such a review? 
Mr. Mitchell felt the group reviewing social and ethical issues in biomedicine 
must possess sufficient technical expertise to evaluate the proposal in a 
scientific as well as ethical context. 
Dr. Walters offered a proposal for discussion. He proposed that: 
1. A working group be established with the mandate of advising RAC. 
2. The working group be composed of nine members (including the chair) with 
equal biomedical and lay representation (e.g., specialists in bioethics 
and law ) . 
3. The working group would use available human research guidelines and sources 
such as "Splicing Life," OPRR- guidelines, etc., rather than developing 
specific guidelines. 
Dr. Walters said the proposed working group would review and structure proposals; 
RAC will continue to fill its role in reviewing and recommending such proposals. 
Dr. Gottesman asked if the proposed working group would perform the same 
functions as IRBs. Dr. Fletcher pointed out that IRBs do not discuss long 
range consequences of research, indeed the Code of Federal Regulations (45 CFR 
46) regarding protection of human subjects explictly states that IRB review is 
to focus on the individual human subject and his rights. Dr. Fletcher said a 
RAC working group on this issue could provide a forum for discussing long term 
consequences to society. The IRB should, however, first review the proposal 
to assure protection of the human subjects; a working group would then review 
the proposal for the consequences to society. 
Dr. McGarrity stated his view that guidelines are necessary and should be 
developed by this proposed working group. Dr. Harvin disagreed. Dr. Harris 
thought the issues with which a working group will contend will be influenced by 
societal demands, perceptions, etc. Demands and perceptions may evolve. For 
this reason, she thought proposals will have to be evaluated on a case-by-case 
basis. She pointed out that RAC's mandate will be limited; and RAC cannot 
address all the issues in the biomedical field. A working group might be a 
temporary partial solution. Dr. Nightingale thought the working group should 
have sufficient expertise to credibly review the proposals and agreed that 
the working group should not be permanent. 
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