G. Any other material which you believe will aid in the review. 
Reporting Requirements 
A. Serious adverse effects of treatment should be reported immediately 
to both your local IRB and the NIH Office for Protection from Research 
Risks, and a written report should be filed with both groups. A copy 
of the report should also be forwarded to the NIH Office of Recombinant 
DNA Activities (ORDA). 
B. Reports regarding the general progress of patients should be filed 
at six-month intervals with both your local IRB and ORDA. 
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). In the event of a patient's death, the autopsy report 
should be submitted to the IRB and ORDA. 
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