Recombinant DNA Advisory Committee - 
one revision which he suggested, which was that the informed consent document include 
the following statement: 
"I understand that while useful information might be generated from my 
participation in this study, it is also possible that no information will be 
generated.” 
Dr. Carmen seconded the motion. 
Dr. Walters asked whether the investigators had accepted the addition of the 14-year 
follow-up to the assent document, or whether it was necessary to include this in the 
motion. Dr. McGarrity asked if Dr. Mclvor would include this in his motion. Dr. 
Mclvor said he was agreeable to this friendly amendment. Dr. Carmen also concurred. 
There being no further discussion on the motion. Dr. McGarrity called for a vote on the 
motion. The motion passed unanimously by a vote of 16 in favor, 0 opposed, and no 
abstentions. 
Dr. McGarrity asked for guidance from the committee on how they wished to proceed 
with the afternoon's agenda in as much as they had received the revised protocol via 
FAX from the University of Pittsburgh. Dr. Gellert said that since the reviewers had just 
received the document, time did not allow for an adequate informed review of the 
revised protocol while still completing the rest of the agenda. Dr. Lotze said there were 
only five minor points, and that he had underlined them all in his copy. It would require 
five minutes or so to go over them. Dr. Schaechter believed it was worthwhile to try to 
attempt to resolve the five questions and suggested scheduling a coffee break, during 
which time the reviewers could sit together and possibly come up with some consensus. 
Dr. McGarrity wanted to be fair to the investigators on this protocol, but also believed a 
thorough review was imperative. If this was possible, without jeopardizing the rest of the 
afternoon's agenda, that he agreed to call for a short coffee break during which time the 
reviewers could meet and discuss the revised protocol. Dr. Wivel noted that Conference 
Room 9 would be available for the primary reviewers to use if they wished. Dr. 
McGarrity called for a brief recess and asked the committee members to reassemble at 
2:10 p.m. 
Dr. McGarrity called the committee back to order at 2:10 p.m. and asked Dr. Gellert to 
give the group a sense of the discussions that had taken place relative to the revised 
protocol. 
(Cont'd) PROPOSED ADDITION TO APPENDIX D OF IHE "NIH GUIDELINES" 
REGARDING A HUMAN GENE TRANSFER PROTOCOL ENTITLED "THE 
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