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Guidance on Reporting Incidents to OHRP

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Air date: Thursday, July 24, 2014, 2:00:00 PM
Time displayed is Eastern Time, Washington DC Local
Views: Total views: 1042, (645 Live, 397 On-demand)
Category: Special
Runtime: 00:48:45
Description: The current HHS regulations for the protection of human subjects in research state that institutions are required to have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, OHRP, and the department or agency head of any unanticipated problems involving risks to subjects or others, any serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB, and any suspension or termination of IRB approval.

This session will address the HHS regulatory requirements that apply to reporting, and will discuss strategies for managing regulatory considerations, including:

• Regulatory background
• What needs to be reported?
• Time frames for reporting
• Common areas of noncompliance reported to OHRP
• OHRP processing of reports
• Corrective actions
• Institutional considerations
• Future of reporting

CE Units: 1.00 CIP unit available. Unfortunately, OHRP is unable to provide documentation of your participation in this event. Please give detailed information (date, time, title, website) about the event on your CIP recertification application.

Incident Reporting Guidance Slides

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Author: Kristina Borror, Ph.D., Office for Human Research Protections, HHS
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CIT Live ID: 14345
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