Recombinant DNA Advisory Committee - 2/10-11/92 
| Discussion 
Dr. Doi inquired whether the percent transduction of the leukemic blasts was the same 
percentage obtained with K562. Dr. Cometta replied that it was less; and that this 
variation can occur from day to day, between 5 and 20% transduction efficiency. 
Dr. Leventhal asked whether Dr. Cometta would retrieve additional bone marrow 
aspiration from these patients at times other than what is outlined in the protocol. The 
investigators should include a statement in the informed consent document regarding extra 
bone marrow being obtained at the time of relapse. Dr. Cometta replied that he would 
not subject the patients to a marrow aspiration that was not otherwise clinically indicated, 
although he would aspirate additional samples if the procedure is being performed for 
clinical reasons. Dr. Leventhal commented that if Dr. Cometta did not get marrow for his 
studies at the time the patients relapse, he potentially would not acquire any information. 
Dr. Cometta replied that he would have peripheral blood for study. Dr. Leventhal 
suggested that a protocol section be incorporated that describes the studies to be 
performed at the time of relapse to ensure that the patients clearly understand the 
procedure. 
Dr. Kelley commented on the issue of the institution's refusal to provide a total guarantee 
in the event of any untoward injury. Dr. Geiduschek thought it would be desirable for this 
type of research to be undertaken only at those institutions that are able to provide this 
guarantee. He asked for opinions on this idea from the lawyers on the RAC. Ms. Buc 
responded that it is her view that it is the institution's obligation to disclose its financial 
status and policies; if the institution cannot guarantee payment, the patient must consider 
this fact when deciding whether to undergo the risks. Mr. Barton remarked that 
traditionally patients have never been charged for drugs in the clinical phase of a protocol, 
and that there is no question that patients have accepted the clause in the informed 
consent documents that places the financial risks of complications on the patient rather 
than the institution. He questioned if this issue was within the purview of the RAC or the 
responsibility of the IRB. In his opinion, this issue should be delegated to the IRBs. 
Dr. Walters stated that there is the long history of the ethical discussion about 
compensation for research-related injuries. The current system is unsatisfactory. This 
issue should be brought to the attention of the NIH Director. Dr. Anderson suggested 
that the RAC propose a motion to bring this issue to the NIH Director as a national 
agenda item. Dr. Wivel added that it would be appropriate for Dr. McCarthy from the 
Office for Protection from Research Risks (OPRR) to address the RAC on this issue and 
to speak about the Code of Federal Regulations pertaining to clinical research. Mr. 
Barton proposed that the RAC discuss this issue in a future meeting, and Dr. B. Murray 
noted his suggestion. 
Recombinant DNA Research, Volume 15 
[369] 
