Recomb man I DSA AiJvwory Committee - 09/14-15/92 
General Counsel and the IRB. Drs. Post and Parkman said that they would not accept 
the stipulation presented by Mr. Capron as a pan of their motion for approval. 
However, Dr. Post recommended that the statement could be offered in the form of 
advice. Ms. Buc suggested that the RAC review the Code of Federal Regulation 
(45CFR46) that addresses IRB regulations as a future agenda item. If the RAC 
proposes changes to the current regulations, these changes could be presented in terms 
of advice to the NIH Director. Dr. Murray reminded the RAC that Dr. McCarthy, 
formerly from the Office for Protection from Research Risks, is on today's agenda to 
present information regarding this subject. 
Dr. Murray called for a vote. The motion to approve the protocol with stipulations 
passed by a vote of 19 in favor, 0 opposed, and no abstentions. 
Drs. Parkman and Post recommended that the issue of providing separate informed 
consent documents for the gene marking and clinical procedures should be placed on the 
agenda for the next RAC meeting as amendment to the Points to Consider in the Design 
and Submission of Protocols for the Transfer of Recombinant DNA into the Genome of 
Human Subjects ( Points to Consider) of the NIH Guidelines. 
IV. PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING 
A SEMLIKI FOREST VIRUS HELPER EXPRESSION SYSTEM/DR. TEMPLE 
Re>iew~Dr. Schaechter 
Dr. Murray called on Dr. Schaechter to present his primary review of the proposal 
submitted by Dr. Gary Temple of Life Technologies, Inc., Gaithersburg, Maryland. Dr. 
Schaechter reviewed the proposal to conduct experiments with a Semliki Forest Virus 
(SFV)-SQL helper expression system at Biosafety Level (BL) 2. Dr. Schaechter 
explained that the gene expression vector system was initially developed in Sweden. It 
would be sold and commercially distributed as a kit. SFV is endemically found in Africa 
and is capable of causing disease. Past experience with laboratories working with this 
virus has resulted in one death; thus, the level of containment was originally elevated 
from BL2 to BL3. This agent is not harmless, symptoms include headaches and fever. 
The expression vector kit being proposed consists of a virus in which foreign DNA can 
be cloned. The virus portion of the expression vector contains several point mutations 
that render it incapable of replication alone. In order for the virus to replicate, it must 
come in contact with a replication competent helper virus. Data demonstrates that the 
incidence of viral replication occurs at a relatively low frequency. Dr. Schaechter noted 
that written reviews were provided by two experts in this area. Dr. Robert Johnston from 
the University of North Carolina and Dr. Sondra Schlessinger from Washington 
University, St. Louis, Missouri. Both of these ad hoc reviewers stated that the data 
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