Accreditation Standards and 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)
HRSO-100.02-2023 Development of a Training Program for Human Research Protection
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
An ethical framework for biomedical research, authored by Emanuel EJ, Wendler D, and Grady C (2008) in Emanuel EJ, Grady C, Crouch RA, Lie R, Miller FG, and Wendler D (Editors), The Oxford Textbook of Clinical Research Ethics (pages 123– 135). Oxford, UK: Oxford University Press.
A Systems Approach to Human Research Protection: Innovation in Healthcare, authored by Alexander G. Karabanow, BSc, BAA; Janice E. Parente, BSc, PhD; Jacquelyn Legere, RN, BN,CIPP/C; Ann Munro Heesters, BEd, BA(Hons.), MA, PhD
CARE Principles for Indigenous Data Governance
Institute of Medicine – Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
Research Ethics Broadly Writ: Beyond REB Review. Anderson, JA, Sawatzky-Girling, B., McDonald, M, Pullman, D., Saginur, R, Sampson, HA, and Willison, DJ (2011), Health Law Review 19(3), 12-24.
Report on the Evaluation of Control Mechanisms in Clinical Research in Quebec (The Deschamps Report), authored by Pierre Deschamps, BCL, CM
SPIRIT 2013 Statement: Defining standard protocol items for clinical trials.
SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials.
The Governance of Health Research Involving Human Subjects (HRIHS), authored by Michael McDonald, BA, MA, PhD
What Makes Clinical Research Ethical? Emanuel EJ, Wendler D, and Grady C. (2000) JAMA 283(20):2701–2711