8.2 Review of Study Related Complaints

1.0 Purpose

The purpose of this policy is to describe the process for reporting research related complaints to the ORA and the IRB, and the process for review of complaints.


2.0 Policy

It is the policy of the Organization that:


3.0 Complainant (or Other Reporters’) Responsibilities


4.0 ORA Responsibilities


5.0 IRB Responsibilities


6.0 Reporting Complaints 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: 1/20/2019 (Approved: 1/20/2016) - original author not recorded

 Revised: 1/19/2018 - revision not documented

 Revised: 1/18/2023 - Clarified definition of “complaints”; noted additional policies related to complaints by research personnel or other interested parties regarding the functioning of one or more components of the HRPP; clarified that the ORA only investigates complaints related to human subjects research; added that complaints that do not involve risk to participants or others, or do not change the risk-benefit profile of the study are reported to the IRB (either at the time of continuing review, or as a special notification item); added comment that all required reports will be submitted to Institutional Officials and Federal Agencies in accordance with HRPP policy 8.7; reorganized sections; stylistic changes.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 5/8/2023 - Changed “IRB Administrator” to “IRB Analyst”{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #6
Created 24 October 2019 21:44:15 by Autumn M Eberly
Updated 7 September 2023 03:28:51 by Robert A Lewis