Attachment II - Page 3 
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risks ard benefits, the IRB should consider only those risks 
and benefits that may result from the research (as distinguished 
from risks and benefits of therapies subjects would receive 
even if not participating in the research). The IRB should not 
consider possible long-range effects of applying knowledge 
gained in the research (for example, the possible effects of 
the research on public policy) as among those research risks 
that fall within the purview of its responsibility. " 
Specific points regarding gene therapy that follow frcm these general 
requirements are: 
1. The Disease and Alternative Therapies 
a. What disease is to be treated? Why was it selected? 
b. Is the natural history of the disease kncwn, so that assessment 
of the success of gene therapy will be clear and straightforward? 
c. What alternative therapies exist? Hew effective are they, and in what 
portion of patients are they effective? 
2 . Research methods 
a. Characterization of vector and inserted DNA 
(1) What is the structure of the vector? How was it prepared? 
[Ill] 
