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qualities of the work being done. 
Dr. Henry Miller spoke in favor of Dr. Anderson's proposal and said that he felt the best 
aspects of both committees be extracted and merged into one committee to arrive at a single 
mechanism with a primary concern in this area. 
Dr. Mclvor said he was in favor of staying with the current mechanism, despite being in favor 
of having a new funding mechanism for human gene therapy protocols. He said he felt the 
current mechanism works well and is able to closely scrutinize these protocols from all angles. 
He said he felt the role of the RAC and the HGTS was to gain an initial awareness of the 
issues involved in human gene therapy and to address them as best as possible. Because this 
is a new area of science the ability of the committees to address the science is sometimes 
made difficult but he said he felt that by conditionally approving protocols after initial review 
and allowing the investigators to supply additional information and make revisions to their 
proposals this has allowed the subcommittee and the committee to work very well as a 
mechanism to identify problem areas and scrutinize the work being undertaken. 
Ms. Buc asked whether there was a means by which a protocol could get to the RAC without 
being approved by the HGTS. Dr. Wivel said protocols must first be provisionally approved 
by the HGTS before coming to the RAC. However, Dr. Anderson amplified this by noting 
that there is a procedure whereby if there are two straight deferrals of a protocol by the 
HGTS the investigator may appeal directly to the RAC for approval. 
Dr. McGarrity asked Dr. Ledley how he felt about the process, having just undergone the 
review process. Dr. Ledley said he felt the two-step process was a good one and that it 
focused the investigators' attention, thoughts and planning on the most critical issues involved 
in the protocol. He said he favored the approach being taken by the RAC whereby the 
investigator is present at the initial critique, rather than the study section model in which the 
investigator receives a "pink sheet" at some later date and does not have the ability to 
interface with the reviewers. 
Dr. Post expressed the opinion that he would like to have more information on the initial 
review before the RAC met to discuss a protocol. He said he felt there should be a 
mechanism short of abolishing the subcommittee to give early feedback to the investigator as 
well as providing some detailed review for the RAC on proposals considered by the 
subcommittee. He also said he felt that as human gene therapy protocols become more 
routine and the numbers submitted for review increase that it is important for the RAC and 
the subcommittee to think in terms of what their proper role is in the review of these 
protocols in order to expedite the process while maintaining a high standard of review. 
Dr. Walters said that he felt this discussion was fruitful insofar as he had not viewed this 
process from the standpoint of a member of the RAC who was not on the subcommittee. He 
said that perhaps some combination of the parent committee and the subcommittee which met 
perhaps six times a year might be required in order to keep up with the volume of proposals 
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