Recombinant DNA Advisory Committee - 10/7-8/91 
Dr. McGarrity put the motion to restrict the patient selection to the adult population of 
18 years of age or older to a vote. The motion failed by a vote of 3 in favor, 13 
opposed, and 1 abstention. 
Dr. McGarrity put the motion to allow Dr. Wilson to treat three patients to a vote. The 
motion passed by a vote of 16 in favor, 0 opposed, and 1 abstention. 
Dr. McGarrity added that the action signifies a new attack on yet another genetic 
disease, and represents an important advance in human gene therapy of genetic diseases. 
He wished Dr. Wilson the best and commented that his group had done an outstanding 
job in the presentation of their material. 
VIII. MINUTES OF MAY 30-31, 1991, MEETING (CONTINUED) 
Dr. McGarrity asked the committee to move to the next item, the approval of the 
minutes from the previous RAC meeting. He noted that Dr. Mclvor had volunteered to 
review them. 
Dr. Mclvor said he had read the minutes for the May 30-31 RAC meeting and seconded 
their approval with some typographical corrections. 
Dr. Post said he was listed as reviewing Dr. Brenner's consent form, and that is incorrect. 
Dr. McGarrity put the motion to approve the minutes to a vote. The motion passed with 
a vote of 15 in favor, 0 opposed, and no abstentions. 
IX. FUTURE ROLE OF THE HUMAN GENE THERAPY SUBCOMMITTEE 
Dr. McGarrity summarized the major points of the previous discussion of this topic. 
Over the years the RAC has characterized itself as undergoing a continuing evolution. 
The development and evolution of the NIH Guidelines includes areas such as industrial 
scale-up, industrial practices, and environmental release. There is a general consensus 
that something must be done to streamline the review process of gene therapy proposals. 
There have been a variety of comments on this issue. Also, there have been a number 
of comments addressing the matter of a rapid reporting of the minutes so that they can 
get back to the group in a timely fashion. He asked Dr. Walters if he would begin the 
discussion as Chair of the HGTS. 
Dr. Walters noted that eight gene transfer protocols and seven gene therapy protocols 
have been reviewed by the HGTS. Six protocols were approved by the subcommittee 
and forwarded to the RAC on the first cycle of review. Three protocols went through 
two cycles of review and three protocols required three cycles of review. Two protocols 
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