Recombinant DNA Advisoiy Committee - 2/4/91 
submitted from Baylor College of Medicine dealing with hepatic cells. Dr. Brenner also 
may be resubmitting a protocol which was deferred earlier by the subcommittee. Dr. 
Waters added that another issue was the letter from Mr. Alexander Capron which was 
received just prior to the previous meeting of the HGTS and which in fact deals with 
some of the issues of what the purview of the subcommittee should be if vectors and 
cells become drug delivery systems. This could be linked with the discussions of purview 
before the committee today. 
Dr. R. Murray noted that the issue of redefining "recombinant DNA" had constantly 
been surfacing over the last couple of years and it was time that the committee decide 
whether it wanted to pursue it and, if so, to deal with it in a thorough manner and come 
to a conclusion on the issues. 
Dr. Mclvor said that the issues of the purview over human genetic engineering and the 
definition of "recombinant DNA" were two separate issues and that could be dealt with 
separately. He did not know exactly what is to be done with the definition, what should 
be included, and why it should be changed. He was not sure the definition should be 
changed since it pretty well covers everything under the purview of the RAC. 
Dr. Schaechter said that if Mr. Mannix's proposal was to simply transform the RAC into 
a Human Gene Therapy Advisory Committee then much of what was being discussed 
was not germane. He asked whether there was sentiment for this type of a proposal 
among other members of the committee, or whether this was simply the viewpoint of Mr. 
Mannix. He was confused by the concept of dealing with the definition of "recombinant 
DNA," and then saying that the committee is only going to deal with human gene 
therapy. 
Dr. R. Murray said it was important that the RAC continue since that appeared to be 
the consensus from comments received during the public hearings. What Mr. Mannix 
was putting forward was a discussion of how the RAC should continue, in what format, 
or under what umbrella, and that to discuss dissolving the RAC would be ignoring the 
message sent by the public. 
Dr. McGarrity added that the public had strongly urged that the NIH Guidelines not be 
allowed to sunset. It is his position as Chairman to ensure that the committee is aware 
that if it decides to sunset the NIH Guidelines it is doing so against the recommendations 
of the public. 
Dr. R. Murray agreed that the NIH Guidelines should not be sunsetted, but that perhaps 
the NIH was not the proper place to have them continue and be updated. Dr. R. 
Murray also said that the current "double review" of human gene therapy protocols by 
the HGTS and the full RAC was beneficial in that it allowed two different groups of 
people to express their views on the merits of such proposals. He underlined two issues 
Recombinant DNA Research, Volume 14 
[489] 
