NOU 23 '94 15=45 
FROM GENZYME E I OTHERflP 
TO 913014969S39 
PAGE. 016 
Page 11 
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. 
PARTICIPANT STATEMENT 
I have read this consent form and have discussed with Dr. Joseph 
Oren and Dr. Henry Dorkin (or his representative) the procedures 
described above. I have been given the opportunity to ask 
questions, which have been answered to my satisfaction. I 
understand that any questions, that I might have will be answered 
verbally or, if I prefer, with a written statement. 
I understand that I will be informed of any new findings 
developed during the course of this research study. 
I understand that participation in this study is voluntary. I 
understand that I may choose not to participate. I understand 
that if, for any reason, I wish to discontinue participation in 
this study at any time, I will be free to do so, and this will 
have no effect on my future care or treatment by physicians or 
the hospital. 
I understand that in the event I suffer injury or illness 
directly caused by Ad2/CFTR-2 or by a properly performed study 
procedure, and such illness or injury occurs within one month 
after administration of the virus, reimbursement will be provided 
for the cost of my medical treatment not covered by medical 
insurance or by third party or government programs. I understand 
that no other form of compensation for such illness or injury 
will be provided. 
If I have any questions concerning my rights as a research 
subject in this study, I may contact the Human Investigation 
Review Committee at (617) 636-7512. 
I have been fully informed of the above-described study with its 
risks and benefits and I hereby consent to the procedures set 
forth above. I have received a copy of this consent form. 
[576] 
Recombinant DNA Research, Volume 20 
