Human Gene Therapy Subcommittee - 11/30/90 
Therefore, any carcinogenic event in a patient with leukemia could be statistically 
related to therapeutic efforts at treating the leukemia, rather than the insertional 
mutagenesis as a result of this protocol. Risk should be determined in people who 
are treated for cancer, but who are not leukemic. Therefore, the source of the new 
cancer could be more readily determined. 
Dr. Parkman said that research in animals as well as humans has shown that total 
body irradiation poses a risk of developing cancer. Even if a patient has a 
recurrence and the marked gene could be found, it would not scientifically prove the 
insertion of that gene was causative for the particular cancer. 
Dr. Epstein said that there were two issues involved in the consent form: (1) 
problems that are likely to arise from therapy, and (2) who will be financially liable 
for any research related problems. 
Dr. Epstein said this consent form places the burden on the patient to ensure the 
hospital bill is paid, rather than telling the patient that if there is a problem in 
payment after undergoing the protocol, the hospital will provide the care at no costs. 
The document clearly points out that the treatment offers no benefit to the patient, 
and there are potential risks to the patient. Further, it states that the patient's 
insurance may not cover the treatment, therefore, the patient must assure the 
hospital of payment. He asked the investigators if there would be any incentive for 
the patient to participate in such a protocol. 
Dr. Kelley asked if the wording for the consent document was taken from the 
standard transplant protocol. Dr. Parkman said that in his experience insurance 
payment authorization must be approved before any transplant takes place. This 
language may have been placed in the document to cover the possibility of an 
insurance company rescinding its original authorization based on this post-transplant 
experimental procedure. 
Mr. Capron pointed to the fact that traditionally research is conducted without cost 
to the patient, and that this consent form reflected a greater regard for money than 
for life or well being. Dr. Childress said that participation was being sought for 
research without medical benefit to the patient, with minimal risks to the patient, 
and with the patient bearing the costs of the research. The informed consent 
document does not clearly explain these issues to the patient. 
Dr. R. Murray said that he was concerned about the possible benefits that might be 
derived from this treatment. If the patient is expected to pay for the treatment, 
there should be a very high likelihood of benefit to the patient. Dr. Zallen said that 
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