Human Gene Therapy Subcommittee - 4/5/91 
Lotze said the insurance company would pay. Ms. Meyers requested that the consent 
form be rewritten to reflect this change. 
Dr. Mclvor said he would like to see evidence of the investigator's ability to quantitate 
gene sequences using PCR, before the protocol goes for final approval to the RAC. He 
suggested the subcommittee provisionally approve the protocol with this stipulation. 
Mr. Capron suggested Dr. Lotze add the word "non-negligent" in the "Compensation for 
Illness or Injury" portion of the consent form. He felt the current wording suggests that 
the patient has no recourse for injuries caused by negligence. 
Ms. Meyers asked if a suitable candidate for the study, but without insurance, will be 
excluded 
Dr. Lotze replied that when an experimental protocol is of unproven benefit, the issue of 
denying people access is less relevant. The issue of payment is one he takes very 
seriously and would have to be worked out on an individual basis. He has received 
assurances from the medical center that this protocol has a high priority, but this does 
not necessarily translate into payment for patients without insurance. 
Mr. Capron asked if the consent form could be modified to reflect that the patients are 
expected to provide insurance coverage for all payments. 
Dr. Lotze proposed two ways to modify the consent form: (1) to put a proviso in the 
consent document, "...or as otherwise determined by agreement between the institution 
and us", (2) to offer that certain portions of a consent document can be deleted by both 
the individual signing as well as the individual overseeing his signature. 
Dr. Parkman moved that the protocol be given provisional approval with the stipulation 
that the investigator or his collaborators provide the appropriate PCR assays, with the 
data represented with an internal control that deals with lymphocytes, and not merely a 
per gram weight assessment. 
Dr. Parkman stated that if the protocol dealt only with the marked TIL cells, there 
would be no costs associated with it. The portion of the protocol that dealt with IL-2 
and IL-4 would be covered. Therefore, if the protocol dealt with just the marked TIL 
cells in isolation, there would be no costs that would be attributable to the experimental 
portion of the therapy. Dr. Anderson pointed out that additional biopsies would still be 
necessary. Dr. Parlonan agreed that since the biopsies are required as part of the 
experimental portion of the protocol, they would not be covered by the patient's 
insurance. He suggested that it might be appropriate to have a separate consent form 
that deals only with the gene marking portion of the protocol and to make this a part of 
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