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 research ethics review at Laurier. Student who plan to conduct research that involves human participants or human biological materials, you will have to obtain ethics clearance to ensure your research meets all relevant ethical guidelines. Research involving human participants is governed by Laurier’s Policy 11.13: Ethics Review of Research Involving Humans and requires clearance from the University Research Ethics Board (REB) before any research begins.

As a student planning to conduct research that involves human participants or human biological materials, you will have to obtain ethics clearance to ensure your research meets all relevant ethical guidelines.

Privacy and Ethics Resources

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans Tri-Agency Framework: Responsible Conduct of Research Privacy and Access at Laurier

Research that May Be 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. Please contact the REB for more information if you think your research may fall under one of the following categories.

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.

Departmental Research Ethics Review

If your research qualifies for departmental ethics review, you must fill out a request for Departmental Research Ethics Committee Review and submit it to your department's research ethics committee (REC) along with the signed Checklist for Departmental REC Review form. If your department does not have a REC, you will need to submit your ethics application to the Research Ethics Board. Please note that all Research Ethics Board applications are processed using the ROMEO research portal and require submission of a different application form.

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).

Before You Apply

Complete the TCPS 2: Course on Research Ethics (CORE) Tutorial

All Laurier researchers must complete the TCPS2 CORE Tutorial and submit the certificate(s) of completion with their ethics application.

Determine Review Process Required

Departmental Research Ethics Committee (REC) Review

Your research activity may qualify for departmental research ethics committee (REC) review if you meet all of the following criteria:

You and all members of your group are undergraduate students.
Your department has a departmental REC.
Your research activity is course-based (i.e. not undergraduate theses or equivalent research projects such as directed studies and major research papers). Such pedagogical activities are normally required of students with the objective of providing them with exposure to research methods in their field of study. Examples of course-based research activities include:
- 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/other students/members of the general public
- Focus groups/group interviews with employees or members of an organization or group
Your supervisor/instructor will not be using the research data as part of their own research program and data will not be used outside of the course.
Your research activity is considered minimal risk to human participants (see below).
Your research does not involve Indigenous Peoples, including First Nations, Inuit and Métis peoples of Canada.
Your research does not involve individuals, groups, or populations in vulnerable circumstances. This includes individuals who lack decision-making capacity (e.g., children, those living with cognitive impairments, persons who are not able to legally consent to participate in research).

If any of the above criteria is not met, the project must be submitted to the University Research Ethics Board (REB).

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.

Types of risk may include physical, psychological/emotional, and social. Examples of research topics and procedures that may be considered higher than minimal risk include:

ingestion, tasting, smelling, application of a substance that pose any health risk
answering questions related to sexual or physical abuse, as well as self harm and suicidal thoughts or actions
providing medical/health information or clinical diagnoses (e.g., depression, anxiety) particularly if associated with identifiers
reporting on illegal activities

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 it does not meet all of the criteria for departmental REC review noted above.

Research that May Be 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. Please contact the REB if you think your research may fall under one of the following categories:

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.