NOU 23 '94 15=51 
FROM GENZYflE ElOTHERPP 
TO 913014969839 
PAGE . 028 
SHS Approval Scamp Patient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page 11 
Title of Project: Adenovirus-Mediated Gene Transfer for Cvstic 
I 
Fibrosis: Safety of Single Lobar Administration in the Luna 
Principal Investigator: Allen Lapev . M.D. 
USE OF SPECIMENS 
I understand that cells, tissue , ..blood, or other specimens removed 
from me during the course of this study may be valuable for 
scientific, research, or teaching purposes, or for the development 
of a new product, which may be distributed commercially. I 
authorize Massachusetts General Hospital and members of its 
Professional Staff to use my cells, tissue, blood, or other 
specimens for these purposes. 
CONFIDENTIALITY 
I understand that medical information produced by this study will 
become part of my hospital record and will be subject to the 
confidentiality and privacy regulations of the Massachusetts 
General Hospital. Information of a sensitive personal nature will 
not be part of the medical record, but will be stored in the 
investigator's research file and identified only by a code number. 
The code key connecting name to numbers will be kept in a separate 
secure location. 
If the data is used for publication in the medical literature or 
for teaching purposes, no names will be used and other 
identifiers, such as photographs, audio video tapes, will be used 
only with my special written permission. I understand that I may 
see the photographs and videotapes and hear the audio tapes before 
giving this permission. 
If an investigational drug or device is to be studied, then I 
understand that the Food and Drug Administration, other regulatory 
agencies, and the industrial sponsor are permitted to have access 
to my medical record and to the data produced by the study, for 
audit purposes. However, they are required to maintain 
confidentiality . 
[588] 
Recombinant DNA Research, Volume 20 
