NOU 23 ‘94 15=42 
FROM GENZYME EIOTHERFIP 
TO 913014969839 
PRGE.010 
Page 5 
NEW ENGLAND MEDICAL CENTER 
CONSENT FORM 
PROJECT TITLE: Adenovirus-mediated gene transfer for Cystic 
Fibrosis: Safety of administration to the lung. 
II. Aerosol Administration 
PI: Henry L. Dorkin, M.D. 
Cl: Joseph Oren, M.D. 
1 . Medical History and Physical Examination 
The purpose of the history and exam is to establish your 
baseline medical condition and then to carefully evaluate for 
any changes in your symptoms or examination that might occur 
after treatment with Ad2/CFTR-2. 
2 . Blood Tests 
Drawing blood from a vein has been performed previously as 
part of your routine care. 
3 . Pulmonary Function Tests 
These are breathing tests which you have previously performed 
as part of your routine care. 
4 . Chest X-Rav and CT Scan of the Chest 
We anticipate that each participant will receive a frontal 
and side view chest x-ray and up to 3 limited CT scans during 
the course of the study. The CT scans will provide more 
information about your lung disease than a standard chest x- 
ray alone. 
5 . Bronchoscopy 
The bronchoscope is a f i.exible . tube with a light that allows 
us to look inside your lung and obtain samples directly from. 
your lung. You may have nothing to eat or drink for 6 to 8 
hours before the bronchoscopy. You will receive a mild 
sedative intravenously prior to the procedure. You will then 
gargle with novocaine to numb the back of your throat. The 
bronchoscope is then passed through your nose or mouth into 
your lung. Additional novocaine will be delivered to help 
prevent you from coughing. The tip of the bronchoscope will 
be placed in one section of your lung. A small brush will be 
passed through the bronchoscope to carefully retrieve cells 
that line the lower airways. The procedure will last about 
30-45 minutes and you may feel drowsy for several hours after 
it is completed. 
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Recombinant DNA Research, Volume 20 
