Human Gene Therapy Subcommittee - 11/30/90 
6. Provide a better description of the financial responsibilities of both the 
patient and the university in the informed consent document. 
Dr. Walters asked for further discussion on the stipulations as presented by Dr. 
Parkman. There were no further comments. He then asked for further discussion 
on the motion that the protocol be tabled pending submission of responses to the six 
stipulations. Dr. Kelley asked if the protocol would have to come back to the HGTS 
before going to the RAC if the six stipulations were met prior to the RAC meeting. 
Dr. Walters said the sense of the motion would require that it comes back to the 
HGTS for approval before being forwarded to the RAC for consideration. 
There being no further discussion. Dr. Walters called for a vote on the motion to 
defer consideration of the protocol. The motion passed unanimously by a vote of 11 
in favor, 0 opposed, and no abstentions. 
V. REGISTRY OF PATIENTS UNDERGOING HUMAN GENE THERAPY 
PROTOCOLS 
Dr. Anderson said that there is a computerized registry of patients undergoing 
human gene therapy protocols in the journal Human Gene Therapy. If the RAC or 
the FDA decided to maintain such a registry, this option is still available. Dr. Zallen 
asked whether this guaranteed that other unaffiliated groups would be submitting 
their patients to the registry. Dr. Anderson said there were no guarantees. Dr. 
Zallen then asked that consideration be given to establishing a registry through a 
centralized group which has knowledge of the experiments in progress. Dr. Walters 
said this item would be put on the agenda for the next meeting of the HGTS for 
discussion. 
VI. FUTURE ROLE OF THE HUMAN GENE THERAPY SUBCOMMITTEE 
Dr. Walters asked Mr. Capron if he could delay discussion of the issues he raised in 
his November 26, 1990, letter regarding the future of the HGTS. Mr. Capron 
agreed since it was received too late to be published in the Federal Register and no 
action could be taken on it by the HGTS. Dr. Walters suggested a group of three to 
four members be appointed to look at the issues raised in the letter and to attempt 
to categorize proposals into those which should be reviewed by the HGTS and those 
which should not be considered. 
Dr. Kelley said a general discussion of these issues was in order so that any such 
group had a feel for the consensus of the entire HGTS relative to these issues as a 
beginning point for their discussions. Mr. Capron concurred. Dr. Childress said that 
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