Revised 8-26-94 
6. Informed Consent 
THE ROCKEFELLER UNIVERSITY HOSPITAL 
CONSENT FORM 
PROGRAM OF CLINICAL INVESTIGATION 
(imprint nameplate here) 
A. I, , understand that the physicians at the Rockefeller University 
Hospital are engaged in research on the nature, diagnosis and treatment of disease. I have 
been informed that this study involves gene therapy research and that the purpose is to evalu- 
ate the treatment of the lung problems associated with cystic fibrosis using a virus containing 
the normal cystic fibrosis gene. 
B. The expected duration of my participation is: Approximately 20 days over a six month 
period, plus several follow-up visits to the out-patient clinic, including visits every 6 months 
for 2 years and thereafter on a yearly basis. 
C. The procedures to be followed are detailed in the attachment to this consent form, pages 
6-5, 6-6, 6-10 through 6-13. 
D. I agree to exercise appropriate birth control methods (preferably "barrier" contraception, 
i.e. , condoms, diaphragm) during and for at least 6 months after the last administration of 
the Ad GV CFTR. 10 vector. 
E. The possible discomforts and risks attendant to this procedure are detailed in the attach- 
ment to this consent form, pages 6-8, 6-9, and 6-13 through 6-16. 
F. The medical benefits that I might reasonably expect from this protocol are detailed in the 
attachment to this consent form, pages 6-4, 6-16, and 6-17. 
G. The alternative procedures, if any, that were considered and why they will not be used 
are: Cystic fibrosis is a fatal disease with no alternative curative therapy other than lung 
transplantation, a high risk, unproven and costly procedure. 
H. I understand that I shall receive a copy of this consent, that the records connected with 
my participation in the clinical investigation will be kept strictly confidential and that the 
Food and Drug Administration (FDA) has the right to inspect the hospital records. 
I. However, I understand that this study does involve an investigational drug. The name of 
the drug is Ad GV CFTR.10. The use of this drug for the purposes of this study has been 
submitted to the Food and Drug Administration (FDA) under an Investigational New Drug 
[ 224 ] 
Recombinant DNA Research, Volume 20 
