c. What precautions will be taken against such spread (e.g., to 
patients sharing a room, health-care workers, or family members)? 
d. What measures will be undertaken to mitigate the risks, if any, to 
public health? 
5. Qualif ications 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 nonmedical) 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 Section III-E). 
b. At what hospital or clinic will the treatment be given? Which 
facilities of the hospital or clinic will be especially important 
for the proposed study? Will patients occupy regular hospital 
beds or clinical research center beds? Where will patients reside 
during the follow-up period? 
Selection of patients 
Estimate the number of patients to be involved in the proposed study 
of gene therapy. Describe recruitment procedures and patient eligibility 
I Recombinant DNA Research, Volume 1 1 
