NOU 23 ’94 15=42 
FROfl GENZYHE EIOTHERAP 
TO 913014969839 
PAGE. 009 
Page 4 
NEW ENGLAND MEDICAL CENTER 
CONSENT FORM 
PROJECT TITLE: Adenovirus -mediated 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. 
administration. We wish tc 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, blood 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 scan 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. 
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: 
Recombinant DNA Research, Volume 20 
[569] 
