NOU 2o '94 15=50 
FROH GEN2YME EIOTHERAP 
TO 913014969859 
PAGE . 02? 
SHS Approval Stamp Patient ID Stamp 
Massachusetts General Hospital 
MEDICAL RESEARCH CONSENT FORM, Page 10 
Title of Project: Adenovirus-Mediated Gene Transfer for Cvstic 
Fibrosis: Safety of Single Lobar Administration in the Luna 
Principal Investigator: Allen Laoev . M.D. 
ALTERNATIVES TO PARTICIPANTS 
You may elect not to participate in this study and this decision 
will not affect your care at the Massachusetts General Hospital. 
Treatments of cystic fibrosis include: chest physiotherapy, 
antibiotics, nutritional and dietary measures, and other agents 
which may or may not reduce the thickness of the mucus. Most of 
these treatments will also be available to you during and after 
the study. Since this study is designed to study gene transfer 
safety rather than efficacy, a decision not to participate will 
not affect your standard CF care management. 
MEDIA ATTENTION 
Gene transfer is very interesting to the general public. Although 
every effort will be made to maintain your privacy, it is possible 
that the news media or other individuals might learn your identity 
and spread this information, even if you do not want this to 
happen. Media requests will be directed so that patient 
confidentiality is maintained. 
COSTS 
All procedures performed for this study will be provided free of 
charge . 
COMPENSATION 
You will be reimbursed $25 for each outpatient visit and $75 for 
each inpatient day to cover travel, expenses, and parking fees. 
The following paragraphs contain the usual considerations involved 
in consenting to' be a subject in a research study and axe required 
by the Subcommittee on Human Studies of the Massachusetts General 
Hospital on all consent forms. 
Recombinant DNA Research, Volume 20 
[587] 
