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SHS Approval Stamp Patient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page £ 
Title of Project: Adenovirus-Mediated Gene Transfer for cystic 
Fibrosis: Safety of Single Lobar Administration in the Luna 
Principal Investigator: Allen Lapev. M.D. 
4 . Chest X-Ray 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 flexible 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 retrieye 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. 
RISKS ASSOCIATED WITH PROCEDURES 
1 . Medical History and Physical Examination 
This examination is similar to what you have previously 
experienced as part of your routine care and is not associated 
with any risks. 
2 . B j , QQd Tests 
The needle may cause pain, minor bleeding, and a bruise at the 
site of the blood draw. 
Recombinant DNA Research, Volume 20 
[583] 
