Recombinant DMA Advisoiy Committee - 5/30-31/91 
the subcommittee who had never been RAC members, and one came from the Director of 
the Committee for Responsible Genetics. He noted that they unanimously opposed abolishing 
the HGTS. Further, a twelfth letter had come from Dr. Miller of the FDA which took the 
opposite view. 
Dr. Walters said the eleven letters opposing the abolishment of the HGTS put forward three 
main arguments: 
1. Local review committees often lack the relevant expertise to evaluate human 
gene transfer and human gene therapy protocols; 
2. To date, the HGTS has identified problems in protocols and requested 
additional data that in fact have led to important revisions in the protocols and 
requested additional data that, in fact, have led to important revisions in the 
protocols or supplements to the protocols which have allowed the RAC to 
approve the protocols the first time they had come before the RAC in light of 
these clarifications and additional data; and, 
3. The existing review process has won the confidence of both the general public 
and political leaders. 
Further, Dr. Walters added the following two arguments for maintaining the HGTS: 
1. If the subcommittee were abolished the RAC would lose ready access to the 
expertise of several highly respected scientists and ethicists who are currently 
rotating off the RAC; and, 
2. The RAC is currently in the process of reviewing and defining its future role, 
and that only after this process is complete should the role of the subcommittee 
be addressed and, if necessary, modified. 
Dr. Walters then commented on the letter of Dr. Miller from the FDA. He noted that from 
the beginning the duplicity of review was evident, but that this was a conscious decision on 
the part of the RAC so as to ensure a public review process under the auspices of NIH. 
Dr. Walters said that Dr. Kelley's letter proposed a "study section model" for the 
subcommittee and that he agreed in part with this concept. However, he said he felt that the 
technical expertise in the science must be present on the subcommittee in order for the review 
to be credible and that he felt the subcommittee must provide an initial review of not only 
the technical aspects of the proposals, but a thorough look at the ethical considerations. 
Dr. Walters said that for these reasons he disagreed with Dr. Anderson's proposal, but that 
he agreed that the RAC should look at this again in a year to evaluate whether the role of 
the subcommittee is continuing to be fruitful and constructive. 
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Recombinant DNA Research, Volume 14 
