Protocol HNS 94-001 
REVISED 11/17/94 
Page 3 of 5 
Possibility of Causing a New Cancer. It is possible that the research could cause 
cancer in normal cells although this risk is believed to be small when the injected 
virus has been properly safety tested prior to its use. The adenovirus vector has only 
been used, to date, on the lining of the breathing tube in over twenty patients with no 
ill effects noted. 
4a. This clinical procedure may involve unforeseeable risks to the unborn 
children, therefore, the participants should practice adequate methods of birth 
control throughout the period of their involvement in the clinical study if they 
are sexually active. To help prevent injury to children, the female participants 
should refrain from breast feeding during participation in the clinical research 
study. 
5. POTENTIAL BENEFITS: 
This treatment may result in shrinkage of the tumor, which may decrease cancer 
associated symptoms or may prolong life. 
6. ALTERNATE PROCEDURES OR TREATMENTS: 
Chemotherapy or other experimental drugs may be an alternative for some 
individuals. These treatments cause shrinkage of cancer in a number of patients. 
Another option is to only control the symptoms of disease and not take chemotherapy 
treatment. 
UNDERSTANDING OF PARTICIPANTS 
7. I have been given an opportunity to ask any questions concerning the procedure 
involved and the investigator has been willing to reply to my inquiries. This 
procedure will be administered under the above numbered, title, and described 
clinical research protocol at this institution. I hereby authorize Dr. 
the attending physician/investigator and designated associates, to administer this 
procedure. 
8. I have been told and understand that my participation in this clinical research study is 
voluntary. I may decide not to participate, or withdraw my consent and discontinue 
my participation at any time. Such action will be without prejudice and there shall 
be no penalty or loss of benefits to which I may otherwise be entitled, and I will 
continue to receive treatment by my physician at this institution. 
Should I decide not to participate or withdraw my consent from participation in this 
clinical research, I have been advised that I should discuss the consequences or 
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