Human Gene Therapy Subcommittee - 11/21-22/91 
the Department of Health and Human Services. 
Dr. Epstein was concerned about the review process of protocols in the event that the 
number of protocol submissions increases substantially. In study sections, proposals are 
reviewed, a definitive decision is made, and a priority score assigned, within thirty 
minutes. Currently, the RAC may spend as much as 2Vi hours reviewing a single 
protocol. The burden of review should be placed on the investigator to submit a 
protocol that can be reviewed expeditiously. 
Dr. Zallen stated that the public's interest should be considered in this decision. With 
the current system of review, the general public is assured that its interests are being 
represented in the process. It is too soon in the process of gene transfer/therapy 
approval to change the ground rules. As the process is now, the public has the 
opportunity for input at various stages of the process, which they might not have with a 
single review committee. 
Dr. Neiman said that the best way to resolve the issue of reviewing increasing numbers 
of protocols in the future is to categorize types of proposals, e.g., standard vectors, 
standard questions, and standard issues that can be reviewed by other mechanisms. He 
added that he supports the proposal for establishing a single review body. Mr. Capron 
agreed that the groundwork should be laid now for developing those categories that do 
not require full review because they are repetitious of design that is comfortable to the 
committee. 
Mr. Capron cautioned that the issues of germ line gene therapy and enhancement may 
be forthcoming and inquired as to whether the RAC was prepared to spend entire days 
contemplating these fundamental issues. Dr. Miller stated that RAC members would be 
equally well prepared to discuss these issues as would the HGTS members. It would be 
easier for the RAC to establish a subcommittee to deliberate the issue of germ line gene 
therapy than it would be for the HGTS to form a subcommittee. 
Subcommittee Motion 
Dr. Erickson made a motion that the HGTS be merged into the RAC, that the number 
of meetings be increased from 3 to 4 per year, and that there will be a transition period 
of 1 year in which the HGTS will meet solely to develop strategies for simplifying the 
protocol review process. The motion was seconded by Dr. Epstein. Mr. Capron moved 
to table the motion until later in the meeting when the HGTS had an opportunity to 
discuss the report from the Working Group on New Approaches to Gene Therapy. Dr. 
Zallen seconded the motion. The motion to table Dr. Erickson's motion was approved 
by a vote of 8 in favor, 4 opposed, and 2 abstentions. 
Recombinant DNA Research, Volume 15 
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