1 
CERTIFICATION OF SUBJECT CONSENT 
Project Title: Adenovirus-mediated gene transfer for cystic fibrosis: 
Safety of dose and repeat administration in the nasal epithelium 
Investigators: Michael J. Welsh, M.D. 
Joseph Zabner, M.D. 
Scott M. Graham, M.D. 
I, , hereby certify that I have 
(subject's name) 
been told by Dr. Michael Welsh or Dr. Joseph Zabner of The University of Iowa Medical Center 
about research on gene therapy for cystic fibrosis and its purposes. I have been told about the 
procedures to be followed, which of them are experimental, and how much time is involved. I 
understand the possible risks and discomforts I may experience and the possible benefits to me 
and to others from the research. I have also been told the extent to which any records which may 
identify me will be kept confidential. 
A written summary of what I have been told is attached. I have been given adequate 
opportunity to read it 
I understand that I have the right to ask questions at any time and that I should contact Dr. 
Michael Welsh (319) 335-7619 or Dr. Joseph Zabner (319) 335-7574 for answers about the 
research and my rights. 
I understand that in the event of physical injury resulting directly from the research 
procedures no compensation will be available in the absence of negligence by a state employee. 
However, medical treatment is available at the University Hospitals and Clinics, but I will be 
responsible for making arrangements for payment of the expenses of such treatments. Further 
information may be obtained from Dorothy M. Maher, Division of Sponsored Programs, Office 
of the Vice President for Research, (319) 335-2123. 
I understand that my participation is voluntary, that I may refuse to participate or 
withdraw my consent for experimental studies at any time without penalty or loss of benefits to 
w'hich I may be entitled. 
I hereby freely consent to take part in this research project. 
Signature of Subject Date 
I, the undersigned, certify that I w'as present during the oral presentation of the written 
summary attached, when it w-as given to the above subject. 
Signature of Auditor-witness 
Date 
[882] 
Recombinant DNA Research, Volume 18 
