Ethics of Research Involving Human Participants Policy – May 28, 2024 of 5

ETHICS OF RESEARCH INVOLVING HUMAN

PARTICIPANTS POLICY

Policy Type:

Management

Initially

Approved:

May 10, 2012

Policy

Sponsor:

Provost and Vice-

President,

Academic

Last

Revised:

May 28, 2024

Primary

Contact:

AVP, Research,

Scholarship and

Community

Engagement

Review

Scheduled:

May 28, 2029

Approver:

Board of Governors

OVERVIEW

Mount Royal University (the University) is committed to advancing human welfare, knowledge and

understanding through research. The University recognizes that Human Participants are

fundamental to this process and that all research involving Human Participants must be conducted

with the highest standards of ethical conduct that respect human dignity and well-being.

The University endorses and upholds the current official Tri-Council Policy Statement (TCPS 2):

Ethical Conduct for Research Involving Humans, and maintains a Human Research Ethics Board

(HREB) to ensure that all research investigations involving human participants are carried out in

compliance with the TCPS 2 and the University’s policies.

SCOPE

This Policy applies to all Employees, Students and individuals affiliated with the University (e.g.,

research associates, emeriti, adjuncts, visiting scholars, etc. hereinafter referred to as Members)

participating in research that involves human participants at or under the auspices of the University:

•

where such research is conducted by members or associated members of the University

acting in their university capacity;

•

where such research is conducted at the University, its affiliated sites, or through its

systems of distributed learning;

•

where such research is administered by the University; or

•

where ethics clearance by the University is required for research pursuant to an affiliation

agreement with other agencies.

PURPOSE

This Policy is intended to:

•

create a research environment in which human research participants are protected;

•

ensure responsibilities are discharged according to the relevant ethical standards, by

promoting awareness of research ethics amongst faculty, staff and students, establishing

an independent research ethics review process;

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•

establish mechanisms for the protection of human participants in research.

GUIDING PRINCIPLES

Over and above the legal obligations to which all researchers and the University are bound to

adhere, the central imperative of Research Involving Human Participants is the respect for human

dignity.

The University adopts the Tri-Council Core Ethical Principles (see Definitions) as principles that

guide both the conduct of all Research Involving Human Participants and HREB when reviewing

the ethical acceptability of such research under its auspices.

POLICY STATEMENT

1. RESEARCH INVOLVING HUMAN SUBJECTS

1.1. The University will regulate the conduct of all Research Involving Human Participants in

accordance with the most current version of the Tri-Council Policy Statement: Ethical

Conduct for Research Involving Humans and, where applicable to specific research, other

relevant national and international standards.

1.2. .

No research to which this Policy applies may be undertaken, nor may University services

or facilities be used, nor may funds for such purposes be released, nor financial accounts

opened unless the research has received formal ethical clearance from HREB before the

proposed research begins and the research has received a Letter of Clearance.

1.3. Any material changes in research to which this policy applies, as proposed, must have

clearance of the University’s HREB.

2. MANDATE AND AUTHORITY OF THE UNIVERSITY HUMAN RESEARCH ETHICS BOARD

2.1. The HREB is established by the Board of Governors of Mount Royal University and

empowered to ensure that all research conducted under the auspices of the University is

designed and conducted in such a manner that it protects the rights, welfare and privacy

of research participants. HREB has the authority to approve, reject, propose modifications

to, or terminate any proposed or ongoing Research Involving Human Participants that is

conducted within, or by members of, the University as outlined in this Policy and TCPS 2.

2.2. The University shall ensure that those who conduct such research understand their

responsibilities for the ethical conduct of their research, and receive appropriate training,

as indicated by the HREB, in the skills necessary for such conduct. This includes not only

awareness of, but understanding of the relevant policies and professional standards.

3. RECOGNITION OF DECISION OF EXTERNAL RESEARCH ETHICS BOARD

3.1. Where an approval for research involving humans is required from a research ethics board

pursuant to this Policy, and where Ethics Approval is also required from a research ethics

board of one or more other institutions pursuant to the human research ethics policy of

that other institution(s) - sometimes referred to as multi-jurisdictional research reviews -

HREB may accept the review of the research ethics board of one of those other institutions

if permitted by, and in accordance with the requirements of, the TCPS. For more than

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minimal risk research, REB authorization should be based on an official agreement (TCPS

2, Article 8.1)

DEFINITIONS

(1) Ethics Approval:

Research ethics approval granted by HREB in accordance with

this Policy.

(2) Human Participants: An individual whose data, biological materials, or responses to

interventions, stimuli, or questions by a researcher are relevant

to answering the research question(s) (from TCPS 2 Glossary).

(3) HREB:

The human research ethics board authorized by the University.

(4) Letter of Clearance

Means the research ethics approval granted by a REB in

accordance with this Policy.

(5) Member

Means any individual who teaches, studies, conducts research;

all Employees, contractors, volunteers, and visitors to the

University; and any other individual acting on behalf of the

University.

(6) Minimal Risk:

Minimal Risk research is defined as research in which the

probability and magnitude of possible harms implied by

participation in the research is no greater than those

encountered by the participant in those aspects of their everyday

life that relate to the research (from TSPS 2 Glossary).

(7) Policy:

means the Ethics of Research Involving Human Participants

Policy.

(8) Research:

research is an undertaking intended to extend knowledge

through a disciplined inquiry and/or systematic investigation

(from TCPS 2 Glossary).

Research also includes activities related to one or more of

scholarly or artistic work which occurs through discovery,

integration, teaching and learning, or application of knowledge

and is usually disseminated through peer-reviewed processes.

(9) Tri-Council Policy

Statement 2 (TCPS

2):

The Tri-Council Policy Statement: Ethical Conduct for Research

Involving Humans (TCPS or the Policy) is a joint policy of

Canada’s three federal research agencies – the Canadian

Institutes of Health Research (CIHR), the Natural Sciences and

Engineering Research Council of Canada (NSERC), and the

Social Sciences and Humanities Research Council of Canada

(SSHRC), or “the Agencies.” The current edition, TCPS 2,

introduces the second set of substantive changes to the Policy

(from TCPS 2 Introduction).

(10) Tri-Council Core

Ethical Principles:

Respect for Persons: A core principle of this Policy that

recognizes the intrinsic value of human beings and the respect

and consideration that they are due. It incorporates the dual

moral obligations to respect autonomy and to protect those with

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developing, impaired, or diminished autonomy (from TCPS 2

Glossary)..

Concern for Welfare: A core principle of TCPS 2 that requires

researchers and research ethics boards to aim to protect the

welfare of participants, and, in some circumstances, to promote

that welfare in view of any foreseeable risks associated with the

research (from TCPS 2 Glossary).

Justice: A core principle of TCPS 2 that refers to the obligation

to treat people fairly and equitably. Fairness entails treating all

people with equal respect and concern. Equity requires

distributing the benefits and burdens of research participation in

such a way that no segment of the population is unduly burdened

by the harms of research or denied the benefits of the knowledge

generated from it (from TCPS 2 Glossary).

(11) University:

means Mount Royal University

RELATED POLICIES

•

Responsible Conduct in Research Policy

•

Enterprise Risk Management Policy

RELATED LEGISLATION

•

Alberta Freedom of Information and Protection of Privacy Act

RELATED DOCUMENTS

•

Procedures for Responsible Conduct in Research

•

Procedures for Conflict of Interest in Research

•

Procedures for the Collection, Storage and Authenticity of Research Data

•

Application for Ethics Review

•

Completion Report

•

Letter of Clearance

•

Office of Research Services Tracking and Signature Form

•

Ethics of Research Involving Human Participants Procedures – two documents

•

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

•

University of Calgary’s Research Ethics Appeal Board Policy

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REVISION HISTORY

Date

(mm/dd/yyyy)

Description of

Change

Sections

Person who

Entered Revision

(Position Title)

Person who

Authorized

Revision

(Position Title)

05/100/2012

NEW

08/31/2017

Editorial – formatting

Director, University

Secretariat

01/22/2020

Editorial

Template Update

Policy Specialist

University Secretary

05/28/2024

Comprehensive

revisions

All

AVP Research

Scholarship and

Community

Engagement

Board of Governors