Tri-Council Policy Statement

Tri-Council Policy Statement
Name	Tri-Council Policy Statement
Formation	1998
Type	Policy framework
Headquarters	Ottawa
Region served	Canada
Languages	English, French

Tri-Council Policy Statement The Tri-Council Policy Statement is a Canadian policy framework governing ethical conduct in human research developed by three federal research agencies. It sets standards for institutional research ethics review, informed consent, and protection of participants across biomedical and social studies.

Background and Development

The policy was created by the three federal agencies Natural Sciences and Engineering Research Council of Canada (NSERC), Social Sciences and Humanities Research Council (SSHRC), and Canadian Institutes of Health Research (CIHR). Its origins trace to shifts in research oversight after events associated with Tuskegee syphilis experiment, debates following publication of the Nuremberg Code, and responses to commissions such as the Kreisky Commission and inquiries like the Royal Commission on Aboriginal Peoples. Development involved consultations with institutions including the Canadian Institutes of Health Research steering committees, the Royal Society of Canada, and university research offices at University of Toronto, McGill University, and University of British Columbia. Early drafts reflected international norms from instruments like the Declaration of Helsinki, guidance from the Council for International Organizations of Medical Sciences, and standards enshrined in statutes such as the Canadian Human Rights Act.

Key Principles and Ethical Framework

The policy articulates core principles influenced by historic documents such as the Nuremberg Code, the Declaration of Helsinki, and reports from the United Nations and World Health Organization. It frames respect for persons, concern for welfare, and justice—concepts resonant with deliberations of the Royal Commission on Health Services and principles embedded in legislation like the Privacy Act (Canada). Ethical procedures draw on institutional mechanisms found at organizations like the National Research Council (Canada), research ethics boards modeled after practices at Johns Hopkins University, Harvard University, and guidance from the Canadian Institutes of Health Research ethics office. The framework addresses consent procedures referenced in rulings by courts such as the Supreme Court of Canada and engages with principles discussed in commissions including the Keenan Commission.

Scope and Applicability

The policy applies to researchers funded by the three agencies across settings from university laboratories at McMaster University and Queen's University to hospital research programs at SickKids Hospital and community projects in regions like the Northwest Territories and provinces including Ontario, Quebec, and British Columbia. It covers clinical research, behavioural studies, and community-based projects involving populations represented by organizations such as the Assembly of First Nations, the Métis National Council, and Indigenous governance structures cited in reports by the Truth and Reconciliation Commission of Canada. The document interfaces with provincial legislation such as the Ontario Personal Health Information Protection Act and institutional policies at hospitals like St. Michael's Hospital and research institutes including the Institute for Clinical Evaluative Sciences.

Implementation and Compliance

Implementation relies on institutional research ethics boards at institutions such as Dalhousie University, University of Calgary, and Université de Montréal, and on compliance mechanisms paralleling audits by bodies like the Office of the Auditor General of Canada. Funding agreements administered through CIHR, NSERC, and SSHRC require adherence, with oversight practices resembling those used by international funders like the National Institutes of Health and the European Research Council. Training programs for investigators draw on curricula developed by groups including the Canadian Association of Research Administrators, the Canadian Institutes of Health Research ethics training modules, and professional bodies such as the Canadian Medical Association and the Canadian Psychological Association. Noncompliance can trigger actions analogous to those instituted by grant agencies including funding suspension or institutional remediation, mirroring processes used by the Wellcome Trust and the Gates Foundation.

Major Revisions and Editions

The policy has undergone several revisions influenced by events and guidance from international and domestic actors such as updates following the HIV/AIDS research expansion, changes prompted by the Universal Declaration of Human Rights, and revisions paralleling updates at organizations like the World Health Organization. Editions have incorporated stakeholder feedback from academia bodies including the Association of Universities and Colleges of Canada and community representatives from organizations like the Canadian HIV/AIDS Legal Network and Indigenous councils referenced in reports by the Truth and Reconciliation Commission of Canada. Major editions reflect evolving norms in data protection influenced by statutes such as the Personal Information Protection and Electronic Documents Act and jurisprudence from courts including the Supreme Court of Canada.

Criticisms and Debates

Critiques of the policy have come from scholars at institutions including York University, University of Ottawa, and Simon Fraser University as well as advocacy groups like the Canadian Civil Liberties Association and the Canadian HIV/AIDS Legal Network. Debates center on adequacy of protections for Indigenous participants highlighted by the Truth and Reconciliation Commission of Canada, tensions between research facilitation and regulatory burden noted by the Association of Universities and Colleges of Canada, and challenges raised in academic journals affiliated with publishers such as Oxford University Press and Cambridge University Press. Observers compare the policy to frameworks in jurisdictions overseen by bodies like the European Commission and the National Institutes of Health, while commentators from think tanks including the Fraser Institute and legal analyses from firms represented before the Supreme Court of Canada critique clarity, enforcement, and the balance between participant protection and research innovation.

Category:Research ethics in Canada