TCPS2 (Tri-Council Policy Statement)

TCPS2 (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans) is the joint research-ethics policy of Canada’s three federal research funding agencies — the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), collectively “the Agencies.” It sets out the ethical principles, articles, and procedural requirements that Canadian institutions, researchers, and Research Ethics Boards (REBs) must apply whenever a study involves human participants, their data, or their biological materials. TCPS2 is the foundational document underlying REB review across essentially every Canadian university, college, and research hospital — the direct Canadian counterpart to the U.S. Common Rule (45 CFR 46).

What TCPS2 covers

TCPS2 applies to research involving humans conducted under the auspices of an institution eligible to receive and administer Tri-Agency funds, regardless of whether the specific study in question is itself Tri-Agency funded. Compliance with the Policy is a condition of an institution’s ongoing eligibility for CIHR, NSERC, and SSHRC funding, which is why virtually every Canadian university and affiliated research hospital has adopted TCPS2 as binding institutional policy for all human-participant research conducted under its name — not only for the subset of projects that happen to carry Tri-Agency grant funds. Institutions outside that funding relationship are not bound by TCPS2, though some (including several private research ethics boards and federal bodies such as Health Canada and the National Research Council) have voluntarily adopted it or an equivalent framework.

Structurally, TCPS2 is organized as a set of chapters and numbered articles, each paired with explanatory guidance. Individual articles and chapters address specific procedural questions — for example, when REB review is triggered, what constitutes free and informed consent, how conflicts of interest must be managed, and how research involving Indigenous communities should be conducted. This page is the general definition of the Policy as a whole; it does not walk through every article and chapter in turn.

History and current version

The original Tri-Council Policy Statement was published in 1998. The Agencies created the Interagency Advisory Panel on Research Ethics (PRE, also called the Panel on Research Ethics) in 2001 to steward the Policy’s ongoing interpretation and revision. Following public consultation, a substantially revised second edition — TCPS 2 — launched in December 2010, with subsequent revised versions issued in 2014, 2018, and, most recently, 2022. TCPS 2 (2022) is the current version of the Policy and is the one referenced by “TCPS2” in current usage. Each revision has kept the same three core principles and overall two-agency-plus-one structure while updating specific articles (for example, expanding guidance on Indigenous research governance and clarifying REB procedures).

Core ethical principles

TCPS2’s guidance on the ethical conduct of research is organized around three core principles, described in Chapter 1 of the Policy. The principles are complementary and interdependent — how each applies, and how much weight it carries, depends on the nature of the research being reviewed.

Respect for Persons

Recognizes the intrinsic value of human beings and requires that participation in research be based on voluntary, ongoing, and adequately informed consent. This principle is the basis for TCPS2’s informed consent requirements and for participants’ right to withdraw.

Concern for Welfare

Requires researchers and REBs to protect — and where appropriate promote — the welfare of participants across the full range of physical, psychological, social, economic, and cultural dimensions, weighed against the research’s foreseeable risks and benefits.

Justice

Requires fair and equitable treatment of participants and groups, including appropriate selection of who is invited to participate in research and who bears its burdens, and attention to power imbalances between researchers and participants.

TCPS2 and the Research Ethics Board (REB)

TCPS2 is the document an REB applies when it reviews a proposed study. Every institution eligible for Tri-Agency funding must maintain, or have access to, an REB constituted and operating according to TCPS2’s requirements, and researchers at that institution must obtain REB approval before recruiting participants or collecting data for non-exempt human research. This is functionally equivalent to the role 45 CFR 46 plays for an Institutional Review Board (IRB) in the United States, but the Canadian terminology is REB, not IRB, throughout TCPS2 and Canadian institutional policy documents. Before submitting a protocol, many researchers and institutions also require completion of TCPS 2: CORE, the Panel’s free online tutorial on the Policy’s requirements — the closest Canadian equivalent to CITI Program training in the U.S., though the two are separate programs administered by different organizations and are not interchangeable for institutions that specifically require one or the other.

TCPS2 compared to the U.S. Common Rule

TCPS2 and the U.S. Common Rule serve the same basic function — setting the ethical and procedural baseline for research involving human participants — but differ in legal status and structure. The Common Rule is a codified federal regulation (45 CFR 46, Subpart A) adopted by twenty U.S. federal departments and agencies; research that meets its triggering conditions is regulated by force of law. TCPS2 is a policy, not a statute: it binds institutions and researchers as a condition of Tri-Agency funding eligibility rather than as a direct legal mandate, though in practice its adoption as institutional policy makes REB review just as mandatory in practice at eligible Canadian institutions. Both frameworks are organized around a central ethics-review body (REB in Canada, IRB in the U.S.) and both build outward from a small set of core ethical principles — TCPS2’s Respect for Persons / Concern for Welfare / Justice descend from the same research-ethics lineage as the Belmont Report’s Respect for Persons / Beneficence / Justice, which underlies the Common Rule. The practical difference researchers most often need to know: consent, review, and documentation language written for a U.S. IRB under the Common Rule does not automatically satisfy a Canadian REB’s TCPS2 requirements, and vice versa — multi-jurisdictional studies need to confirm which framework, or both, actually governs a given site.

Frequently asked questions

What does TCPS2 stand for?

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, second edition. “Tri-Council” refers to the three Agencies — CIHR, NSERC, and SSHRC — that jointly issue it.

Is TCPS2 a law?

No. TCPS2 is a policy issued by the three federal funding Agencies as a condition of institutional funding eligibility, not a statute. Because virtually all Canadian universities and research hospitals depend on Tri-Agency funding, they adopt TCPS2 as binding institutional policy for human research generally, which makes REB review effectively mandatory in practice even for studies that are not themselves Tri-Agency funded.

Do I need to complete TCPS 2: CORE before REB submission?

Most Canadian institutions require researchers to complete the TCPS 2: CORE tutorial (or confirm equivalent training) before or alongside REB submission, though the specific requirement is set by each institution’s own REB, not by TCPS2 itself.

How is TCPS2 different from the individual articles and chapters within it (such as Article 2.1 or Chapter 9)?

TCPS2 is the umbrella policy document as a whole. Its individual chapters and numbered articles address specific procedural questions in depth — for example, when REB review is required, what constitutes valid consent, how conflicts of interest are managed, or how research involving Indigenous Peoples should be conducted. This page defines the Policy overall rather than any single article or chapter.

References

• Government of Canada, Panel on Research Ethics, “Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022)” (ethics.gc.ca)
• TCPS 2 (2022), Chapter 1: Ethics Framework (core principles)
• TCPS 2 (2022), Chapter 2: Scope and Approach (institutional eligibility and applicability)
• CIHR, “Ethics resources” (cihr-irsc.gc.ca)
• TCPS 2: CORE (Course on Research Ethics), tcps2core.ca