8.7 Reporting Incidents to Institutional Officials and Federal Agencies

Last Revised: 8/1/2023

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements to ensure prompt reporting of incidents to Institutional Officials, Federal Agencies (including OHRP and FDA) and other Common Rule Departments and Agencies, and to AAHRPP.


2.0 Policy

It is the policy of the Organization that:

3.0 Definitions


4.0 IRB/ORA Responsibilities


5.0 Institutional Responsibilities


6.0 Investigator Responsibilities


7.0 Contents of Reports


8.0. Reports to AAHRPP


Document History:

 Written: 1/20/2016 (Approved: 1/20/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised: 8/15/2022 - Clarified that IO may (but is not required to) report incidents or noncompliance or UPs not associated with Federally funded research to Federal agencies; clarified that decision by the IO to report is made after due consideration of recommendations of the IRB, and in consultation with IRB Executive Chair and Organizational officials; clarified that copies of the report will be made available to the PI after submission to the agencies; referenced HRPP 1.3 for reporting of incidents where UNMC is the IRB of record for other relying sites; reorganized lists of responsibilities for clarity.

 Revised: 8/1/2023 – added sections 2.4 and 8.0 regarding notification to AAHRPP.


Revision #10
Created 24 October 2019 21:45:52 by Autumn M Eberly
Updated 17 April 2025 16:12:42 by Robert A Lewis