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SHS Approval Stamp Patient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page 1 
Title of Project: Adenovirus-Mediated Gene Transfer for Cystic 
Fibrosis: Safety of Single Lobar Administration in the Luna 
Principal Investigator: Allen Laoev . M.D. 
expected that any correction of the CFTR gene defect will be 
temporary and not produce any improvement in your CF. 
PROCEDURES 
Screening /Enrollment 
Please note that the procedures outlined in this section are 
described in detail in the following section. 
If you agree to participate in the study, 3 weeks prior to the 
administration of Ad2/CFTR-2 you will come to the hospital for an 
extensive screening evaluation. You should expect to spend three 
to four hours at this visit. At that time your physician will 
review your medical histcry, perform a complete physical 
examination, and obtain a full set of pulmonary function tests, 
which you have previously performed as part of your routine care. 
Blood will be drawn from your vein (a total of approximately 60 cc 
or 1/4 cup) for multiple studies. These studies will include a 
test to determine whether or not you have immunity to adenovirus, 
so that we will know if you have ever been exposed to the common, 
naturally occurring adenovirus. The presence of antibody to the 
adenovirus provides an additional measure of safety should, you 
develop a reaction to the adenovirus. We will also determine the 
specific gene for cystic fibrosis which you carry in your 
chromosomes from a blood sample. By collecting specimens of nasal 
secretions, stool, and urine, we will determine whether you 
currently have a natural type of adenovirus in your body, which 
could make administration of Ad2/CFTR-2 unsafe. If you are a 
female of child bearing potential, a pregnancy test will also be 
done . 
One week prior to application of Ad2/CFTR-2, a physical 
examination will be performed, and blood tests, cultures, a 
limited set of pulmonary function tests, and a chest x-ray will be 
obtained . 
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Recombinant DNA Research, Volume 20 
