Recombinant DNA Advisory Committee - 2/4/91 
Dr. Mclvor said the question then before the committee was whether or not it was 
possible to undertake an adequate scientific review of the proposal with the material 
submitted. 
Dr. McGarrity asked for a recommendation from the floor, either in the form of a 
motion or in the form of friendly advice, in order to come to closure on this agenda 
item. 
Dr. Anderson regretted that he had not thought to ask Dr. Lotze if he had received the 
comments from the HGTS meeting. Dr. Anderson noted it was the expressed intent of 
the subcommittee that a revised protocol be available for the RAC to review. The 
revised protocol was available back in Pittsburgh. If there was a procedure in place 
whereby the protocol could be temporarily approved, pending a review by the primary 
and secondary reviewers of the revised protocol to ensure the verbal statements had 
been carried over into the written version of the protocol. 
Dr. Gellert was confused by references to a revised protocol, and thought it was 
unfortunate that some sort of miscommunication had resulted in the revised protocol not 
being available for review. However, the committee had gotten into trouble before by 
approving a protocol and then taking a telephone vote to confirm informal agreements 
made at the meeting. Dr. Gellert then made a motion to postpone a vote on this 
protocol until such time as the revised protocol has been made available for review. 
This could be done by the next meeting of the RAC. 
Dr. B. Murray seconded the motion. She added that she was in attendance at the HGTS 
meeting, and that she believed it was evident that the subcommittee was asking that the 
revised protocol be made available to reviewers prior to the meeting of the RAC. 
Dr. Carmen asked what the consequences of a 4-month delay would be. Dr. Lotze said 
his primary concern was that a large group of investigators had been formed at the 
University of Pittsburgh, who were enthusiastic about working on the protocol. Further, 
patients had indicated an interest in receiving immunotherapy based on recent publicity 
in both local and national media. The investigators would move along with all other 
aspects of the protocol outside the purview of the RAC. He was concerned that this 
delay could result in preventing all the information being gleaned from these protocols 
due to the inability to perform the gene marking experiments. 
Dr. Atlas asked how many of the questions that were being asked dealt with portions of 
the protocol dealing with gene marking versus the question of IL-2/IL-4 administration. 
Dr. Walters read the motion made by Dr. Epstein at the November 30, 1990, meeting of 
the HGTS. His motion was stated as follows: 
Recombinant DNA Research, Volume 14 
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