Recombinant DNA Advisory Committee - 10/7-8/91 
presented orally at a HGTS meeting that were not in prior written 
submissions to ORDA. 
3D. If a protocol is deferred, the summary of the prior discussion, along with 
minutes of the meeting, will be submitted to the HGTS prior to its next 
review of the protocol. 
3E. Once a protocol has been fully or provisionally approved by the HGTS, it 
will be placed on the agenda at the next meeting of the RAC, whose 
members will be provided with any summary statements of the HGTS's 
consideration of the protocol, relative minutes, and the written material 
submitted by the principal investigator to cover points presented orally. 
Dr. Geiduschek seconded the motion. 
Dr. Leventhal proposed, with respect to her working group's activities, that the term 
gene transfer be replaced by "follow-up the protocols already approved." Mr. Capron 
said he would substitute the phrase "follow-up the human subject protocols already 
approved." 
Dr. Post said that Mr. Capron’s suggestions would help the relationship between the 
RAC and the HGTS, but asked why they should freeze the discussion for a year. Dr. 
Post proposed that this motion taken up at the next RAC meeting after the 
recommendations from Dr. Leventhal's and Dr. R. Murray's working groups. 
Mr. Capron suggested that the phrase "during the coming year" be changed to "pending 
taking actions." 
Dr. Anderson expressed his concern that the primary area of attention is shifted from 
what is best for the development of the field of gene therapy to having the best 
bureaucratic procedure. The point is that there really is no need for two separate 
reviews. 
Dr. Leventhal said that the RAC would very much like to make it easier for the 
investigator to understand, in a timely fashion, what comments had been made at the 
meeting. The charge of her working group is to develop a regular format for follow-up 
and feedback of active protocols. However, the RAC needs to be considerate of the 
investigators and not subject them to an overabundance of reporting. The second charge 
of the working group is the possible development of categories of protocols will exist that 
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