Recombinant DNA Advisory Committee- 9/12-13/94 
In his review of approved protocols, Mr. Capron noted a discrepancy in the number of 
gene marking protocols that was approved by the RAC and that by the NIH Director. 
The total should be 24 for both approvals. 
II. CHAIR REPORT ON MINOR MODIFICATIONS TO NIH-APPROVED HUMAN GENE 
TRANSFER PROTOCOLS/DR WALTERS 
Dr. Walters stated that 10 minor modifications were approved to the following human 
gene transfer protocols since the June 9-10, 1994, RAC meeting: 
DATE 
PROTOCOL# 
INVESTIGATORS 
6/23/94 
9206-018 
Malcolm Brenner 
7/05/94 
9312-059 
Edward Oldfield, Zvi Ram 
7/11/94 
9306-043 
Hilliard Seigler 
7/11/94 
9306-048 
Jeffrey Galpln, Dennis Casciato 
7/11/94 
9312-062 
Richard Haubrich 
7/11/94 
9403-068 
Joseph Rosenblatt 
7/13/94 
9303-037 
Kenneth Culver, John VanGilder 
8/31/94 
9303-041 
Robert Wilmott, Jeffrey Whitsett, Bruce Trapnell 
8/31/94 
9212-035 
James Wilson 
8/31/94 
9303-038 
Helen Heslop, Malcolm Brenner, Qiona Rooney 
III. CHAIR REPORT ON ACCELERATED REVIEW OF HUMAN GENE TRANSFER 
PROTOCOLS/DR WALTERS 
Dr. Walters stated that the RAC and ORDA have approved the first human gene transfer 
protocol under the newly adopted Accelerated Review process. On August 3, 1994, 
NIH/ORDA approved the protocol submitted by Dr. Jonathan Simons, Johns Hopkins 
Oncology Center, Baltimore, Maryland, entitled: " Phase I/II Study of Autologous Human 
GM-CSF Gene Transduced Prostate Cancer Vaccines in Patients with Metastatic Prostate 
Carcinoma (Protocol #9408-082). Dr. Simons’ protocol was eligible for Accelerated 
Review under the category entitled: "Lethally Irradiated Tumor Cells/No Replication 
Competent Virus-RAC-approved vector constructs with minor modifications/additional 
tumor cells." 
IV. MINUTES OF THE JUNE 9-10, 1994, MEETING 
The RAC approved a motion made by Dr. Smith and seconded by Dr. Dronamraju to 
accept the June 9-10, 1994, RAC minutes by a vote of 17 in favor, 0 opposed, and 1 
abstention. 
V. DATA MANAGEMENT UPDATE/DR SMITH 
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Recombinant DNA Research, Volume 20 
