5. CONFIDENTIALITY : 
i 
A record of your participation in this research will be maintained, but this record will be 
kept confidential. You will be assigned a study number and information will be kept 
under the number rather than your name. All requests for information will be directed to 
the University of Iowa Health Science Relations Office to minimize the risk that your 
identity will be disclosed to the public. Gene therapy 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 identify and spread this 
information, even if you do not want this to happen. 
6. DISCLOSURE OF INFORMATION TO REGULATORY AGENCIES : 
The U.S. Food and Drug Administration (FDA), National Institutes of Health, and 
Genzyme Corporation may inspect and copy your medical records relating to this study, 
and the results of the study will be reported to the sponsor, the FDA and perhaps to other 
regulatory agencies. This information will be treated confidentially and, in the event of 
any publication regarding this study, your identity will not be disclosed. 
7. RIGHT TQ ASK QUESTIONS: 
Questions about this research will be answered by either Dr. Michael J. Welsh, M.D., 
University of Iowa Medical Center, telephone (319) 335-7619 or Dr. Joseph Zabner, 
MD., University of Iowa Medical Center, telephone (319) 335-7574. 
8. RIGHT TO WITHDRAW : 
Your participation in this study is voluntary. No penalty or 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 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. Welsh may terminate your participation in this study at any time he 
deems appropriate, after he has explained the reasons for doing so and has helped arrange 
for your continued care by your own physician if that is appropriate. Reasons that he 
might discontinue your participation could, for example, include a significant worsening 
of your clinical status unrelated to the experimental procedure. 
9. COMPENSATION : 
There will be no charge to you for participating in this study nor will you be charged for 
any tests that we perform. 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. In addition, we will reimburse you for your travel expenses to and from 
the University Hospitals for each day that you come to the clinic for an outpatient visit. 
The rate will be $0.25 per mile and your parking expenses. 
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