Recombinant DNA Advisory Committee - 10/7-8/91 
to supply the results of the protocols so that the subcommittee could decide whether 
there were categories of protocols that no longer needed to be reviewed by the 
committee because they were safe. The end result of knowing what has happened to the 
patients might very well be the streamlining of the review process. However, the 
emphasis is more on results of the approved protocols. 
Dr. Post said that there were good examples of why the HGTS does not really function 
as a subcommittee of the RAC. He noted that Dr. Freeman had repeatedly argued that, 
"Well, the subcommittee approved this." He did not get approval by the RAC, and the 
reasoning that led the subcommittee to approve this proposal is not clear. There are 
really two, quite separate, reviews that are not linked in a subcommittee/ committee 
relationship. Two reviews are not necessary as illustrated by the fact that both Dr. 
Freeman and Dr. Rosenberg seemed to present the same material to the RAC that they 
had presented to the subcommittee. The Science article (August 9, 1991, volume 253) 
quoted one gene therapy company as saying they were thinking of bypassing the RAC 
review because it was so cumbersome. The article stated that if duplication of review 
continues, scientists would be better off spending their time and resources doing research 
rather than flying in for RAC and HGTS meetings. The RAC should think very 
seriously of trying to streamline the process into one single review at this level. The 
RAC could be reconstituted in recognition that it would have gene therapy as its primary 
mission. Outside consultants could also be used to cover other issues before the RAC. 
There could be some type of a pre-meeting review where the primary and secondary 
reviewers would consult in the study section format with the investigators. 
Dr. Atlas agreed with Dr. Post. Today's events were good examples wherein the 
investigators gave a presentation of the research to the RAC that was previously 
presented to the HGTS. The subcommittee did not say, "Here is what we reviewed, here 
is what we thought were the key issues, here is why we recommended this or that." The 
RAC had to listen to the original data and ask questions which may or may not have 
been previously asked. If the subcommittee is retained, it should give input from its 
review in the form of a report to avoid a duplication of efforts. 
Dr. Bourquin reemphasized that most of the real expert review of the protocols before 
the RAC is done in the subcommittee. There is a different review that occurs in the 
RAC due to the composition of the committee. He endorsed combining the two 
committees because the in-depth review that the subcommittee performs is needed in the 
RAC. With the emphasis for the RAC being human gene therapy, the function of the 
subcommittee must be acquired by the RAC through restructuring to provide expertise in 
that particular area. Issues like the Actinomycetes should be handled by the creation of a 
working group of experts composed of committee members and ad hoc consultants to 
make a recommendation to the RAC. 
Recombinant DNA Research, Volume 15 
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