3 
"Vie, therefore, recommend that: 
"1. The membership of the RAC be modified to include adequate 
representation to deal credibly with these issues. 
"2. Procedures should be developed for the coordinate consider- 
ation of experiments involving the use of recombinant DNA 
technology in humans by Institutional Review Boards (IRBs), 
the Office of Protection from Research Risks (OPRR), the 
Food and Drug Administration (FDA), Institutional Biosafety 
Committees (IBCs), the Office of Recombinant DNA Activities 
(ORDA), and the Recombinant DNA Advisory Committee (RAC). 
"3. The NIH Guidelines for Research Involving Recombinant 
DNA Molecules should be reviewed for their adequacy and 
clarity in dealing with human experimentation. 
"We recognize that the issues which will be dealt with by the RAC 
represent only some of the social and ethical issues associated 
with the applications of genetic and biomedical technologies. In 
addition, we believe that the general oversight function needed for 
these broader issues is not easily combined with the RAC's role in 
setting Guidelines and reviewing specific experiments. The expertise 
and experience of the RAC will be available to bodies which may 
exercise oversight of the broader issues. We expect continuing national 
discussion to lend new insight in dealing with the specific cases to 
be considered by RAC." 
The RAC discussed this proposal at its September 19, 1983, meeting. It was 
noted that the recommendation was based on several premises. These are: (1) 
there is currently no other national body that deals with ethical issues in 
the biomedical field; (2) RAC's expertise could be supplemented by adding 
experts in the ethical issues of using human subjects; and (3) RAC would review 
proposals on a case-by-case basis in response to investigator-initiated research. 
RAC's review would supplement review by Institutional Biosafety Committees (IBCs) 
and Institutional Review Boards (IRBs). The RAC unanimously accepted the 
working group's recommendation. 
Mr. Mitchell said RAC requested the Working Group on Social and Ethical Issues 
at its December 13, 1983, to discuss questions such as whether the language of 
the Guidelines as currently written is adequate, or how review procedures 
would function. 
Rosalind Gray of the Division of Legislative Analysis at the NIH said the 
House of Representatives in its closing hours before recess had passed major 
legislation concerning the NIH. That bill is an amalgamation of earlier 
versions of bills concerning the NIH. This compromise legislation contains an 
amendment to create a "President's Commission on the Human Application of 
Genetic Engineering." The proposal, originally sponsored by Albert Gore, Jr. 
(D-Tenn), would establish a 15 member panel to monitor developments in this 
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