July 30, 1990, Human Gene Therapy Subcommittee 
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 working 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-un 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. 
Dr. Parkman raised the question of financing of therapy not incurred on site at the NIH. 
Dr. Anderson said this issue was being discussed at all levels at the NIH and that it 
impacts on a number of protocols. He said the Clinical Center Director's Office and the 
Bioethics Program Office were trying to determine appropriate wording and that it would 
be included in the consent and assent forms. 
Recombinant DNA Research, Volume 14 
[177] 
