July 30, 1990, Hunian Gene Therapy Subconmittee 
forms to be specified." 
Ms. Areen seconded the motion. 
Dr. Epstein asked if Dr. Rosenberg could have the consent form amended by the 
following day for the meeting of the RAC to include any changes discussed during the 
day, as well as those mentioned in Mr. Capron's letter. Dr. Rosenberg agreed that he 
would work on the consent form and have an amended consent form ready by the time 
the RAC begins its considerations. 
Dr. Miller noted that if the subcommittee had concerns about local concentration effects 
that would cause unanticipated toxicity, that they urge a lowering of dose, or a decreased 
number of cells to be administered or a greater period between administration of the 
cells. He said that he felt the protocol was very conservative, but that any concerns 
should be quantitative in nature. These could be ameliorated by dose reduction, rather 
than by restricting or prohibiting the protocol. 
There being no further discussion, the motion was put to a vote. The motion passed by 
a vote of 13 in favor, none opposed and no abstentions. 
Whereupon, Dr. Walters called for a brief recess before continuing with the next agenda 
item. 
Dr. Walters reconvened the subcommittee at 3:40 p.m., and asked Dr. Leventhal to 
begin discussion of the next agenda item. 
Recombinant DNA Research, Volume 14 
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