Research Involving Humans
If you are a student conducting research that involves humans, you will have to obtain approval to ensure your research meets all relevant ethical guidelines. Depending on your circumstances, there are two possible paths to approval: departmental ethics review or Research Ethics Board (REB) review.
Regardless of whether you go through departmental or REB review, research involving human participants is governed by Laurier’s Policy 11.13: Ethics Review of Research Involving Humans.
The Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS2) describes principles, standards and procedures for governing research involving human participants in Canada. It is the basis for both REB and departmental ethics review at Laurier.
All Laurier researchers must complete the TCPS2 Course on Research Ethics (CORE) tutorial and submit the certificate(s) of completion with their ethics application.
Every project that involves collecting information from human participants requires a consent/information letter. Such documents inform participants about your project, explain what they will be asked to do as participants and set out their rights and responsibilities.
Departmental Ethics Review
Your research may qualify for departmental ethics review if you meet all the following criteria:- You and all members of your group (if applicable) are undergraduate students.
- Your research involves minimal risk to human participants (see below).
- Your supervisor will not be using the research data as part of his or her research.
- Your research does not involve Indigenous Peoples, including First Nations, Inuit and Métis peoples of Canada.
What Is Minimal-Risk Research?
Minimal-risk research is research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in the aspects of their everyday life that relate to the research.
If you are not sure whether your research qualifies as “minimal risk,” contact the Research Ethics Board for information and advice.
Research Ethics Board Review
Your research must go through Research Ethics Board (REB) review if any of the following apply:
- You or any members of your group (if applicable) are graduate students.
- Your research involves more than minimal risk to human participants.
- Your supervisor will be using the research data as part of his or her research.
- Your research does involve Indigenous Peoples, including First Nations, Inuit and Métis peoples of Canada.
More details:
Who Must Apply for REB Review?
All research (both funded and non-funded) involving human participants and human biological materials that is considered to be under Laurier’s jurisdiction/auspices must obtain REB clearance prior to commencement. This includes research conducted by members or associated members of the university (e.g., Laurier faculty, emeritus faculty, staff, sessional instructors, administrators, students, visiting or adjunct scholars, postdoctoral fellows, paid or unpaid associates or assistants) acting in their university capacity, and research that utilizes Laurier resources (e.g., equipment, email, meeting rooms).
What Is Defined As Research?
Research is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation (TCPS 2, 2014).
Researchers are required to seek REB review and clearance prior to obtaining and/or using this data for research purposes.
Research with human participants and human biological materials includes both primary data collection and the secondary use of data.
Primary data collection includes the of use surveys, questionnaires, interviews, focus groups, observation, and experimental methods to gather data from human participants.
Secondary use of data refers to the use in research of information originally collected for a purpose other than the current research purpose. Examples include:
- Social science or health survey datasets that are collected for specific research or statistical purposes, but then reused to answer other research questions; and
- The use of health care records, school records, biological specimens, vital statistics registries or unemployment records, all of which are originally created or collected for therapeutic, educational or administrative purposes, but which may be sought later for use in research.
What Is the Definition of Human Participants?
Human participants are those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question (TCPS 2, 2014).
What Is the Definition of Human Biological Materials?
Human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids (TCPS 2, 2014).
Please note that research involving human biological materials may require clearance from the Institutional Biosafety Committee (IBC) if it includes biohazardous materials (e.g., human tissues, cells, blood, and body fluids). For further information, refer to Biohazardous and Radioactive Materials.
What Research is Exempt from REB Review?
Some research may be exempt from REB review. Determination of exemptions is based on institutional or regulatory criteria, including information provided in Chapter 2 of the TCPS 2 (2014), Articles 2.1-2.6. Researchers are required to consult with the REB on the applicability of these exemptions to their research prior to commencing any projects. Some examples of research that is exempt includes:
- Research that relies exclusively on publicly available information when it is accessible to the public and appropriately protected by law, or publicly accessible and there is no reasonable expectation of privacy (e.g., Statistics Canada public use files).
- Research involving the observation of people in public places (e.g., stadium, planetarium, beach, museums, parks, or library) where there is no intervention staged by the research or direct interaction with the individuals or groups, those under observation 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.
- Note: Anonymous is distinct from anonymized or coded data that was initially collected with identifiers. Secondary use of anonymized and coded data is required to undergo REB review. Please see Identifiability of Information and Secondary Use of Data for details.
- Laurier students on co-op placements or similar work terms may be asked by their employer to undertake a variety of projects and assignments involving human participants. Such projects will be exempt from REB review when the project is used exclusively by the employer (i.e. it will not be used for academic purposes at Laurier) and there is no reference or association between the project and Laurier.
- Creative practice activities in and of themselves do not require REB review (e.g., an artist makes or interprets a work of art). However, a creative practice that seeks responses from participants whose responses will be analyzed to answer a research question is subject to REB review.
Note: Various university policies, agreements and privacy legislation further regulate the use of data collected and maintained by Laurier. Researchers seeking access to such data should ensure compliance with these items. Please see Privacy and Access at Laurier for more information.