guidelines? and 3) What role does public discussion play in 
policy determination? 
The use of somatic cell therapy, like any other new 
therapy, has certain unknown and unpredictable risks and 
benefits associated with its use. We urge a clear statement 
that, until more is known about the risks involved with the 
use of somatic cell therapy, human models for risk assessment 
are developed only for people who have no other options. With 
this proposal, we are not attempting to distinguish this form 
of treatment from any other new form of treatment per se, but 
merely to recognize that we are at the threshold of a new 
development and should proceed in a manner that is cautious 
and draws on our past experiences. 
The "Points to Consider in the Design and Submission of 
Human Somatic-Cell Gene Therapy Protocols" document addresses 
many of the difficult ethical and social issues raised by the 
use of human gene therapy. However, although the document is 
very specific about not entertaining proposals for germ-line 
therapy at the present time, it is only a recommendation on 
how to proceed with a submission of a proposal, and not the 
articulation of a binding policy. 
Germ-line manipulation, unlike somatic cell therapy, 
represents a qualitative leap in the use of genetic 
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