Attachment V - Page 3 
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. 
Specifically, 
a. What potential public health benefits or hazards are postulated? 
b. If there significant likelihood that the inserted DNA will 
spread from the patient to other persons or to the environment? 
c. Will any precautions be taken against such spread (e.g., to 
patients sharing a room, health-care workers, or family 
members) ? 
d. Is the proposed procedure sufficiently different from existing 
therapeutic procedures to require special risk-assessment or 
risk-mitigating practices to protect public health? Why or 
why not? 
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 nonoedical) will be 
involved in the proposed study? What 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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