M EDICAL RECORD 
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CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study 
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STUDY NUMBER: CONTINUATION: page_9_of 21_ pages.: 
the lining of the lung or in the rectum for a number of days after administra- 
tion and up to 15 days in a few instances. It is likely that this will be 
true for humans as well. In the animal studies, control animals that did not 
receive AdCFTR, yet were in the same environment as the animals treated with 
AdCFTR, did not get "infected" with AdCFTR. With regards to the potential 
effect of your treatment with AdCFTR on other individuals, we believe that 
it's extremely unlikely that there would be any risk of you causing harm to 
other individuals through AdCFTR should you leave the Clinical Center while 
AdCFTR can still be detected in your body secretions. This is based on the 
animal studies described above, the accumulated knowledge about the CFTR gene, 
and from many studies of administrating live adenovirus to humans for vaccine 
trials and vaccines. Further, although we believe that it is extraordinarily 
unlikely, given the design of this protocol, that administration of AdCFTR to 
you has a risk of AdCFTR combining with another virus or other genetic infor- 
mation in your body to create a risk to you or others , we cannot prove this 
absolutely. 
Despite our belief that administration of AdCFTR to you, as described in this 
protocol, does not pose a risk to you or others, no animal is identical to 
humans in regard to adenovirus infection, therefore it is impossible to prove 
this absolutely without administrating AdCFTR to humans. In this context, as 
part of your consent to participate in this protocol, we are asking you to 
agree to the following: 
1. To minimize the possibility of your getting a virus (like an 
adenovirus) infection from other individuals, for 10 days 
prior to receiving AdCFTR, we ask that you either remain in your 
hospital room on the 7 West patient care unit or wear a mask and gloves 
when you are elsewhere in the Clinical Center. When hospital staff or 
other individuals visit with you (no one under age 15 will be allowed to 
visit), they will be asked to wear masks, gowns and gloves. 
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2. To minimize the possibility of "spread" of AdCFTR to other people, for a 
minimum of 15 days after receiving AdCFTR we ask that you either remain 
in your hospital room or wear a mask and gloves when elsewhere in the 
Clincal Center. When hospital staff or other individuals visit with 
you, they will be asked to wear masks, gowns and gloves. 
3. In the unlikely (but not impossible) event that AdCFTR (or a combination 
of AdCFTR with another virus) is detected in secretions from your body 
(sampled from nose, back of throat, feces and urine) for longer than 15 
days, we ask that you remain in the "isolation" conditions described in 
(2) until the virus disappears. While it is not anticipated that the 
virus will persist, it is a theoretical possibility. If it does, there 
is no way to estimate how long the virus would persist in your secre- 
tions and, theoretically, it could do so indefinitely. 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 16 
[780] 
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