Human Gene Therapy Subcommittee - 4/5/91 
Dr. Leventhal mentioned that she and Dr. R. Murray had comments about the consent 
form. Dr. Leventhal recommended the protocol be approved but wished to relate the 
consent form changes to Dr. Deisseroth. 
Ms. Meyers stated that the consent form would not be understandable to a layperson and 
needed clarification as to which costs the patient would bear. 
Dr. R. Murray said his lack of expertise made it impossible for him to judge whether it 
was clearly demonstrated that the investigators could detect the neo gene in 300,000 cells 
using PCR. Since this was a "worst case scenario" calculation and quite probably the 
actual conditions will be better, the chances are that they will be able to make the 
detection. He deferred to people who work with this system. The variation from patient 
to patient could present a problem if only ten patients are studied. Dr. R. Murray felt 
the informed consent form was inadequate with respect to hazards of chemotherapy that 
are within the experimental part of their protocol. Also, technical terms are included 
that could confuse the patient. He said that he had sent his suggestions to the 
investigators and felt the form was greatly improved, particularly in reducing the 
technical terminology to simple language. However, he questioned whether the language 
level was appropriate for an eighth grade education. 
Mr. Capron said that the consent form remained inadequate. Dr. Deisseroth's attempt 
to respond to Dr. R. Murray's suggestion to replace "autologous cells" with the phrase 
"your cells" introduces a problem of second person and third person. He wondered if the 
problem of the consent form is reflective of a larger problem that needs to be addressed 
in the protocol itself. Simply stated, what happens as one has side-by-side an 
investigational treatment and an investigational means of assessing the effect of the 
treatment. The only way to make this protocol clear is to have two separate 
descriptions. There should be a description of the therapeutic agents and their risks and 
benefits, and a separate section describing the method of assessing the origin of relapse, 
how that will be achieved, and its risks and benefits. 
Dr. Walters said that while the gene marking protocols probably arose as amendments to 
existing clinical protocols, there should be a separate consent form that simply states, 
"This is a separate component of an ongoing study, and this really doesn't have anything 
to do directly with your treatment." 
Mr. Capron emphasized that the treatment is itself an experiment. There are concerns 
about describing an experiment as a treatment. It should be clear to the patient that the 
treatment is performed with the hope that something of benefit will be learned. 
Dr. Parkman said that clinical researchers like to avoid taking the patients multiple 
consent forms as it is preferable to have one consent form that covers everything. 
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Recombinant DNA Research, Volume 14 
