8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others

Last Revised: 5/8/2023

1.0 Purpose

The purpose of this policy is to describe the process for reporting potential unanticipated problems (UPs) involving risk to the ORA and the IRB, and the process for review of potential UPs.


2.0 Policy

It is the policy of the organization that:


3.0 Definitions


4.0 Investigator (or Other Reporters’) Responsibilities


5.0 IRB/ORA Responsibilities


6.0 Reporting UPs to Institutional Officials, OHRP, FDA, and Department or Agency Heads

All required reports will be submitted in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

 Revised: 11/27/2018 - revision not documented

 Revised: 1/18/2023 - Clarified that certain events are always referred to convened IRB for review and determination if the event constitutes a UP, and other events are first reviewed by the ORA and only referred if determined by the ORA to be potentially represent a UP; simplified text; stylistic changes.

 Revised: 5/8/2023 - Corrected regulatory reference in section 2.1; modified section 5.1 to reflect IRB actions as opposed to investigator actions (eg, “requiring modification of the protocol” as opposed to “modifying protocol”); correcting misspellings.


Revision #8
Created 24 October 2019 21:44:33 by Autumn M Eberly
Updated 17 April 2025 16:10:48 by Robert A Lewis