d) It is possible that participation in this study could cause my immune 
system to respond against the altered virus such that subsequent 
treatments with the altered virus would not be possible, or that an 
allergic reaction may be developed. That would mean that gene 
therapy would not be possible with this type of adenovirus. 
e) The gene therapy may cause more than a normal amount of the 
normal CF protein to be produced in the nasal cells, and it is 
conceivable that this could be harmful or produce an allergic reaction. 
This does not occur in animals, even when many hundred times 
normal production is present; however, this has not been tested in 
humans. 
2) Several procedures are likely to be associated with transient discomfort, 
including blood drawing for blood counts or arterial blood gas, measurement of 
nasal electrical activity, brushing or biopsies of the nasal epithelium, and 
respiratory isolation. Each of these procedures or situations are addressed with 
interventions, such as numbing medicine, to minimize these discomforts. 
3) The altered adenovirus could be dangerous to a fetus if I am pregnant. 
Pregnancy and breast-feeding excludes participation and birth control will be 
required. If a pregnancy accidentally occurs, the medical researchers should be 
notified immediately. 
4) During the study, I can have the usual problems of CF patients, including 
infection of my lungs. If I should develop a CF-related illness, the doctors 
would initiate appropriate treatment for that complication. If the study protocol 
is not felt to be responsible for provoking such a complication, usual methods of 
payment for CF treatment should be sought. 
5) I will have two or three chest X-rays during the course of this study; the dose of 
radiation is small. 
Despite our best efforts, it is possible that unforeseen risks and/or 
discomforts may occur. We will do as careful a study as possible, but it must be 
recognized that unexpected events or complications could occur. 
Benefits : I understand that the benefits of participating in this study relate to 
improved understanding of the possibilities for gene therapy in CF. I am unlikely to 
benefit directly from the nose study of adenoviral gene therapy. Overall, the greater 
benefits of this study relate to better understanding of modified viruses for 
delivering gene therapy, and for designing future studies, which might involve giving 
gene therapy to the airways of the lung. 
Alternatives : I understand that there are standard medical therapies available if I 
choose not to participate in this study, and that this study is not likely to change my 
requirement for standard medical therapy for CF. 
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Recombinant DNA Research, Volume 17 
