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

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

Effective Date: June 2023
Revised: N/A

Purpose

This document outlines the process for the review of ethical conduct of course-based research projects in research-intensive designated courses at Cambrian College.

Definitions

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.

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 in research-intensive designated courses 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).

Research-Intensive Course: 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.

Scope

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 Research Ethics Committee (REC).

Course-based research involving human participants is subject to ethics review if the research is minimal risk and conducted by students or is faculty-led. 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 exempt or not normally requiring 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., tell 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 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). Another example is 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.
  • Courses where students are serving as consultants with an organization that is running an internal program evaluation/quality improvement study. If the data was also being used for a research project, then ethics review would be required.
  • Assignments that rely on publicly available data (e.g., that involve 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. 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 Masters or PhD 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@cambrian.ca.

Ethics Review Process for Research-Intensive Designated Courses

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

  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 with a copy of the TCPS 2: Core certificate to the REC at research@cambriancollege.ca.
    1. Applications are to be submitted by the second Friday in June.
    2. 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 unless the research is different in the sections. In this case a separate application must be submitted.
  1. 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.
  2. 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.
    1. Ethics approval of research-intensive courses 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. If there is a change in the course faculty, research activities or procedures, an Amendment Form must be submitted to the REC.
  1. The faculty member has each student (or group) complete the Student Application Form for Ethics Review of Course-Based Research.
    1. Students must submit the Student Application Form and all supporting documentation prior to the start of the course-based research project.
    2. Students must complete the TCPS 2: CORE-2022 tutorial and submit their certificate of completion to the faculty member (required for all project members).

Note that group projects only require a single application that lists all students involved in the project as co-investigators. Faculty, to the best of their abilities, must ensure that students’ applications meet the basic requirements for ethics approval. Data collection cannot commence without the ethics approval of the student application by the faculty.

  1. The appointed delegated non-REC faculty member monitors the ethical conduct of students’ research projects.

Faculty Responsibilities

  • Complete the TCPS 2: CORE-2022 tutorial and submit Faculty Application Form to the REC
  • Adhere to all procedures for ethical research in accordance with REC’s requirements, TCPS 2 (2022), 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
    • Research does not involve
    • 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

Student Responsibilities

  • 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