New Findings : I understand that I will be given any new information gained during 
the course of the study that might affect my willingness to continue my participation. 
Confidentiality : I understand that every effort will be taken to protect my identity as 
a participant in this study, However, there is no guarantee that the information 
cannot be obtained by legal process or court order. I will not be identified in any 
report or publication of this study or its results. The FDA may review all the 
records of this study, and perhaps report it to other regulatory agencies. 
Financial Costs of the Research : I understand that the costs of this research will be 
borne by monies from the N.I.H. and the CF Foundation. I will not be charged for 
any tests or admissions to the GCRC if done solely for research purposes. If I have 
a CF-related problem, that develops during this study, I understand that I would be 
responsible for the cost of treatment, just as I would be if I were not in the research 
study. 
Compensation in Case of Injury : I understand that in the event of physical injury 
resulting directly from the research procedures, financial compensation cannot be 
provided. All forms of medical diagnosis and treatment, whether routine or 
experimental, involve some risk of injury. In spite of all precautions, I might 
develop medical complications from participating in this study. If such 
complications arise, the researchers will assist me in obtaining appropriate medical 
treatment but the University of North Carolina at Chapel Hill does not provide 
financial assistance for medical or other costs. I understand that I do not waive any 
liability rights for personal injury by signing this form. 
Payments to Participants : I understand that I will receive $75.00 for each day in the 
hospital and $75.00 for each day of screening and follow-up visits for up to one year 
to compensate for the time and inconvenience of participation. In addition, travel 
expenses will be compensated to and from UNCH at the rate of $.25/mile, and 
parking expenses. If I am withdrawn from the study, I will receive payment for 
completed visits and hospitalization days as described above. 
Right to Refuse or to Withdraw from the Study : I understand that my participation 
is voluntary and that I may refuse to participate, or may discontinue my 
participation at anv time without penalty, or jeopardizing my continuing medical 
care at this institution, or losing benefits that I would otherwise be entitled to. 
However, after the virus is placed in the nose, I also understand that freedom to 
discontinue participation in study procedures does not mean that I am free to leave 
the hospital (respiratory isolation) until the virus is not present, or the local Health 
Department officials (after discussions with the UNC Biosafety Committee, the 
Human Rights Committee, and the Principal Investigators) have approved my 
leaving the hospital. 
I also understand that Drs. Michael Knowles, Richard Boucher, or Larry 
Johnson has the right to stop my participation in the study at any time. This could 
be because I have had an unexpected reaction, or have failed to follow instructions, 
or because the entire study has been stopped. 
Recombinant DNA Research, Volume 17 
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