NOU 23 '94 15=44 
FROM GENZYnE EIOTHERRP 
TO 913014969839 
PAGE .014 
Page 9 
NEW ENGLAND MEDICAL CENTER 
CONSENT FORM 
PROJECT TITLE: Aaenovirus-mediaced 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. 
antibiotics, nutritional and dietary measures, and ocher agents 
which may or may not reduce the thickness of the mucus. Most of 
these treatments will also be available to you during and after 
the study. Since this study is designed to study gene transfer 
safety rather than efficacy, a decision not to participate will 
not affect your standard CF care management. 
MEDIA ATTENTION 
Gene transfer is very interesting to the general public. 
Although every effort will be made to maintain your privacy, it 
is possible that the news media or other individuals might learn 
your identity and spread this information, even if you do not 
want this to happen. Media requests will be directed so that 
patient confidentiality is maintained. 
COSTS 
All costs of the study will be the responsibility of the study 
sponsor. During the time that you are participating in this 
study you will, however, regain susceptible to the problems that 
are normally associated with cystic fibrosis, such as infections 
of the lungs. If during the course of this study, you should 
develop a complication of ycur cystic fibrosis, we would initiate 
the appropriate treatment; for example, if you should develop a 
pneumonia, we would begin treatment with antibiotics. 
WHOM TO CONTACT 
If you have questions about this research or problems during the 
study you should call Dr. Joseph Oren or Dr. Henry Dorkin, New 
England Medical Center, telephone (617) 636-5085, or through the 
page operator by calling (617) 636--5114. You will be informed of 
any significant new findings discovered during the course of this 
study which might influence your continued participation. 
RIGHT TO WITHDRAW 
Your participation in this study is voluntary. No penalty of 
loss of benefits to which you are entitled will occur if you 
decide not to participate. After enrollment in the study, you 
may discontinue participation at any time before application of 
the virus without penalty. Because you will receive a virus for 
[ 574 ] 
Recombinant DNA Research, Volume 20 
