Attachment VI - Page 16 
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IV. Reporting Requirements 
A. Serious adverse effects of treatment should be reported vrenediately 
to both your local IRR and the NIH Office for Protection from 
Research Risks (phone: 301-496-7005). 
B. Reports regarding the general progress of patients should be filed 
at six-month intervals with both your local IRB and the NIH Office 
of Recombinant DtA Activities (ORDA) (phene: 301-496-6051). These 
twice-yearly reports should continue for a sufficient period of 
time to allow observation of all major effects (at least three to 
five years) . If a patient dies, the autopsy report should be 
submitted to the IRB and ORDA. 
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