nOj 2.1 '94 15 ; 49 
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SHS Approval Stamp Patient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page 7 
Title of Project: Adenovirus-Mediated Gene Transfer for Cvstic 
Fibrosis: Safety of Single Lcbar Administration in the Lung 
Principal Investigator: Allen Laoev. M.D. 
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 medication 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. Foil awing the procedure you may develop a 
fever which may last approximately 24 hours. In rare cases an 
infection that will require antibiotics may develop. 
RISKS ASSOCIATED WITH_GENE TRANSFER 
The risks associated with gene transfer are largely unknown. 
Possible risks are as follows: 
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Recombinant DNA Research, Volume 20 
