Office of Science. HQ Expectations of DOE Site IRBs . Reporting Unanticipated Problems and Review/Approval of Projects that Use Personally Identifiable Information Libby White May 7, 2009. Office of Science. HQ Expectations of DOE Site IRBs Unanticipated Problems.
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OHRP guidance recommends that the PI report an unanticipated problem to the IRB(s) within 2 weeks and that the PI/the PI’s organization report the unanticipated problem to OHRP within 6 weeks (or within 1 month of notifying the IRB(s).
While DOE Order 443.1A does not define “prompt,” we request that you notify the HSR Program Manager(s)
within 48 hours of learning of any
unanticipated problem that does not involve PII.
for protecting PII in accordance with
Federal and DOE requirements
research and/or EEOICPA;
for websites established for the submission of
information that includes PII;
discovery to: 1) the DOE Project Officer; and
2) the applicable IRBs.