NOU 23 '94 15=44 
FROM GENZYME BIOTHERAP 
TO 913014969839 
PAGE. 013 
Page 6 
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. 
genes into the chromosome. However, this also means that any 
correction of the genetic defect in you lung will only be 
temporary . 
6. We do not know the effects of altered adenovirus on an embryo 
or fetus of a pregnant woman; therefore you will not be 
allowed to participate if you are pregnant. If you are a 
woman, we will do a pregnancy test. All participants, men 
and women, will be asked to use a reliable form of 
contraception such as barrier methods (condom and diaphragm) 
or oral contraceptive pills during this study and for six 
months afterward to prevent pregnancy. 
PERMISSION FOR AUTOPSY 
As described above, we do not believe that administration of 
Ad2 /CFTR- 2 will cause a reaction that would cause your death. 
However, in the unlikely event of death from any cause during the 
course of the study (for example, in a traffic accident), it 
could be of vital importance to future patients for us to 
determine the effects of Ad2/CFTR-2. Therefore we would ask your 
family to grant permission for -an autopsy. 
POTENTIAL BENEFITS 
Single administration of the normal gene using the modified 
adenovirus in this study will provide no long term benefit. The 
correction of the genetic defect of CF, if it occurs, is unlikely 
to persist for more than 3 to 4 weeks. The primary benefit will 
be a better understanding of the possibilities for CFTR gene 
transfer with the altered virus. In particular, information 
regarding the amount of virus needed and the effects of the virus 
on the cells of the airways will be critical for further studies, 
which would involve administering the virus to the airways of the 
lung to treat the disease on a long-term basis. In terms of 
therapy, however, this initial study will not change your cystic 
fibrosis symptoms and therefore will not be of immediate benefit 
to you. 
ALTERNATIVE TREATMENTS 
You may elect not to participate in this study and this decision 
w'ill not affect your care at the New England Medical Center. 
Treatments of cystic fibrosis include: chest physiotherapy, 
[573] 
Recombinant DNA Research, Volume 20 
