12 
In response to the RAC directive to evaluate the options presented in 
"Splicing Life," the Working Group for Development of Response to President's 
Commission's Report on Ethical and Social Issues met on June 24, 1983, at 
the NIH. 
The working group developed and agreed, unanimously, to forward the following 
recommendations to RAC to be considered at the September 19, 1983, meeting: 
"The Working Group agrees that there is a need for ongoing 
consideration of the ethical and social implications of the 
application of genetic technology to humans. Within this 
context, RAC should be prepared to consider social and 
ethical issues related to the applications of recombinant 
DNA technologies. For specific cases which come before the 
committee, RAC should consider explicitly issues such as 
those raised in the Splicing Life report of the President's 
Commission for the Study of Ethical Problems in Medicine 
and Biomedical and Behavioral Research. 
"We, 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 
consideration of experiments involving the use of 
recombinant DNA technology in humans by Institutional 
Review Boards (IRBs), the Office for 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 D1A Advisory Committee. 
"(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 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 iasight in dealing with 
the specific cases to be considered by RAC." 
[196] 
