Recombinant DIVA Advisory Committee - 10/7-8/91 
They are simply categories. Another issue of concern that has been on everybody's mind 
is the potential for inheritable changes and for genetic enhancements in the field of gene 
therapy. The subcommittee is thinking about what it is going to do to inform itself, the 
RAC, and the American public, about responding to these basic issues. It would be 
valuable to have two groups working on these issues as well as the NIH Guidelines issues. 
Dr. Mclvor said that as a member of both the HGTS and the RAC, he is sensitive to the 
problem of relaying information from the subcommittee meetings to the parent 
committee. He said that the current system works. 
Mr. Capron asked Dr. Kelley to consider reformulating his first principle. The Atomic 
Energy Commission got itself into a lot of trouble by trying to promote and regulate the 
field. There are a lot of people around, in private industry and at the NIH, who can 
promote this field. Perhaps the notion should be that the RAC does not intend to 
unduly, improperly, or unnecessarily obstruct the field. Dr. Kelley agreed with the 
reformulation. 
Dr. Gellert suggested that when proposals start going through both rounds of review 
without any changes, then the subcommittee will be plainly redundant. As yet, there 
have not been any that are even close. The double review is not yet redundant. If there 
is an effort to amalgamate the committees or reduce the role of the subcommittee, it is 
very likely that applications will come to the full committee twice with no particular 
saving of effort. 
Dr. B. Murray stated that even though a protocol might come to the same committee 
twice, at least everybody is exposed to the full discussion. There could be some 
advantage to having it come to the same committee twice instead of two different 
committees in the same time interval. 
Dr. Geiduschek said that the need for two non-overlapping groups to do the review 
implies a lack of confidence in the reviewers. Even with minutes, having the first review 
and the second review done by non-overlapping committees results in wasted effort. A 
single group doing the review, even multiple times, is better than the situation as it 
exists. 
Ms. Buc expressed concern about having the interaction between the investigator and 
either of the committees be in the form of post hoc letters which are not part of the 
public process. There is a value to the discussions being public; the minutes are the way 
to solve that problem. 
Dr. Epps suggested the development of an interim solution. Mr. Barton suggested they 
ask one of the overlapping members between the subcommittee and the RAC to give a 
Recombinant DNA Research, Volume 15 
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