Recombinant DNA Advisory Committee - 2/10-11/92 
Committee motion 
Dr. Doi moved that Dr. Cometta's protocol be approved; Ms. Buc seconded the motion. 
Dr. Geiduschek proposed an amendment to change the wording in the informed consent 
document regarding the financial responsibility of the patient. The rewording would read, 
"I recognize that, despite the absence of personal benefit, the Indiana University Medical 
Center has placed upon me the legal obligation for any financial burden that might arise if 
emergency medical treatment is required as a result of my participation in this research 
protocol." Since Dr. Geiduschek wanted this stipulation required for approval, Dr. Wivel 
pointed out that the IRB at Indiana University has the final decision on what is in the text 
of the informed consent document. Dr. Gellert seconded the motion to amend the 
informed consent document. 
More discussion ensued regarding Dr. Geiduschek's amendment. Ms. Buc commented that 
there were several issues involved in the discussion. The first issue was prejudicial 
selection of participation in the protocols with only insured patients being entitled to 
enroll. The second issue was patient injury and the two questions it raised: (1) Who 
would perform and pay for the emergency medical care? and (2) What kind of 
compensation would the patient receive for pain and suffering? Another question was an 
inevitable outcome of this discussion; in the overall picture, how important is the section 
on informed consent? Ms. Buc said that she would respectfully disagree if the RAC 
should elevate this issue above all other concerns of risks and benefits. An informed 
consent document should be a balanced reflection of all of the different issues that go into 
a patient's decision. 
Dr. B. Murray called for a vote on Dr. Geiduschek's amendment to the protocol. The 
amendment was defeated by a vote of 2 in favor, 13 opposed, and 1 abstention. The vote 
was called on the original motion, which was to approve Dr. Cornetta's protocol. The 
motion to approve the protocol was passed by a vote of 15 in favor, 0 opposed, and no 
abstentions. 
XIII. PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES 
REGARDING A HUMAN GENE TRANSFER PROTOCOL ENTITLED: 
TREATMENT OF PATIENTS WITH METASTATIC MELANOMA AND RENAL 
CELL CANCER USING IN VITRO EXPANDED AND GENETICALLY-ENGINEERED 
(NEOMYCIN PHOSPHOTRANSFERASE) BULK CD8(+) AND/OR CD4(+) TUMOR 
INFILTRATING LYMPHOCYTES AND BULK CD8(+ ) AND/OR CD4(+ ) 
PERIPHERAL BLOOD LEUKOCYTES IN COMBINATION WITH RECOMBINANT 
INTERLEUKIN-2 ALONE, OR WITH RECOMBINANT INTERLEUKIN-2 AND 
RECOMBINANT ALPHA INTERFERON 
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Recombinant DNA Research, Volume 15 
