Revised 8-26-94 
tential effect of your treatment with Ad^vCFTR-lO on other individuals, we be- 
lieve that it is extremely unlikely that there would be any risk of you caus- 
ing harm to other individuals through AdcvCFTR.lO should you leave the hospi- 
tal while AdsvCFTR.10 can still be detected in your body secretions. This is 
based on the animal studies described above, the accumulated knowledge about 
the CFTR gene, from many studies of administrating live adenovirus to humans 
for vaccine trials and vaccines, and from human studies evaluating gene thera- 
py to the lung of individuals with cystic fibrosis using a vector very similar 
to AdsvCFTR.10. Further, although we believe that it is extraordinarily un- 
likely, given the design of this protocol, that administration of AdcvCFTR.lO 
to you has a risk of AdcvCFTR.lO combining with another virus or other genetic 
information in your body to create a risk to you or others, we cannot prove 
this absolutely. Finally, there is the possibility that the Ac^vCFTR.lO vector 
might combine with another virus and cause serious infection in the lung. 
While theoretically possible, this has never been observed in either animal or 
human studies with similar adenovirus vectors. 
Despite our belief that administration of Ad^vCFTR-lO 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 Ad^vCFTR-lO to humans. In this 
context, as part of your consent to participate in this protocol, we are as- 
king you to agree to the following: 
1. To minimize the possibility of "spread" of Ad^-vCFTR-lO to other people, for 
a minimum of 2 days after receiving AdgvCFTR.10 we ask that you either remain 
in your hospital room or wear a mask and gloves when elsewhere in the hospi- 
tal. When hospital staff or other individuals visit with you, they will be 
asked to wear masks, gowns and gloves. 
2. In the unlikely (but not impossible) event that AdcvCFTR.10 (or a combina- 
tion of AdcvCFTR.lO with another virus) is detected in secretions from your 
body (sampled from nose, back of throat, feces and urine), we may ask that you 
remain in the hospital 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. Should the events in 
(3) above occur, all efforts will be made to make you comfortable and to pro- 
vide for reasonable social and personal needs. 
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, cir- 
cumstance where the physicians caring for you believe that because of an unex- 
pected event Ad^vCFTR.10 had combined with another virus or other genetic in- 
formation to create a new virus believed to be dangerous to others. In this 
event your physicians 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, there- 
fore we are required to inform you of the theoretical possibility of this oc- 
curring. 
[232] 
Recombinant DNA Research, Volume 20 
