Recombinant DNA Advisory Committee - 10/16/90 
Dr. Wivel said that with regard to gene therapy it was obvious 
that a tremendous gap exists between the research that is ongoing 
at NIH and the rest of the country with development of human gene 
therapy protocols. Most people, when questioned, had no 
anticipation that they would be receiving requests to perform 
human gene therapy trials. Further, they felt uncomfortable and 
unqualified to deal with them at this point. 
Dr. Wivel said that this last point bears on discussions which 
have taken place vis-a-vis the role of the RAC and the Human Gene 
Therapy Subcommittee relative to their educational functions. 
Should there be workshops for both IBCs and individual 
investigators? He noted that one exception was Baylor College of 
Medicine in Houston where a group is actively planning a human 
gene therapy protocol. He noted that the group there is well 
trained and capable of performing such a trial and that the RAC 
could expect to see a proposal from them within 12-18 months. 
Dr. Wivel said that other issues were brought up which deserve 
comment. One of the most interesting related to the issue of the 
future of the NIH Guidelines and the RAC. He noted that 
representatives of the FDA, as well as the University of 
California, had suggested there was sufficient scientific 
rationale for sunsetting the NIH Guidelines , based on over 15 
years of experience and knowledge gained in the field of 
recombinant DNA research. 
However, Dr. Wivel noted that these were the only two comments 
received which expressed this feeling. The overwhelming majority 
of responses indicated that the NIH Guidelines should continue to 
serve a role as a national code of practice for the field and 
should be kept in place with timely modifications. 
Another important issue outlined by Dr. Wivel was the matter of 
whether the RAC and the NIH should continue to have a role in 
reviewing environmental releases. He noted that it is generally 
perceived that NIH does not have the primary expertise in this 
area and that other Government agencies have a regulatory role to 
play in this issue. 
Dr. McGarrity thanked Dr. Wivel for an excellent summary of the 
regional meetings and said he would like to present some overall 
observations that he had made during the meetings. He said that 
in general, the RAC received high marks for the job it has been 
doing. He noted the wide range of constituencies that the RAC 
has around the country and the world. He said that it was worthy 
of note that the meetings were not attended by bench scientists, 
but that the people in attendance were administrators, members of 
IBCs, safety officers, and many participants from outside the 
traditional academic environment, including professional 
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