R1 – Research Involving Human Participants

Approver: President and CEO
Policy Owner: Vice President, Indigenous Strategy, Business Development and Research
Effective Date: March 2024
Replaces: Research Involving Human Participants Policy and Procedures (September 16, 2008)

See the R1 – Research Involving Human Participants Procedures ›

1. Preamble

1.1

RRC Polytech (“RRC Polytech”) is committed to ensuring the highest ethical standards are maintained in all research endeavors involving Human Participants. Researchers, RRC Polytech, and RRC Polytech’s Research Ethics Board are jointly responsible for safeguarding the rights and well-being of Human Participants in research activities. The RRC Polytech research ethics practices are governed by the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans “TCPS2 (2022)”. The most recent version of the Policy Statement shall always govern.¹

¹ The version in effect as of the effective date of this Policy is the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS2 (2022).

1.2

Research ethics approvals shall be guided by the three core principles of ethical approval adopted in the TCPS2 (2022), including

Respect for persons, meaning that Ethics Reviews will recognize the intrinsic value of human beings and the respect and consideration that they are due;
Concern for welfare, meaning that researchers will be required to demonstrate in an ethics review, concern for participant welfare including without limitation, their physical, mental, and spiritual health, as well as their physical, economic, and social circumstances, regardless of the degree of vulnerability of the participant; and
Justice, meaning that all research involving Human Participants will meet 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 the research or denied the benefits of the knowledge generated from it.

2. Purpose

2.1

The purpose of this Policy is to:

Create a research environment that protects Human Participants and their communities;
Establish the guidelines employed by RRC Polytech to regulate and monitor all research activities involving Human Participants through the RRC Polytech Research Ethics Board (“RRCP-REB”);
Ensure that all research involving RRC Polytech employees and students, or using College equipment, resources, or facilities follows the applicable ethical standards;
Establish the RRCP-REB and set out the roles and responsibilities of the RRCP-REB and other parties involved in approving and conducting research; and
Ensure that research conducted under the auspices of RRC Polytech is conducted in compliance with the TCPS2 (2022), the Tri-Agency Framework: Responsible Conduct of Research (RCR), and the Tri-agency Guide on Financial Administration (TAGFA).

3. Definitions

Note: The TCPS2 (2022) contains a detailed glossary of terms related to the research process. Researchers engaged in the ethics review process should familiarize themselves with these terms in addition to the definitions below.

3.1

Consent: An indication of agreement by an individual to become a participant in a research project. Throughout this Policy, the term “consent” means “free (or voluntary), informed and ongoing consent.”

3.2

Ethics Review: The review of research projects involving Human Participants by the RRCP-REB in accordance with this Policy and Procedures, which is required before a Human Research project commences.

3.3

Human Participant: A person who, by virtue of their involvement in a data-gathering situation or activity, is a primary source of data or information.

3.4

Human Research: Refers to research that involves a collection of human specimens, data or information from persons, through intervention or otherwise. Human Research may include, but is not limited to, procedures of low degree of invasiveness such as surveys, interviews, naturalistic observations, exercise or psychometric testing, examination of patient records, as well as more invasive procedures such as blood sampling or administration of substance.

3.5

Minimal Risk: Where the risks of harm anticipated in the proposed research are neither greater nor more likely, considering probability and magnitude, than those ordinarily encountered in life, including those encountered during the performance of routine physical or psychological examinations or tests.

3.6

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (“TCPS2 (2022)”): The TCPS2 (2022) 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). The TCPS2 (2022) Policy is a Canadian guideline for the ethical conduct of research involving Human Participants. Various agencies, including RRC Polytech, are required to apply the ethical principles and the articles of the Policy as a condition of research funding. Reference to the TCPS2 (2022) throughout this document will always be taken to refer to the most recent version of the TCPS Policy.

3.7

Tri-Agency Framework: Responsible Conduct of Research (“RCR”): The Framework sets out the responsibilities and corresponding policies for researchers, Institutions, and the Agencies, that together help support and promote a positive research environment.

3.8

Tri-agency Guide on Financial Administration (“TAGFA”): TAGFA is a comprehensive resource for grant recipients and administering institutions to ensure understanding of the principles and directives that govern post-award administration of grants funded by CIHR, NSERC and/or SSHRC. TAGFA requires that the provision of gifts and incentives to participants requires the prior approval of the administering institution’s research ethics board. Grant recipients have an ethical duty to protect participants’ confidential information and provide documentation to justify the gifts and incentives.

3.9

Principal Researcher(s): The person(s) primarily responsible for conducting a particular research activity. The Principal Researcher bears responsibility for the research project and the approvals and reporting process.

3.10

Procedures: Refers to the Procedures for Research Involving Human Participants established by the VP Indigenous Strategy, Business Development and Research pursuant to this Policy.

3.11

RRC Polytech Research Ethics Board (RRCP-REB): An independent committee formed by the RRC Polytech President to perform Ethics Reviews of research projects involving Human Participants at RRC Polytech.

3.12

Research Ethics Protocol: A document submitted by an applicant for consideration by the RRCP-REB. This document contains a detailed description of the rationale for conducting Human Research and the purpose of the study, including the procedures to be followed during the study and when managing the results.

4. Application

4.1

This Policy applies to research activities, either funded or unfunded, that include Human Participants and involve RRC Polytech through:

The inclusion of College personnel either as researchers or subjects including, management, faculty, staff, trainees, associates, affiliates, and students (including students carrying out research as part of class assignments);
An affiliation between RRC Polytech and other institutions and/or members of the public (including, but not limited to, partnerships and/or sponsorships);
Non-college individuals or organizations using RRC Polytech name or its resources and/or conducting research on College students and/or employees.

4.2

This Policy does not apply to:

Quality assurance and improvement, ongoing information gathering activities that are related directly to the normal administering, or improving of an operation, program, service, or activity within RRC Polytech;
Teaching and learning evaluation activities that are for internal use only;
Employee performance review activities;
Research involving secondary analysis of previously gathered data from data repositories, or through mechanisms set out by legislation or regulations and are protected by law;
Research involving data in the public domain in a context where the persons to whom the information refers have no reasonable expectation of privacy;
Observations of people in public places, where there is no reasonable expectation of privacy, as long as the researchers are not intervening or directly interfering with the individuals they are observing; and
Skill development activities in an RRC Polytech program course whereby students/classmates pretend to be study participants but are not actually participants.

5. Policy

5.1

All Human Research projects conducted in association with RRC Polytech shall be scientifically valid and/or appropriate in a scholarly sense.

5.2

The design, review and conduct of all research involving Human Participants to which this Policy applies shall comply with the ethical requirements set out in the TCPS2 (2022) and any conditions or requirements imposed by the RRCP-REB in the course of the Ethics Review.

5.3

Researchers to whom this Policy applies are required to familiarize themselves with the ethical principles and articles of the TCPS2 (2022) and to adhere to all TCPS2 (2022) requirements at all stages of their research.

5.4

In accordance with this Policy and TCPS2 (2022), researchers will:

Protect and respect the rights of the Human Participants and follow procedures to comply with ethical, scientific, methodological, medical, and legal standards;
Take steps to ensure confidentiality and protection of the privacy of those who participate in research endeavors;
Ensure free and informed consent in their research processes, such that Human Participants are informed of the intent of the research, the risks and benefits of participating, and that their right to withdrawal remains even after providing consent;
Ensure Human Participants are aware of the role of the Principal Researcher(s) and the research team and what they can expect from the research relationship;
Conduct research in a manner that ensures there is no undue influence, coercion, deception, constraint, or undue inducement to participate in research activities; and
Disclose any real, potential or perceived conflict of interest arising from their proposed or actual research, including individual, institutional or community conflicts of interest that may have an impact on their research. For greater certainty, conflicts of interest may arise in situations where the researcher is subject to competing incentives as a result of their research. The principles set out in TCPS2 (2022) Chapter 7— Conflicts of Interest, as well as any other RRC Polytech Policy that deals with conflicts of interest, and comply with any instructions to manage the conflict.
Conduct research in a manner that adheres to the Tri-Agency Framework: Responsible Conduct of Research and F4 Research Funding Compliance Policy.

5.5

This Policy and its Procedures shall uphold academic freedom and high ethical, scientific, and professional standards to protect Human Participants in research from real and potential harm.

5.6

RRC Polytech considers the improper treatment of Human Participants in research a serious offence. A breach of this Policy may result in penalties, including, but not limited to, the withdrawal of privileges to conduct research involving Human Participants and/or disciplinary action up to and including termination.

6. Research Ethics Board

6.1

The RRC Polytech Research Ethics Board (RRCP-REB) is the entity responsible for conducting Ethical Reviews of research projects involving Human Participants at RRC Polytech and is established by the President. RRC Polytech shall appoint members to the RRCP-REB in accordance with the Procedures.

6.2

Human Research projects described in paragraph 4.1 of this Policy fall within the jurisdiction of the RRCP-REB and require prior Ethical Review and approval by the RRCP-REB in accordance with the Procedures.

6.3

No research project involving Human Participants may be initiated, nor will funds for such purposes be released without RRCP-REB approval. For research or scholarly work where the researcher is in doubt whether the RRCP-REB review and approval is required, it is the responsibility of the researcher to consult with the Research Partnerships and Innovation Office or the RRCP-REB Chair. The RRCP-REB has the authority to order any research activity brought to its attention that has not been approved through the ethics review processes described in this policy and its associated procedure manual to immediately cease.

6.4

The Core Principles and the TCPS2 (2022) shall guide the Ethical Review process carried out by the RRCP-REB. Where any issues or discrepancies arise during an Ethics Review, the Principal Researcher and the RRCP-REB shall refer to the TCPS2 (2022).

6.5

Research can be conducted on individuals and communities. At times, the focus of the research may be on individual needs involving participants who may belong to an identifiable community which may be racial, social, geographical, gendered, professional, or by identity. In situations where the benefits or risks to an individual conflict with the benefits or risks to a community, community needs will be prioritized in all ethical reviews.

7. Research Involving Indigenous Peoples

7.1

RRC Polytech recognizes that historically, research involving Indigenous peoples in Canada has been defined and carried out primarily by non-Indigenous researchers. The approaches used have generally not reflected Indigenous worldviews, and the research has not necessarily benefited Indigenous peoples or communities. With this context in mind, RRC Polytech researchers will follow a framework for the ethical conduct of research involving Indigenous peoples, as outlined by the TCPS2 (2022) Chapter 9 – Research Involving the First Nations, Inuit and Métis People of Canada and which incorporates First Nations principles of ownership, control, access, and possession (“OCAP Principles”). The guidelines of the RRCP-REB are not intended to override or replace ethical guidelines offered by Indigenous peoples. Its purpose is to ensure, to the extent possible, that research involving Indigenous peoples is premised on respectful relationships.

7.2

To provide an Indigenous lens, the RRCP-REB shall have a standing member with expertise in carrying out research or working with Indigenous people or communities.

8. Responsibilities

8.1

The Vice President, Indigenous Strategy, Business Development and Research has the responsibility to establish and approve Procedures under this Policy, with input from the RRCP-REB. The VP, Academic may amend the Procedures from time to time as appropriate.

8.2

The RRCP-REB is responsible for reviewing the ethical acceptability of research to which this Policy applies including approving, rejecting, proposing modifications to, or terminating any proposed or ongoing research involving Human Participants in accordance with TCPS2 (2022).

8.3

Researchers are responsible for knowing when they are conducting a project that requires a submission to and approval from the RRCP-REB, and for carrying out all aspects of their research in compliance with this Policy, its associated Procedures, and the TCPS2 (2022).

8.4

All members of RRC Polytech Community who are involved in conducting, supervising, or approving Human Research activities are responsible for familiarizing themselves with this Policy, its associated procedures, and the TCPS2 (2022).

9. Review Period

9.1

This Policy will be reviewed within five (5) years.

9.2

This Policy and its associated Procedures may be amended by the RRCP-REB from time to time to accommodate future approved amendments to the TCPS2 (2022) or as otherwise deemed appropriate. In the event that the TCPS2 (2022) is updated before the revision of this Policy, the RRCP-REB will adhere to the most recent TCPS2 (2022).

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