report of ongoing experiments to demonstrate the 
N2 infected cells were representative of the major 
group of uninfected TIL cells; and (3) the 
informed consent form be revised. 
July 5, 1988 
First mailing to Human Gene Therapy Subcommittee 
by ORDA. 
July 13, 1988 
Review of proposed amendment by NIH IBC with 
approval conditional upon RAC approval and receipt 
of results from preliminary work in vivo in the 
mouse . 
July 13, 1988 
Formal submission of proposed amendment to ORDA by 
Drs. Anderson, Blaese, and Rosenberg. 
July 18, 1988 
Second mailing to Human Gene Therapy Subcommittee 
by ORDA. 
July 29, 1988 
Human Gene Therapy Subcommittee review of proposed 
amended protocol and discussion with investigators 
which resulted in the Neiman motion to defer 
approval being accepted unanimously and agreement 
by the Subcommittee to review any additional data 
submitted by September 15, 1988. 
Sept 16, 1988 
Submission of additional data to Dr. McGarrity by 
Drs. Anderson, Blaese, and Rosenberg. 
Sept 20, 1988 
Mailing of additional data to members of the Human 
Gene Therapy Subcommittee. 
Sept 29, 1988 
Conference call by members of Human Gene Therapy 
Subcommittee and consultants with unanimous 
judgment to defer approval reached by members and 
consultants to be presented at the October 3, 
1988, RAC meeting. 
In reporting on the July 29, 1988, meeting of the Subcommittee, 
Dr. Walters said the Human Gene Therapy Subcommittee wrestled 
with the issue of whether the protocol was, in reality, human 
gene therapy and whether it fell under the jurisdiction of the 
RAC and its Human Gene Therapy Subcommittee. After deliberation, 
it was decided the protocol was "very similar to human gene 
therapy," and that the Subcommittee should review it. 
Dr. Walters said the Subcommittee unanimously approved a motion 
made by Dr. Neiman as follows: 
"consideration of the protocol be deferred until animal 
model testing is completed to include: 
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