Recombinant DNA Advisory Committee - 5/30-31/91 
Dr. R. Murray then discussed this history of this proposal from the standpoint of the ad hoc 
committee which had been convened to look into the comments received during the public 
hearings undertaken by the RAC, at which this issue was first discussed. He said that he did 
not consider this proposal to be without merit but that it was perhaps premature in light of 
the ongoing process of evaluating the role of the RAC for the future. He noted that by 
having the dual role it allowed him to more readily deal with the patient concerns and ethical 
issues which he was concerned with, without having the intense discussion of the technical 
issues of the protocol being discussed at the same time. He summarized by saying he felt that 
the role of the RAC should be clarified before any decisions could be made relative to 
abolishing the HGTS. 
Dr. Kelley said he agreed with the concept of having a national review of the technical issues 
surrounding human gene therapy protocols, however he noted that it was clear that the rate 
of submission of these protocols would increase dramatically in the future and that this should 
be taken into account in these deliberations. He outlined the process of study section peer 
review which the NIH has used to help in making funding decisions on research grants and 
noted that it provided a detailed review by experts which he felt should be mirrored by the 
HGTS. He said that he felt the HGTS review should be more like that done by study sections 
and that with increases in both technical expertise as well as ethicists familiar with the area 
that this could be accomplished with minimal change in the subcommittee structure. He 
added that he would like to see the subcommittee assign a priority score to each proposal with 
the aim of eventually developing a funding mechanism for this research. He said this could 
be accomplished by means of some sort of a set-aside mechanism or by high program 
relevance, but he wished to see the association of a priority score and funding mechanism 
being brought to bear on each application. 
Dr. Kelley said that ideally he would like to see the RAC continue to act much in the same 
way the national advisory councils do, making sure that there is broad representation of the 
public interest and expertise across a wide range so that there will continue to be public 
review at the national level for these protocols. He said that he thought Dr. Anderson's 
proposal was appropriate insofar as questioning the current workings of the HGTS and the 
RAC. He said that currently there is a lot of interest in the field and he believe that this kind 
of thinking could be brought to bear and used to support the discipline as the field develops. 
Dr. McGarrity noted that there were some differences in what was currently being done versus 
the "study section model," the major one being that study sections really only deal with 
reviewing extramural grant proposals, while the HGTS is looking at proposals from the 
intramural NIH community and privately financed studies as well. Further, he asked what the 
threshold would be for a proposal to move from the HGTS to the RAC for review. 
Dr. Wivel noted that in the current NIH system the study sections do not service one institute, 
but rather review proposals in a given area of expertise for many institutes and the funding 
body is the institute council. Therefore if the HGTS were to review a protocol it would be 
I forwarded to the relevant categorical institute, center or division (ICD) for funding, leaving 
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