Recombinant DNA Advisory Committee - 5/30-31/91 
Dr. McGarrity noted that there were still many members who wished to ask questions but that 
for a number of reasons it was necessary to t^e the morning coffee break at this point. He 
asked the committee to reassemble at 10:45 a.m. 
Dr. McGarrity called the committee back to order at 10:45 a.m., and noted that during the 
coffee break Dr. Walters had asked to comment further on the informed consent document. 
He suggested that these comments should be entertained and that then the committee should 
try to come to some resolution on this protocol. 
Dr. Walters said he felt this informed consent document had done the best job of separating 
the gene marking study from the underlying therapy of any the committee had thus far seen. 
He noted that he had spoken with Dr. Murray and Dr. Deisseroth during the break and that 
he had three suggestions which had been agreed on by all parties: 
1. To change the title of the protocol to "Gene Marking of Bone Marrow Cells in 
Patients with Chronic Myelogenous Leukemia;" 
2. Place the paragraph which Dr. R. Murray had commented on relative to the 
participation in the study being optional and unrelated to the bone marrow 
transplantation protocol at the very beginning of the consent form so that 
patient could see and know that they can have the bone marrow transplantation 
without taking part in the gene marking study; and, 
3. Under "Purposes of the Study," to insert a phrase at the beginning of this 
section which would clarify the aim of the study by stating, 'To genetically mark 
cells in order to identify the origin of relapse." 
Dr. McGarrity said he felt the informed consent portion of the protocol had thus been taken 
care of and noted that he felt the technical algorithms and statistics had also been well 
described and that they showed that a positive result would be informative, while a negative 
result would offer no further information. 
Dr. Deisseroth said that this issue of the negative result was discussed with a few of the 
reviewers at the break and that after discussion they had come to the conclusion that if a 
negative result were obtained it was of more than no value. The probability of a negative 
outcome being due to an event other than relapse from the systemic circulation is very, very 
low that this also provides some information. 
Dr. Krogstad said that his conclusion was now that it might be reasonable to allow a finite 
number of patients to be tested and use the results from this finite group to clarify some of 
the issues brought up in this protocol. He said there were so many unknowns that it would 
be impossible to move ahead without having some human data. 
Dr. Haselkorn added that he felt the protocol should contain positive controls on all samples 
Recombinant DNA Research, Volume 14 
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