Recombinant DNA Advisory Committee - 06/1-2/92 
Dr. D. Miller moved to approve the protocol contingent on the following stipulations: 
(1) animal model toxicity data should be submitted in a tabulated format, (2) a section 
should be added to the protocol that describes a well devised plan detailing the criteria 
for stopping the protocol in the event that untoward effects are observed, and (3) 
revisions will be made in the informed consent document regarding the retroviral vector. 
Mr. Capron seconded the motion. 
The motion to approve the protocol passed by a vote of 19 in favor, 0 opposed, and 1 
abstention. 
Other Business 
Dr. Murray convened the afternoon session. She presented plaques to the outgoing 
members of the RAC: Drs. Bourquin, Kelley, Schaechter, and Mr. Barton. Dr. Murray 
thanked them for the expert advice that they provided to the RAC and commended 
them for their tireless efforts. 
VI. PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING 
HUMAN GENE TRANSFER PROTOCOLS ENTITLED (1) TREATMENT OF HIV 
INFECTION WITH TRANSPLANTATION OF GENETICALLY ALTERED 
SYNGENEIC PERIPHERAL BLOOD LYMPHOCYTES (PBL) AND (2) TREATMENT 
OF HIV INFECTION WITH REINFUSION OF GENETICALLY ALTERED 
AUTOLOGOUS PBL/ DR SMITH: 
Review-Dr. Haselkorn 
Dr. Murray called on Dr. Haselkorn for his review. Dr. Haselkorn began his review of 
the protocol submitted by Dr. Clay Smith of the Memorial Sloan Kettering Cancer 
Center, New York, New York, by noting that the investigators submitted a manuscript in 
addition to their submission of the protocol. This manuscript contained critical data that 
was necessary for a complete review of the protocol. The investigators had concerns 
regarding the distribution of this manuscript to the committee members because this 
distribution may jeopardize the acceptance for publication. Dr. Haselkorn acknowledged 
that there may be a basis for the investigators concerns about distribution of the 
publication; however, there is no reason why the data could not have been extracted and 
presented to the RAC in the form of a report. Dr. Parkman inquired as to the name of 
the journal to which the investigators submitted this manuscript. Dr. Haselkorn stated 
that the journal was Science. Dr. Gilboa stated that Dr. Ben Kaufman ( Science ) had 
reiterated his concerns regarding distribution of the manuscript. Dr. Leventhal inquired 
as to why the manuscript could not be circulated to the committee members only? Dr. 
Wivel responded that materials submitted for review by the RAC are part of the public 
domain. Any documents that come before the RAC can be obtained through the 
Recombinant DNA Research, Volume 15 
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