Human Research Ethics Compliance

Routine audits are conducted to check for general ethical compliance.

Studies are selected if they meet any of the criteria set out below: 
i.    more than minimal risk, 
ii.    involve current/active participant engagement,
iii.    conducted by a PI with multiple active protocols, 
iv.    are multi-year/longitudinal, and
v.    involve a research agreement.

For routine audits of clinical trials, the following studies are prioritized: 
i.    Health Canada regulated, and
ii.    UM investigator-initiated (UM is the Sponsor).

Additional clinical trials are selected for audit if they meet any of the criteria set out below:
i.    involve current/active participant engagement, 
ii.    conducted by a PI with multiple active protocols, and
iii.    multi-year/longitudinal.

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

Directed Audits are conducted following a request from a senior University administrator, an REB Chair(s), the Director, Human Research Ethics and Compliance, a research participant or potential participant with concerns related to the ethical conduct of the research. The focus of the audit normally depends on the nature and scope of the request. However, the Research Compliance Specialist may, at their discretion, expand the scope of the audit at any time during the audit process.

A researcher acting as PI in a UM investigator-initiated clinical trial may request an audit to support preparation for an upcoming Health Canada inspection. 
 

Data management audits are undertaken with the aim of reviewing a study’s continuing and long-term data management practices. Studies/protocols are selected if they meet at least one of the following criteria:

i.    Are multi-year/longitudinal,
ii.    Involve the storage of identifiable data for a prescribed period or indefinitely, or
iii.    Involve a data sharing agreement.

Clinical trial protocols are selected for data management audits if they meet at least one of the following criteria:

i.    Health Canada regulated,
ii.    Investigator-initiated/are UM-sponsored,
iii.    Involve the storage of identifiable data for a prescribed period or indefinitely.

While data management audits focus on data management practices, the Research Compliance Specialist may, at their discretion, expand the scope of a data management audit at any time during the audit process.

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)