Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
Participation in the study is strictly voluntary. If you (your child) do not wish to volunteer, 
other options will be discussed and made available. Should any problems arise, one of the 
doctors will make you (your child) aware of these developments and discuss the plans of action. 
1. I have read the above statements and voluntarily agree to the participation in this 
study/treatment. 
2. I have had adequate opportunity to discuss with Dr. all the purposes and 
hazards related to this study/treatment. 
3. I have been told of alternate courses of action in my (my child’s) situation. 
4. I understand that the study/treatment proposed may result in risks which are currently 
unforeseeable. 
5. I understand that the gene marking study may or may not provide useful information. 
6. I understand that I may withdraw myself (ray child) from this study/treatment at any 
time. However, if withdrawal is done after chemotherapy has been given but prior to 
receiving the marrow transplant, this is likely to result in severe, possibly fatal toxicity. 
7. I understand that financial compensation is not provided for participation in this 
study/treatment. 
8. I understand that in the event of non-negligent physical injury to myself (my child) from 
this study/treatment, financial compensation is not available but medical treatment 
necessary will be provided at no direct cost. 
9. I understand that refusal to participate in this study will involve no loss of benefits or 
jeopardize my care at this hospital. 
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