Attachment VI - Page 11 
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f. If a treated patient dies, will an autopsy be requested? If 
so, please indicate what special studies, if any, will be 
performed. 
4. Public health considerations 
Describe the potential benefits and hazards of the proposed 
therapy to persons other than the patients being treated. 
a. What potential benefits or hazards are postulated? 
b. Is there any expectation that the recanhinant DNA will spread 
from the patient to others or to the environment? 
c. Vhat precautions will be taken, if any, to protect others 
(e.g. , patients sharing a room, health-care workers, or 
family marbers) from such potential hazards? 
5 . Qualifications of investigators, adequacy of laboratory and clinical 
facilities 
Indicate the relevant training and experience of the personnel who 
will be involved in the preclinical studies and clinical administra- 
tion of gene therapy. In addition, please describe the laboratory 
and clinical facilities where the proposed study will be performed. 
a. What professional personnel (medical and normedical) will be 
involved in the proposed study? that are their specific quali- 
fications and experience with respect to the disease to be 
treated and with respect to the techniques employed in molecular 
biology? Please provide curricula vitae (see III-D) . 
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