Proposed amendment, human gene therapy 
is very broad. Cenes regulate numerous biochemical processes Including the 
production of hormones, enzymes and antibodies. Once human genetic engineering 
is established as a clinical treatment for some human disorders it is 
reasonable to expect, from past experience, that the research community will 
seek applications of gene therapy beyond the initial range of cases where some 
social consensus may have been reached. At the present time, beyond the applica- 
tions of HSCT to the treatment of life-threatening or severely disabling diseases, 
no justification has been offered for the contention that the potential 
benefits of such therapy will outweigh the risks to people and serve the 
general welfare. 
Committees like the RAC or Institutional Review Boards serve their social 
purpose after society has reached some consensus over broad policy issues. The 
burden of proof must be on those who wish to introduce a new technology. Once 
broad consensus is reached, the RAC and the IRBs can then implement those policies 
and, among other things, render decisions involving grey areas. To date, the 
prospect of applying HSCT to dread disease ha6 not drawn significant public 
opposition. Beyond 6uch uses, we begin to entir a range of controversial applica- 
tions about which there has not been adequate national debate. By stipulating 
the boundaries within which NIH will review HSCT protocols, acknowledgement is 
given to the limited nature of public discussion and consensus on the use of 
human genetic engineering. 
Arguments advanced for forbidding all uses of HSCT are based on the pre- 
diction that once we begin to accept any use of this technology, all uses are 
legitimized. Support for this thesis is nourished by past failures of our 
regulatory system to control applications of technology that have been extended 
beyond their ; initial public purpose in ways that transgress the boundaries 
of democratic control. The establishment of restricted zones of application 
of HSCT at the outset will make it possible to support the most urgent and 
humane applications of HSCT with less fear that such support gives tacit 
approval to other uses that, propelled by economic and professional pressures, 
may slip through the review process. 
Many technical problems must be overcome if HSCT is to be used in clinical 
treatment. It is imperative that this therapy not be used on people, even 
experimentally, until the technical problems of targeting and delivery to 
specific cells or tissues have been solved. However, the pressure to test gene 
therapy on human subjects is building rapidly. Some investigators are even 
willing to forego the usual requirement that human trials await successful 
animal tests on the grounds that, as a life-saving measure, a patient is 
entitled to "anything available." We oppose this view. Moreover, we do not 
believe that Informed consent by Itself is a sufficient standard for protecting 
the dignity of individuals with life-threatening or severely disabling illnesses 
against Inappropriate and adventuresome uses of medical technologies. 
2. Enhancement Therapies 
The application of HSCT for the alteration of human characteristics such 
as height or skin tone raises profound ethical problems. For example, clinically 
healthy individuals who wish to receive genetic therapy to increase their height 
[70] 
Recombinant DNA Research, Volume 1 1 
