will be granted in the event of a patient’s death following participation in this study. 
Accurate determination of the cause of death is of vital importance to future patients. 
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, titled and described clinical research 
protocol at this institution. I hereby authorize Dr. Jack A. Roth, the attending 
physician/investigator and designated associates to administer the treatment. 
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 
effects of my decision with my physician. 
In addition, I understand that the investigator may discontinue the clinical research 
study if, in the sole opinion and discretion of the investigator, the study or treatment 
offers me little or no future benefit, or the supply of medication ceases to be available 
or other causes prevent continuation of the clinical research study. The investigator 
will notify me should such circumstances arise and my physician will advise me about 
available treatments which may be of benefit at that time. 
I will be informed of any new findings developed during the course of this clinical 
research study which may relate to my willingness to continue participation in the 
study. 
9. I have been assured that confidentiality will be preserved except that qualified 
monitors from Genetic Therapy, Inc., the Food and Drug Administration, or National 
Cancer Institute may review my records where appropriate and necessary. Qualified 
monitors shall include assignees authorized by the Surveillance Committee of this 
institution provided that confidentiality is assured and preserved. My name will not be 
revealed in any reports or publications resulting from this study, without my expressed 
consent. 
10. I have been informed that, should I suffer any injury as a result of participation in this 
research activity, reasonable medical facilities are available for treatment at this 
institution. I understand, however, that I cannot expect to receive any credit or 
reimbursement for expenses from this institution or any financial compensation from 
this institution for such injury. 
Recombinant DNA Research, Volume 16 
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