Accreditation Standards and Normative Documents

businessman pressing button on virtual screens

Accreditation Standards

HRA Canada’s accreditation program is based on the standards developed by Human Research Standards Organization (HRSO).
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.

Normative Documents

Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

CAN/HRSO-100.01-2020 Development of a Human Research Protection Program (HRPP)

CAN/HRSO-200.01-2021 Ethical Review and Oversight of Human Research

CAN/HRSO-300.01-2022 Conduct of Human Research

Council for International Organizations of Medical Sciences (CIOMS): International Ethical Guidelines for Biomedical Research Involving Human Subjects

Good Clinical Data Management Practices (GCDMP)

International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guideline

Interpretations – Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018) Interpretations

ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice

Material Incidental Findings – Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)

The First Nations Principles of Ownership, Control, Access, and Possession OCAP® (OCAP® is a registered trademark of the First Nations Information Governance Centre (FNIGC))

Tri-Agency Framework: Responsible Conduct of Research (2016)

Tri-Agency Research Data Management Policy (2021)

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022)

World Medical Association – Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects

World Health Organization – Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants