Human Gene Therapy Subcommittee - July 29-30, 1991 
Dr. Mclvor said he would vote against the motion. The current structure facilitates 
responses to the investigators. Often protocols are approved with provisions by the 
HGTS and then forwarded to the RAC. If those provisions are met, the protocol can 
be approved within a period of two months. As it currently stands, the system works. 
The suggestion to the RAC to consider merging committees should be made at some 
time in the future. 
Dr. Leventhal said perhaps the HGTS should ask the RAC to consider ways of 
maximizing the efficiency of the review. For example, if a protocol passes the 
subcommittee unanimously with no concerns, it will not need RAC review. 
Mr. Capron noted that the HGTS had just voted to set up a working group to examine 
categories of research that would need less review. It could also examine the 
possibility of a category of protocols that will not need much review. Those protocols 
would go to the next scheduled meeting of the RAC or HGTS. Perhaps, this motion 
could be folded into that resolution. Dr. Erickson said he would withdraw his motion 
if the seconder would withdraw with the idea that working group will look at this issue. 
Dr. Walters said that this was a retroactive friendly amendment to Mr. Capron's 
motion from the last agenda item. The amendment is an elaboration of what the 
working group will examine. 
Dr. Walters suggested two proposed working groups. He stated that if members have a 
strong interest in either of these topics, they are welcome to join either of the working 
groups. The first working group wfil: (1) examine the efficiency of the total review 
process, (2) examine the relationship of the subcommittee to the RAC, (3) classify the 
types of experiments that do not need full-fledged review, and (4) examine the HGTS 
system for reviewing the progress of protocols. Dr. Leventhal will chair this first 
working group, and Drs. D. Miller, Mclvor, and Erickson will be members of this 
working group. Tlie second working group will look at the question of germ line 
genetic intervention. Dr. Parkman will chair this working group, and Mr. Capron and 
Drs. R. Murray and Zallen will be members of this working group. 
VII. PROPOSED ADDITIONS TO APPENDIX D OF THE NIH GUIDELINES 
REGARDING TWO HUMAN GENE THERAPY PROTOCOLS ENTITLED; 
IMMUNIZATION OF CANCER PATIENTS USING AUTOLOGOUS CANCER 
CELLS MODIFIED BY INSERTION OF THE GENE FOR TUMOR NECROSIS 
FACTOR AND IMMUNIZATION OF CANCER PATIENTS USING AUTOLOGOUS 
CANCER CELLS MODIFIED BY INSERTION OF THE GENE FOR INTERLEUKIN- 
2 
Dr. Parkman said the investigators propose to isolate tumor cells from patients who 
have advanced tumors that have failed standard chemotherapy and who have a limited 
life expectancy. The isolated tumor cells will be grown in short-term culture and 
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Recombinant DNA Research, Volume 14 
