Ethics of Research Involving Human Participants Procedures – May 28, 2024

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PROCEDURES FOR ETHICS OF RESEARCH

INVOLVING HUMAN PARTICIPANTS

Procedure

Type:

Management

Initially

Approved:

May 10, 2012

Procedure

Sponsor:

Provost and VP,

Academic

Last

Revised:

May 28, 2024

Administrative

Responsibility:

AVP, Research,

Scholarship and

Community

Engagement

Review

Scheduled:

May 28, 2029

Approver:

Executive Leadership Team

PROCEDURES

1. RESPONSIBILITY OF RESEARCHERS AND SCHOLARS

A researcher who plans to conduct Research Involving Human Participants is required to:
1.1. Be familiar with all University policies related to research, including without limitation the

University Ethics of Research Involving Human Participants Policy, the most current version

of the Tri-Council Policy Statement (TCPS 2): Ethical Conduct for Research Involving

Humans, and all related University research policies and procedures.

1.2. Bring to the attention of the Chair of such researcher’s department, or where the researcher

is in a non‐departmentalized faculty, the Dean or the Dean’s designate, any research project

proposed by the researcher, or proposed by a student working under the direction of the

researcher through submission to the Office of Research, Scholarship and Community

Engagement research management system.

1.3. Submit an application for ethics review and approval using the current form specified by the

HREB for each project relevant to this Policy prior to conducting the research or accessing

the data of Human Participants, and include in the application sufficient details required by

HREB in order to discharge its duties as set out in Section 2 of the Ethics of Research

Involving Human Participants Policy.

1.4. Consult HREB to obtain a determination as to whether a research project requires research

ethics review prior to engaging in any research activities should there be any doubt as to

whether a research project constitutes Research Involving Human Participants requiring

ethics review.

1.5. Conflicts of interest (COIs) involving the researcher(s) must be declared to and be managed

by HREB as part of its review. These COIs must be declared as specified in the Procedure

for Conflict of Interest in Research in order to satisfy federal policies on the Responsible

Conduct of Research.

1.6. Promptly inform HREB of any similar or equivalent proposal to research ethics boards or

similar bodies at other institutions, and to funding agencies or regulatory bodies. HREB shall

determine if concurrent applications are acceptable.

1.7. Adhere to the submitted protocol as approved.
1.8. Ensure that all researchers involved in the project are aware of and comply with this Policy,

as well as all other relevant policies of the University.

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1.9. Maintain any issued Letter of Clearance in good standing throughout the life cycle of the

research project (TCPS 2, Article 6.1.4).

1.10. Ensure that any modifications to the study personnel, funding, protocol, consent form or any

recruitment procedures are cleared by the HREB prior to implementation, except where

necessary to eliminate apparent immediate hazards to participants.

1.11. Report all serious and unexpected study related events to the HREB in accordance with

applicable regulations and guidelines.

1.12. Promptly notify HREB when the study concludes or request an extension (normally of one

year) if the Letter of Clearance expires.

1.13. Submit a Completion Report by the expiry date stated on the Letter of Clearance, if an

extension is not requested and the research is complete.

2. COMPOSITION OF HREB

2.1. The Board of Governors of Mount Royal University delegates to the Provost and Vice-

President Academic (VPA) responsibility for membership and implementation of HREB.

2.2. The Chair of the HREB is a faculty member appointed by the Provost and Vice-President

Academic, normally for a period of up to three years. At the expiry of the initial three-year

term, the appointment may be renewed for an additional term, normally for a period of up to

three years, with the agreement of the HREB Chair and at the discretion of the Provost and

Vice-President Academic.

2.3. Members of HREB will be appointed by the Provost and Vice-President Academic in

consultation with the HREB Chair. Normally appointments will be for a three-year term, with

the possibility of renewal for a further three-year term. Terms of individual appointments

should be staggered in order to ensure continuity of expertise.

2.4. The Provost and Vice-President Academic, in consultation with the HREB Chair, will appoint

a Vice-Chair, for a period of up to three years. The HREB Vice-chair will chair the meetings

and make decisions in the absence of the HREB Chair.

2.5. HREB will consist of at least eight (8) core members, in addition to the Chair, composed of

a diverse group of people, with:

2.5.1. members selected for representation and methodological and research expertise

in the disciplines, fields and methodologies (including Indigenous and non-

Western approaches) covered by the HREB. Expertise is the guiding principle for

member selection, but the HREB will also strive to achieve broad representation

across the University's faculties.

2.5.2.  one member knowledgeable in research ethics.
2.5.3.  one community member with no affiliation to the University.
2.5.4.  one student member of the University.

2.6. The majority of the above members should have both the training and the expertise to make

sound judgements on the ethics of research proposals involving human participants.

2.7. Additional members may be appointed by the Provost and Vice-President Academic,

including but not limited to:

2.7.1. a member knowledgeable in the relevant law that is not the legal counsel of the

University.

2.7.2. additional community members in keeping with the overall size of the Board.

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2.7.3. ad hoc members appointed for special purpose reviews, who will not be part of the

decision.

2.7.4. substitute members to serve as replacements for regular members when they are

unable to attend meetings.

3. HREB CHAIR

3.1. The Chair of HREB is responsible for ensuring that the research ethics review process

adhered to by HREB conforms to the requirements of the Tri‐Council Core Ethical Principles

and all other relevant requirements, laws, regulations, policies, standards and guidelines

that are relevant to research ethics review.

3.2. The role of the Chair is to:

3.2.1. provide leadership for HREB.
3.2.2. facilitate the research ethics review process, based on University policies and

procedures and the most current version of the Tri‐Council Policy Statement:

Ethical Conduct for Research Involving Humans.

3.2.3. oversee decisions of the HREB for consistency.
3.2.4. ensure that HREB decisions are recorded accurately and communicated clearly to

researchers in writing as soon as possible by the Chair or their designate.

3.2.5. ensure appropriate quorum requirements are met for each Research project being

reviewed.

4. RESPONSIBILITIES OF HREB

4.1. The HREB shall:

4.1.1. Determine if it is the appropriate body to review the application and whether the

application is within its jurisdiction or expertise.

4.1.2. Consider methodological aspects of the research as necessary to assess the risks

and benefits.

4.1.3. Determine whether proposals are acceptable on ethical grounds.
4.1.4. Determine the level and frequency of continuing review of the research appropriate

to the degree of risk, provided it is not less than once per year.

4.1.5. Determine that free and informed consent will be obtained and maintained.
4.1.6. Determine if the research is compliant with the University’s Policy on Ethics of

Research Involving Human Participants, the current TCPS and other relevant

standards.

4.1.7. Follow the current TCPS guidelines regarding intensity and nature of review

(Article 6.12), multi-jurisdictional research (Chapter 8), and delegated review

(Article 6.12).

4.1.8.

Refer any significant issues of research integrity, risk management, or other risk

declarations identified during the course of review, and not covered under this

Policy, to the appropriate institutional authority for review, as discussed in the

Responsible Conduct in Research Policy, Code of Conduct Employees Policy,

Student Code of Academic Integrity Policy, Enterprise Risk Management Policy,

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or any other relevant policies. If the issues are not relevant to the Ethics of

Research Involving Human Participants Policy, HREB shall not delay review on

their account.

4.2. In discharging their responsibilities described in the Ethics of Research Involving Human

Participants Policy, HREB shall:

4.2.1. normally host monthly meetings during the academic year. Other meetings may

be called by the Chair as necessary.

4.2.2. normally, HREB meetings shall be face-to-face, though where circumstances

require it, alternate communication mediums may be utilized.

4.2.3. achieve quorum for protocol decisions (i.e., clearance, sanctions, and related

matters) with at least five (5) members, including a diverse group of people, of

whom:

i. two members have broad expertise in the methods or areas of research

under review;

ii. one member is knowledgeable in ethics; and
iii. one member has no affiliation with the institution and is recruited from the

community served by the University.

4.2.4. It is preferred that HREB decisions are made by consensus. Where consensus is

not achieved the decision shall be made by majority vote.

4.2.5. Members of HREB must act with integrity and adhere to the highest ethical

standard at all times. If HREB is reviewing research in which a member of HREB

has a personal interest (e.g., as a researcher or as an entrepreneur), conflict of

interest principles require that the member not be present when HREB is

discussing or making its decision.

4.2.6. In order to preserve the independent decision-making capacity of HREB,

University administration at the level of Associate or Vice Dean/Director or above

shall not be members of HREB, nor attend meetings other than as an invited guest

or applicant.

4.3. HREB may terminate ethics clearance:

4.3.1. where there is clear evidence that it is not being conducted in accordance with its

requirements; or

4.3.2. that is associated with unexpected harm to participants.

4.4. HREB shall specify a process for continuing review of approved projects in consultation with

the researcher.

4.4.1. In accordance with the principle of proportionate review, research that poses at

most Minimal Risk to participants will require only a minimal process, normally

consisting of an annual report.

4.4.2. HREB may require researchers conducting projects that are deemed greater than

Minimal Risk to submit to additional review elements such as random audit of the

consent process, review of documents, or establishment of a safety monitoring

committee and report on a shorter time frame.

4.4.3. In cases where researchers depart from the approved research, HREB shall

specify appropriate review procedures or actions, to be carried out by the

appropriate institutional authority and coordinated by the Office of Research,

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Scholarship and Community Engagement (ORSCE). The HREB shall be promptly

notified of the results of any such review process by the ORSCE.

5. REVIEW OF UNDERGRADUATE RESEARCH

5.1. The University encourages undergraduate student involvement in Research Involving

Human Participants. These activities are subject to the same review requirements as faculty

research, but may be delegated to non-HREB members at the department, Faculty, or

equivalent level (TCPS 2, Article 6.12). The HREB has a responsibility to ensure that

delegated reviewers have the appropriate expertise, training, and resources required, and

special attention should be given to the assessment of real, potential, or perceived conflicts

of interest.

5.2. Research Involving Human Participants undertaken by undergraduate students outside of

the formal requirements of a designated University course, such as an Honours Thesis, r

Directed Study project or through Institutes or Centres must be supervised by a faculty

member, who is ultimately responsible for the ethics of the project and should provide

appropriate mentorship regarding ethics and methodology. In these projects, the full HREB

application is used. The level of risk will determine the nature of the review.

5.3. Research Involving Human Participants, posing no more than Minimal Risk, and undertaken

within the formal requirements of a course is subject to course-based review by HREB,

using an abbreviated process and forms. Recruitment and data gathering activities cannot

commence prior to issuance of clearance by the HREB or a delegated committee as

described in the following section.

5.4. Course-based clearance is issued to a single course instructor, who is responsible for

implementing the proposed activity in compliance with the Ethics of Research Involving

Human Participants policy and any additional conditions imposed by the HREB.

5.5. Course-based research activities that are, in the opinion of the HREB, greater than Minimal

Risk to participants shall be subject to full board review.

6. DELEGATED ETHICS COMMITTEES

6.1. HREB may choose to delegate review of Minimal Risk, course-based undergraduate

Research Involving Human Participants to a departmental or institutional student research

committee.

6.2. Those conducting the delegated review are accountable to the HREB and must comply with

any directions from them regarding their procedures or decisions.

6.3. The process for reconsideration of a delegated review is escalation to HREB review.

7. RECORDS, REPORTS AND COMMUNICATIONS

7.1. The HREB shall, for every decision, communicate in writing to the applicant the decision

made and the reasons for the decision.

7.2. The HREB shall retain records of the following for the duration of the research and an

additional five years, or as directed by the Alberta Freedom of Information and Personal

Privacy Act:

7.2.1. The application made and any modifications, including all attachments;

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7.2.2. Minutes of its meetings, clearly documenting decisions, any dissents, and the

reasons for them; and

7.2.3. All other documentation relevant to the decisions

7.3. HREB records as specified above shall be made available to authorized representatives of

the University, the researchers, funding agencies, and other relevant authorities involved in

the research.

7.4. The HREB shall report to the Board of Governors of Mount Royal University on an annual

basis. The report shall, at a minimum, consist of decisions issued, reasons for those

decisions, continuing review requirements and results of continuing review, training of MRU

Members, the adequacy of resources provided, and any confirmed violations of protocols

and sanctions imposed by the HREB.

7.5. The HREB, its Chair and Vice-Chair shall maintain open lines of communication with the

HREB Research Compliance Officer (RCO) and the Provost and Vice-President, Academic,

who shall do the same.

8. TERMS OF CLEARANCE

8.1. If HREB determines that the research proposed in an application is acceptable, it shall direct

the issuance of a Letter of Clearance that is compliant with the applicable granting agency

standards, as appropriate.

8.2. A Letter of Clearance may impose conditions and require scheduled or event-driven

reporting to HREB. The rigour of the conditions and the reporting required shall be, at least,

proportionate to the risk level and the assessment required. Further details of continuing

review are detailed in TCPS 2, Article 6.14.

8.3. HREB retains a continuing interest at all stages of the research life cycle, and may withdraw

or modify a Letter of Clearance at any time with written notification to the researcher.

Normally, if HREB is considering such withdrawal or modification, the researcher will be

given opportunity to make a submission.

8.4. The Letter of Clearance is normally valid for one year from the date of issuance, with

exceptions for some student research. Prior to that date, an application for renewal must be

submitted if the research procedures involving humans is to continue.

8.5. If at any time the researcher wishes to modify the study, the researcher will follow the

modification procedures outlined in Section 1 Responsibilities of Researchers and Scholars.

Such modifications may not be implemented prior to approval, which will not alter the expiry

date of the Letter of Clearance.

8.6. If an extension is not requested and the research is complete, the researcher will follow the

modification procedures outlined in Section 1 Responsibilities of Researchers and Scholars.

No further applications will be considered from a researcher until all such reports are in good

standing.

9. RECONSIDERATIONS OF HREB DECISIONS

9.1. Researchers have the right to request, and HREB has the obligation to provide,

reconsideration of decisions. In cases where HREB and the researcher cannot reach an

agreement through face-to-face discussion, the researcher has the right to file an appeal.

10. APPEALS OF HREB DECISIONS

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10.1. Researchers wishing to file an appeal shall make a written request to the Associate Vice

President, Research, Scholarship and Community Engagement (AVP, RSCE), who shall

convey it to the Chair of the Appeal Board.

10.2. As established by a formal agreement between Mount Royal University and the University

of Calgary, the HREB Appeal Board is the Research Ethics Appeal Board of the University

of Calgary. The University of Calgary’s policy governing the Research Ethics Appeal Board

may be consulted on their Research Office website. The AVP RSCE, is responsible for

updating and maintaining this agreement.

10.3. Decisions of the Research Ethics Appeal Board are final and binding in all respects.

11. COMPLAINTS OR CONCERNS REGARDING A RESEARCH PROJECT

11.1. The Research Compliance Officer shall be listed as the contact point for research

participants or potential participants who wish to complain or comment about a research

project.

11.2. All complaints and responses will be recorded in the protocol file.
11.3. The Research Compliance Officer will determine if a complaint warrants re-examination by

the HREB of a previously approved project.

11.4. In all cases complaints will receive a written response from the Research Compliance

Officer detailing HREB’s actions in response to the complaint. If the Research Compliance

Officer is the subject of the complaint, the Provost and Vice-President, Academic shall

appoint another individual from HREB to respond.

12. VIOLATIONS OF POLICY

12.1. Violations of this any and other University research policy are subject to procedures

detailed in the Responsible Conduct of Research policy.

12.2. Otherwise, the HREB’s role in violations of policy is detailed in Section 4 Responsibilities

of HREB.

13. EDUCATION

13.1. The HREB Chair shall jointly coordinate with the AVP, RSCE the holding of general

meetings, education retreats or workshops, or attendance at conferences during which

HREB members may take advantage of educational opportunities that may benefit the

operation of the HREB, discuss general issues arising out of HREB activities and

recommend revisions to policies and procedures.

13.2. The Chair of the Human Research Ethics Board will work with the AVP, RSCE to develop

appropriate ethics training curricula for faculty and students of Mount Royal.

14. HREB SUPPORT

14.1. The University shall provide sufficient financial support to HREB to enable them to

effectively carry out their responsibilities including consideration of reassigned time for the

HREB Chair.

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14.2. The Office of Research, Scholarship and Community Engagement shall host the HREB

Office, and shall provide the administrative support required to process applications, take

minutes, and maintain appropriate records.

15. HREB OPERATIONAL PROCEDURES

15.1. The HREB shall formalize all operational procedures and make them publicly available.
15.2. The HREB operational procedures must comply with all University policies and procedures.

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).

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(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

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

•

Ethics of Research Involving Human Participants Policy

•

Enterprise Risk Management Policy

•

Responsible Conduct in Research 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

•

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

05/28/2024

Comprehensive

revisions

All

AVP Research

Scholarship and

Community

Engagement

Executive

Leadership Team