From : DE'JEL GENETICS £ MOLEC BIOL 
PHONE No. : 21b 3tS 3590 
May. 28 1993 12:06PM 
P01 
CONSENT FORM 
p 4. Effect of Episomc'Bascd Anii.sen.se cDNA Transcription of Insulin-Like Growth Factoi 1 
on Tnmorigenicity of Human 
Blood for special tests will be drawn at the start ot the study and at each 
one of my clinic visits. Approximately 2 tablespoon of blood will be drawn at 
each visit. I will receive skin tests (like a tine test for tuberculosis, Tb) at the start 
of the study and at six months. I will have additional MRI scans of the head 
performed 4, 8 and 16 weeks, after the cells are injected. 
Because this gene therapy is a new form of treatment, all risks cannot be 
foreseen or eliminated. It is even possible that I may * experience a life 
threatening complication as a result of my participation in this study. In the event 
of my death even if it docs not arise because of the cancer, an autopsy will be 
requested. All costs related to culturing my cancer cells in the laboratory in 
order to expand the numbers of cells, for laboratory studies needed to rule out 
infection in the cultured cells, for altering these cells genetically, and for 
monitoring my health during the 48 hour period following the injections, will be 
covered by research funds. 1 will be followed for routine care by my personally 
selected neurosurgeon and physician. Costs for any complications arising from 
this study and for follow up visits specifically related to llie research study will be 
born by the study program. 
I have read the preceding consent form information and 
understand that this treatment which I will receive is part of a 
clinical research study. I know that it is not possible to predict if I 
will receive personal benefit from participation in this study and that 
there may be certain unpredicted risks associated with this treatment. 
1 have the option of not participating in this study. If I do 
participate I may withdraw at any time. Any additional care I should 
choose to have at this institution would not be jeopardized by such 
action. 
I understand that a record of my progress while on the study 
will be kept in confidential form at University Hospitals of 
Cleveland, and that the confidentiality of these records will be 
carefully guarded. These records may be reviewed in a confidential 
manner by outside agencies such as the National Institutes of Health, 
the National Cancer Institute, the Federal Food and Drug 
Administration, the manufacturer of the vector or by persons 
authorized to review this research study at Case Western Reserve 
University. No information by which I can be personally identified 
will be used or published. New Findings from this study will be made 
known to me. 
[152] 
Recombinant DNA Research, Volume 18 
