Recombinant DNA Advisory Committee - 06/1-2/92 
Dr. Post expressed concern regarding the fact that information forwarded to ORDA will 
not be confidential. A way of solving this dilemma is to request protocol information 
after it is made public. Mr. Capron said that this is not a sufficient criterion. 
Dr. Murray suggested that ORDA send a letter requesting a compendium of abstracts, 
papers, IRB reports, and FDA reports as discussed previously. Dr. Leventhal added that 
if the information received over the period of one year becomes too unmanageable, the 
RAC may propose an alternative reporting procedure. 
IX. PROPOSED CATEGORIES OF GENE TRANSFER: 
Dr. Murray called on Mr. Capron to open the discussion on proposed categories of Gene 
Transfer. Mr. Capron stated that the RAC is gaining significant experience in reviewing 
gene transfer experiments encompassing broad areas of research. The RAC should 
begin to consider protocol review in terms of the degree of risk that is associated with 
the proposed research. The RAC should consider at least three categories of gene 
transfer experiments: (1) retroviral gene marking alone, (2) gene insertion for purposes 
of modifying the effects of therapeutic agents, and (3) gene insertion to restore normal 
cell 
function. 
Dr. Walters noted that the RAC has not reviewed any protocols relating to the direct 
genetic treatment of cancer. Although 20 of the first 26 protocols submitted to the RAC 
involved cancer patients, these protocols proposed the use of gene transfer to supply 
cytokines or chemotherapeutic agents to malignant cells or to boost the immune system. 
These protocols have not addressed genetic therapy, e.g., P53 or ras oncogenes. 
Dr. D. Miller stated that he was in disagreement with categorizing gene transfer 
experiments. He did not recognize a need for reviewing protocols differently. However, 
the RAC may want to distinguish between gene therapy and cellular therapy such as the 
protocol submitted by Dr. Oldfield. Dr. D. Miller noted that the FDA has a protocol 
category entitled cell therapy. 
Dr. Parkman said that the only distinction that can be made between gene transfer 
categories would be that gene marking experiments may be reviewed differently than 
protocols designed to obtain a therapeutic effect. The purpose of this discussion is that 
in the future RAC may want to review certain categories of experiments from a different 
administrative perspective. Gene marking experiments may be one of these categories. 
For example, the safety issues involving the addition of a second vector to Dr. 
Deisseroth's protocol may have been dealt with independent of the entire protocol. 
Dr. DeLeon stated that it might be remiss for the RAC to separate categories of gene 
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