Incident Reporting and Compliance
This video reviews the regulatory requirements for reporting unanticipated problems to OHRP, including how to determine when an unanticipated problem or adverse event must be reported. (November 10, 2020)
Watch: Reporting to OHRP (1): Unanticipated Problems (18:05)
OHRP staff member Lisa Buchanan explains what constitutes unanticipated problems, adverse events, serious non-compliance, and continuing non-compliance, in addition to discussing IRB suspensions and terminations. She also explains requirements for written procedures for reporting to OHRP. (Mar 3, 2017)
OHRP staff member Lisa Buchanan discusses what investigators should do when a reportable incident occurs, actions that IRBs need to take, when to report an incident to OHRP, and how OHRP will process incident reports. (Mar 3 , 2017)
OHRP’s Kristina Borror addresses the HHS regulatory requirements that apply to reporting incidents and strategies for managing regulatory considerations. Topics include: the regulatory background, what needs to be reported and when, common areas of noncompliance, and institutional considerations. (Jul 24, 2014)
CE: 1:00 CIP Unit (OHRP doesn't provide documentation but viewers can provide the date, time, title, and URL on the CIP recertification application.)
Director of OHRP's Division of Compliance Oversight, Kristina Borror, discusses how to respond to allegations of noncompliance and how to prepare for an investigation. (Feb 23, 2012)
Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.
Michael Carome, formerly of OHRP, discusses the criteria for determining if an incident or outcome is an unanticipated problem involving risk to subjects or others (according to the HHS regulations), the differences between adverse events and unanticipated problems, and how to respond . (Jul 5, 2010)
Watch: Reviewing and Reporting Unanticipated Problems and Adverse Events
