Ottawa, ON – The Digital Governance Standards Institute (DGSI), in collaboration with the Human Research Standards Organization (HRSO), is pleased to announce the publication of the second edition of the National Standard of Canada, CAN/DGSI 131 / HRSO 200.01, Ethical Review and Oversight of Human Research.
This standard strengthens Canada’s framework for the ethical review and oversight of human research and outlines the requirements of Research Ethics Boards (REBs) in safeguarding the rights, welfare, and interests of research participants within a Human Research Protection Program (HRPP). The National Standard applies to all public and private, for-profit and not-for-profit organizations engaged in the ethical review and oversight of human research across disciplines.
CAN/DGSI 131 / HRSO 200.01 establishes harmonized requirements to support consistent, proportionate, and accountable ethical review processes across jurisdictions. Conformity with this NSC, alongside CAN/DGSI 129 / HRSO 100.01, helps ensure that REBs operating within a Human Research Protection Program (HRPP) have the governance structure and documented procedures necessary to oversee research responsibly.
The second edition incorporates updated normative references, strengthened governance provisions, clarification of REB of record responsibilities in multi-institutional research environments, and expanded guidance for review coordination and oversight during disruptive events and publicly declared emergencies.
“Public trust in research rests on the assurance that studies involving humans are subject to independent, competent, and consistent ethical review within a properly governed human research protection program (HRPP). This new edition of the standard clarifies and integrates important changes in normative text, strengthening the foundations of ethical oversight of human research in Canada.” Janice E. Parente, PhD
Key Components of the Standard
- REB Governance and Mandate
Clear requirements for formal authority, independence, resourcing, and integration within a Human Research Protection Program (HRPP). - REB Composition and Expertise
Multidisciplinary membership, including ethics and legal expertise, Research Participant representation, diversity considerations, and management of conflicts of interest and roles. - Proportionate and Documented Review Processes
Structured criteria for Full-Board and Delegated Review, with mandatory documentation and transparent decision-making. - Comprehensive Ethical Review Criteria
Risk–benefit assessment, scientific validity, informed consent (including broad and deferred consent where justified), privacy protections, and safeguards for Research Participants. - Lifecycle Oversight and Multi-Site Coordination
Requirements for Initial, Ongoing, Continuing, and Concluding Review, including streamlined processes for multi-institutional research and secure records management.
By reducing variability in the interpretation of regulations, policies, and guidelines, CAN/DGSI 131 / HRSO 200.01 supports harmonization, accountability, and public trust in the conduct and oversight of human research in Canada and internationally.
The DGSI and HRSO extend their sincere appreciation to the members of the Technical Committee, subject matter experts, public reviewers, and organizational partners who contributed their time, expertise, and insight to the development of CAN/DGSI 131 / HRSO 200.01. Their collaborative efforts, thoughtful review, and commitment to strengthening the ethical oversight of human research have been instrumental in ensuring that this National Standard of Canada reflects current best practices, regulatory expectations, and the evolving needs of Canada’s research community.
The Standard is available via CAN/DGSI 131 / HRSO 200.01.
About the Digital Governance Standards Institute (DGSI)
The Digital Governance Standards Institute develops digital technology governance standards fit for global use. The Institute works with experts, as well as national and global partners and the public to develop national standards that reduce risk to Canadians and Canadian organizations adopting and using innovative digital technologies in today’s digital economy. The Institute is an independent division of the Digital Governance Council. To learn more about the organization and its initiatives, visit www.dgc-cgn.org or contact info@dgc-cgn.org.
About Human Research Standards Organization
HRSO is a Canadian, not-for-profit, standards development organization that develops standards of relevance to Canadians conducting, overseeing, and participating in human research. HRSO adheres to the World Trade Organization (WTO) Agreement on Technical Barriers to Trade: Code of Good Practice for the Preparation, Adoption, and Application of Standards in the development of service and management standards for human research. https://www.hrso-onrh.org/