M.J. Welsh and A.E. Smith, RAC Application 
of the airway will be critical for further studies which might involve giving the virus to 
the bronchial airways of the lung to treat the disease. 
4. ALTERNATIVES THAT ARE AVAILABLE TO. YOU : 
You may elect not to participate in this study and this decision will not affect your care at 
the University of Iowa. Treatments of cystic fibrosis include: chest physiotherapy, 
antibiotics, nutritional and dietary measures, and experimental agents which might reduce 
the thickness of the mucus. Other than the use of DNase, these treatments will also be 
available to you during and after the study. Since this study will not directly treat your 
lungs, a decision not to participate will not affect your health. 
5. CQNFIDENIIALHY: 
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. 
6. DISCLOSURE OF INFORMATION TO REGULATORY AGENCIES : 
The U.S. Food and Drug Administration (FDA) 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 TO ASK QUESTIONS : 
Questions about this research will be answered by either Dr. Michael J. Welsh, MJD., 
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 withdraw from the investigational part of the study. 
However, you will not be able to leave the hospital room until the cultures from nasal 
swabs show that you no longer have live virus on the lining of your nose or in your blood 
or urine. Thus, it is likely that you will have to remain in the hospital for at least two 
weeks and possibly longer. 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 
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