June 1, 1990, Human Gene Therapy Subcommittee Minutes 
subcommittee would have in dealing with this confidentiality. Dr. Anderson said if the 
material could be provided to a subcommittee of the HGTS and then that 
subcommittees reports on the data, it should not interfere with the confidentiality. Dr. 
Mclvor asked whether the material could be presented in hard copy. Dr. Anderson said 
all he had was the letter, and the subcommittee could not require someone in a foreign 
country to do anything. Dr. Mclvor noted that this was a collaborative study that was 
part of the proposal being considered. Dr. Epstein said without hard data he was less 
likely to believe an approval would be forthcoming from the subcommittee. Dr. Walters 
said that Dr. Wivel could write a letter to Dr. Bordignon indicating the importance of 
the data along with a request to submit numbers and graphs so that the review could go 
forward. Dr. Anderson volunteered to do it. 
Dr. Epstein said he felt it was necessary to include a date for receipt of the additional 
materials in the motion, and it was determined that all materials were to be provided by 
July 16, 1990. 
Dr. R. Murray called the question on the motion. Dr. Walters asked Dr. Epstein to 
repeat the motion. Dr. Epstein once again presented the motion including the 8 provisos 
and the date of receipt of materials. Dr. Parkman suggested a ninth proviso be added to 
include biological outcome measures. Dr. Epstein accepted this as a friendly 
amendment. 
Whereupon, there being no further discussion on the motion. Dr. Walters called for a 
vote on the motion. The motion passed by a vote of 14 in favor, zero against, and no 
abstentions. 
Dr. Leventhal volunteered to review the assent forms since she has experience in this 
field. Dr. Walters asked for other volunteers and he appointed a committee of Drs. 
Murray, Zallen, Childress, Leventhal, and Mr. Brewer to review the assent forms. He 
also appointed a committee made up of Drs. Mclvor, Parkman, Kelley, Mulligan, and 
Neiman to review the Milan data. 
Dr. Anderson thanked the subcommittee for their extremely conscientious and superb 
review, but said the investigators were concerned that the RAC could not meet at a date 
sooner than October 7, 1990. He suggested having the RAC meet the same day as the 
subcommittee as he felt the rest of the review would not take long and would afford the 
subcommittee plenty of time to accomplish their tasks. Dr. Mclvor suggested that Dr. 
Parkman be made a consultant to the RAC for this meeting. Dr. Wivel said he 
anticipated a split meeting, much in the same fashion as had been done previously. 
Dr. Walters suggested moving the date for submission of materials up an additional week 
to allow for review of materials before the July 30 date. He asked if the investigators 
could have the revised protocol and all materials submitted by July 2, 1990. Dr. Blaese 
Recombinant DNA Research, Volume 14 
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