Recombinant DNA Advisory Committee - 06/1-2/92 
Dr. Deisseroth noted that MD Anderson provides care to all patients, irrespective of 
their financial capability. Any resident of Texas has the right to receive the most 
advanced therapeutic treatment available at MD Anderson. 
Dr. Secundy noted that the tools and steps outlined by Dr. Deisseroth could easily be 
identified and stated clearly in the informed consent document. There is a concern that 
many of the patients eligible for the protocol have already been through the MD 
Anderson system, and some patients may be excluded who have not been enrolled in the 
system previously. Dr. Deisseroth responded that the system is not closed, and that 
patients come from all levels of society. Multiple visual and verbal communications are 
provided in addition to written documentation to ensure that all patients have a clear 
understanding of the background, procedures, and risks associated with the protocol. Dr. 
Secundy asked Dr. Deisseroth if he would include the steps described, i.e, the videotape, 
the conversations with the nurse practitioner, the various other steps, as part of the 
informed consent document? Dr. Deisseroth stated that he will provide the RAC and 
other interested parties with documentation of the systems that are in place at MD 
Anderson. Dr. Deisseroth stated that any committee member is welcome to observe the 
informed consent process at MD Anderson because it is a model institution that treats 
people from all levels for society. 
Dr. Parkman stated that the level at which the informed consent document is written is 
not uncommon for patients undergoing experimental bone marrow transplants at the 
Childrens Hospital of Los Angeles. Patients with this disease are well informed and 
educated about their disease because they have experienced many manifestations of their 
disease over the years. 
Mr. Barton reminded the RAC that it is its particular responsibility to review the 
portions of the informed consent documents pertaining to the gene transfer/therapy 
aspects of the protocol. He asked Dr. Deisseroth if the videotape discusses the gene 
therapy issues. Dr. Deisseroth responded that the videotape does not cover these issues. 
Dr. Dronamraju asked Dr. Deisseroth the approximate percentage of his patients who 
are non-English speaking? Dr. Deisseroth stated that about 30% of his patients do not 
speak English. Dr. Dronamraju inquired as to whether or not this document could be 
written in simpler, less technical terminology. Dr. Deisseroth responded that if he uses 
this approach, than the patients would not be informed adequately. 
Dr. D. Miller returned to discussion of the scientific aspects of the protocol. He asked if 
the investigators were looking for contaminating blasts in peripheral blood and bone 
marrow cells. Are they screening by PCR for BCR-abl recombination? This procedure 
would provide a sensitive assay for the number of blast cells contributing to 
reconstitution. This strategy could be used to determine if the purging techniques are 
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Recombinant DNA Research, Volume 15 
