Attachment II - Pq. 9 
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 area 
are: 
1. Age and sex of patients 
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? 
c. From what geographical area will patients be recruited? How many 
patient-candidates will be available per year? 
It is recognized that problems of equity in patient selection are likely to be 
no problem in the early phases of gene therapy since it is recognized that 
recruitment of experimental subjects initially will be difficult. Should gene 
therapy be successful, problems of equity in allocation of resources to 
patients desiring gene therapy may arise. The working group will address this 
problem at that time. 
Suggested by Arno G. Motulsky 
[ 240 ] 
