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Revised Draft 2nd Edition of the TCPS (December 2009)

Introduction

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS or the Policy) is a joint policy of Canada’s three federal research agencies – the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council of Canada (the Agencies).

This Policy expresses the Agencies’ continuing commitment to the people of Canada to promote the ethical conduct of research involving human participants. It has been informed, in part, by leading international ethics norms, all of which may help, in some measure, to guide the conduct of human research in Canada and by Canadian researchers abroad.

This edition represents the first substantive changes to the Policy since its adoption in 1998. It is a major revision, reflecting over a decade of experience with this Policy by the research community, applying it in response to existing and emerging ethical issues and new areas of research. It also distills the experience of the Interagency Advisory Panel on Research Ethics, which was created in 2001 primarily to steward the evolution and interpretation of this Policy, and to provide the Agencies with independent advice on issues related to the ethics of human research. This edition, which replaces the original TCPS, draws on the advice provided to the Panel by its working groups and committees. As well, it reflects the significant and valuable input from the research community and all those who provided feedback on the draft that the Panel circulated publicly, in December 2008.

Mandate of the Agencies

The people of Canada, through Acts of Parliament1 have created and funded the Agencies to promote and assist research within their respective legislative mandates. In discharging their mandates, the Agencies wish to promote research that is conducted according to the highest ethical standards. The Agencies have therefore adopted this Policy as a benchmark for the ethical conduct for research involving human participants. As a condition of funding, the Agencies require that researchers and their institutions apply the ethical principles and the articles of this Policy and be guided by the applications to the articles.

Compliance with the Policy

To be eligible to receive and administer research funds from the Agencies, institutions must agree to comply with a number of Agency policies set out as schedules to a Memorandum of Understanding (MOU) between the Agencies and institutions. (See Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards at www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp). This Policy is Schedule 2 to that MOU. Institutions must therefore ensure that research conducted under their auspices adhere to this Policy. Researchers are expected, as a condition of funding, to adhere to the TCPS.

In addition to this Policy on the ethics of human research, institutions and their researchers must adhere to the other policies referenced in the MOU, which include policies on research integrity, peer review and conflicts of interest in research.2

Organizations and entities not party to the MOU are welcome to adopt this Policy to guide the ethical aspects of the design, review and conduct of human research. Since the adoption of the original Policy in 1998, many bodies in Canada and abroad have adopted, adapted and been guided by this document. The Agencies hope that this Policy will continue to serve as a model and guide for the ethical conduct of human research.

The Agencies recognize that considerations around the ethical conduct of human research are complex and continually evolving. We therefore welcome comments and discussion, and commit to the continued evolution of this document.

Endnotes

[1] See Canadian Institutes of Health Research Act, Statutes of Canada, 2000, Chapter 6; Natural Sciences and Engineering Research Council Act, Revised Statutes of Canada, 1985, Chapter N-21; Social Sciences and Humanities Research Council Act, Revised Statutes of Canada, 1985, Chapter S-12.

[2] Schedules 4, 6 and 14, respectively.