Recombinant DNA Advisory Committee - 7/31/90 
that were being undertaken by the RAC and the HGTS would be 
required. He could choose to proceed to this type of clinical 
experimentation without review, but he did not feel he was 
scientifically ready at this point. Further, Dr. Bordignon had 
said he was pleased to take part in the process and he felt the 
process was a good one. 
Presentation and Discussion of Proposed Addition to the "Points 
to Consider” Document to Expedite Minor Modification on Approved 
Protocols: 
Dr. McGarrity called on Dr. R. Murray to begin the discussion of 
this agenda item. Dr. R. Murray said the rationale behind the 
proposed change to the "Points to Consider" document was to allow 
for investigators to make minor modifications or changes in their 
protocols without having to wait for the next meeting of the RAC 
or the HGTS. He said the first paragraph of the proposed 
addition was developed by Dr. Areen and reads as follows: 
"A minor change in protocols approved by the Human Gene 
Therapy Subcommittee and the RAC is a change that does 
not significantly alter the basic design of a protocol 
and that does not increase risk to the subjects. If 
the change has been approved by the relevant 
Institutional Review Board and Institutional Biosafety 
Committee and the Chair of the Human Gene Therapy 
Subcommittee, the Chair of the RAC may then give 
approval. The Chairs will report on any such approvals 
at the next regularly scheduled meetings of the 
respective committees." 
Dr. R. Murray suggested that a sentence be added before the 
sentence beginning, "The Chairs will report...." which would read 
as follows: 
"The Chair of either committee may consult with one or 
more other committee members, if deemed necessary." 
Dr. R. Murray said this may not be self-evident and that he was 
sure the current Chairs would be doing this in any event, but 
that for future Chairs who may not have the same "democratic 
outlook" he suggested this sentence be inserted. 
Dr. McGarrity said he was completely comfortable with this and 
would support the inclusion of the additional sentence. 
Mr. Brewer said this proposed addition was developed to address 
the problem that, without such language, all changes would have 
to go through the entire process. With the limited number of 
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Recombinant DNA Research, Volume 14 
