June 1, 1990, Human Gene Therapy Subcommittee Minutes 
6. "That full data from the Milan experiments be provided for review by a 
subcommittee of this committee 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. Parkman said it was his understanding that the HGTS would meet on July 30, 1990, 
the day before the meeting of the full RAC. Dr. Epstein said it could be brought back 
to the subcommittee at that time. Dr. Anderson requested that if the subcommittee 
were to approve the protocol, the RAC conduct a meeting prior to the scheduled 
October 7 meeting. Dr. Walters suggested the wording be changed to indicate that the 
review could take place either at the RAC meeting or the subcommittee meeting, 
whichever occurred first. 
Dr. Parkman said he viewed this as more an inclination of the subcommittee's position in 
regard to approval, or a temporary approval. He said that in order to give final approval 
the subcommittee needed to see the final document, both the protocol and consent form, 
and the Milan data. 
Dr. Leventhal suggested that all information be delivered at least two weeks prior to the 
subcommittee meeting to Dr. Parkman so that he can ensure that the verbal replies 
given by the investigators at this meeting are incorporated into the final documents. Dr. 
Leventhal said this would mean the final documents would have to be to Dr. Parkman by 
July 13, 1990. 
Dr. Epstein said two more provisos were in order to go along with his motion, which 
would be the following: 
7. "That a final version of the inclusion/exclusion criteria reflect the parameters that 
were in the discussion, including the age and length of time on PEG- AD A; and, 
8. "That a specific protocol be provided for the follow-up evaluation of the 
immunological and clinical status." 
Dr. Parkman seconded the motion. 
Dr. Kelley said he would offer a friendly amendment, to change the final sentence in the 
sixth requirement to read, "Milan and related data...." so as to allow the investigators the 
opportunity to provide other data to support their hypothesis as well as the Milan data. 
Dr. Epstein accepted this amendment. 
Dr. Childress noted that in Dr. Bordignon's letter he had stated that the material is 
unpublished and should be considered confidential. He asked what problems the 
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