the hospital before the doctors have demonstrated that I have no virus in my 
nose or body, the researchers have a responsibility (and legal right) to keep me 
for at least 72 hours against my will until review of the situation takes place. 
Several physicians will be responsible for my welfare during this study, i.e., 
Michael Knowles, M.D., Richard Boucher, M.D. and Larry Johnson, M.D. 
Exclusions : I understand that I should not participate in this study if any of the 
following apply to me: 
Worsening of pulmonary function or "exacerbation" in the past three weeks. 
Lack of adequate birth control, i.e., men must be demonstrated to be infertile 
(azoospermic) and women must have practiced standard contraception 
(condoms, IUDs, birth control pills, or abstinence) for at least one month and 
have a negative pregnancy test. 
Systemic steroids (cortisone) must not have been used within the past three 
months. 
No participation in other therapeutic research studies within the past month, for 
example, the use of DNAse. 
Patients with known mild CF genetic mutations, specifically those with normal 
pancreatic digestive function. 
Patients whose blood does not have antibodies to adenovirus type 5; a lack of 
"seropositivity" should exclude me from participating. 
Patients without adequate organ system function (cardiac, hepatic, renal, 
endocrine), so that complications would not produce clinical difficulties. 
Risks and Discomforts : I understand that this study might involve the following 
risks and/or discomforts: 
1) Gene therapy is experimental, and several complications are possible. 
a) Although the virus that is being used has been modified so that it 
cannot reproduce itself, there is a slight possibility that something 
would occur during the study that would allow the virus to multiply. 
The results of this event are not fully known, although it is likely that 
the virus would be killed after it has been there for several days to 
weeks, since my body has immunity to the adenovirus type 5. 
b) The virus could damage nasal cells, or the inflammatory response 
could cause local inflammation in the nose. It is possible, although 
highly unlikely, that this could cause permanent damage. It would 
likely cause local pain or inflammation in the nose that would 
resemble a "cold", or could cause sinusitis. 
c) It is possible that this virus could spread to others in the surrounding 
environment, although this is unlikely. However, if signs are present 
that this is occurring, or could occur, i.e., live viruses in nasal washes, I 
will be asked to remain in the hospital in respiratory isolation for up 
to four weeks after virus is placed in the nose. 
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Recombinant DNA Research, Volume 17 
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