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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. 
which safety data in humans is not yet available, the risks are 
not yet fully defined. Therefore, if after having received the 
virus, you wish to withdraw from the study, you may do so but we 
request that you continue to return to the clinic for evaluation. 
If you feel that you are not able to make this commitment, we 
recommend that you not enter the study. 
In addition. Dr. Oren cr' : Dr. Dorkin may terminate your 
participation in this study at. .any time they deem appropriate, 
after they/he has explained the reasons for doing so and has 
helped arrange for your continued care by your physician if that 
is appropriate. Reasons that they/he might discontinue your 
participation could, for example, include a significant worsening 
of your clinical status unrelated to the experimental procedure. 
STIPEND 
You will be compensated for the time and inconvenience involved 
in participating in the research in the amount of $75 for each 
day that you spend in the hospital for a maximum of $300. In 
addition, we will reimburse you for your travel expenses to and 
from the New England Medical Center for each day that you come to 
the clinical for an outpatient visit. The rate will be $0.25 per 
mile and your parking expenses. 
DISCLOSURE 
Representatives of the Federal Food and Drug Administration 
(FDA), the National Institutes of. Health (NIH) , other regulatory 
agencies, and the study sponsor, Genzyme Corporation, may inspect 
the records of patients participating in the study, and your 
signature will keep your identity confidential, except as 
required by law. If information on this study is published, your 
identity will not be disclosed. 
CONFIDENTIALITY 
A record of your participation in this research will be 
maintained, but this record will be kept confidential, except as 
required by law. You will be assigned a study number and 
information v/ill be kept under the number rather than your name. 
Recombinant DNA Research, Volume 20 
[575] 
