8.4 Review of Noncompliance Involving the PI or Study Personnel

Last Revised: 3/6/2024

1.0 Purpose

The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the PI, study team, and/or subjects. Noncompliance by the IRB and/or Other Components of the HRPP is addressed in HRPP 8.5 (Noncompliance by the IRB or Other Components of the HRPP).


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Reporting Noncompliance to the ORA


5.0 ORA Responsibilities


6.0 IRB Responsibilities


7.0 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: 1/19/2018 - revision not documented

 Revised: 1/18/2023 - Simplified purpose statement; corrected regulatory citations in section 2.4; added caveat that reporting will occur in accordance with the Organization’s FWA; clarified definition of noncompliance; clarified criteria for serious noncompliance in section 3.1.1; specified additional conditions which might be considered serious noncompliance (sections 3.1.1.1 and 3.1.1.2); clarified definition of continuing noncompliance; simplified description of reporting to ORA (section 4.0); revised to separate and delineate responsibilities of ORA and of IRB; minimized specific details of processes associated with ORA and/or IRB review (moved to SOP); stylistic changes for clarity.

 Revised: 3/8/2023 – Deleted reference to “minor” non-compliance and substituted “neither serious nor continuing”; minor revisions in wording of definition of non-compliance, serious non-compliance, and continuing non-compliance; changes “alleged non-compliance” to “possible non-compliance”; simplified section on reporting non-compliance to ORA; deleted list of types of people who may report non-compliance and of possible ways to report non-compliance; simplified section on ORA responsibilities; clarified method of reporting non-compliance discovered at time of CRO or other audit; stylistic changes.

 Revised: 3/6/2024 – revised Title, Purpose (section 1), and section 3.1 to clarify that this policy includes noncompliance by research subjects; revised section 5.1.6 to clarify that IRB, IO and Compliance Officer informed of ongoing investigation as appropriate, based on nature of noncompliance.


Revision #10
Created 24 October 2019 21:44:52 by Autumn M Eberly
Updated 17 April 2025 16:11:27 by Robert A Lewis