MJ. Welsh and A.E. Smith, RAC Application 
CERTIFICATION OF SUBJECT CONSENT 
PROJECT TITLE: Cystic Fibrosis Gene Therapy: 
In Vivo Safety and Efficacy in Nasal Epithelium 
INVESTIGATORS: Michael J. Welsh, M.D. 
Joseph Zabner, M.D. 
Devra P. Rich, Ph.D. 
Scott M. Graham, M.D. 
I, hereby certify that I have been 
(subject's name) 
told by Dr. Michael Welsh of 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 Jerry M. Burrows, Office of the Vice President for Research, 
(319) 335-2139. 
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 
which 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 was present during the oral presentation of the written 
summary attached, when it was given to the above subject 
Signature of Auditor-witness 
Date 
Recombinant DNA Research, Volume 16 
[937] 
