Human Gene Therapy Subcommittee - 7/30/90 
possible to present it for consideration. 
Dr. Walters said this issue was as yet unresolved and the 
subcommittee would have to discuss this further. 
5. That proceeding to Phase 2B of this protocol would 
require approval bv the IBC and IRB: 
Dr. Walters said this was covered in the revised protocol. 
6. That full data from the Milan experiments and anv 
related data be provided for review bv a worlcina group 
of the subcommittee prior to a meeting of the RAC and 
that a formal review of those data be brought to the 
RAC when this protocol comes up for approval? 
Dr. Walters said this would continue to be discussed by the 
subcommittee . 
7. That a final version of the inclusion/exclusion 
criteria reflect the parameters that were addressed in 
the subcommittee discussion. including age, length of 
time on PEG-ADA; and. 
Dr. Parkman said these criteria had been included in the revised 
protocol . 
8. That a specific protocol be provided for the follow-up 
evaluation of the immunological and clinical status. 
Dr. Walters said the protocol for long-term follow-up was revised 
and is on pages 61 and 62 of the revised protocol. 
Dr. Walters said this left three issues yet to be finalized: 
1. The consent form; 
2. The intraperitoneal route of administration; and, 
3. The Milan data. 
Dr. Anderson said that the investigators were very willing to 
incorporate comments made on the assent and consent forms and 
that he felt it was unnecessary to go into a discussion of those 
issues. He suggested, if the subcommittee wished, that the 
Chairman could provide a final judgment on whether these issues 
had been addressed and incorporated into the final forms. 
Recombinant DNA Research, Volume 14 
[ 67 ] 
