Human Gene Therapy Subcommittee - 11/21-22/91 
Dr. Parkman accepted Dr. Leventhal's stipulation as a friendly amendment to his motion 
for approval of the protocol. Dr. Wivel repeated the 3 stipulations for approval: (1) 
include the following sentence in the informed consent document: "It is possible that the 
study may lead to improved bone marrow transplantation therapy for others in the 
future, although it is also possible that no new information will be gained at all;" (2) 
submit in vitro data demonstrating that transduced leukemia cells survive the freezing 
process; and (3) submit a statistical section that addresses the interpretation of 
recurrence of labeled bone marrow cells and an early stopping rule if marked marrow 
cells are demonstrated in the first 3 patients. The motion to approve the protocol with 
the above stipulations passed by a vote of 11 in favor, 2 opposed, and no abstentions. 
Dr. Epstein asked a procedural question regarding opposing votes. He noted that in 
study sections when there are 2 negative votes on a proposal, a minority report is 
required to be written regarding the reasons for voting against the protocol. He 
proposed that the same procedures should apply to the HGTS. Since Dr. Zallen and 
Ms. Meyers cast the dissenting votes, Dr. Walters asked them to explain the issues that 
precipitated the negative votes. Dr. Zallen said that she was concerned about the 
patient being held responsible for research related costs. If researchers do not have the 
resources to cover these costs, than the patient should not be held responsible. Ms. 
Meyers was in agreement with Dr. Zallen. Dr. Walters asked Dr. Zallen and Ms. 
Meyers to draft a paragraph regarding their concerns about compensation for gene 
therapy related injury. 
V. REPORT FROM THE WORKING GROUP ON THE FUTURE ROLE OF THE 
RECOMBINANT DNA ADVISORY COMMITTEE/Drs. R Murray, Childress, and 
B. Murray 
Dr. B. Murray presented background information regarding the establishment of the 
Working Group on the Future Role of the RAC. The charge of the working group was 
to propose a recommendation for the RAC regarding the future of the HGTS. The 
recommendation is that the HGTS be merged with the parent committee, the RAC. 
The working group proposed three ways in which this transition could be accomplished: 
(1) HGTS members would be brought onto the RAC as full voting members; this action 
would require changing the RAC charter to increase the committee membership. (2) 
HGTS members would be brought onto the RAC as non-voting members; this would 
allow them to participate in protocol review, but they would not be allowed to vote. (3) 
The HGTS and RAC would have combined meetings in which the subcommittee would 
vote first followed by the RAC. It is proposed that if the HGTS and the RAC merge, 
the number of meetings be increased from 3 to 4 per year. 
Mr. Capron proposed a fourth option, namely, that the HGTS would review protocols; if 
protocols are approved unconditionally, a recommendation would go the chair of the 
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