Human Gene Therapy Subcommittee - 11/21-22/91 
purging procedures have any positive outcome. He stated that he did not want to 
include purging as another variable in this protocol; purging effects will be examined 
after results of this study have been acquired. 
Dr. Parkman stated that Dr. Cometta's protocol is designed to answer some of the same 
scientific questions as Dr. Brenner's protocol; however, there are several differences, 
including the different patient population. Therefore, Dr. Parkman encouraged the 
HGTS to consider this protocol in addition to Dr. Brenner's since both studies would 
yield valuable information regarding leukemic relapse. Dr. Leventhal agreed with Dr. 
Parkman because this protocol poses no additional research-related risk to the patient. 
Dr. Leventhal noted that because the efficiency of marking is extremely low in terms of 
detection, this type of marking would not be a good technique for evaluating the 
effectiveness of purging. 
Dr. Miller was concerned that patients will be required to pay for medical costs incurred 
as a result of untoward research-related injury. Dr. R. Murray added that the RAC had 
discussed this issue previously. In previously approved protocols, the researchers have 
always changed the compensation clause to state that complications arising from the 
research would be covered by the institution. Dr. Cometta noted that Dr. Lotze from 
the University of Pittsburgh received approval from the HGTS and the RAC with similar 
language. Mr. Capron stated that the entire biomedical research system has never 
required institutions to compensate patients for untoward injuries resulting from 
research, excluding negligence. Dr. Miller added that the difference between traditional 
research protocols and gene transfer protocols is that the transfer protocols offer no 
therapeutic benefit to the patient. Dr. Walters suggested that the HGTS refer this issue 
to Dr. Healy, the Director of NIH, since this issue is unresolved. 
Dr. Mclvor said that since there is the possibility that the marker gene will not be 
detected in the patient, a sentence or clause should be included in the informed consent 
document that informs the patient that it is possible than no new information will be 
obtained at all. This clause should be added: "Although there is no guarantee that the 
research will produce useful information...." 
Subcommittee Motion 
A motion was made by Dr. Parkman and seconded by Dr. Gellert to approve Dr. 
Cometta's protocol with the following stipulations: (1) include the following sentence in 
the informed consent document: "It is possible that the study may lead to improved 
bone marrow transplantation therapy for others in the future, although it is also possible 
that no new information will be gained at all," and (2) submit in vitro data demonstrating 
that transduced leukemia cells survive the freezing process. 
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