physicians and researchers associated with the research project. The Food and Drug Administration, Sandoz 
Company (which manufactures the drug) and the National Cancer Institute may also have access to this 
information. All precautions to maintain confidentiality of medical records will be taken. Your personal 
identity will not be revealed in any publication or results. Study records will be maintained indefinitely for 
the purpose of analysis and follow-up. 
If you have any questions about your rights as a research participant, please contact Karen Hansen in the 
Institutional Review Office of Fred Hutchinson Cancer Research Center at 667-4867. 
Investigator’s Statement 
I have provided an explanation of the above research program. The subject was given an opportunity to 
discuss the procedures, including possible alternatives, and to ask any additional questions. A signed copy of 
this consent form has been given to the subject. 
Investigator’s Signature /Date 
Subject’s Statement 
I agree to this study and to the conditions described in the Basic Oncology Consent Form which I have read 
and signed. I understand that the Food and Drug Administration and personnel from Sandoz Company may 
review medical records involving an investigational drug, including material with identifying information. 
I have had an opportunity to ask questions and I understand that future questions I may have about the 
research will be answered by one of the investigators listed above and that any questions I have about my 
rights as a research subject will be answered by the person identified above. 
I am aware that I and/or my insurance carrier is responsible for the costs incurred in the therapy provided, 
including adverse effects. I acknowledge that I will receive a signed copy of this consent form. 
Patient 
/Date 
Witness 
/Date 
Parent/legal guardian /Date Other parent/legal guardian /Date 
[for patients < 18 years old] [if reasonably available] 
meC - 10/08/91 
Copies: Patient, Medical Records, Research File 
Recombinant DNA Research, Volume 15 [643] 
