Recombinant DNA Advisory Committee - IjAj’iX 
Mr. earner said that this issue was one which needed to be looked at in the broader 
sense of the future role of the RAC. Concerns over the future role of the RAC was the 
impetus for the public hearings and that input was sought on how the public viewed the 
committee, but that this was too important a question to resolve on the basis of public 
input and that a more in-depth consideration of the future role of the RAC was 
indicated. 
Dr. Miller said that one of the recurrent themes in the discussion of redefining 
"recombinant DNA” was that of a process versus product based approach to the oversight 
of recombinant DNA research. This issue should be one which the RAC should focus 
on, rather than looking at technique-based triggers for RAC oversight. 
Dr. McGarrity asked whether the committee would recommend to the Director, NIH, 
that any human gene therapy proposal involving recombinant DNA by definition, or 
techniques that would achieve the same objective, should be reviewed by the RAC. Dr. 
Walters noted that RAC had agreed to review recombinant DNA introduced into human 
beings as well as DNA or RNA derived from recombinant DNA, which already 
expanded the purview of the committee. Such a determination would be the next step in 
this line of thinking. 
Dr. Wivel said that for such a determination to be made it would constitute a change in 
the definition of "recombinant DNA,” and would require publication in the Federal 
Register for comment and would follow the same process as any proposal to modify the 
NIH Guidelines. 
Mr. Mannix said that rather than having two different definitions of "recombinant DNA." 
It would be simpler to change the RAC's charge to include all types of human genetic 
intervention. Dr. Schaechter disagreed with this approach, noting that it would merely 
make the RAC into a HGTS and would create a vacuum as far as guidelines for the rest 
of recombinant DNA research. Dr. Schaechter called attention to the strong public 
support of the RAC as a place for public discussion of issues of recombinant DNA 
research, reflecting the trust that the public had placed in it. He did not want the RAC 
to lose this position as a public forum. 
Mr. Mannix said that in reading the transcripts of the public hearings, he became aware 
of the extent of support for maintaining the status quo because the RAC has worked 
reasonably well. However, he also noted the absence of many people coming out and 
saying there were any real risks to worry about. At NIH today there is a need for an 
AIDS Advisory Committee and a need for a committee to oversee human gene therapy. 
However, there is no longer a need for a committee to oversee recombinant DNA 
research that does not involve human subjects. Therefore, the RAC should reorient 
itself and its traditions and should expand its purview in the area of human gene therapy. 
It would be far more direct to say that with respect to human gene intervention all such 
experiments should come before the RAC, regardless of the actions necessary for 
ensuring that this is done. 
Recombinant DNA Research, Volume 14 
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