Recombinant DNA Advisory Committee - 10/7-8/91 
were deferred, either by the HGTS or the RAC. There was one protocol that was 
deferred by the subcommittee, and then not pursued by the principal investigator. In the 
last two HGTS meetings, seven new protocols were submitted. Five were approved on 
the first round and two were deferred. 
Dr. Walters suggested a parallel review process rather than a sequential review process 
as a way to streamline review procedures. He suggested simultaneous submission of 
protocols to the local Institutional Review Board (IRB), IBC, ORDA (for consideration 
by the HGTS and the RAC), and FDA. The subcommittee could provide a forum for 
the consideration of issues like germ line intervention. 
Dr. Leventhal said one of the benefits to parallel processing of protocols would come in 
the final processing of the consent form. This is really the responsibility of the IRB; the 
RAC spends more time on consent forms than is within its purview. 
Mr. Capron said he wrote a motion that the RAC endorse the process established by the 
HGTS to reexamine how each committee handles various aspects of gene transfer 
experiments, including those with expected therapeutic effects as well as marking. The 
RAC would look forward to the results of the working groups on germ line therapy 
chaired by Dr. Parkman and the follow-up of approved gene transfer protocols chaired 
by Dr. Leventhal. The RAC should establish a working group to develop a set of 
principles to guide its operations and future formulation of guidelines, along the lines 
that Dr. Kelley suggested. Barring major new developments, the RAC should not further 
debate the issue of merging itself with the HGTS during the coming year, pending the 
recommendations of the three working groups. In the interim, the following procedures 
could be employed to facilitate the effective and efficient review of protocols involving 
human subjects. 
3A Immediately after the review of the protocol by the HGTS, the primary 
reviewer (working with the committee Chair and the Executive Secretary) 
will prepare a summary of the points needing further attention, which will 
be submitted to the principal investigator. 
3B. Such statements will also be promptly circulated to members of the 
subcommittee, and any points that they identify as having been omitted 
from a summary will be added to the list and conveyed to the principal 
investigator. 
3C. As a standard routine matter, the principal investigator will be asked to 
provide a written summary and copies of any slides regarding material 
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Recombinant DNA Research, Volume 15 
