Recombinant DNA Advisory Committee - 5/30-31/91 
that this was clearly stated and consistent for all patients. 
Dr. Leventhal then turned her attention to the informed consent document. She said that in 
Section Four she didn't feel it was fair to tell the patients that the virus being used for the 
marking vector was "extensively studied" or that it was being used for "treatment" of patients, 
since neither of these was correct in her view. She said the paragraph which currently states, 
"Extensive study of this virus marking procedure has been imdertaken in mice, monkeys and 
humans," should be changed to read: 
"This virus marking procedure has been studied in mice and in monkeys. This 
same virus, and a virus like it, are now being used in studies in patients here 
and at other institutions. No adverse effects have been observed in all of this 
study because the vector is modified so that it cannot cause an infection in the 
cells of the body. It only marks a small number of blood cells in the autologous 
marrow." 
Dr. R. Murray said he did not have prior problems with the technical aspects of the protocol 
and he said his review would primarily be directed at the consent form. He said he had a 
problem with separating the therapeutic aspects of the protocol from the experimental aspects 
of the protocol. He said he had suggested earlier that the paragraph titled "Alternative 
Procedures and Treatments" be deleted and a paragraph inserted entitled "Intents of Therapy" 
where patients could agree to participate in various aspects of the protocol individually. He 
said it appeared that if the patient signs the form as it now appears that they are agreeing to 
participate in everything. Furthermore some terms needed to be defined for the patients. He 
said the term "autologous" could be changed to "your own cells," and the term "drug regimen" 
made the protocol sound as if it were therapeutic. He also pointed out that he was confused 
by the meaning of the sentence which states, "The use of marked cells to identify the sources 
of relapse may be of benefit to patients on future protocols, but this research has only a small 
chance to be of immediate benefit to you." He said this was confusing and should be clarified. 
On the whole, he said he felt the revised consent form was better than the original but he said 
it still needed some refinement. He also noted that Mr. Alexander Capron had reviewed this 
same protocol and mentioned these same issues in his letter in reference to the consent form. 
Dr. Mclvor said that he wanted clarification that after culturing these colonies it was 
impossible to distinguish between normal and blast colonies, since this is a distinction in this 
protocol from the AML protocol which was approved at the prior RAC meeting. He said he 
also wanted to know the percentage transduction rate that has been achieved thus far. He 
said the presence of BCR-ABL verifies that the colonies are leukemic but that since the 
investigators also hope that non-leukemic colonies will also be labeled he felt this needed to 
be based on the presence of something, rather than the absence of the BCR-ABL PCR 
product. He said this needed to be clarified since the aims of the protocol were twofold: one, 
to determine source of relapse; and secondly, the extent to which there is stem cell 
involvement in this process. He said the first aim seemed to be attainable with this protocol 
but said he felt the committee needed clarification on the second aim. Further, Dr. Mclvor 
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Recombinant DNA Research, Volume 14 
