Research Ethics Review Operating Procedure

To guide ethical research practices at Cambrian College (‘the College’) involving human participants.

All research under the auspices of the College involving human participants.

Examples of Research subject to ethics review:

• Research involving human participants where the researcher’s affiliation with Cambrian College is explicit in the research plan, regardless of where the research is conducted.
• Research conducted by a Cambrian College employee who is undertaking graduate studies (Master’s or PhD) that uses Cambrian College resources (e.g., for recruitment of data collection) to meet degree requirements.
  • The Cambrian College employee must first obtain ethics approval from the institution at which they are studying prior to seeking approval from Cambrian College’s REC.
• Research involving College students or employees as human participants.
• Research utilizing College resources such as physical space, class time, email lists, bulletin boards, internet or intranet services, computers, or student/staff collaboration.
• Course-based research conducted by Cambrian students (see Guidelines for the Ethics Review of Course-Based Research Involving Humans).

Research activities exempt or not normally requiring ethics review:

• Quality assurance and quality improvement studies, program evaluations, performance reviews, or testing within normal educational requirements when used solely for assessment, management or improvement purposes.
  • If data collected for these purposes is later intended for research, a REC review is required.
• Research that relies exclusively on information about individuals available in the public domain where there is no direct interaction or reasonable expectation of privacy. This includes publicly available information, documents, records, archival materials, or published third-party interviews.
• Research involving the observation of people in public places, provided that it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups. The individuals or groups targeted for observation must have no reasonable expectation of privacy and any dissemination of research results does not allow identification of specific individuals.
• Research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information. Secondary use refers to the use of information collected for another purpose but later intended for research.

Anonymized information: the information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and the risk of re-identification of individuals from remaining indirect identifiers is low or very low.

Anonymous information: the information never had identifiers associated with it (e.g., anonymous surveys) and the risk of identification of individuals is low or very low.

Conflict of interest: a situation in which a person can derive personal benefit from actions, decisions or research in their official capacity. Any real, potential or perceived conflict of interest, as well as institutional or community conflicts of interest shall be disclosed by the Principal Investigator, which will prompt a full committee review.

Course-based research: a pedagogical approach that calls learners to conduct research as a mandatory component of their required coursework. Research methods and practices are integrated into course-level learning outcomes and related assessments.

Delegated review: consists of a review of research involving human participants by the Research Ethics Committee Chair or by one reviewer designated by the Chair from among members of the Committee. Their feedback is required to be provided to the Committee within 10 business days.

Human participant: an individual whose data, biological materials, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question(s).

Minimal risk: research in which the probability and magnitude of possible harm implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research.

Principal Investigator: the individual who submits a research ethics application and is responsible for the ethical conduct of the study, and the actions of any member of the research team.

Research: an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation.

Research Ethics Committee (REC): an autonomous entity, accountable to the Board of Governors through the Vice President Academic, responsible for reviewing and monitoring all research involving human participants in accordance with the TCPS 2.

All research under the auspices of the College requires ethics review by and approval from Cambrian’s Research Ethics Committee prior to the start of the study.

Research Application Forms are available on the College’s Research Ethics webpage.

The Research Coordinator and/or REC Chair can help clarify any questions related to the ethics application process and requirements. Questions can be directed to research@cambriancollege.ca.

• Students conducting research projects involving human participants as part of their course work in course-based research must adhere to the Guidelines for the Ethics Review of Course-Based Research Involving Humans. Course-based research follows a different process and is typically exempt from the requirement to obtain institutional approval.
• Students that wish to conduct research that is not part of a course requirement must have supervision by a Cambrian College faculty or staff member, and that the supervising Cambrian employee must be listed as the Principal Investigator on both the Ontario College Research Ethics Application Form and the Institutional Permission Form.

1. Institutional Permission

1.1. Anyone who plans to conduct research at Cambrian College, on behalf of the College, or using the College’s data or resources, must obtain institutional permission before starting any research activities.

1.2. Institutional permission is distinct from research ethics approval. Approval from one body does not constitute approval from the other.

1.3. The Office of the Vice President, Academic, in consultation with the department most relevant to the proposed research, grants institutional permission. Institutional permission may be granted or denied based on factors such as the project’s costs, required effort, associated risks, impact on members of the College community, and use of institutional resources.

1.4. To request institutional permission, researchers must submit the completed Institutional Permission Form to research@cambriancollege.ca

2. Research Ethics Application Process

2.1. Once researchers have received institutional permission to conduct research, they can submit their ethics application to the Research Ethics Committee (REC) for ethics review and approval.

2.2. To complete this process, researchers must:

1. Submit the completed Ontario College Research Ethics Application Form, along with all supporting documents (e.g., consent forms, survey or questionnaire questions, recruitment script, etc.) to research@cambriancollege.ca for ethics review.

3. Ethical Review Process

3.1. Consistent with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), the Research Ethics Committee (REC) applies a proportionate approach to review, whereby the level of scrutiny is determined by the level of foreseeable risk to participants. The more invasive or risky the research, the more rigorous the review. The REC assesses each submission on a case-by-case basis to determine whether full or delegated review is required.

3.2. All research proposals are initially reviewed by the REC Chair (or delegate) to determine the appropriate level of review required. Determinations regarding the level of review are final.

         a. Full Committee Review

• Research requiring full review includes, but is not limited to, studies that:

1. Involve more than minimal risk to participants;
2. Include children or other individuals or groups with diminished capacity for consent (e.g., institutionalized persons, individuals living with disabilities, older adults, or others who may be vulnerable);
3. Involve deception or partial disclosure;
4. Include procedures or questions that may cause physical or psychological distress;
5. Address sensitive questions, themes or topics; or
6. Present a real, potential, or perceived conflict of interest

• A full review requires that the research protocol be reviewed at a meeting of the full REC. In such cases, researchers may be invited to participate in discussions about their proposals and to provide clarification, but they may not be present during the REC’s deliberations or decisions.

          b. Delegated Review

1. The research involves no more than minimal risk to participants.
2. The research involves the use of secondary data that are anonymized or unidentifiable. Annual renewals or continuing ethics review of approved research (especially when the research remains minimal risk).
3. Review of changes or amendments to approved research when the changes do not increase the level of risk.
4. Delegated reviews are normally completed within two weeks of receiving a complete application. The Chair reports all delegated review decisions to the full REC at the next scheduled meeting.

4. Review of Multi-Site Research

4.1. Research protocols that have been reviewed and approved by a Research Ethics Board (REB), other than that of Cambrian College’s REC, may be considered for delegated review under the following conditions:

1. 1. 1. The research involves no more than minimal risk, as defined by the TCPS 2; and
      2. The REC is satisfied that the reviewing REB operates in accordance with TCPS 2.

5. Research Conducted in Another Jurisdiction or Country

5.1. All research projects conducted in another jurisdiction or country, are required to undergo ethics review both (a) by Cambrian College’s REC; and (b) by the appropriate REB, where such exists, which has authority in the country or jurisdiction where the research is to take place.

6. Indigenous Research

6.1. Research involving Indigenous peoples, communities, or organizations must be conducted in accordance with chapter 9 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). When reviewing studies of this nature, the REC must confirm that researchers have adequately addressed the ethical standards and expectations set out in chapter 9.

6.2. Researchers must demonstrate meaningful engagement with Indigenous peoples, communities, or organizations, as appropriate to the nature and context of the research. Evidence of engagement may include:

1. 1. 1. Consultation with community representatives or governing bodies;
      2. Letters of support, partnership, or co-development agreements; or
      3. Documentation describing how Indigenous perspectives were incorporated into the project design.

6.3. Research proposals must address Indigenous rights to self-determination and governance over research, including:

1. 1. 1. Ownership, Control, Access, and Possession (OCAP®) or similar community data principles; and
      2. Agreements on how data will be collected, stored, shared, and used.

6.4. Researchers should include plans that demonstrate mutual benefit and capacity building for participating Indigenous communities, such as opportunities for training, collaboration, or co-authorship.

6.5. Plans for review and dissemination of results must include culturally appropriate methods and respect community protocols for feedback or approval before public release, where applicable.

6.6. When research involves Indigenous participants but is not specific to a community or organization, the Research Ethics Committee (REC) will determine whether community engagement is warranted and ensure that the researcher demonstrates cultural awareness and sensitivity to Indigenous contexts.

7. Decisions by the REC

7.1. The REC Chair, or Research Ethics Coordinator, provide written decisions resulting from the ethics review of research protocols to the Principal Investigator within two weeks of the meeting. The REC meets monthly as required.

7.2. A decision on a submission can fall into one of the following categories:

1. 1. 1. Approval without questions or modifications.
      2. Approval subject to clarifications and/or modifications.
      3. Deferred, pending receipt of additional information or major revisions.
      4. Not approved.

7.3. If the application is not approved as submitted, the REC will provide the researcher with written feedback outlining the rationale for the decision and recommendations for amendments.

7.4. The researcher may re-submit the revised application for ethics review at any time after addressing the REC’s recommendations.

8. Reconsideration of Decisions

8.1. An applicant has the right to request reconsideration of a negative REC decision.

8.2. Reconsideration shall be conducted promptly by the same REC responsible for the original decision. The applicant will be given the opportunity to attend the REC meeting to clarify or discuss the application, but may not participate in the REC’s deliberation or vote.

8.3. If the decision of the REC remains negative following reconsideration, the applicant may file a formal appeal.

9. Appeals Process

9.1. When the applicant does not agree with the decision of the REC, they may appeal the decision to the Appeal Committee. As per the College’s agreement with Laurentian University (LU), the Research Ethics Board (REB) at LU provides this arm’s length service.

9.2. The LU REB will conduct a full review of the application and associated documentation, which may include the original ethics application, the original REC decision, all subsequent written communications, and documents and records, including REC minutes pertaining to the submission.

9.3. The Appeal Committee will render a final and binding decision by majority vote. The Appeal Committee may:

1. 1. 1. uphold the original decision,
      2. modify the original decision, or
      3. impose specific conditions for approval of the project.

9.4. The Appeal Committee will communicate its decision in writing, with reasons, to the researcher and to Cambrian’s REC. The Appeal Committee will provide advice to the REC in the event of the modification of the original decision of the REC, or in the event of the imposition of specific conditions for approval of the project.

10. Modifications to Proposed Research

10.1. Researchers are responsible for informing the REC if a change is required to an approved application.

10.2. Any request for modification of approved research by REC shall include an explanation of why the modification is required, with specific reference to relevant sections of the Tri-Council Policy.

11. Conflicts and Recusal

11.1. REC members must declare any real, potential, or perceived conflict of interest in relation to a research application and, where such a conflict exists, must recuse themself from the review and decision-making process for that application, consistent with TCPS‑2.

11.2. Researchers may submit a written request identifying a REC member whose participation may create bias—either in favour of or against the proposed research. The REC Chair will review the request and if the identified member’s participation could reasonably be seen as biased, the member will be recused from the review of that specific application.

11.3. To request a change, researchers must complete and submit a Change Request Form prior to implementing the requested change to their research.

11.4. The Change Request then follows the Ethics Review Process, whereby the change is reviewed by the REC Chair who determines whether the changes require delegated or full review by the REC.

12. Adverse Events

12.1. Principal Investigators and supervisors must promptly report any adverse, undesirable, or unintended effects that arise from the research—whether anticipated or not—to the REC.

12.2. Reports are to be directed to the REC Chair (or delegate) as soon as possible. The Chair will review the report and, if necessary, refer it to the full REC for assessment. A meeting may be called ad-hoc to address the adverse event.

12.3. The REC will determine whether modifications to the research protocol, additional participant safeguards, or suspension of the study are required to protect participants. The REC’s decision will be communicated in writing to the Principal Investigator, who is responsible for implementing any required actions.

13. Research and Renewal and Completion

13.1. Research ethics approval is valid for a period of one year. Researchers are responsible for ensuring that their ethics approval time frame does not lapse.

13.2. To request renewal for a research project, researchers must complete the Renewal/Completed Status Report Form and submit it to the REC (research@cambriancollege.ca), as per the TCPS 2 (2022) guidelines. If an extension is not required, researchers must complete this form to indicate the completion of a project.

13.3. For studies conducted less frequently (e.g., biannual surveys) or for long-term projects that exceed the one-year ethics approval period, researchers must still submit a renewal request prior to the expiry date of their current approval. This ensures ongoing ethical compliance and uninterrupted continuation of research activities. The REC may request progress updates or modifications to maintain oversight throughout the extended research period.

If ethics approval expires, the project is considered closed, and researchers must submit a new ethics application for review and approval before any further research activities (including data collection or analysis involving participants) may resume

14. Publication of Research

14.1. Cambrian College has no institutional constraints on the publication of research results. However, the College may agree to delay publication for no more than 12 months from the date of completion of a project to satisfy any pre-existing and related agreements with funding agencies.

14.2. In addition, where a source provides “Confidential Data”, the research is to be published without any identifiable reference to confidential data.