Definitions and TCPS 2 Statement for Research Involving Humans

The following resource provides you with supplementary definitions and statements in relation to research involving humans.

Definitions

The following are definitions in relation to research involving humans. 

Research

Research is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation (TCPS 2, 2022).

Researchers are required to seek Research Ethics Board (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.

Human Participants

Human participants are those individuals whose data, biological materials, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question (TCPS 2, 2022).

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, 2022).

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).

Tri-Council Policy Statement

The Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans (TCPS2) describes the principles, standards and procedures for governing research involving human participants in Canada. It is the basis for research ethics review at Laurier.

All 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 must obtain ethics clearance to ensure your research meets all relevant ethical guidelines.