Recombinant DNA Advisory Committee - IjAj'iX 
Dr. Walters said that when the protocol was approved by the HGTS, one of the 
stipulations was to include the definition of how the homing experiments were to be 
carried out. A revised informed consent form was to be supplied and this was to include 
the following changes: 
1. That a list of co-investigators and associate investigators be deleted from 
the informed consent document; 
2. That the investigator add, at the beginning, a statement of the purpose of 
the study, highlighting that there will be gene marking of some of the cells 
that will be infused into the patient with an emphasis on what is different 
in this case from the kind of therapy that otherwise would be given; 
3. Editorial changes in the discussion of the issue of confidentiality; 
4. Editorial changes in the discussion of the issue of long-term withdrawal 
from the protocol to include the patient's right to withdraw, but also 
stressing the importance of staying with the study on a long-term basis; 
5. Removal of an error introduced by word processing which caused two 
sentences to be juxtaposed relating to potential side effects; and, 
6. Clarification of issues as to what the patients would be paying for and what 
costs would be borne by the study, as well as any additional costs which 
may accrue to patients as a result of their participation in the experimental 
portion of the study. 
Dr. Walters noted that the subcommittee had given approval for the proposal to come 
directly to the RAC via the primary and secondary reviewers for the subcommittee. 
Dr. Mclvor asked if Dr. Walters found the methodology for the homing experiments to 
be sufficiently clarified. Dr. Walters had not seen anything written that updated the 
protocol in any way, and he supposed that the investigators would be addressing this in 
their comments. 
Dr. Geiduschek said that despite the fact that only a small portion of this protocol came 
directly under the auspices of the RAC, it was important that the investigators 
appropriately inform the patients that the gene marking aspect of the protocol is of no 
conceivable benefit to the patient. Further, it appeared that the patients were defraying 
a substantial portion of the cost of the study. He was worried about the long-term 
consequences of allowing such a protocol to go forward without more detailed 
consideration by the committee. 
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Recombinant DNA Research, Volume 14 
