Attachment II - Page 7 
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their specific qualifications and their experience 
with respect to the disease to be treated? 
(b) At what hospital or clinic will the treatment be given? 
Which facilities of the hospital or clinic will be 
especially important for this study? Will patients 
occupy regular hospital beds or clinical research 
center beds? 
B. Selection of Subjects 
The IRB shall determine that: 
"(3) Selection of subjects is equitable. In making this assessment 
the IRB should take into account the purposes of the research and 
the setting in which the research will be conducted." 
Specific points regarding gene therapy that follow from this general 
requirement are: 
1. Age and sex of patients (and possible controls) 
2. Criteria for selecting or excluding patients 
a. What concurrent diseases or conditions would disqualify a 
potential study participant? 
b. Will gene therapy be administered early in the course of 
patients' illnesses or only when their symptoms become quite 
severe? What is the justification for the proposed timing 
of treatment? 
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