NOU 23 '94 15=50 
FROH GENZYflE EIOTHERflP 
TO 913014969839 
PAGE . 026 
SHS Approval Stamp Patient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page 9 
Title of Project: Adenovirus-Mediated Gene Transfer for Cystic 
Fibrosis: Safety of Single Lobar Administration in the Luna 
Principal Investigator: Allen Lapev. M.D. 
6. We do not know the effects of altered adenovirus on an embryo 
or fetus of a pregnant woman,- therefore you will not be allowed 
to participate if you are pregnant. If you are a woman, we 
will do a pregnancy test. All participants, men and women, 
will be asked to use a reliable form of contraception such as 
barrier methods (condom and diaphragm) or oral contraceptive 
pills during this study and for six months afterward to prevent 
pregnancy . 
PERMISSION FOR AUTOPSY 
As described above, we do not believe that administration of 
Ad2/CFTR-2 will cause a reaction that would cause your death. 
However, in the unlikely event of death from any cause during the 
course of the study (for example, in a traffic accident), it could 
be of vital importance to future patients for us to determine the 
effects of Ad2/CFTR-2. Therefore we would ask your family to 
grant permission for an autopsy. 
POTENTIAL BENEFITS 
Single administration of the normal gene using the modified 
adenovirus in this study will provide no long term benefit. The 
correction of the genetic defect of CF, if it occurs, is unlikely 
to persist for more than 3 to 4 weeks. The primary benefit will 
be a better understanding of the possibilities for CFTR gene 
transfer with the altered virus. In particular, information 
regarding the amount of virus needed and the effects of the virus 
on the cells of the airways will be critical for further studies, 
which would involve administering the virus to the airways of the 
lung to treat the disease cn a long-term basis. In terms of 
therapy, however, this initiitl study will not change your cystic 
fibrosis symptoms and therefore will not be of immediate benefit 
to you. 
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Recombinant DNA Research, Volume 20 
