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COMMITTEE FOR RESPONSIBLE GENETICS 
Advisory Board 
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‘Ctacutita Council 
Nachama L. WHhar 
Eracwlita Oiractor 
Proposed Addition to the end of Section III-A-4 of the NIH 
Guidelines on Recombinant DNA Molecules. 
The RAC will not review and the NIH will not approve any 
human genetic therapy: 
1. that is not aimed 6olely at the relief of a life- 
threatening or severely disabling condition; or 
2. that could alter germ line cells. 
Furthermore, the RAC will not review and the NIH will not approve 
any in vitro, recombinant DNA experiments that alter human germ 
line cells or early human embryos. 
Rationale 
This addition to the NIH Guidelines is proposed in order to 
place a clear statement in the public record describing NIH's policy 
on experiments in human genetic engineering. The published "Points 
to Consider in the Design and Submission of Human Somatic-Cell Therapy 
Protocols" define a process for reviewing protocols but set no 
limitations and place no boundaries on human gene therapy experiments 
and on research on human germ line cells. This proposal is designed 
to give assurance to the public that, by opening up possibilities 
of human genetic engineering in areas where there is wide social 
consensus or, at least, no strong public opposition, the technology 
will not be applied to other situations where adequate public debate 
has not taken place. 
1. Somatic Cell Therapy for the Treatment of Disease 
Medical technologies that have initially been developed with 
governmental approval for specific purposes are easily adapted to 
other circumstances without commensurate accountability, once public 
attention and debate have waned. In our present socioeconomic 
environment, there are 6trong professional and business motivations 
for increasing the application of medical technologies. 
Human somatic cell gene therapy (HSCT) is currently being 
considered for use in life-threatening diseases. An American 
scientist already has carried out such experiments outside the 
United States. But the potential range of applications of HSCT 
Recombinant DNA Research, Volume 1 1 
[69] 
