16.0 INFORMED CONSENT 
All patents and/or their legal guardian must sign a document of informed consent 
consistent with local institutional and Federal guidelines stating that they are aware 
of the investigational nature of this protocol and giving an account of the possible side 
effects of treatment. Further, patients must be informed that no efficacy of this 
therapy is guaranteed, and that unforseen toxicides may occur. Patients have the right 
to withdraw from this protocol at any time. No patient will be accepted for treatment 
without such a document signed by him or his legal guardian. 
See attached document of informed consent. 
Patients may be asked to volunteer for other appended or ancillary protocols which 
investigate other questions such as issues of supportive care, the use of hematopoietic 
growth factors, management of infectious diseases and/or their prophylaxis, and 
pharmacokinetic studies. Such protocols will not be implemented without the review 
and approval of the Clinical Trials Committee. In circumstances where such 
protocols are approved, a separate informed consent document, consistent with the 
above guidelines, will be obtained. A patients participation in such ancillary protocols 
is voluntary and will be effect his/her participation or eligibility for the primary 
question of high-dose chemotherapy and ABMT. 
1. I have read the above statement and voluntarily agree to the participation in this 
study/treatment. 
2. I have had adequate opportunity to discuss with Dr. 
name of investigator 
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 I may withdraw myself/my 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. 
6. I understand that financial compensation is not provided for participation in this 
study/treatment. 
Recombinant DNA Research, Volume 14 
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