9 
"The requirement for RAC review should not be considered to preempt 
any other required review of experiments with human subjects. IRB 
review of the proposal should be completed before submission to NIH." 
Dr. Walters asked that a footnote also be added to Section III-B-4-b since humans 
might be considered animals. Dr. Gottesman suggested the following footnote: 
"For recombinant DNA experiments involving human subjects, see Section 
III-A-4. " 
Dr. McGarrity moved that a resolution endorsing the reinstitution of the HHS 
Ethics Advisory Board be sent to RAC. Dr. Littlefield felt he could not support 
this motion. He thought the Working Group on Social and Ethical Issues might 
welcome reinstitution of the HHS Ethics Advisory Board but not demand it. 
Dr. Gottesman pointed out that the Ethics Advisory Board might not function 
as the Working Group on Social and Ethical Issues anticipates. Dr. Harvin felt 
that such a resolution would imply criticism of HHS; thus, he said he would 
not support it. Dr. Walters pointed out that a similar discussion had occurred 
at the June 24, 1983, meeting of the Working Group for Development of Response; 
at that meeting no resolution was adopted. Dr. Harvin suggested that if some 
statement is to be sent to RAC the following language might be more appropriate: 
"We would feel the implementation of the functions of the Ethics 
Advisory Board would be supportive of efforts to address moral 
and ethical problems in medicine." 
Dr. McGarrity agreed to this substitute language. This language was carried 
by a voice vote. 
Dr. Nightingale said that although she had supported the statement, she felt 
the working group had not sufficiently thought through this issue. She noted 
that other groups such as a President's Commission or an Institute of Medicine 
group of the National Academy of Science might also be endorsed. She thought 
the Working Group on Social and Ethical Issues might explain its support for 
reinstitution of the Ethics Advisory Board by the fact it itself is a HHS 
working group. 
Mr. Mitchell asked how the proposed RAC working group might be constituted. 
He noted that Dr. Walters had earlier suggested equal numbers of scientists and 
lay members be appointed to the working group. Dr. Walters suggested individuals 
with expertise in basic science, clinical medicine, law, and ethics might be 
appointed to the working group. Dr. Harvin suggested that no specific composi- 
tion be designated; rather ORDA might appoint members as the need arises. 
Dr. Milewski indicated that in most instances the RAC chair in consultation 
with ORDA appoints working group members. Dr. Walters asked if a total of 9 
members including the chair was a reasonable size. The working group agreed 
that 9 members would supply adequate expertise. 
Mr. Mitchell asked if the proposed working group should develop and institute 
guidelines. Drs. Gottesman, Harvin, Harris, and Walters thought a case-by-case 
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