TCPS 2 Review Requirements for Course-Based Research Activities
The 2018 update to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans states that “Research requiring research ethics board review (REB) includes course-based research activities, the primary purpose of which is pedagogical, because of the possible risks to those recruited to participate in such activities, and the fact that, from their perspective, such activities may appear indistinguishable from those that meet this Policy’s definition of research.’ Application of TCPS 2 Art. 2.1. In March of 2021, the Secretariat released an interpretation that further clarified the requirement for ethics review of course-based research activities that were for pedagogical purposes, “Course-based research activities intended primarily for pedagogical purposes fall within the jurisdiction of the REB’ (Application of Article 2.1 and Article 6.12). Such research activities are assigned to students to teach them how to conduct research in a structured educational context. This includes, for example, asking students to conduct interviews to collect data to be used in a course assignment or to practice interviewing techniques. Participants in the activities may be exposed to risks (typically minimal risk) due to their participation. They may not distinguish these activities from others that meet the definition of research in TCPS 2.” (Interpretation #8 in the Panel of Research Ethics Governance document).
Does My Project Require Research Ethics Board (REB) Review?
- If the project falls within the TCPS 2 definition of ‘research’ ethics review is required.
- Research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation, where the term “disciplined inquiry” refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.
- Some examples of course-based research are included below:
- The purpose of the assignment is for students to learn a data collection research skill (e.g., conduct an interview, run a survey, etc.), but the work does not include analysis and reporting. For participants, participating in the data collection activity carries many of the same risks as it would if the assignment were a complete research project, as outlined in the new TCPS 2 guidance. Participants could be outside of the course or students taking the course.
- The purpose of the assignment is for students to practice research skills in the analysis and presentation of results. Still, the data collection is done by the instructor from participants outside of the course. Even though students are not collecting the data, persons outside the course are being recruited and providing data to the instructor, and the students will be handling the participant data. For participants, participating in the data collection activity carries many of the same risks as it would if the assignment were an entire research project, as outlined in the new TCPS 2 guidance.
The following types of course assignments DO NOT require a research ethics review
- Assignments that require students to collect information from people as part of professional skill training. For example, a course focusing on developing professional trainer skills includes an assignment where students collect physiological data from participants and provide them with an exercise program. Another example could be a business course in marketing where students are partnered with a local business, provided with relevant data about the customers, and create a marketing campaign (e.g., developing entrepreneurial skills).
- Courses where students serve as consultants with an organization running an internal program evaluation/quality improvement/quality assurance study. This type of program evaluation data collection does not require REB review (TCPS 2 Article 2.5), so no course-based ethics review is required for projects that involve students assisting organizations with program evaluation. However, an ethics review would be necessary if the data was also used for a research project.
- Assignments that involve students learning/practicing a research skill with other students in the class but that do not require students to provide real data about themselves. For example, conducting mock interviews with each other in a clinical psychology class, developing a survey and having classmates look through it and provide feedback on the survey design, etc.
- Assignments where the instructor creates a dataset by surveying the class, and students practice data analysis methods with the dataset. In this assignment, the instructor should only collect anonymous and non-sensitive data from students and have an alternative for those who do not want to provide information about themselves (e.g., tell students to pretend they are someone else when answering the questions).
The following criteria must be met regarding the risk for a Course-Based Research Application:
- Projects are no more than minimal risk to the participants (i.e. 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).
- The research participants will be drawn from the general adult population, capable of giving free and informed consent and will not include vulnerable participants such as children, persons who are not legally competent to consent; mentally incompetent persons; legal wards or prisoners and those dependent upon the researcher(s) for care/therapy.
- The student projects will not involve personal, sensitive, or incriminating topics or questions that could place participants at risk.
- The student projects will not change or involve participants' behaviour(s) beyond the range of “normal” classroom activity or daily life.
- The student projects will not involve physically invasive contact with the research participants or taking any samples (e.g., cortisol, muscle biopsies, scratching the skin, administering eye drops).
- The student projects will not involve deception (TCPS 2 Article 3.7B).
- All course-based research may be subject to GREB review via the Quality Assurance Review Program (PDF 124 KB).
If a student project falls outside these risk elements, the student(s) must submit a standard GREB Standard Application Form in TRAQ.
GREB Course-Based Ethics Application Procedure and Instructor Responsibilities:
- The instructor for the course completes and submits the GREB Course-Based Research Application Form in TRAQ. If students are doing independent projects that are quite unique from each other, or the project falls outside the acceptable parameters of risk for the course-based review and clearance, then the student(s) would need to submit an individual standard GREB application for consideration.
- The course instructor is responsible for submitting the course syllabus, protocol/methods, and associated templates to be used for the research projects (e.g., consent form template, recruitment scripts, general scripts for interviews/focus groups, general survey questions) for projects where all the students are following a similar plan for the project/assignment and the ethics review and clearance is for the course project/assignment at the course level.
- Applications should be submitted before the course starts to allow for appropriate ethics review time to avoid delays in students starting the assignment/project. For example, submit by August 1st for fall semester courses, December 1st for Winter semester courses, etc.
- Once the course project/assignment has ethics clearance, it is the responsibility of the instructor to vet the individual projects. The instructor should have their students submit their plans for each project and review these proposals and supporting documents (e.g., recruitment scripts, letters of information, interview guide, etc.). Note: For some assignments, the instructor may have predetermined the same data collection process and document language for all students; in that case, vetting individual projects may not be necessary.
- The instructor must retain all documents related to individual projects (e.g., project proposal, letter of information, survey questions, etc.) for one year. This is to have the documentation available in the event there is a participant complaint about the student project.
- Ethical clearance must be reviewed and renewed annually via submission of the Annual Renewal Event form in TRAQ. If the course is ongoing, the instructor should renew the ethics clearance yearly. Other factors, such as a significant change to TCPS 2 requirements, the course-based application form, or a comprehensive change to the project/assignment, could result in a request to submit a new application for review.
- If changes are made to the protocol for the course-based research activity and/or any of the documents or templates students will use, then instructors must submit an Amendment Event Form in TRAQ.
- The GREB Adverse Event Form must be used to report adverse events, protocol deviations, data breaches or participant complaints to GREB in TRAQ.
- If a new instructor takes over the course, an Amendment Event Form must be submitted in TRAQ. When the new instructor only covers the course for the short term, or a course will alternate between instructors. Instead of removing the previous instructor, the new instructor can be added as an additional instructor for the course by submitting the GREB Change in Study Team Request Event Form in TRAQ.