Human Gene Therapy Subcommittee - 11/30/90 
Dr. R. Murray said he had concerns about procedural matters, exclusionary 
questions, and issues regarding payment for therapy. He said the investigator had 
answered most of these questions. The issue of payment for experimental therapy 
offering no benefit to the patient was lessened because there is a potential for 
therapeutic response. However, the issue of injury still remains. The investigator 
needs to clarify the issue that patients may be asked to pay for the processing of the 
TIL cells based on a therapeutic response. Dr. R. Murray requested comments from 
the ethicists on the HGTS in regard to the exclusion of pregnant females. 
Mr. Capron called attention to inconsistencies in the protocol due to typographical 
errors. Dr. Lotze said that in preparing the Points to Consider, there were several 
errors as a result of having different people supplying responses for the document. 
Dr. Walters asked if the revised consent form, which was a result of the 
investigator's responding to Ms. Areen's concerns, is the corrected version. Dr. 
Lotze agreed. 
Dr. Erickson said he was amazed that there was so little mention of the study of 
TILs in the protocol and asked for further comments concerning the mechanism of 
TIL activity. 
Mr. Capron brought up questions relating to the informed consent document. Is it 
standard procedure to list all staff who may possibly take part in the experiments on 
the first page of such a document. Further, why is the patient required to initial 
every page. The main purpose of the informed consent document is to inform the 
patient of the possible risks/benefits of a procedure, and not to create a complex 
legal document. The purpose of the protocol should be simple and clear. 
Dr. Childress said that issues in the consent document such as confidentiality and 
right to withdraw are scattered throughout the document. These sections should be 
pulled together to clarify the intent and to make it easier to read. Dr. Zallen agreed 
with Dr. Childress and noted several other inconsistencies in the document. 
Dr. Mclvor said that the investigators has not provided definitive results on whether 
gene tagging can be used to determine TIL homing to tumor. Therefore, a primary 
question before the HGTS is whether there should be two protocols in process 
simultaneously using gene marking to follow TIL homing to tumor. Dr. Parkman 
said that unless Dr. Rosenberg had changed his technology, the question of 
contamination by peripheral blood versus homing has not be answered. Dr. 
Parkman asked the investigator if he would technologically address this issue in a 
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Recombinant DNA Research, Volume 14 
