Ethical Conduct of Research Involving Human Participants

Policy Number: RES 104	Policy Title: Ethical Conduct of Research Involving Human Participants
Supersedes Existing Policy? Yes	Policy Owner: Manager, Research Administration
Associated Procedure: Yes	Policy Sponsor: Executive Director, Indigenous Engagement and Applied Research
Next Review Date: October 2029	Date Last Approved by the CET: October 7, 2026

1. Introduction and Purpose

Loyalist College is committed to upholding ethical research standards and protecting the rights and dignity of all individuals involved in research activities. The purpose of this policy is to promote respect for human dignity in all research activities conducted in affiliation with Loyalist College.

It establishes the ethical principles and procedures that guide researchers and the Loyalist College Research Ethics Board (REB) in assessing the ethical acceptability and potential risks of research involving human participants.

2. Application

This policy applies to all research involving human participants conducted in affiliation with Loyalist College. This policy is applicable to all employees, students, and any other individual who engages with college employees, students, equipment, and/or facilities for research activities involving human participants, as well as databases of information used within a study about such individuals.

Research that falls within the scope of RES 103 Conducting Research by and with Indigenous Peoples and Communities involving human participants must comply with the requirements of that policy in addition to those provided under this policy.

Researchers conducting any research activities affiliated with Loyalist College must also abide by the principles and standards outlined within RES 101 Financial Administration of Research Funds and RES 102 Responsible Conduct of Research.

In the event of a discrepancy between the Tri-Agency policies and this policy, the Tri-Agency requirements will prevail.

3. Definitions

Confidentiality. An ethical and/or legal responsibility of individuals or organizations to safeguard information entrusted to them from unauthorized access, use, disclosure, modification, loss, or theft.

Conflict of interest. or the purposes of this policy, a conflict of interest is the incompatibility of two or more duties, responsibilities, or interests (personal or professional) of an individual or institution as they relate to the ethical conduct of research, such that one cannot be fulfilled without compromising another.

Consent. An indication of agreement by an individual, or their authorized third party, to become a participant in a research project.

Data linkage. The merging or analysis of two or more separate data sets (e.g., health information and education information about the same individuals) for research purposes.

Delegated Research Ethics Board review. The level of REB review assigned to minimal risk research projects as determined by the REB chair(s).

Full Research Ethics Board review. The level of REB review required for research projects that exceed minimal risk. A full review is conducted by the full membership of the research ethics board and is the default requirement for the ethical review of research involving human participants.

Human participants. Individuals (living or deceased) whose data, biological materials, or responses to interventions, stimuli, or questions by a researcher are relevant to answering the research question(s).

Identifiable information. Information that may be reasonably expected to identify an individual, alone or in combination with other available information. Identifiable information may also be referred to as personal information.

Incidental findings. Unanticipated discoveries made in the course of research that are outside the scope of the research.

Minimal risk research. Research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects of their everyday lives that relate to the research.

Personal health information (PHI). Identifying information about an individual in oral or recorded form, if the information:

relates to the physical or mental health of the individual, including information that consists of the medical history of the individual’s family;

relates to the providing of health care to the individual, including the identification of a person as a provider of health care to the individual;

is a plan of service within the meaning of the Fixing Long-Term Care Act for the individual;

relates to payments or eligibility for health care in respect of the individual;

relates to the donation by the individual of any body part or bodily substance of the individual or is derived from the testing or examination of any such body part or bodily substance;

is the individual’s health number; or

identifies an individual’s substitute decision-maker.

Principal investigator. The researcher who is responsible for the ethical conduct of the research, and for the actions of any member of the research team at a local site. For course-based research, the professor assumes the role and responsibilities of the principal investigator.

Privacy. An individual’s right to be free from intrusion or interference by others.

Research Ethics Board (REB). A body of researchers, community members, and others with specific expertise (e.g., in ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all research involving humans conducted within the institution’s jurisdiction or under its auspices.

4. Policy

Loyalist College is committed to fostering a research environment that upholds the ethical research standards and protections for the rights and dignity of all individuals involved in research activities. Research involving human participants conducted under the auspices the college must comply with the ethical principals and requirements of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) and this policy. The college maintains the Loyalist College Research Ethics Board (REB) to independently assess the ethical acceptability of research involving human participants within its jurisdiction or under its auspices.

5. Guiding Principles for Ethical Conduct of Research Involving Human Participants

5.1 TCPS2 Core Principles

The ethical conduct of research involving human participants is guided by the three core principles of the TCPS2:

Respect for Persons: recognition of the intrinsic value of human beings and the respect and consideration that they are due. This principle incorporates dual moral obligations to respect participant autonomy and to involve individuals in circumstances of vulnerability, including those with developing, impaired, or diminished autonomy in decision-making.

Concern for Welfare: recognition that researchers should aim to protect the physical, mental, spiritual, economic, and social wellbeing of participants by providing those individuals with enough information to adequately assess the risks and potential benefits associated with their participation in the research.

Justice: recognition of the obligation to treat people fairly and equitably, including additional consideration for individuals with greater levels of vulnerability.

5.2 Principles of Consent

Researchers must clearly provide prospective participants, or their authorized third parties, with all information needed to make an informed decision about participating in a research project.

Researchers must demonstrate adherence to the following principles of consent:

Free and Informed Consent: consent must be given voluntarily and can be withdrawn at any time. If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials, which must be respected within the limits of the research design and methodology.

Ongoing Consent: consent must be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research.

Consent Must Precede Collection of, or Access to, Research Data: unless a condition exists that may alter the consent requirement as outlined in section 5.2.2 below, research can only begin after the participants, or their authorized third parties, have provided their consent.

Documented Consent: evidence of consent must be contained in a signed consent form or in documentation by the researcher of another appropriate means of consent.

5.2.1 Consent Requirements for Secondary Use of Identifiable Information

Researchers must seek REB review, but are not required to seek participant consent, for research that relies solely on the secondary use of non-identifiable information. Researchers who have not received consent from participants for secondary use of identifiable information can only use such information for these purposes if they have satisfied the REB that:

a) identifiable information is essential to the research;

b) the use of identifiable information without the participants’ consent is unlikely to negatively affect the welfare of the persons to whom the information relates;

c) the researchers will take appropriate measures to protect the privacy of individuals and to protect the identifiable information;

d) the researchers will respect and comply with any known preferences previously communicated by individuals regarding the use of their information;

e) it is impossible or not feasible to seek consent from the individuals that the information relates to; and

f) the researchers have obtained any other necessary permission for secondary use of information for their research purposes.

If researchers are approved to use identifiable information without asking for consent and later want to contact individuals for more information or for concerns related to their wellbeing, they must first seek approval from the REB prior to making contact.

5.2.2 Alterations to the Consent Requirement

The REB may approve changes to consent requirements if it reviews the request, records the decision, and confirms that all of the following conditions are met:

a) the research involves no more than minimal risk to the participants;

b) the change to the consent requirements is unlikely to negatively impact the wellbeing of the participants;

c) it is impossible or not feasible to carry out the research or address the research question properly, given the research design, if the prior consent of participants is required;

d) if a change to consent is requested, the researcher must clearly and precisely explain the change and the extent of the change; and

e) the plan to provide a debriefing (if any) that may also offer participants the possibility of refusing consent and/or withdrawing data and/or human biological materials.

A debriefing process must be a part of all research projects involving a change to consent requirements whenever it is possible, feasible, and appropriate. The debriefing process must be outlined within Appendix B Application for Ethics Review.

5.2.3 Decision-Making Capacity

For research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the researcher and the REB will ensure that, as a minimum, the following conditions are met:

a) The researcher involves participants who lack the capacity to decide on their own behalf to the greatest extent possible in the decision-making process;

b) The researcher acquires and maintains consent from an approved decision-maker (an authorized third party), always acting in the best interests of the person involved;

c) The authorized third party is not the researcher, any other member of the research team, or anyone with a conflict of interest;

d) The researcher demonstrates that the research is being carried out for the participant’s direct benefit, or for the benefit of other persons in the same category. If the research does not have the potential for direct benefit to the participant but only for the benefit of the other persons in the same category, the researcher must show that the research will expose the participant to only a minimal risk and minimal burden and demonstrate how the participant’s welfare will be protected throughout their participation in the research project; and

e) When consent for participation is provided by an authorized third party, and a participant acquires or regains decision-making capacity during the course of the research, the researcher must immediately seek the participant’s consent to continue any further participation.

Where an authorized third party has provided consent for an individual who lacks legal capacity but that person has some ability to understand the significance of the research, the researcher must determine the wishes of that individual with respect to their participation. If the individual indicates that they do not wish to participate, they will not be included in the research.

5.3 Privacy and Confidentiality

Researchers are responsible for protecting identifiable and confidential information entrusted to them through the research process. The college will support researchers in fulfilling their confidentiality obligations and will provide appropriate institutional safeguards to protect research data.

Researchers must describe their proposed measures for meeting confidentiality obligations in safeguarding the collection, use, dissemination, retention, and disposal of information and explain any reasonably foreseeable disclosure requirements:

a) Through Appendix B Application for Ethics Review, submitted to the REB; and

b) during the consent process with prospective participants.

5.3.1 Data Linkage

Researchers who propose to engage in data linkage must achieve REB approval prior to carrying out the data linkage. The submitted Appendix B Application for Ethics Review must describe the data that will be linked and the likelihood that identifiable information will be created through the data linkage.

Where data linkage involves or is likely to produce identifiable information, researchers must satisfy the REB that:

a) the data linkage is essential to the research; and

b) appropriate security measures will be implemented to safeguard the information.

5.3.2 Incidental Findings

Within the limits of consent provided by the participant, researchers will disclose to the participant any material incidental findings discovered in the course of research. In some cases, incidental findings may trigger legal reporting obligations. Researchers should be aware of these obligations and, as part of the initial consent process, inform participants of the limits to confidentiality.

5.4 Disclosures of Conflicts of Interest

A conflict of interest may jeopardize the integrity of a research project. Therefore, conflicts of interest must be assessed in order to protect the wellbeing of the participants and their ability to make informed and independent decisions during the research activities. In accordance with ADMIN 107 Conflict of Interest, researchers and members of the REB must disclose any real, potential, or perceived conflict of interest.

6. REB Review Requirement

The Loyalist College Research Ethics Board (REB) must review and provide approval for any proposed research involving:

living human participants
research involving human biological materials from living or deceased individuals, including human embryos, fetuses, fetal tissue, reproductive materials, and stem cells.

Approval must be given by the REB prior to the start of participant recruitment.

Research does not require REB approval when it:

Relies only on information that is publicly available under legislation or regulation and protected by law;

Relies only on information in the public domain and the individuals to whom the information refers have no reasonable expectation of privacy;

Involves observation of people in public places where:
- it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
- individuals or groups targeted for observation have no reasonable expectation of privacy;
- any dissemination of research results does not allow identification of specific individuals;

Relies only on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage, recording, or dissemination of results does not produce identifiable information;

Is for the purposes of quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management, or purposes of improving the performance of the college or its employees or students. Data collected in this manner is not eligible for publication unless REB approval was acquired prior to beginning any data collection; or

Involve creative practice activities that, in and of themselves, do not require REB review. However, research that uses creative practice to gather responses from participants that will be analyzed to answer a research question is subject to REB review.

7. Proportionate Review Approach

Loyalist College’s REB will adopt a proportionate approach to ensure that the level of scrutiny of a research project is determined by the level of risk it poses to participants. Those proposals that do not exceed minimal risk will receive a delegated review, and those that exceed minimal risk will be provided with a full board review. A full board review is the default level of review.

A proportionate approach to assessing the ethical acceptability of the research, at either level of review, involves consideration of the method and design of the research, the foreseeable risks, the potential benefits, and the ethical implications of the research. Researchers must clearly distinguish between the risks that are attributable to the research and the risks to which participants would normally be exposed; the REB will evaluate those risks that are attributable to the research within their review.

8. Course-based Research

Course-based research varies in scope, but includes activities such as students conducting interviews, administering standardized tests, or distributing questions. It also includes conducting projects that pose research questions, gathering data from human participants, and analyzing that data for presentation.

Research performed as a course assignment or quality assurance of a course or program and intended only for the professor’s review or class presentation may be eligible for a modified review process. In such instances, the professor must submit Appendix B Application for Ethics Review on the first instance that the assignment is included in a course. Upon approval, the professor must submit Appendix C Renewal or Amendment Request Form annually in addition to a completed Appendix F Acknowledgement of Course-based Research Form upon each offering of the course in which the research project is included.

This form, when completed, notifies the REB of the previously approved coursework that is being undertaken, the students involved, and the specific research questions being explored.

Within course-based research, the professor holds primary responsibility for the REB application and for student adherence to ethical treatment of human participants, including the principles of consent and confidentiality; student(s) hold secondary responsibility. The professor must ensure that acceptable research ethics, standards, and practices are taught to students who engage in research-based course assignments and research projects.

Minimal risk is appropriate for student course-based research projects; any research project involving greater than minimal risk must be submitted for REB approval following RES 104B Procedure for Ethics Approval of Research Involving Human Participants. If REB approval is required, the professor must ensure that students submit and obtain REB approval in writing prior to the onset of research projects involving human participants.

9. The Loyalist College Research Ethics Board (REB)

9.1 REB Membership

The Loyalist College REB is established by the college. Through membership, the college bestows the REB with the mandate to review the ethical acceptability of research on behalf of the college, including approving, rejecting, proposing modifications to, or terminating any proposed or ongoing research involving humans.

Membership of the REB should be consistent with Loyalist College’s commitment to equity, diversity, and inclusion and strive to ensure intersectionality of membership.

In alignment with the TCPS2, the REB will consist of at least five members of whom at least:

a) two members have expertise in the relevant research disciplines, fields, and methodologies covered by the REB.

b) one member is knowledgeable in ethics.

c) one member is knowledgeable in the relevant law.

d) one community member has no affiliation with the college.

It is advisable that each member be appointed to formally fulfil the requirements of only one of the above categories.

To ensure independent decision making by the REB, senior administrators of the college will not serve on the REB.

9.2 Ad Hoc Advisors

In the event that the REB lacks expertise or knowledge to review a research proposal, it will seek the advice from ad hoc advisors with the appropriate qualifications or relevant competencies.

Ad hoc advisors are not members of the REB and will not be counted in the quorum for the REB or be permitted to vote on REB decisions. Rather, their input provides a form of consultation for consideration in developing the REB’s final decision.

9.3 Terms of Appointment of the REB

The REB membership selection process will be fair and impartial.

In appointing and renewing REB members, the college will consider the qualifications and expertise the REB requires.

The college will provide REB members with necessary training opportunities to effectively review the ethical issues raised by research proposals that fall within the mandate of their REB.

REB members will be appointed, rotated, and held accountable to the Appendix A Loyalist College REB Terms of Reference.

9.4 The REB Chair(s)

The REB Chair(s) are responsible for ensuring that the REB process complies with the TCPS2 and all applicable college policies while providing overall leadership for the REB by presiding over meetings, overseeing the minutes, determining project risk levels, and monitoring all decisions, dissents, and the associated reasons. The REB Chair(s) will monitor the REB’s decisions for consistency and ensure that all decisions are documented and communicated clearly to researchers and the Manager, Research Administration in a timely manner.

9.5 REB Quorum and Attendance

The REB will have monthly meetings and will normally meet in-person to review proposed research that is not assigned to a delegated review. The REB may also meet whenever necessary during the academic year at the discretion of the REB Chair(s).

A quorum for full board review meetings is 50%, plus one additional member present and not including ad hoc advisors, observers, research ethics administration employees, or others that may attend an REB meeting. Decisions requiring full board review should be adopted only when the members present have the specific expertise, relevant competence, and knowledge necessary to provide an adequate ethics review of the proposals under consideration.

9.6 Record Keeping

The REB will prepare and maintain comprehensive records, including all documentation related to research proposal submissions, attendance at all REB meetings, and accurate minutes reflecting REB decisions. Where the REB denies approval for a research proposal, the minutes must include the rationale for the decision.

10. External and/or Multi-Jurisdictional Research

Prior to the commencement of a research project which seeks to engage the Loyalist College community, researchers not affiliated with Loyalist College must have their project approved at the institutional level in advance of the project being submitted to the REB for approval. This process is outlined within RES 104A Procedure for Institutional Approval of External Research Involving Human Participants. Institutional approval does not constitute REB approval; RES 104B Procedure for Ethics Approval of Research Involving Human Participants will be required once institutional approval has been achieved.

In instances where a research proposal has been previously approved by another Research Ethics Board affiliated with an institution eligible to administer Tri-Agency funds and deemed minimal risk, Loyalist College’s REB may accept the reviewing REB’s decision at the REB Chair(s)’ discretion.

The REB will accept applications from researchers who are planning to conduct a study at more than one college in Ontario in collaboration with other college REBs after REB approval has been obtained from their home institution.

11. Non-compliance Implications

Failure to comply with this policy, including failure to obtain REB approval or failure to comply with the conditions of their approval, constitutes a breach of RES 102 Responsible Conduct of Research.