NOU 23 *94 15‘- 48 
FROT1 GENZYHE B 1 OTHERRP 
TO 913014969839 
PPGE.021 
SHS Approval Stamp Patient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page 4 
Title of Project: Adenovirus-Mediated Gene Transfer for Cvstic 
Fibrosis: Safety of Single Lobar Administration in the Luna 
Principal Investigator: Allen Laoev . M.D. 
Hospital Admission/Administration of Ad2/CFTR-2 
If you are eligible for participation in the study you will be 
admitted to the hospital for 4 days. On the first day, a physical 
examination will be performed, and blood tests, cultures, 
pulmonary function tests, and a limited chest CT scan will be 
obtained. Later that day, Ad2/CFTR-2 will be administered to you 
in an aerosol that you will breathe into your lungs. Since the 
risks of delivering Ad2/CFTR-2 by aerosol are currently unknown, 
the aerosol will be delivered to you inside a canopy to prevent 
spread of the virus. We will also ask that you wear a gown, 
gloves, and protective eye wear while receiving the aerosol. 
After application of Ad2/CFTR-2 you will be required to be in 
respiratory isolation fcr 24 hours from the time of 
administration. We wish to keep you in isolation so that no one 
else will be exposed to the virus. This means that you will be 
confined to a hospital room and visitors will be required to wear 
protective masks, gloves and gowns. Because of the unknown risk 
of the virus to a fetus, women who are pregnant will not be 
allowed to visit you while you are in isolation. 
In order to carefully evaluate the safety of Ad2/CFTR-2 
administration, the following studies will be performed during 
your hospital stay (these studies are described in detail in the 
following section) : 
The physical examination, olood tests, and cultures will be 
repeated on the 2nd, 3rd, and 4th hospital days. Pulmonary 
function tests will be repeated on the 2nd day, and a limited 
chest CT scar, will be obtained on the 3rd hospital day. Unless 
there are complications you will be released from the hospital 
after the examination and testing on the 4th day. 
Recombinant DNA Research, Volume 20 
[581] 
