Guidelines for the Ethics Review of Research-Intensive Courses Involving Humans

This document outlines the process for the review of ethical conduct of course-based research projects involving humans at Cambrian College.

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans- TCPS 2 (2022) is a federal mandate that promotes high ethical conduct, standards and procedures for research that involves human participants. The TCPS 2 (2022) applies to those conducting, participating in, or reviewing human research in institutions, including research conducted in courses.

Course-based research is designated as minimal risk research projects, involving human participants, that students complete as part of their coursework. The goal of course-based research is to help students develop critical thinking, problem-solving skills, and research skills that they can apply in their future careers or academic pursuits. Course-based research also allows students to gain a deeper understanding of their course materials and the research methods used in their field of study. This is reflected explicitly in a course learning outcome and identified on the course outline.

Faculty may assign class research projects and activities in which students must collect data from human participants. These projects may be conducted by individual students, small groups, or as a single class project. Course-based research projects involving human participants require Research Ethics Committee (REC) review and approval before the start of the research project.

Course-based research may not fit the standard definition of research in that the results are not intended for publication or generalization to other situations; however, the potential for risks to participants requires that the protocols and consent processes be reviewed by the Cambrian College REC.

Course-based research involving human participants is subject to ethics review. It must be minimal risk and conducted by students under the guidance of faculty. Course-based research typically uses methods involving:

• Structured or semi-structured interviews with key informants working in a particular area/field (e.g., professors, not-for-profit organizations, employers).
• Surveys with family/friends/members of the general public.
• Focus groups/group interviews (e.g., with employees or members of an organization or group)
• Observational activities where individuals observed have an expectancy of privacy.

Course-based research that is exempt or does not normally require review by the REC:

• Assignments that involve students learning/practicing a research skill with other students in the same course, but do not require students to provide real data about themselves (e.g., mock interviews with each other, developing a survey and having classmates review it and provide feedback on survey design).
• Assignments where the faculty creates a dataset by surveying the class and students practice data analysis methods with the dataset. In this type of assignment, the faculty member should only collect anonymous data and non-sensitive data from students and have an alternative for those who do not want to provide information about themselves (e.g., instruct students to create mock responses).
• Assignments or activities that require students to collect information from people as part of professional skill training or standard of practice within a profession (e.g., observation, assessment, intervention, evaluation, auditing). For example, a business course where students create a marketing campaign with a business partner to develop entrepreneurial skills, or a Kinesiology course where students collect physiological data from a participant and provide them with a custom exercise program.
• Course activities where students are serving as consultants with an organization that is running an internal program evaluation or quality improvement study, as long as the data is not also being used for a research project.
• Assignments that rely on publicly available data (e.g., the observation of people in a public place and/or that rely on the secondary use of anonymous data which has no identifiers associated with it).
• Activities considered quality assurance or program evaluation (for example, KPI surveys and program review activities).

Note: the guidelines outlined in this document are limited to course-based research projects, not larger-scale projects required to fulfill the requirements for a thesis. Thesis projects follow a separate process. Research that does meet the criteria for course-based research requires full REC review and approval in the following instances:

• if it is a direct extension of the faculty member’s research;
• if it involves more than minimal risk as defined by the Tri-Council Policy Statement; and
• if it involves the collection of data which will subsequently be used towards the completion of a Master’s or PhD level degree.

In these cases, students must complete a full research ethics application.

If you are unsure if a project falls outside the scope of the procedures outlined in this document, contact research@cambriancollege.ca.

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

Course-Based Research: defined as minimal risk research that occurs within the context of a specific course offering, where students are being taught how to conduct research involving human participants as part of their assigned research course work.

Delegated Non-REC faculty member: a faculty member who is deemed “faculty supervisor” for the purposes of course-based research projects involving human participants.

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

Informed consent: any prospective participant must be provided with full disclosure of all information necessary for making an informed decision to participate in a research project.

Minimal risk: research in which the probability and magnitude of possible harms 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.

Research: defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation, where research is the intended purpose (TCPS 2, 2022).

Research Ethics Committee (REC): an autonomous entity, accountable to the Board of Governors, formally constituted to review and monitor all research involving human participants through the application of the core principles of research ethics, as defined in the TCPS 2 (2022).

Ethics Review Process for Course-Based Research

Faculty members assigning students research projects involving human participants must receive approval by the REC prior to start of the project. Faculty is responsible for providing research ethics oversight of student projects. The following outlines the ethics review and approval process for course-based research projects.

1. Faculty member completes the mandatory, online TCPS 2: Core-2022 Tutorial.

2. Faculty member completes and submits the Faculty Application Form for Ethics Review of Course-Based Research to the REC at research@cambriancollege.ca. They must also include all relevant information about the course-based research project and a copy of their TCPS 2: Core certificate.

2.1. Applications are to be submitted annually and should be submitted by the end of the term immediately preceding it. For example:

1. 1. Fall Courses: Applications must be submitted by the end of the Spring term (August).
   2. Winter Courses: Applications must be submitted by the end of the Fall term (December)
   3. Spring Courses: Applications must be submitted by the end of the Fall term (April).

2.2. Upon receipt of the application, the REC will notify the Chair of the department that an application from their school has been received.

2.3. One single application can be submitted for all sections of a course and should include all faculty teaching the course and all research assignments planned. If more than one faculty member teaches the same course, each faculty member is to be included in the application. If the research methodology is different in the different sections, a separate application must be submitted.

3. The REC reviews the Faculty Application Form and communicates its decision to the faculty member(s) in a timely manner, with a copy to the Chair of the department.

4. Upon approval, the REC appoints the faculty member(s) as a delegated non-REC faculty member to review and monitor student research projects for their course.

4.1. Ethics approval of course-based research projects will be granted for one academic year and must be renewed annually using the Renewal/Completed Status Report Form, providing that there are no changes to the research activities, procedures, or faculty teaching the designated research-intensive course.

4.2. If there is a change in the course faculty, research activities or procedures, an Amendment Form must be submitted to the REC by the faculty.

5. The faculty member has each student (or group) complete the Student Application Form for Ethics Review of Course-Based Research.

5.1. Students must submit the Student Application Form and all supporting documentation to the faculty member prior to the start of the course-based research project.

5.2. Students must complete the TCPS 2: Core-2022 Tutorial and submit their certificate of completion to the faculty member. This is required for all project members.

5.3. Faculty will review student applications to ensure compliance with ethical requirements and notify the student in writing that their research can proceed.

6. The appointed delegated non-REC faculty member monitors the ethical conduct of students’ research projects. The faculty is responsible for ensuring that all student recruitment materials and research procedures remain within the scope of the approved course-level review.

6.1. Recruitment should only use convenience sampling (i.e., surveying friends, family, and other students in the course). All recruitment methods must be approved in the course-level ethics application.

6.2. The methodology of the research, and research topics, must be appropriate to the course, minimal risk, and may not create undue influence or coercion.

7. Upon completion of the term, the delegated non-REC faculty member must submit a report of all course-based research projects to the REC (research@cambriancollege.ca). This report should include the titles and research questions of each student research project

• Complete the TCPS 2: Core-2022 Tutorial and submit the Faculty Application Form to the REC.
• Adhere to all procedures for ethical research in accordance with REC’s requirements, TCPS 2 (2022) guidelines, and the ethical standards set out in Cambrian’s Research Ethics Policy and Procedures.
• Oversee, mentor, train, and educate student researchers on the ethical conduct of research.
• Monitor the ethical conduct of students’ research projects.
• Develop related course learning outcomes.
• Ensure that student course-based research projects meet the criteria for minimal risk:
  • Research participants are drawn from the general adult population (or persons able to understand and consent to participate in the research). All participants must be capable of giving free and informed consent and may not include participants who may be vulnerable in the context of research such as young children and persons who are not legally competent to consent.
  • Research does not involve any personal, sensitive or incriminating topics or questions which could place participants at risk and does not manipulate behaviour of participants beyond the range of “normal” classroom activity or daily life.
  • Research does not involve physically invasive contact with the research participants.
  • Research does not involve deception.
  • Research participation incentives should not be so large or attractive as to encourage reckless disregard of risks or result in undue inducement.
• Ensure that permission is obtained for research conducted at other institutions/entities.
• Safeguard the privacy and confidentiality of the participants.
• Ensure that data will be anonymized and confidential.
• Ensure that results will be disseminated or shared within the course context exclusively.
• Ensure the proposed project will not be used for the purpose of the faculty’s own research project.
• Communicate any changes to the research project, timelines, adverse or unanticipated events, and other ethical implications to the REC as soon as possible.

• Complete and submit the Student Application Form to their faculty for review and approval by the deadline provided, including all required supporting documentation (e.g., consent letter and forms, recruitment correspondence, and research instruments such as surveys, test, questionnaires, etc.).
• Complete and submit the TCPS 2: Core-2022 Tutorial certificate for all team members.
• Ensure that all research activities are conducted with the highest ethical standards.
• Obtain permission from all outside agencies that will be involved in the study (e.g., companies, community agencies, School Districts, Hospital, Indigenous Governments, etc.) prior to undertaking the research.
• Seek advice and guidance from their faculty, ask questions, or communicate concerns.

The above lists do not anticipate all possible situations. If unsure about a particular student project or procedure, please contact research@cambriancollege.ca.