2 
The Chairman, Mr. Mitchell, called the meeting of the Working Group for Devel- 
opment of Response to President's Commission's Report on Ethical and Social 
Issues to order at 9:00 a.m. , June 24, 1983. He said that at its April 11 
meeting the Recombinant CNA 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 by the 
President's Commission for the Study of Ethical Problems in Medicine and Bio- 
medical and Behavioral Research. He said the Working Group for Development of 
Response was instituted in response to the RAC directive. 
Mr. Mitchell called on Ms. Janet Sobell of the Division of Legislative Analysis 
at the National Institutes of Health (NIH) to review the situation regarding 
legislation and genetic engineering. Ms. Sobell said a bill (H.R. 2788) intro- 
duced by Representative Albert Gore (D-Tenn) to create a commission for over- 
sight of human genetic engineering (Attachment II) had been amended to the NIH 
reauthorization bill (H.R. 2350) which has been cleared by committee and is 
awaiting action on the floor. All indications suggest that the bill will most 
likely be passed by the House. In the Senate, the NIH reauthorization bill 
(S. 77) is pending floor action. S. 77 does not contain a provision to create 
an oversight commission. Should H.R. 2350 and S. 77 pass as written, a con- 
ference committee will meet to develop compromise legislation. At this time, 
the probability that Mr. Gore's proposed commission will be accepted in com- 
promise legislation is good. 
[Ms. Sobell noted that Representative Gore had held hearings on June 22, 1983, 
concerning dissemination of genetically engineered organisms in the environment. 
The hearing produced testimony that currently there are no methods for estima- 
ting the risks of disseminating novel organisms. The Congressional panel 
appeared to feel more risk assessment was needed.] 
Dr. Nightingale reported that she had participated in the June 2 Institute of 
Medicine (National Academy of Sciences) workshop on the desirability of crea- 
ting an ethics commission. She said participants in this workshop appeared to 
support the establishment of a commission for oversight of ethical issues in 
medicine. 
Dr. Gartland noted that the Department of Health and Human Services (HHS) had 
at one time an Ethics Advisory Board. He asked Dr. Charles McCarthy of the NIH 
Office for Protection from Research Risks (OPRR) for information on the status 
of that board. Dr. McCarthy said that HHS regulations specify an Ethics 
Advisory Board. Such a board was instituted by former Secretary Califano, but 
terminated in September 1980. Although technically required, that board has 
not been reactivated. 
Dr. McCarthy said that in general presidential commissions have been construc- 
tive as they have had "action forcing" clauses; the departments are forced to 
act or to explain why no action has been taken. He said the President's 
Commission for the Study of Ethical Problems in Medicine and Biomedical and 
Behavioral Research offered recommendations rather than directives. 
[163] 
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