2 
Mr. Mitchell, the Chair, called the meeting of the Working Group on Social and 
Ethical Issues (formerly the Working Group for Development of Response to 
President's Commission's Report on Ethical and Social Issues) to order at 10.15 
a. in. , December 13, 1983. He began by summarizing the history of RAC s recommen- 
dation to consider ethical, legal, and social implications of genetic engineering 
in humans. 
At its April 11, 1983, meeting, the Recombinant ENA Advisory Committee (RAC) 
endorsed a proposal to form a working group to comment and report to RAC on the 
"Report on the Social and Ethical Issues of Genetic Engineering with Human 
Beings" issued in November 1982 by the President's Commission for the Study of 
Ethical Problems in Medicine and Biomedical and Behavioral Research. 
The President's Commission report entitled "Splicing Life" suggested continuing 
oversight of the field of genetic engineering is desirable and outlined three 
possible oversight mechanisms. 
1. Build on the successful history of the RAC. The composition of RAC could 
be modified to that of a public-private sector body such as those that 
have operated in other areas. The Federal Interagency Committee on Recom- 
binant DNA could be reactivated. 
2. Create a Genetic Engineering Ccmmission of 11 to 15 members from outside 
the government which could meet regularly to deal 9olely with this field. 
This group could have a majority of nonscientists and draw on a series 
of technical panels to provide expertise in laboratory research, agriculture, 
manufacturing, medicine, government, and international issues. 
3. Activate a President's Commission to oversee important developments in the 
biomedical arena. Oversight of genetic engineering could be integrated 
into the consideration given other biomedical areas. In this case, however, 
limited attention would be given to issues such as agriculture and patenting 
questions. 
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 agreed, unanimously, to forward the following recommendation to 
RAC to be considered at the September 19, 1983, RAC 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 
ENA 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 
Ccmmission for the Study of Ethical Problems in Medicine and 
Biomedical and Behavioral Research. 
[21ft] 
