The Digital Governance Standards Institute (DGSI) and the Human Research Standards Organization (HRSO) collaborated on the recently published second edition of a national standard of Canada seeking to strengthen the framework for the ethical review and oversight of human research.
“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),” said Janice E. Parente, HRSO president, in a news release.
The DGSI explained that the national standard titled “CAN/DGSI 131 / HRSO 200.01, Ethical Review and Oversight of Human Research” identifies the requirements of Research Ethics Boards (REBs) in protecting research participants’ rights, welfare, and interests within an HRPP.
The DGSI added that the national standard aims to equip REBs operating within HRPPs with the structures and procedures for responsibly overseeing research, with requirements harmonized to ensure consistent, proportionate, and accountable ethical review processes across jurisdictions.
The DGSI noted that the national standard applies to public, private, for-profit, and not-for-profit organizations involved in ethically reviewing and overseeing human research across disciplines. According to the DGSI, the national standard’s second edition:
- updated the normative references
- fortified the governance provisions
- clarified the responsibilities of REBs of record in multi-institutional research environments
- added to the guidance for review coordination and oversight during disruptive events and publicly declared emergencies
“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,” Parente said.
National standard’s components
The DGSI’s news release noted that the national standard covers:
- the requirements for REBs’ formal authority, independence, resourcing, and integration within an HRPP
- considerations concerning REBs’ multidisciplinary membership, including ethics and legal proficiency, research participant representation, diversity, and the management of conflicts of interest and roles
- criteria for full-board and delegated review, with mandatory documentation procedures and transparent decision-making
- ethical review criteria relating to risk-benefit assessments, scientific validity, informed consent, privacy protections, and safeguards for research participants
- requirements for initial, ongoing, continuing, and concluding reviews, including streamlined processes for multi-institutional research and secure records management
The DGSI and HRSO expressed gratitude to the Technical Committee members, subject matter experts, public reviewers, and organizational partners who helped develop the national standard’s second edition.