Recombinant DNA Advisory Committee - 06/1-2/92 
2 retrovirus be rescued and allow the T cell to manufacture IL-2 independently, resulting 
in leukemia? The vector proposed for this protocol differs from LNL6 and GINa in 
that is has an additional gene. The RAC should be informed regarding the properties of 
this vector in animal models. 
Dr. Geiduschek asked if cell expansion was observed in response to the presence of IL-2 
during the cell culturing procedures? 
Mr. Capron noted that he had several concerns regarding the informed consent 
document. He suggested changing the language in the 7 to 18 year old assent form from 
' 'you can start drugs or radiation straight away" to "you can start drugs or radiation right 
away". He noted some confusion in a statement that refers the patient to Section 17. 
This section should read as Section 15. 
Mr. Capron noted that the informed consent document would be more understandable if 
there was one form for the child and another form for the child's parent(s). Addressing 
both child and parent in one document leads to confusing language. Dr. Leventhal 
suggested that the separation of the informed consent documents is not an appropriate 
topic for the RAC to discuss. This issue should be addressed by the local Institutional 
Review Board (IRB). 
Mr. Capron asked Dr. Brenner if there is an obvious reason why patients who have 
tested positive for the human immunodeficiency virus (HIV) have been excluded from 
participation in this study. 
Presentation-Dr. Brenner 
Dr. Murray called on Dr. Brenner to respond to the questions presented by the primary 
and secondary reviewers as well as the other committee members. Dr. Brenner stated 
that the protocol is designed to generate an anti-tumor response in patients with 
advanced or resistant neuroblastoma. Patients over the age of 21 years are excluded 
from the protocol because St. Jude's is a pediatric hospital. This language is standard 
for St. Jude informed consent documents. He stated that he is not aware of any 
neuroblastoma patients over the age of 21 years who have this disease. 
In regard to the presentation of the informed consent document to the patient, this 
procedure is the responsibility of the patient advocate. The patient advocate is usually 
from the psychology or social work department and is never a co-investigator on the 
research protocol. There are one or two protocol participants available during the 
presentation whose sole responsibility is to answer questions. Dr. Zallen stated that this 
response sufficiently answered her concerns regarding the informed consent process. 
Recombinant DNA Research, Volume 15 
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