IV. Reporting Requirements 
A. Serious adverse effects of treatment should be reported immediately 
to both your local IRB and the NIH Office for Protection fran 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 
CNA Activities (ORDA). 
B. Reports regarding the general progress of patients should be filed 
at six-month intervals with both your local IRB and OREA. 
These tw ice-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 OREA. 
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