Human Gene Therapy Subcommittee - 11/21-22/91 
RAC. In this way, approval by the RAC would be dealt with in the same manner as 
minor modifications. The RAC members would be informed of the chair's decision. If 
any RAC members desired discussion of a particular protocol by the entire RAC, then 
the protocol would be included as an agenda item. He recommended that the HGTS 
consider this proposal because the other options provided by the working group may 
actually slow down the approval process. 
Dr. Epstein proposed that there should be only one committee, the RAC; but it would 
be divided into two subcommittees which would meet independently on the first day of 
the RAC meeting. One subcommittee would review the scientific merits of the protocol 
while the other subcommittee would review the ethical and legal aspects of the protocol. 
The subcommittee meetings would be followed the next day by a full RAC meeting. 
This process would eliminate the distinction between the HGTS and the RAC. If there 
is crossover between the two subcommittees, the issues could be resolved at the full 
RAC meeting. 
Dr. Leventhal disagreed with Dr. Epstein's proposal arguing that significant knowledge is 
gained from the discussions between experts at these meetings. Scientists would be 
deprived of important information and ideas presented by the legal and ethical experts 
and vice versa. RAC meetings provide an educational process for all participants. Dr. 
Leventhal stated that the major problem with the current review system is that the RAC 
is not apprised of HGTS discussions. 
Dr. Miller said that he was originally opposed to dissolving the HGTS but now is in 
favor of it. He agreed that protocol review would be more efficient and quicker when 
dealt with by one committee as opposed to two. Dr. Mclvor agreed that the review 
process should be handled by a single committee. 
Dr. McGarrity stated that, with regard to Dr. Epstein's proposal, it would be a mistake 
to fragment the review of any proposal. Problems would be handled more efficiently by 
the large group. He added that if the vector experts, the ethicists, and the clinicians gave 
independent reviews of protocols, the basic intrinsic value of the review process would be 
destroyed. He cautioned the subcommittee to keep in mind that the number of 
protocols being submitted in the future could double or triple, and added that the RAC 
should consider this anticipated increase when establishing the number of meetings per 
year. 
Dr. Parkman suggested that a three-day meeting would resolve any problems arising 
from an increase in the number of protocol submissions. The first two days would 
function in the subcommittee manner as proposed by Dr. Epstein; these two days would 
be followed by a third day of full RAC review of issues not resolved at the subcommittee 
level. Dr. Parkman added that four meetings per year would be preferable to three. 
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