Recombinant DMA Advisory Committee - 3/3-4/94 
Responding to Dr. Walters' question about compensation for research injuries, Dr. Hersh 
said that the revised language was suggested by the IRB of the Arizona Cancer Center. 
Any medical costs associated with toxic side effects of investigational drugs will be 
covered by the insurers or third party payers. Regarding the number of patients in the 
trial, Dr. Hersh said that 15 "evaluable" patients will be entered onto the study. 
Dr. Steven Kradjian of Vical responded to Dr. DeLeon’s question about the number of 
study sites. He agreed to submit a revised Points to Consider document that specifies a 
single site, the Arizona Cancer Center. Dr. Hersh said that a request for autopsy will be 
added to the Informed Consent document and submitted for IRB approval. 
Committee Motion 
A motion was made by Dr. Doi and seconded by Dr. DeLeon to approve the protocol 
contingent on review and approval of the following: (1) a revised statement in the 
Informed Consent document indicating that an autopsy will be requested in the event of 
death (including IRB approval), and (2) a revised Points to Consider document that 
specifically addresses a single site, the Arizona Cancer Center. The motion to approve 
the protocol passed by a vote of 13 in favor, 0 opposed, and no abstentions. 
There was a follow-up discussion on the issue of autopsy request. Dr. Vogelzang said 
that the statement was omitted from the Informed Consent document because he 
considered it improper to require patient autopsy for participation in the trial. Dr. 
Parkman explained that the RAC does not require an autopsy; however, it is 
recommended that a statement requesting autopsy should be included in the Informed 
Consent. Dr. Hersh agreed to coordinate with Dr. Vogelzang to have this statement 
included in the revised Informed Consent document. 
XrV. REPORT ON THE GENE THERAPY ADVISORY COMMITTEE (GTAC) OF THE 
UNITED KINGDOM/MR* TAYLOR 
Mr. Anthony Taylor, Secretariat of GTAC, United Kingdom, provided the RAC with an 
overview of the activities of this committee which is responsible for review of human 
gene transfer proposals in the United Kingdom. Mr. Taylor explained the origin of 
GTAC. GTAC was established following the recommendation of the Clothier 
Committee in 1991 that endorsed the concept that gene therapy should be considered as 
a mainstream approach to medical research and should be subjected to all the ethical 
considerations of medical research. This concept was endorsed at the parliamentary 
level in the United Kingdom and GTAC was established within the Department of 
Health to provide oversight of gene therapy research within the United Kingdom. 
GTAC will report on developments in gene therapy to the Secretary of State for Health. 
GTAC is chaired by Dr. Judith Lloyd, former Professor of Pediatric Medicine at the 
University of London. GTAC is composed of 16 members: 8 of whom possess expertise 
in the areas of medicine and science, and 8 who represent expertise in such areas as 
clinical psychology, genetic counseling, industry, law, ethics, nursing, and the media. He 
noted that one member is a leading British Broadcasting Company journalist. 
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Recombinant DNA Research, Volume 19 
