Human Research Ethics Compliance

Routine audits are conducted to confirm ongoing compliance.

Active studies are selected for routine audit if they meet any of the criteria set out below: 

1. Studies that are deemed by an REB to be more than minimal risk where participant engagement has begun and/or is ongoing.

2. Studies involving the collection and storage of personal health information. 

3. Studies that use deception.

4. Multi-year studies where there are new participant pools each year.

5. Longitudinal studies where a Researcher follows the same participants for multiple years. 

6. Studies that are conducted by a Researcher with multiple active Protocols.

Where a PI has multiple, active protocols, Research Randomizer may be used to identify one study to audit. 

In addition to assessing compliance with REB-approved research studies, University policies and procedures and applicable legislation, Routine Audits are conducted:

• To identify areas of Noncompliance, if any, based on Audit Observations.
• To suggest Corrective Actions on Noncompliance as required.
• To suggest best practices.
   

Directed Audits are related to the ethical conduct of research are conducted following a request from a senior University administrator, an REB Chair(s), a relevant director(s), a Researcher, and/or a research participant or potential participant. The focus of the Directed Audit will depend on the nature and scope of the request. 

In addition to assessing compliance with REB-approved research studies, University policies and procedures and applicable legislation, routine audits are conducted:

• To identify areas of Noncompliance, if any, based on Audit Observations.
• To suggest Corrective Actions on Noncompliance as required.
• To suggest best practices.
   

When initiating an audit, the Research Compliance Specialist shares with the PI a study specific audit plan for the study under audit. The study specific audit plan includes details on the protocol, audit objectives, audit scope, audit criteria, study documents required for review, researcher and study personnel interviews, audit reports, and audit follow-up plans. Below are audit plan templates for social and health research and for biomedical research.

Open file: Audit Plan Template for Social and Health Research (PDF)

Open file: Audit Plan Template for Biomedical Research (PDF)
 

Following an audit, the Research Compliance Specialist prepares an initial audit report for the PI. The purpose of the initial audit report is to give the PI an opportunity to respond to any audit observations by providing any clarifications, additional information, feedback, and/or proposals for corrective action.

Open file: Initial Audit Report Template (PDF)

The Human Research Ethics Compliance Program implements Standard Operating Procedures (SOPs) to achieve greater efficiency and quality in compliance operations. To get copies of the Program’s SOPs contact the Research Compliance Specialist at Marion.Kiprop@umanitoba.ca   

This document contains pertinent information for staying compliant with approved research protocols, University research policies, procedures, and with applicable contractual obligations. This document applies to Social and Behavioral Sciences, Health Research Involving Interventions, Surveys/Questionnaires, Focus Groups/Interviews, Observations, Quality of Life Research, Prospective and Retrospective Examinations of Medical Records and Other Personal Records, Genetic, Registries, etc. 

Open file: Maintaining Human Research Ethics Compliance for Social and Health Research (PDF)
 

This document summarizes the Human Research Ethics Audit Program. Specifically, this document offers guidance on the following topics:

•    What to expect if your study/protocol is selected for audit. 
•    What happens during an audit.
•    The criteria used to audit studies.  
•    The documents required for review during an audit. 
•    The possible outcome of research compliance audits.  

Open file: Preparing for a Research Ethics Compliance Audit (PDF)
 

This document outlines common compliance issues that researchers face pre-approval and post -approval. Addressing these issues proactively can help you maintain research compliance and avoid potential pitfalls. This document applies to Social and Behavioral Sciences, Health Research Involving Interventions, Surveys/Questionnaires, Focus Groups/Interviews, Observations, Quality of Life Research, Prospective and Retrospective Examinations of Medical Records and Other Personal Records, Genetic, Registries, etc.

Open file: Common Compliance Issues for Social and Health Research (PDF)
 

This list of audit tips aims to provide researchers (PIs and Advisors) with pointers for maintaining human research ethics compliance ultimately contributing to the protection of participants’ rights, safety, and welfare.

Open file: Audit Tips for Researchers (PDF)