consent form and are the same as those risks which are part of the standard 
clinical evaluation of individuals with CF. The risks related to Ad^CFTR.lO 
delivery itself are more accurately described as speculative risks. 
Adenoviruses are a common cause of respiratory problems in man and are not 
usually serious, therefore, infection with adenovirus itself does not pose a 
major risk. There is a potential that the AdcvCFTR.10 virus will acquire some 
genetic material from another adenovirus or other virus leading to production 
of a "mutant" adenovirus thus posing a risk not only to the study subject but 
also to that subject's environment. This risk is reduced markedly by the fact 
that no individuals with evidence of adenovirus or other major viral infec- 
tions will be included in the study and by the isolation procedures employed 
before, during and after administration of AdcvCFTR. 10 . Even if a "mutant" 
adenovirus is produced, by a process of either complementation or recombina- 
tion, the risk to the study subject or to the environment is mitigated by the 
fact that the most likely outcome would be either a replication competent and 
likely less virulent adenovirus (if recombination occurs) or the release of 
small amounts of AdcvCFTR.lO (if complementation were to occur). Since 
AdcvCFTR.10 is replication deficient this will have limited spread. Further- 
more, while these risks are theoretically possible, they have not been ob- 
served in studies involving AdcvCFTR.10 administration to animals at similar 
doses to those intended for human use. One final speculative risk is that 
protein produced by the CFTR gene in Ad^/CFTR-lO may be recognized as "for- 
eign" by the participants' immune system. This is unlikely as study subjects 
are chosen so as to exclude those individuals who do not produce a CFTR pro- 
tein, so that the normal protein produced by Ad^vCFTR.10 is less foreign to 
them. 
9.6 Post-Study Patient Follow-up. The detailed data for the study will accrue 
during the baseline period, the vehicle control period and the AdcvCFTR.10 
treatment period. Following discharge, there will be follow-up every 6 months 
for months 12, 18 and 24, and thereafter on a yearly basis. 
9.7 Clinical Facilities for the Study. The study will be conducted on an out- 
patient and inpatient units of The Rockefeller University Hospital. The inpat- 
ient unit is appropriately equipped to handle all relevant inter-current ill- 
nesses and adverse reactions and the investigator physicians are fully quali- 
fied to handle these patients and relevant possible complications. Following 
discharge, follow-up evaluations of the patients will be on the inpatient unit 
and in the Outpatient Clinic as dictated by the protocol. 
9.8 Privacy and Confidentiality. The privacy of the patients and all confiden- 
tiality issues will be handled in accordance with the hospital, RAC and FDA 
guidelines . 
9.9 Reporting of Serious Adverse Effects. As detailed above, reports of ad- 
verse reactions will be made to the IRB , IBC , RAC, and the FDA within 24 hours 
of its recognition in accordance with the guidelines of each of these groups. 
9.10 Future Directions. Based on this initial safety and efficacy data, fu- 
ture studies will be designed regarding dose, form of administration frequency 
of administration and safety and efficacy parameters. Appropriate statistical 
and data base considerations will be determined in consultation with appro- 
priate biostatistical consultation. 
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