A new checklist could prevent research institutions from getting written up by federal inspectors during an evaluation of how well they protect research volunteers.
The two primary health agencies charged with overseeing human subjects research released May 17 a joint, final guidance on written procedures for institutional review boards. IRBs are ethics panels that must review and approve most research on humans before any testing can begin.
Regulations by the Health and Human Services Office for Human Research Protections and the Food and Drug Administration call for written IRB procedures. But this requirement often trips up institutions. Inadequate written procedures...
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(Updated to include additional comments in the ninth and tenth paragraphs.)