intervention or for the use of genetic means to enhance human 
capabilities rather than to correct defects in patients, the sub- 
committee does not believe that these effects will follow immediately 
or inevitably from experiments with somatic-cell gene therapy. 
The subcommittee will cooperate with other groups in assessing the 
possible long-term consequences of somatic-cell gene therapy and 
related laboratory and animal experiments in order to define appro- 
priate human applications of this emerging technology.' 
"2. The CRH has also urged the Recombinant Advisory Caimittee (RAC) and 
the National Institutes of Health (NIH) not to review or approve any in 
vitro recombinant DMA experiments that alter human germ line cells or 
early human anbryos. The subcommittee understands that human germ line 
cells would be covered by provisions for cells in tissue culture in the 
NIH Guidelines for Research Involving Recombinant CNA Molecules, and 
that Federal support for human enbryo research is precluded by statute. 
fFxecutive Secretary's Note: Subsequent to the meeting the final clause 
of this point was modified to read as follow^ "that HHS support fot 
reseach involving human in vitro fertilization is precluded by regulation 
unless reviewed by an Ethical Advisory Board which must render advice 
as to the acceptability of the procedure.") 
"3. The subcommittee shares with the CRG a belief in the need for continued 
broad, public discussion of these issues, and we believe that the RAC 
and the subcarmittee provide appropriate forums for such discussion. 
"4. Because specific proposals for research can provide a helpful impetus 
for, and illumination of, the discussion of general policy about gene 
therapy, we believe that the contribution of the RAC and the subcommittee 
to the public discussion would be detrimentally affected by the prohi- 
bition suggested by the CRG on the RAC reviewing proposals for certain 
types of gene therapy. Furthermore, the suggested limitations would 
diminish the flexibility that is one of the strengths of the RAC's 
functions of providing advice. 
"5. With respect to human germ line cells and anbryos, this subcommittee 
has not specif ically addressed the complex issues involved but expresses 
its concern that the CRG recommendation would impede research and 
clinical advance in human reproductive biology. 
"6. The subcommittee plans to inform the public of its stand on these and 
other issues. 
"7. For the above reasons, the subcommittee recommends no change in the NIH 
Guidelines with regard to the issues raised by the CRG." 
The subconmittee adopted this statenent and recommendation by a vote of eight 
in favor, none opposed, and no abstentions. This document is to be considered 
by the RAC at its meeting on September 29, 1986. 
Recombinant DNA Research, Volume 1 1 
[39] 
