8.5 Noncompliance by the IRB or Other Components of the HRPP

1.0 Purpose

The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the IRB and/or other components of the HRPP.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Responsibilities of the ORA, Chief Compliance Officer (CCO) and Institutional Official (IO)


5.0 Reporting Noncompliance to Organizational 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: 1/20/2016 (Approved: 1/20/2016) - original author not recorded

 Revised: 1/11/2018 - revision not documented

 Revised: 3/7/2023 – revised definitions; clarified that the ORA will conduct initial evaluation and pass recommendations to CCO; simplified throughout; stylistic changes.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 5/9/2023 – Deleted reference to “minor” non-compliance and substituted “neither serious nor continuing”; revised definition of serious non-compliance to include putting Organization at risk of significant regulatory, financial or reputational harm; revised definitions of serious non-compliance and continuing non-compliance to delete parts of the definition more appropriate for PI or research staff non-compliance; clarified possible actions of CCO.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #6
Created 24 October 2019 21:45:08 by Autumn M Eberly
Updated 19 May 2023 01:02:03 by Robert A Lewis