UPCC 3394, June 1994 
University of Pennsylvania 
Informed Consent 
Treatment of advanced CNS malignancy with recombinant adenoviru$:Phase IB 
therapy. Should complications occur, it might not be possible to detect them 
promptly and institute therapy. 
Loss of privacy. Gene therapy is very interesting to the general public. 
Although every effort will be made to maintain your privacy, it is possible that the 
news media or other individuals might learn of your identity and spread this 
information, even if you do not want this to happen. 
Participation in multiple studies may be hazardous to you. If you are already 
participating in another research study, please inform us fully. You should not 
participate in multiple studies, unless you and the investigators agree that your health 
and the outcome of the study will not be jeopardized. 
6) Expected benefits. You may not benefit in any way from this research study. If the 
treatment does result in killing of tumor cells, the tumor may become smaller for a 
period time, but it is not known if this will occur. 
7) Alternative procedures. Alternative treatments for brain tumors include standard 
surgery, chemotherapy or sometimes implantations of radioactive sources into the 
brain. 
8) Costs to subject or insurance carrier resulting from participation in the study. There 
will be no cost to you for your participation in the study. Any costs resulting from care 
you require as part of the study or because of complications from the study will be 
provided through the Clinical Research Center of the University of Pennsylvania. 
9) Payments. You will not be paid for participating in this study. 
10) Confidentiality. You will not be identified in any reports on this study. The records 
will be kept confidential to the extent provided by federal, state and local law. The 
Federal Food and Drug Administration may inspect the records of this investigation. 
The extreme amount of public interest in gene therapy may cause members of the 
media to try to find out who you are. If they succeed, you might be subject to 
frequent requests for interviews and your privacy may be reduced. Every effort will 
be made to protect your privacy but this may not be possible. 
1 1) Management of physical injury. You will remain in the hospital for 2 weeks after the 
surgery. If problems or questions arise when you are not in the hospital you should 
contact Dr. Jane Alavi at 662-6319 or 662-6059 (24 hour number) or Dr. Stephen Eck (734- 
8226, a beeper, 24 hour number). In the event of a physical injury which may result 
from research procedures, the University will provide medical treatment. Additional 
medical treatment will be provided in accordance with the determination by the 
University of its responsibility to provide such treatment. However, the University does 
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