Attachment VI - Page 12 
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h. At what hospital or clinic will the treatment be given? Vhich 
facilities of the hospital or clinic wall be especially important 
for the preposed study? Will patients occupy regular hospital 
beds or clinical research center beds? Where will patients reside 
during the follow-up period. 
C. Selection of subjects 
Estimate the number of patients to be involved in the preposed study 
of gene therapy. Describe recruitment procedures and patient eligibility 
requirements paying particular attention to whether these procedures 
and requirements are fair and equitable. 
1. How many patients do you plan to involve in the preposed study? 
2. Ffcw many eligible patients do you anticipate being able to identify 
each year? 
3. What recruitment procedures do you plan to use? 
4. What selection criteria do you plan to employ? Wiat are the exclusion 
and inclusion criteria for the study? 
5. How will patients be selected fairly, if it is not possible to treat 
all who need treatment? 
D. Informed consent 
Indicate how patients will be informed about the proposed study and 
how their consent will be solicited. The consent form should adhere 
to the requirements of 45 CFR 46. If the study involves pediatric or 
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