These points are addressed in detail in section 4.3. In vivo Use of a Replication Deficient, 
Recombinant Adenoviral Vector to Transduce Epithelial Cells of The Human Respiratory Tract. 
Based on a risk/benefit judgment and on knowledge of the condition being studied, we 
would recommend that the protocol be classified as more than minimal risk but without direct 
benefit to participants. 
5.4 Period of time for study completion: Patients will be initially treated for two weeks of 
intravenous antibiotics prior to initiation of the vector delivery. Participants will be treated twice 
and nursed in isolation until the viral surveillance cultures show that the adenovirus has been 
eliminated. It is anticipated that this will require 2 weeks of hospitalization with each treatment. 
Then they will be followed until 56 days (8 weeks) after therapy. Therefore, the total duration 
will be approximately 20 weeks per patient. We anticipate that it will take approximately 3 
years to complete this study. 
5.5 Funding: The cost of this study will be supported by grants from the Cystic Fibrosis 
Foundation and the National Institutes of Health. There will be no additional charges made to 
the patients or their families. 
5.6 Payment for studies: There will be no compensation for participation in this study. 
5.7 Method to be used in procuring consent of subjects: The patients participating in this 
protocol will receive a full oral explanation of the goals and the methods of this study. Fully 
informed consent will be obtained in every case. A copy of the consent form is attached. 
5.8 Permission of the patient’s attending physician: All patients to be enrolled in this study 
are followed at Children’s Hospital Medical Center. Their attending physician(s) are members 
of the Division of Pulmonary Medicine, and they will be asked for permission to enroll their 
patients. 
[4041 
Recombinant DNA Research, Volume 17 
