10/12/22, 6:05 PM TCPS 2: CORE-2022

TCPS 2: CORE-2022

Module A2 - Scope of TCPS 2

Research that requires REB review
Research involving human participants requires ethics review and approval by a REB before recruitment begins
(Article 2.1). To understand the scope of the TCPS 2, it is necessary to understand how it defines “research” and
“human participants”.

Definition of research
TCPS 2 defines research 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” (Application of Article 2.1).

Initial exploratory work to help a researcher design a study or establish a research partnership does not fall
within this definition of research, and therefore does not require REB review. Consultations with a community to
obtain the authorization to proceed with a research study or to obtain information that will be used to develop the
research proposal are examples of exploratory work (Articles 6.11 and 10.1).

Pilot studies are smaller versions of the main study (e.g., fewer participants, shorter duration) that fall within this
definition, and require REB review (Application of Article 2.1 and Article 10.1).

Definition of 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(s)”. This definition includes living
participants and data collected from them. It also includes biological materials derived from both living and
deceased individuals, including human embryos, fetuses, fetal tissue, stem cells, and human reproductive
materials (a human gene, human cell, ovum or sperm or a part of any of them) (Application of Article 2.1).

Who is not a human participant?

Sometimes researchers seek information from individuals because of their expertise or in their official capacity,
for example as a public servant or a spokesperson for an organization. In these cases, the researcher is seeking
information that is not personal to the individuals who are providing it or that is normally provided in the
ordinary course of their employment. In this context, they are not research participants. However, it is of note
that in certain circumstances these individuals may also be research participants, for example, where the research
focuses in whole or in part on collecting their personal views (Application of Article 2.1; TCPS 2
Interpretations, Scope, Question 12).

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