temporarily increase the heart rate and amiloride, which is a "fluid pill" medication when 
taken by mouth. At the very low doses that will be applied to the lining of the nose, these 
medications should not cause problems. 
The drawing of blood from a vein or from an artery for blood tests could cause a bruise at 
the site, minor bleeding, and momentary pain. 
We anticipate that a subject will have two computerized tomographic X-rays of the chest 
during the course of the studies. Although there are no known adverse effects of this 
amount of radiation, the long term effects of such radiation are not known with certainty. 
The risk associated with the radiation that you will receive from this study is 
approximately equal to one fifth of the annual allowable dose to a radiation worker. 
The altered adenovirus, could be dangerous to an embryo or fetus if you are pregnant; the 
risks are currently unknown. You will not be allowed to participate if you are pregnant. 
If you are a woman, we will do a pregnancy test. You will be asked to adopt some form 
of contraceptive precaution, such as oral contraceptives or an intrauterine device, during 
this experiment. 
During the time that you are participating in this study you will remain 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 your cystic 
fibrosis, we would initiate the appropriate treatment; for example, if you should develop 
an pneumonia, we would begin treatment with antibiotics. However, in that case, we 
would ask that you or your insurance company arrange for payment for the therapy. 
We do not expect that you will experience any major harmful effects of this study. 
However, because it could be of importance for future patients, an autopsy would be of 
value in determining the effects of the treatment. Therefore, in the unlikely event of 
death from any cause (for example, a traffic accident) during the course of the study, we 
will request that permission for an autopsy be granted. 
3. POTENTIAL BENEFITS TO YOU OR TO OTHERS WHICH MAY BE 
EXPECT EP F ROM TH E R E SEA RC H: 
It is unlikely that participation in this study will directly benefit you. The correction of 
the genetic defect of cystic fibrosis will likely be limited to only the actual area where the 
virus was applied to the nose. The primary benefit will be a better understanding of the 
possibilities for gene therapy with the altered virus in cystic fibrosis. In particular, 
information regarding the amount of virus needed and the effects of the virus on the cells 
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. 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. 
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