modification of the human species, and moves us into the realm 
of human experimentation on the newly born or the unborn. 
Once this realm has been entered, the National Research Act of 
1984 requires that informed consent is necessary to carry out 
these experiments. The notion of informed consent, however, 
is not a meaningful one for future generations. 
The proposed additions to the permanent guidelines before 
you today would be a clear and unambigious policy statement of 
the RAC's position on germ-line therapy. By limiting an area 
of research at this time when significant ethical and social 
questions remain unresolved, the RAC will make a clear 
statement of public record that human germ-line experiments 
should not be done at this time. 
What will RAC do if it receives a proposal for altering 
human germ line cells? What mechanism will the IRB's or the 
RAC use to evaluate informed consent for future generations? 
We argue in favor of an explicit statement in the guidelines 
that a major review, including public discussion, would be 
needed before any such proposal would be considered. 
Although the current review system, based on submission 
of proposals, may be appropriate for evaluating some forms of 
somatic cell therapy, it is premature and inadequate to use 
these same mechanisms for germ- line therapy experiments. 
Recombinant DNA Research, Volume 1 1 
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