Recombinant DMA Advisoiy Committee - 2/4/91 
Dr. B. Murray said that if the definition were broadened and made more consistent, it 
would not result in an increased workload or review because what is really being looked 
at is product, not process. She said that if the NIH Guidelines are left in place there 
needs to be some sort of committee responsible for revising them when special requests 
and new information become available. She said she would be happy to see a complete 
revision of the definition and would anticipate seeing mostly human gene therapy 
proposals coming before the RAC, with the occasional request to downgrade something 
as has been the case in the last year. 
Dr. R. Murray believed Dr. Walters was trying to point the committee in the direction 
whereby "recombinant DNA" is not redefined, but instead the purview of the RAC is 
refocused not on how DNA is derived but instead on the use of the DNA. Dr. R. 
Murray suggested that the RAC then include in its purview, experiments which derive 
the DNA from PCR techniques, but only where the introduction of the DNA poses a 
potential hazard or in cases involving human gene therapy, human manipulation, or any 
introduction into humans. 
Dr. R. Murray said that if this were to be the case, the RAC would be focusing purely on 
the application, rather than the process, and this may introduce some complications but 
that it would then focus on the areas of concern which have changed over time. 
He also pointed out that the use of the term "genetic intervention" would be an 
appropriate term for what the RAC would include in its oversight. This would not 
exclude the committee from looking at areas where review may be needed, due to some 
novel approaches of dealing with DNA that are as yet unknown. 
Dr. McGarrity asked whether the committee believed that this was something that the 
HGTS should be asked to consider at its next meeting and then returned to the RAC 
with reconunendations at its next meeting. Dr. R. Murray said that more discussion was 
clearly necessary in this area. However, it would require substantive discussion and if 
this was not possible within the time constraints of the HGTS and the RAC, then may be 
a good idea to reconvene the Planning Subcommittee to continue the discussion. 
Dr. Geiduschek said that the ORDA staff would have to play a significant role in 
providing a detailed assessment of the consequences of broadening any definition or 
expanding the purview of the RAC. It was important to be aware of all the implications 
of a particular expansion in relation to the activities of the RAC. He cautioned that 
enough time be set aside for these discussions to allow for these far-ranging implications 
to be discussed in-depth. 
Dr. McGarrity asked Dr. Wivel for an assessment of the agenda for the April meeting of 
the HGTS. Dr. Wivel said that Dr. Lotze's protocol from today will undoubtedly be on 
the agenda and there was the possibility of the need to discuss a protocol that may be 
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Recombinant DNA Research, Volume 14 
