Recombinant DNA Advisory Committee - 06/1-2/92 
convey no useful information. 
Review-Dr. Secundy 
Dr. Secundy said that most of her comments were regarding the informed consent 
document. She said that she would submit the minor changes to Dr. Dunbar. It is 
important for investigators to remember that the simplification of the document does not 
dilute the product. It is crucial that the investigators pay particular attention to 
simplifying and clarifying the language in these documents. It may not be entirely clear 
to the patient what is new about a particular protocol when he/she may have already 
enrolled in the therapeutic protocol. The only difference between these protocols and 
the therapeutic studies is the gene marking aspect. 
Other Comments 
Expanding on Dr. Secundy's comments, Dr. Parkman initiated a discussion regarding 
RAC review of the gene marking aspects as opposed to the therapeutic portions of the 
protocols. The therapeutic protocols are free standing entities. Patients may enter these 
studies without being obliged to enter the gene transfer protocols. Therefore, the 
therapeutic protocols should not fall within the purview of the RAC. Conversely, if a 
therapeutic protocols exists exclusively as a part of gene therapy study, than the therapy 
components of the protocols are subject to discussion by the RAC. 
Mr. Capron agreed that review of the therapeutic portion is probably unnecessary by the 
RAC as long as the experimental protocol is designed to test a method of treatment, it is 
approved by the local IRB, and is acceptable without the genetic transfer component. 
Dr. Parkman stated that the RAC should review the entire protocol only when 
therapeutic toxicities are possible as a result of the gene transfer procedures. Dr. 
Dunbar's protocols are therapeutic trials that exist as a reasonable standard of care at 
many institutions. The RAC should focus on the incremental element that deals with the 
introduction of foreign genetic material. What is the incremental risk associated with 
CD34( + ) enrichment when there exists a baseline of unpurged cells? Are there 
risks/benefits associated with these manipulations? The RAC should focus on these 
issues. 
Committee Motion 
Dr. Parkman made a motion that when gene transfer/therapy protocols are functionally 
an addendum to a pre-existing clinical protocol, the RAC will address only the gene 
transfer/therapy aspects of the protocol and not the original therapeutic protocol. The 
motion was seconded by Dr. Walters. 
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Recombinant DNA Research, Volume 15 
