14 
prevent the kind of circus-like atmosphere that sometimes surrounds medical 
firsts. 
Dr. Walters said the working group feels part of its mandate is to inquire 
about broader issues, and Part II of the points to consider document will 
raise broader social questions. For example, it might ask what effect, if 
any, the proposed s erratic cell gene therapy is likely to have on the repro- 
ductive cells of treated patients. It might also inquire about possible 
ccrrmercial aspects of the particular gene therapy protocol including the 
possibility of patenting the technique. These types of questions were 
raised in reports such as "Splicing Life." 
Dr. Walters said Part. Ill of the document will request documentation 
including a copy of the original protocol or grant application in which 
the gene therapy technique is described. 
Dr. Walters said the first draft of the document was discussed at the 
October 12, 1984, plenary meeting of the Working Group on Human Gene 
Therapy. This meeting was announced in the Federal Register and open to 
the public. Subgroups of the working group were then formed to revise 
portions of the document. The resulting draft is to be discussed at a 
working group meeting on November 16, 1984. This meeting has been announced 
in the Federal Register and will be open to the public. The document which 
emerges frem that meeting will be circulated to all RAC members for comment. 
When those Garments have been incorporated, public comment will be solicited 
by publishing the draft document in the Federal Register and sending it to 
individuals and religious groups interested in the issues posed by human 
gene therapy. The document will be revised in light of public comment and 
the working group will subsequently submit the document for RAC review at 
the next RAC meeting . 
Dr. Gottesman emphasized that in the review of individual proposals, the 
working group expects many IRB concerns will "overlap" with concerns dis- 
cussed in the "Points bo Consider." However, IRB concerns will focus 
specifically on risk/benefit considerations for the particular patients; 
and the working group anticipates there will be both scientific and social 
issues that a broader group such as RAC or its working group can approach 
more easily than local ccrnmittees. Dr. Gottesman emphasized that the 
working group document focuses on somatic cell gene therapy as the first 
proposals presented to RAC undoubtedly will involve somatic cell therapy 
experiments . 
Dr. MoGarrity asked whether IRBs and IBCs would be required to review and 
approve of proposals prior to NIH review. If local committees must review 
proposal prior to NIH review, would local committees be responsible for 
evaluating the entire proposal? Would RAC and its working group offer 
advice and support to local ccrnmittees should these committees be uncom- 
fortable evaluating proposals prior to RAC review? 
[146] 
