13 
Mr. Mitchell expressed the opinion that RAC possesses the firm grounding 
in the technology necessary to objectively apply ethical considerations to 
deliberations on proposals involving human genetic engineering. Dr. Harvin 
supported this view. Dr. Saginor expressed the belief that RAC should not 
allow fear and anxiety to dictate RAC's decisions on somatic cell therapy. 
Mr. Mitchell then introduced Dr. LeRoy Walters of the Center for Bioethics, 
the Kennedy Institute, Georgetown University. Dr. Walters was a member of 
the working group. 
Dr. Walters said the working group recommendations are based on several 
conclusions. These are: (1) there is currently no other national body 
comparable to the RAC that deals with ethical issues in the biomedical 
field; (2) RAC's expertise should be supplemented by adding experts in the 
area of research involving human subjects; existing Federal regulations 
regarding human subjects could be applied without the need to devise an 
entirely new code of research ethics for the area of gene therapy; (3) the 
appropriate role for RAC would be to 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 Institu- 
tional Review Boards (IRBs). 
Dr. Gottesman said that RAC has already implicitly included ethical 
considerations in its deliberations; the working group is suggesting that 
in the case of human experimentation the ethical considerations should be 
explicitly stated. She noted that the primary goal of IRBs is to protect 
the individual patient; there is currently no mechanism for evaluating the 
effect on the broader community of procedures involving use of recombinant 
DNA in humans. 
Dr. McGarrity asked about the status of legislation to establish a presi- 
dential commission for oversight of genetic engineering in nan. Dr. Gartland 
replied that Representative Albert Gore's (D-Tenn) bill to establish a 
Genetic Engineering Commission is now attached as an amendment to Represen- 
tative Henry Waxman's (D-Cal) bill for the general reauthorization of the 
NIH. Tb date, this bill has not passed the House and no bill regarding such 
a Commission has been introduced in the Senate. Mr. Mitchell said such a 
Genetic Engineering Commission would probably deal with global issues 
ra tlier than the specific issues of individual research projects. Dr. Walters 
agreed and suggested the RAC and a commission would fill complementary 
functions. 
Dr. Gottesman moved acceptance of the working group recommendations, and 
agreement that RAC will review such proposals when they come before it. By 
a vote of thirteen in favor, none opposed, and no abstentions the motion 
was carried. 
[197] 
