Dr. McCarthy noted that in the Cline case, the proposal describing the experi- 
ment was sent to the Institutional Review Board (IRB), the Institutional Bio- 
safety Committee (IBC), and the RAC for review. At that time, Cr. Fredrickson, 
former NIH Director, ruled the proposal had to be reviewed first by the IRB 
for the protection of the particular human subjects involved prior to RAC 
review. This issue was never resolved as Or. Cline left the country to perform 
his experiments. Dr. McCarthy noted that IRBs do not review protocols for their 
social consequences. 
Dr. Martin said his laboratory would soon submit a proposal involving somatic 
gene therapy with a human patient. He predicted the following course of events: 
the IRB will review the proposal, then the IBC will review it, and the IBC will 
subsequently solicit RAC's approval under Section III-A-2 of the Guidelines 
because of the release of reccmbinant ENA in the environment. 
Dr. Martin said he feared public response if RAC does not evaluate ethical 
issues in the use of recombinant ENA technology. He suggested that RAC might 
evaluate such proposals in the context of the President's Ccmmission report. 
He suggested RAC's composition might need to be altered to reflect this respon- 
sibility and to increase its credibility for review of ethical aspects. 
Dr. Walters thought it might be premature to develop another review body to deal 
with general medical issues, such as reproductive decisions or mood alteration 
technology. (Xaestions involving genetic engineering, which are the most imme- 
diate, can be handled by the system already in place. The system is composed 
of two national bodies, the RAC and OPRR, and two networks of local bodies, 
the IBCs and the IRBs. Ihe IRBs and OPPR are responsible for the well being 
of the human subjects; RAC could be responsible for the social and ethical 
issues. He thought this system adequate to raise issues and bring questions 
to public attention. He felt, however, that it is important to evaluate the 
RAC's composition, and perhaps appoint a few individuals with a background 
in dealing with public policy issues. 
Mr. Mitchell asked Dr. Martin if he had a preference concerning the type of 
group which would review his proposal to use gene therapy on a human patient. 
Dr. Martin replied that he would prefer RAC review the proposal. RAC has an 
excellent record and the scientific grounding to understand the proposal. He 
felt, however, that RAC must have public credibility as well as credibility in 
the scientific community. He suggested that appointment of an ethicist would 
increase RAC's credibility with the public. 
Dr. Harvin said any review committee must have the public's confidence. A 
review committee must demonstrate that it can make good decisions for the 
people. RAC has thus far maintained the public's confidence. He expressed 
his opinion that RAC is the best committee for review of ethical questions. 
He questioned the "big government” solution of forming a new committee for 
every issue. He felt the smaller the group, the better the decisions. 
Mr. Mitchell said the President's Ccmmission report implicitly trusts RAC's 
decisions in the scientific and technical areas, but does not appear to trust 
f 165] 
