Recombinant DMA Advisory Committee - 5/30-31/91 
which are likely to be submitted in the future. 
Dr. Walters said that he felt the last meeting of the subcommittee was one of the best they 
had in terms of review from both the technical and ethical standpoints and he said he was 
stunned when shortly thereafter he received the memorandum from Dr. Anderson which 
outlined his proposal to abolish the HGTS. 
Dr. Kelley said that as long as the two committees have different functions it is inevitable that 
one should be more informed than the other. He said that otherwise the process would be 
redundant. He said he felt more scientific expertise was needed on the HGTS as the numbers 
of protocols coming before it increases. 
Dr. Atlas said that being asked to review a protocol and not having the minutes of the 
subcommittee review leads to ambiguity and that he felt a mechanism was necessary for being 
able to have this information available to the reviewers. Further he said he was concerned 
that when lay people and the public are asked to serve a role on the committee that they not 
be totally indoctrinated by their scientific colleagues and therefore the role of the 
subcommittee should continue to be aimed at a more technical approach to the review of 
these protocols and that a somewhat different review be undertaken by the RAC which would 
encompass the public viewpoint as well as the detailed scientific protocol review which has 
taken place in the subcommittee. 
Dr. Gellert suggested that the minutes of the subcommittee be circulated to the members of 
the RAC before each meeting so that they could be used as a refresher as to the issues 
considered by the subcommittee. Dr. Wivel noted that when the meetings are only 4-6 weeks 
apart this provides a problem for being able to obtain the minutes for these meetings in time 
for the RAC meeting. He suggested that the unedited transcripts could be provided, but 
noted that they were quite lengthy. Dr. Walters said he felt that the RAC reviewers should 
be provided those sections of the transcripts which pertain to the protocol that they are 
assigned to review if they were unable to attend the subcommittee meeting. Dr. Mclvor said 
that perhaps the person who did the review at the subcommittee meeting could provide a 
synopsis of his review for the RAC reviewers in the form of a single-page letter. 
Dr. McGarrity noted that a more taxing problem for the reviewers is the last minute 
submission of information on protocols which often times arrives right up to the morning of 
the RAC meeting. He asked if there should be a deadline put in place for materials coming 
in for the RAC meeting. Dr. Anderson said he was not in favor of such a deadline because 
in many cases it would mean that the reviews would take place without having the most 
current data available for review. Dr. Gellert said that he felt that by having data coming in 
until the last minute made it difficult to write reviews beforehand and that he felt there should 
be some time set beyond which the information would not be considered. 
Ms. Buc said there were disadvantages to setting a deadline. One was that important 
scientific information may not be available in time. Secondly, it puts investigators who are 
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Recombinant DNA Research, Volume 14 
