II 
MEDICAL RECORD 
I 
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 
| STUDY NUMBER: CONTINUATION: page_10of ?J_ pages. 
Should the events in (3) above occur, all efforts will be made to make you 
comfortable and to provide for reasonable social and personal needs. 
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| 
You should understand, that we can only ask you to agree to these conditions, 
but cannot compel you to do so , that is , should you choose to leave at any 
time despite our advice, we cannot stop you from doing so. The one exception 
to this is in the extraordinarily unlikely, but theoretically possible, 
circumstance where the physicians caring for you believe that because of an 
unexpected event AdCFTR had combined with another virus or other genetic 
information to create a new virus believed to be dangerous to others. In this 
event the NIH Clinical Center regulations allow your physicians to keep you 
against your will for up to 72 hours. During that period, they have the 
option to ask for a court order to keep you confined until the risk to others 
is over. We believe it would be extremely unlikely for this to occur, but we 
cannot prove that it is impossible, therefore we are required to inform you of 
the theoretical possibility of this occurring. 
Exclusion criteria: 
Individuals who do not meet the inclusion criteria will be unable to partici- 
pate in the protocol. 
Individuals with active respiratory tract infection in the 3 weeks prior to 
beginning the protocol will not be able to participate. Similarly individuals 
with active respiratory tract infections in the 3 weeks prior to parts 2 or 3 
of the protocol will not be allowed to enter these parts. Criteria for 
diagnosis of infection are rhinitis, pharyngitis, conjunctivitis, bronchitis, 
evidence of fever or changes in sputum requiring antibiotics or a change in 
antibiotics . 
Individuals with evidence of cardiac, renal, central nervous system, major 
psychiatric disorder, musculoskeletal disease or immunodeficiency disease, 
(including evidence of human immunodeficiency virus infection, HIV) will be 
unable to participate in the protocol. The absence of HIV infection is 
critical because it might be dangerous to administer AdCFTR to such individu- 
als given that severe or lethal adenoviral infections have been repeated in 
individuals with HIV infection. 
All individuals receiving corticosteroids or other immunosuppressive medicines 
(medicines that decrease the body's capacity to respond to infections), will 
not be able to participate. 
Protocol : 
The clinical study will include 10 individuals with cystic fibrosis. After 
baseline (part 1; see below) and control vehicle (part 2; see below) periods 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 16 
[781] 
