Gene Therapy for CF using Cationic Liposome Mediated Gene Transfer: Phase I Trial 
gene transfer can be thoroughly studied. 
BENEFITS 
The primary benefit of my participation in this study will be an improved understanding 
of a possible new therapy for treating CF. I understand that the medical research team does not 
expect that administration of the normal CF gene to the inside of the nose will benefit me 
directly, but that this study could be an important first step towards new therapies in which the 
normal CF gene could be administered to the lungs of CF patients. Such future studies could be 
beneficial to myself and to other CF patients. 
ALTERNATIVES 
Standard cystic fibrosis therapy (chest physiotherapy, nutritional measures, antibiotics) 
as well as experimental therapies (rh DNase) are also available for the treatment of CF. If I 
decide not to participate in this study, it will not affect my care at the University of Alabama 
at Birmingham, and I will continue to receive the best available standard treatment for CF. I 
agree that by participation in this study, I will not enter another experimental study (for 
example, a rh DNase trial) at the same time. All standard CF therapy will remain available to 
me during my participation in this study. I understand that as a participant in this research study, 
if significant findings come forward during the course of the study which are relevant to my 
continued participation, I will be informed of these findings. 
CONFIDENTIALITY 
Every effort will be made to insure that information collected within this study will be 
kept confidential. I understand that federal, state, or local law could result in the release of my 
records, and that the Food and Drug Administration and associated organizations may also 
review the results of this study. My name will not be used in any report or publication 
concerning this study. 
COST OF THE RESEARCH STUDY 
I understand that I will not be charged for my participation in this study. If, despite all 
of the best precautions, a complication occurs as a result of this study, the medical research team 
will help me obtain appropriate medical care. If a health problem which is not caused by the 
study occurs while I am participating, I understand that the usual methods of payment (for 
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