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Incident Reporting and Compliance

Reporting to OHRP: What’s Necessary, What’s Not - Part 1 of 2

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)

Watch: Reporting to OHRP 2: What’s Necessary, What’s Not

Reporting to OHRP - Part 2 of 2

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)

Watch: Reporting to OHRP 2

Guidance on Reporting Incidents to OHRP

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.)

Watch: Guidance on Reporting Incidents to OHRP      

When the Feds come a'Knockin': How to Prepare for an OHRP Compliance Evaluation of your Program

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)

 

Watch: When the Feds come a' Knockin': How to Prepare for an OHRP Compliance Evaluation of your Program

Reviewing and Reporting Unanticipated Problems and Adverse Events

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