AU VUUi 
Recombinant DNA Advisory Committee - 06/7-8/93 
would abstain from voting on this protocol. Dr. Post noted his intention to abstain from 
voting on this protocol due to a conflict of interest. 
Committee Motion 
A motion was made by Dr. Parkman and seconded by Dr. Miller to approve the protocol 
contingent on the submission of a revised Informed Consent document including the 
following: (1) a recommendation that contraception be used by males as well as females, 
(2) a request for autopsy in the event of death, and (3) an explanation of long-term 
patient follow-up. The motion passed by a vote of 14 in favor, 0 opposed and 4 
abstentions. 
XIV. CLOSED SESSION FOR EXPEDITED REVIEW OF A HUMAN GENE TRANSFER 
PROTOCOL 
A closed session of the full RAC was held to provide an in-depth review of the May 11, 
1993, expedited approval by the NIH Director of a human gene transfer protocol 
submitted by Drs. Ivor Royston and Robert Sobol of the San Diego Regional Cancer 
Center, San Diego, California. Approval was granted for additional treatments using a 
new retrovirus vector, GlNaCvi2. The RAC concurred with the recommendations of the 
intramural and extramural reviewers and the NIH Director's decision to approve the 
expedited review protocol. 
In open session the following day, Dr. Walters summarized the committee motion on 
Drs. Sobol and Royston's protocol and read a statement prepared by the RAC regarding 
expedited review procedures. 
"The RAC recommends that ORDA urge Principal Investigators to provide timely 
notice when considering a minor modification to a previously approved protocol 
or a request for expedited review. This recommendation is intended to facilitate 
patient care and the quality of the review process." 
XV. AMENDMENT TO SECTION IV-C-3-c OF THE NIH GUIDELINES REGARDING 
PUBLICATION OF THE RECOMBINANT DNA TECHNICAL BULLETIN AND DATA 
MANAGEMENT OF THE NIH-APPROVED HUMAN GENE TRANSFER 
PROTOCOLS/MS. WILSON 
Ms. Wilson proposed to discontinue publication of the Recombinant DNA Technical 
Bulletin ( Bulletin ) on the basis that most of the information is duplicated elsewhere. 
RAC meeting minutes are currently published in the Journal of Human Gene Therapy 
(Mary Ann Liebert, Inc.). Federal Register notices, including proposed and major actions 
to the NIH Guidelines , are distributed through ORDA to IBC Chairs, RAC members, 
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Recombinant DNA Research, Volume 17 
