Recombinant DNA Advisory Committee - 06/1-2/92 
Mr. Capron opposed the motion stating that the RAC should not force investigators to 
present their gene therapy protocols as addendums to previously approved clinical 
protocols. He proposed a substitute motion that the RAC should not evaluate the 
underlying experiment. This substitute motion differs from Dr. Parkman's motion in that 
the investigators can submit the protocol as a whole or as an addendum to a pre-existing 
therapeutic protocol. 
Dr. Walters suggested that this difference could be clarified by distinguishing between 
gene therapy experiments versus gene marking addendums. Dr. Parkman agreed with 
Dr. Walters that the discussion should be limited to gene marking experiments. In fact, 
the RAC may define specific marker genes that have exhibited no intrinsic risks to 
patients. New genes being proposed could be used for marking that may have 
deleterious consequences and would have to be evaluated by the RAC. 
Dr. Geiduschek stated that it is still appropriate for a particular subset of gene marking 
protocols and gene therapy protocols to be reviewed and scrutinized by the RAC for the 
quality of the outcome in relationship to the risks associated with the procedure. IRB 
approval is not enough to exempt a protocol from review by the RAC. There will come 
a time in the future when there will be a shift from this point of view; however, it is still 
too early in the history of gene transfer to consider relinquishing these responsibilities. 
Dr. Haselkorn stated that this motion would establish a very dangerous precedent. The 
exclusion of any collection of data when considering a proposal is a mistake. Dr. 
Dronamraju was in agreement with Dr. Geiduschek stating that this separation is very 
artificial. Dr. Krogstad said that he was sympathetic to Dr. Parkman's comments; 
however, he is concerned about initiating very strict guidelines about protocol review. 
Ms. Meyers stated that patients are subjected to a high level of risk associated with some 
of the therapeutic procedures performed in these protocols, e.g., bone marrow 
transplantation. The RAC should step back and evaluate the precedent that has been 
established for approving duplicate protocols. How long does the RAC have to wait 
before safety information of the gene transfer procedures is obtained? There are 
increased numbers of patients are being exposed to risks associated with gene transfer. 
The danger is not in somebody dying; the risk is associated with the effects of gene 
transfer should the patient survive for a long period of time. 
Dr. Murray noted that another complicating issue is that some of the approved protocols 
are not put into clinical use for an extended period of time. If the RAC does not allow 
duplicate approvals, they are establishing a prioritizing system. Dr. Parkman agreed that 
the RAC is not in the business of establishing franchises on gene transfer experiments. 
Well designed approved protocols motivate other investigators to resolve unanswered 
questions. 
Recombinant DNA Research, Volume 15 
[721] 
