Recombinant DNA Advisory Committee - 09/14-15/92 
Dr. ZaJlen asked questions regarding the informed consent for this protocol. Is the 
uninfected donor aware of the HIV status of the infected twin prior to reviewing the 
informed consent document? The recipient consent form states that there will be no 
costs assigned for the procedures associated with this study. It states that immediate 
medical care will be provided in the event of physical injury resulting from participation 
in this study; however, there is no provision for free medical care. She asked the 
investigators to explain the discrepancy. The donor consent form should clearly state 
that the donor will have to donate cells at three different times. 
Dr. Chase said that the protocol would provide useful information if the design was 
limited to several defined populations of patients rather than such a broad range of 
diagnoses. 
Dr. Walters noted that although the investigators have stated that patients are eligible 
for a similar protocol without the gene marking aspect, this option has been omitted as 
an alternative therapy in the informed consent document. 
As a follow-up to Dr. Zallen's comments regarding financial compensation for injury, Mr. 
Capron suggested that the investigators limit liability to non-negligent injuries so that the 
patients do not perceive themselves as waiving their rights to recover compensation if 
they are injured through negligence. Mr. Capron suggested revising the language in the 
informed consent document regarding this issue. 
Dr. Haselkom explained that the RAC recently reviewed another protocol involving HIV 
in identical twins that was submitted by investigators at Sloan-Kettering Memorial 
Cancer Center in New York. Would there be competition between investigators for the 
same groups of patients? 
Presentation--Dr. Walker 
Dr. Murray called on Dr. Walker to respond to the questions and comments of the 
primary reviewers and other members of the RAC. 
Dr. Walker addressed the issue of disease stage. Currently, there is a list of 
approximately 24 identical twin pairs that are eligible to participate in this study. 
Approximately one-half to two-thirds of these twins have expressed interest in entering 
this protocol if it is approved by NIH. The fact is that there are very few individuals that 
fulfill the criteria of this study. Therefore, it is not possible to study the various disease 
stages in a controlled manner. However, important information will be obtained 
regarding the efficacy of administering activated T cells. 
Dr. Walker explained that the concurrent protocol (approved by the National Institute of 
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