Recombinant DMA Advisory Committee - 5/30-31/91 
no role for the RAC in this process, since it is not a council and does not have funding 
authority. 
Dr. B. Murray said she found it interesting that members of the RAC who had never been on 
the subcommittee did not submit written responses to Dr. Anderson's proposal. She said she 
felt at a disadvantage in having to act on proposals which were already in a pre-approved state 
and where the attitude was to rush these protocols through since they had already received 
a technical review by the HGTS. She said she envisioned at some point that one committee 
or the other should subsume the responsibilities of the other but that there be a single 
committee in which no less rigorous review would be given and where less duplication would 
take place in the overall review of human gene therapy protocols. She did note that by having 
the subcommittee it allowed ORDA to continue to use the expertise which otherwise would 
drop by the wayside as members rotate off the RAC or the HGTS, but that she felt this could 
be accomplished by appointing ad hoc members to whatever committee evolves from this 
process. 
Dr. Anderson said he agreed with Dr. Kelley's comments insofar as getting a study section 
started to look at human gene therapy proposals because he felt the time had come for such 
a study section. However, he said he thought that the subcommittee was not the mechanism 
to do this in so much as the RAC and HGTS are already under criticism as being regulatory 
in nature and NIH does not have a regulatory responsibility and this would only further 
complicate this issue and he felt it would never be allowed to happen. He also noted that his 
purpose in presenting this proposal was to get the committee to begin to look at the role of 
the subcommittee and to begin to discuss what its future role should be, and he noted that he 
felt this was what was in fact happening during this discussion. 
Dr. R. Murray said he would oppose the "study section model," because he felt it would do 
nothing to solve the problem Dr. B. Murray raised about the committee members not feeling 
fully informed. He noted that advisory councils have more things to do and less time for 
review of proposals than the RAC and if the "study section model" were followed there would 
be even less review in the RAC than is now taking place. Secondly, he added that the study 
sections do not allow for the interface with the investigators which takes place at both the 
HGTS and the RAC, and he added that he found this refreshing and enlightening to have the 
investigators present to defend their protocols and that it was an educational process which 
improved everyone's knowledge of the field and where the field is going. 
Dr. McGarrity underlined the fact that the Charter of the RAC also states that meetings will 
be held in public, and noted that this differs from the standard review of grant proposals by 
study sections. 
Dr. Schaechter agreed with the comments of Drs. B. Murray and R. Murray and noted that 
down the road an avalanche of human gene therapy protocols was coming and that it was 
important to look at these issues without having a mission orientation and to stay away from 
trying to prioritize protocols, but rather to simply evaluate the scientific, human and societal 
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Recombinant DNA Research, Volume 14 
