The University IRB follows federal regulations and guidance for reporting unanticipated problems involving risks to participants or others (Unanticipated Problems), serious or continuing noncompliance ...

For research involving medical devices, the University IRB will comply with the requirements set forth in 21 CFR Part 812. Per FDA regulations at 21 CFR 812, FDA’s regulations specify the ...

DEFINITIONS: This section defines these terms in relation to UAB IRB requirements. Reportable Event: A reportable event is any unanticipated problem, adverse event or other incident that has the ...

The IRB reviews research involving human subjects if one or more of the following apply: The research is sponsored by WMU, regardless of the location of the project. The research is conducted by, or ...