Recombinant DMA Advisoiy Committee - 5/30-31/91 
read likewise in this case. He also questioned who made the determination in the event of 
injury or illness who made the decision as to what constituted necessary medical treatment. 
He said this should be clarified. 
Mr. Brewer added that the use of the term "cure" was altogether too definitive and that 
perhaps it should be replaced by something along the lines of "the best medically indicated 
treatment." He said that in the discussion of the risks there was no reference to adverse 
efiects on antibiotic therapies and said he felt it should be made clear to the patients that this 
procedure may in fact weaken the effects of such therapies. 
Mr. Brewer noted that the introduction and summary were confusing to him and he had made 
an effort to roughly rewrite these sections. He said, however, that since he was a lay person 
that it should not be held to be a requirement that the protocol be revised in this respect and 
he offered it to Dr. Brenner for his use. 
Ms. Buc said the assent document stated the following: "You will also receive a total of eight 
bone aspirates." She said this should be put into language understandable to a child. 
Dr. Mclvor said the protocol was, in fact, subject to the same limitations in terms of coming 
up with informative results as the other protocols which had been addressed at today's 
meeting. He asked what was known about what might be contributing to tumor relapse in 
neuroblastoma and asked if there had been any studies in animals looking at this issue. He 
specifically was interested in knowing how many cells were necessary in order to form a tumor 
in an experimental system and if anything had ever been tried to determine the clonality. 
Dr. Krogstad said he felt many of the questions which were being asked would not be 
answered during this discussion, but only through performing experiments, and he said he 
hoped that in the future the investigators carrying out this research will update the committee 
on what their evolving information is concerning these topics which are heavily debated during 
these meetings. 
Dr. McGarrity noted that as part of the approval process all investigators are asked to update 
the RAC as to the progress on their protocols at least once every six months. 
Dr. Anderson noted that they had been giving updates at each meeting of both the HGTS and 
the RAC since their protocols had been approved and said he felt there was no problem in 
continuing this process. Dr. McGarrity noted that with the increased number of protocols and 
the increasing number of investigators who are not geographically located in the Washington, 
D.C. metropolitan area, that perhaps consideration should be given to written short reports 
rather than oral reports before the RAC and HGTS. 
Dr. McGarrity then asked Dr. Brenner to respond to the comments of the reviewers. Dr. 
Brenner said that as far as his responses to the provisions laid down by the HGTS, he felt the 
answer to their first provision was found in Appendix E, which describes how the investigators 
plan to analyze the marrow and determine whether it contains relapsed cells. He continued 
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Recombinant DNA Research, Volume 14 
