Does My Course-Based Assignment/Project Require Research Ethics Review?

As discussed above, the new definition of course-based research activities is relevant for making the determination, along with the TCPS2 definition of research (See Application of Art. 2.1).

“[Research requiring review] 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.”

TCPS2 definition of research, “For the purposes of this Policy, ‘research’ is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. 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.”

If the course assignment fits one of the following criteria, then research ethics review is required:

• Students are expected to conduct a research project, with human participants, that meets the TCPS2 definition of research. This is more likely at the graduate course level.
• The project does not meet the strict definition of research in the TCPS2 but includes all the elements of a research project (recruiting participants, collecting data, analysis, and reporting – if only to the class/instructor). As per the TCPS2 guidance on course-based research activities, from the participant’s perspective there is not much difference in terms of risks and other issues (e.g., consent) between participating in this type of research project and one that meets the strict definition of research. Participants could be outside of the course or students taking the course.
• 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 assignment does not include analysis and reporting. For participants, taking part in the data collection activity carries many of the same risks as it would if the assignment were a full research project, as outlined in the new TCPS2 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 analysis and presentation of results, but 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, taking part in the data collection activity carries many of the same risks as it would if the assignment were a full research project, as outlined in the new TCPS2 guidance.

The following types of course assignments do not require research ethics review.

• Assignments that require students to collect information from people as part of professional skill training. For example, a Kinesiology course focused on developing professional trainer skills that includes an assignment where students collect physiological data from a participant 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 (i.e., developing entrepreneurial skills).
• Courses where students are serving as consultants with an organization that is running an internal program evaluation/quality improvement/quality assurance study. This type of program evaluation data collection does not require REB review (Art. 2.5), so no course-based ethics review is required for projects that involve students assisting organizations with program evaluation. However, if the data was (also) being used for a research project, then ethics review would likely be required.
• Research activities where the specific data collection does not require REB review. Assignments that rely on publicly available data Art. 2.2), that involve observation of people in a public place and are in accordance with Art. 2.3, and/or that rely on the secondary use of anonymous data (Art. 2.4). Note: In the TCPS2, “anonymous” data refers to data that never had identifiers associated with it. If the secondary use dataset has only been de-identified or anonymized, and is individual level data, then its use for course-based research activities would likely require research ethics review (Art. 5.5B).

The following examples involve learning a research skill, but because they take place entirely within the class and it is not necessary for participants to provide data about themselves, MREB has determined course-based research ethics clearance is not required for these types of assignments.

• 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, 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 type of 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).

Instructors who need assistance applying the above criteria to their specific course/assignment are encouraged to contact the MREB Ethics Office for a determination of whether research ethics review is required (mreb@mcmaster.ca).

Course-Based Ethics Application Process and Instructor Responsibilities

The following outlines the process for the course-based application and review, and the instructor’s responsibilities in overseeing the projects and the ongoing reporting for the ethics file.

This is for course 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. 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 (see below), then the student(s) would need to submit an individual standard MREB application for review.

1. The Instructor for the course completes and submits the “Instructor’s Course-Based Application” in the MacREM system (see Q. 1.2 in the Screening section when creating a new project).
2. Applications should be submitted at least one month prior to the start of the course, to allow for the ethics review time and prevent a delay in students starting the assignment/project. For example, submit by August 1^st for Fall semester courses, December 1^st for Winter semester courses, etc.
3. The form will be directed to the appropriate Student Research Ethics Committee, or MREB if necessary, by the Research Ethics Officer.
4. 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 individual project, and review each of these proposals and supporting documents (e.g., recruitment scripts, letter of information, interview guide, etc.). The instructor ensures that the data collection plan and documents are in compliance with the approved ethics protocol and the TCPS2. Note: For some assignments, the instructor may have predetermined the same data collection process and document language for all students, and in that case the vetting of individual projects may not be necessary.
5. If the assignment/project will involve collecting data through another institution or agency (such as schools, hospitals, government agencies etc.), be aware that approval from the other institution may be required prior to data collection.
6. All documents related to individual projects approved by the instructor (e.g., project proposal, letter of information, survey questions, etc.) must be retained by the instructor for a period of two years. This is in order to have the documentation available in the event there is a participant complaint about the student project.
7. Ethical approval for the course-based research activity is reviewed and renewed annually via the Annual Report (TCPS2 Art. 6.14). If the course is ongoing, then the instructor should renew the ethics clearance each year via the Annual Report. There is no set limit on how long the ethics clearance can continue to be renewed. Other factors, such as a major change to TCPS2 requirements or the course-based application form, or a comprehensive change to the project/assignment, could result in a request from MREB to submit a new application for review. The Annual Report is a sub-form created in MacREM when viewing the cleared ethics application.
8. If there are substantive changes made to the protocol for the course-based research activity and/or any of the documents/templates students will use, then instructors must submit an Amendment form and have the changes approved by MREB prior to implementation (TCPS2 Art. 6.16). Minor administrative changes can be submitted via the For Information Only (FIO) form to keep the ethics file updated. Contact the ethics office if you are unsure which form to use for submitting changes. The Amendment and FIO forms are sub-forms created in MacREM when viewing the cleared ethics application.
9. The Reportable Event form should be used to report an adverse event, protocol deviation, data breach or participant complaint to MREB as soon as possible. The Reportable Event form is a sub-form created in MacREM when viewing the cleared ethics application.
10. If a new instructor is taking over the course, then a For Information Only form should be submitted with the new instructor’s information replacing the previous instructor in the contact section. When the new instructor will only be covering the course for the short-term, or a course will alternate between instructors, then instead of removing the previous instructor, the new instructor can be added as an additional instructor for the course. The new instructor will need to submit a For Information Only form (or Amendment) to document any changes they are making to the course assignment and related documents (at the least, their name and contact information will need to replace the previous instructor on documents going to participants).
11. If you have any questions about the ethics review process or your responsibilities as an instructor overseeing a course-based research activity with human participants, please contact the MREB Secretariat (mreb@mcmaster.ca).

Parameters of Risk for a Course-Based Research Application

Once the course-based research application has ethics clearance, the instructor will be able to vet individual projects, so long as all the following are TRUE:

• Projects are no more than minimal risk to the participants. As defined in the TCPS2, “[minimal risk research is] 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 persons dependent upon the researcher(s) for therapeutic care.
• The student projects will not involve any personal, sensitive or incriminating topics or questions which could place participants at risk.
• The student projects will not change or involve behaviour(s) of participants beyond the range of “normal” classroom activity or daily life.
• The student projects will not involve physically invasive contact with the research participants, for example, taking blood or urine samples, cortisol, muscle biopsies, tissue for genetic testing.
• The student projects will not involve deception.

If a student project falls outside ANY of these elements of risk, you and the student(s) must submit a standard MREB application through the MacREM online system for review of the individual project. The application will be directed to the appropriate Student Research Ethics Committee or to MREB. Given the time required for the ethics review process and the short timeline within a semester long course, it is highly recommended that instructors craft course assignments/projects that stay within the above risk parameters and are therefore covered by the course-based research application clearance.