NOU 23 ’94 15=43 
FROM GEM2YT1E EIOTHERAP 
TO 913014969639 
PAGE. 011 
Page 6 
NEW ENGLAND MEDICAL CENTER 
CONSENT FORM 
PROJECT TITLE: Adenovirus -mediae ed 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. 
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 . Blood Tests 
The needle may cause pain, minor bleeding, and a bruise at 
the site of the blood draw. 
3 . Pulmonary Function Tests 
There are no significant associated risks. 
4 . Chest X-Rav and CT Scan of the Chest 
The radiation exposure from a limited CT scan will be 
approximately 1/2 of a routine single CT scan of the chest, 
and represents less radiation than that from a chest x-ray. 
Although there are no . known . adverse effects from this amount 
of radiation, the long term effects are not known with 
certainty. 
5 . Bronchoscopy 
The risks associated with bronchoscopy relate both to the 
sedative medications and to the procedure itself. Although 
the amount of sedative medication is small, it might decrease 
your breathing rate. Your breathing, oxygen saturation, 
blood pressure, and heart rate will be closely monitored 
during the procedure. Allergic reactions to the novocaine, 
which is the same meditation used by dentists to numb the 
mouth, may occur but are extremely rare. 
The bronchoscopy itself may be uncomfortable and you may 
experience some pressure in the nose and throat. Once inside 
the lung, the bronchoscope may cause coughing, which can be 
partially controlled with additional novocaine, and a small 
amount of bleeding. Following the procedure you may develop 
Recombinant DNA Research, Volume 20 
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