Recombinant DMA Advisoiy Committee - 5/30-31/91 
Dr. McGarrity thanked Dr. Anderson for his report and asked him to present the next item 
on the agenda. 
IX. PROPOSED AMENDMENT TO THE POINTS TO CONSIDER IN THE DESIGN AND 
SUBMISSION OF PROTOCOLS FOR THE TRANSFER OF RECOMBINANT DNA INTO 
THE GENOME OF HUMAN SUBJECTS REGARDING THE HUMAN GENE THERAPY 
SUBCOMMITTEE BE ELIMINATED FROM THE REVIEW PROCESS INVOLVING 
HUMAN GENE THERAPY PROTOCOLS: 
Dr. Anderson said he would address what he considered to be the advantages and 
disadvantages of the proposed amendment. He said there were three misconceptions that had 
come to light in the various written comments received which he felt needed to be addressed 
concerning this proposal: 
1. That there should be less review of human gene therapy protocols; 
2. That investigators were unhappy with the Human Gene Therapy Subcommittee 
for various reasons; and, 
3. That there was a feeling that the RAC was not capable of doing as good a job 
of reviewing human gene therapy protocols. 
Dr. Anderson said that one advantage of the proposal would be to make the RAC the primary 
body with the ability to make the most informed decision on a human gene therapy protocol. 
He said at present the subcommittee goes through the technical details and when the protocol 
comes before the RAC it merely sees a summary of what has happened and is asked to ensure 
that any questions posed by the subcommittee are answered. He said he did not believe that 
the RAC is making the kind of informed decision that it could and should be making on these 
protocols. 
Dr. Anderson said he doubted the RAC would vote today to dissolve the HGTS, but that his 
aim in submitting this proposed amendment was to start the RAC thinking about when and 
how to phase out the HGTS and how this expertise could be conserved by making the 
members of the HGTS simply ad hoc members of the RAC. He said he felt that as RAC 
members are replaced that possibly what should take place is that these replacements come 
from the HGTS. 
Dr. Anderson said he felt there was a duplication of effort in the current process which results 
in the RAC not being as informed as it could be. He suggested that the RAC could meet 
four times a year instead of the three times it currently meets, and by doing so ORDA's job 
of having to put together duplicate materials for meetings as well as the time of many 
reviewers who serve on both committees would be conserved. He noted that Dr. Mclvor had 
objected to this concept on the basis that some protocols would take longer to receive 
approvals. Dr. Anderson said that he felt the good proposals would in fact get quicker 
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Recombinant DNA Research, Volume 14 
