13 
The subworking group agreed Sections 1 1 -A and II-B would remain in Part II of 
the points to consider document. The issues addressed in Section II-C would 
be discussed in the introduction to the document with emphasis placed on scientific 
safeguards and patient benefit. 
Dr. Walters called the attention of the sib working group to Part III of the 
document. The subworking group agreed this portion of the document as written 
was adequate. 
Dr. Walters said Mr. Robert Mitchell, the Chair of the RAC, had asked the 
sufcworking group to discuss whether the Working Group on Hunan Gene Therapy 
should evaluate germ line gene therapy with particular emphasis on the issue 
of enhancement of characteristics . The working group would function as a 
study group in evaluating these issues. If the working group agrees to accept 
this responsibility, the proposed directive would go to the RAC for approval 
since such discussions are not part of the original mandate of the Working 
Group on Human Gene Therapy. 
Dr. Waiters felt this discussion would be a reasonable approach since the 
working group would not wish to be in the posture of not having evaluated 
these issues when the first somatic cell gene therapy proposals are submitted. 
Dr. Anderson felt germ line gene therapy protocols would not be submitted to 
RAC in the near future. At present, no investigator has even begum to work on 
the techniques necessary for human germ line therapy. He said the data generated 
using mouse models suggest the high degree of difficulty associated with germ 
line modifications; a large percentage of the few embryos surviving microinjection 
of the recombinant FNA suffer lethal mutations. 
Dr. Gottesman said although germ line applications cure not possible in the near 
future, the working group might begin to discuss the issues associated with these 
applications. As part of that discussion, the working group could evaluate the 
state of the art. It could discuss the technical barriers to these procedures, 
where the technology is, and where it is going. The ethical problems presented 
by germ line therapy will not be resolved by waiting to receive the first germ 
line therapy protocols. Dr. Gottesman said it would also be nice to have in 
hand a discussion of how germ line therapy differs frcm scmatic cell therapy 
when the first somatic cell gene therapy protocol is reviewed. She suggested 
RAC should be very careful, however, in choosing language for the project's 
mandate. 
Dr. Mir ray agreed the working group and RAC would have to be careful in construc- 
ting the mandate since some individuals might interpret consideration of an 
issue a form of promotion of that issue. Dr. Gottesman said RAC and the working 
group might indicate this study is initiated in response to comments received 
on the points to consider document. 
Dr. Walters said several comments had been received on the composition of the 
Working Group on Human Gene Therapy; he asked the subworking group for their views 
on this issue . 
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