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SHS Approval Scamp Patient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page £ 
Title of Project: Adenovirus-Mediated Gene Transfer for Cvstic 
Fibrosis: Safety of Single Lobar Administration in the Luna 
Principal Investigator: Allen Lapev. M.D. 
Outpatient Follow-up Procedures 
On days 7, 14, 21 and 28 after treatment you will return to the 
clinic for a physical examination, blood tests, cultures, and 
pulmonary function tests. On day 7 only a bronchoscopy will be 
performed, which is described in detail below. Since you will 
receive sedative medications during this procedure, you must have 
someone available to drive you home afterward. On day 28 only a 
limited chest CT scan will be repeated. To monitor the long term 
safety of application of Ad2/CFTR-2 a history and physical 
examination will be performed on a monthly basis for 6 months (2, 
3, 4, 5 and 6 months post-administration) and every 3 months after 
(9 and 12 months post-administration) for a total of one year. 
Thereafter we will contact you on an annual basis for ten years to 
assess your health. 
DESCRIPTION OF PROCEDURES 
A brief description of each of the studies and associated risks 
are as follows: 
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. 
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Recombinant DNA Research, Volume 20 
