Recombinant DNA Advisory Committee - 10/7-8/91 
proposed treatment should not be described as a vaccine. With respect to the statement 
on benefits and risks, the investigators must be capable of making a prediction. The use 
of the phrase, "It is not possible to predict whether any personal benefit...," should be 
modified. These patients should be informed that they are participating in a procedure 
that may fail as a therapy; however, valuable scientific information relating to your 
disease may be obtained. The paragraph on risks and discomforts does not list the extra 
time that participating patients will have to spend in the hospital as one of the 
discomforts. With regard to compensation, the patients should be assured that under no 
circumstances will they accrue additional costs as a consequence of their participation in 
this study. 
Dr. Geiduschek said unless these concerns are substantially answered by discussion at the 
meeting, he will recommend not to approve this protocol. 
Mr. Brewer made reference to the section of the Points to Consider where references to 
the actual protocol were made rather than summarizing the pertinent information. Mr. 
Brewer said the Points to Consider is a public document intended for lay people, and it 
should summarize the requested information and not refer to the larger and more 
complex protocol document. 
Mr. Brewer said that the patient selection criteria should be more focused concerning 
the possibility of benefits to the patients. In the laparotomy section of the informed 
consent document, the risks from anesthesia ought to be addressed separately from the 
possible risks of other procedures. In the voluntary participation portion of the consent 
form, it is clear that patients can withdraw at any time; however, clinical data still needs 
to be collected. It should be made clear that the data will be collected as a result of 
routine follow-up care in order to assure against any complications arising from 
participation, and that the patient should give specific consent for the collection of any 
other data. Lastly, it was not made clear by the investigator if the stop criteria are 
mostly qualitative or if there are some quantitative determinants used. 
Dr. Mclvor criticized the submitted vector information in the protocol and suggested that 
the RAC establish a standard for the presentation of vector information. The 
expectation should be that the investigators supply a print-out of the actual sequence, 
indicate who generated it, supply a standard retroviral map of the vector, and supply a 
description of how the vector was constructed. The RAC should also establish a 
standard regarding the safety testing of cell lines. The investigator should perform 
extensive helper assays as well as other assays to screen for infectious agents when this 
protocol uses a new cell line. 
Dr. Post said that the mechanistic work and efficacy work should have been done with 
irradiated cells rather than live cells. He expressed concern that only one experiment 
[12] 
Recombinant DNA Research, Volume 15 
