Attachment II - Page 16 
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b. At vhat hospital or clinic will the treatment be given? Which 
facilities of the hospital or clinic will be especially irrportant 
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 patients 
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. Hew many patients do you plan to involve in the preposed study? 
2. How 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? What are the exclusion 
and inclusion criteria for the study? 
5. Hew will patients be selected if it is not possible to include 
all who desire to participate? 
D. Informed consent 
Indicate how patients will be informed about the proposed study and 
how their consent will be solicited. The consent procedure should adhere 
to the requirements of DHHS regulations for the protection of human 
subjects (45 Code of Federal Regulations, Part 46). If the study 
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