Normative and Informative References

Normative and Informative References

HRA Canada’s accreditation program is based on the standards developed by Human Research Standards Organization (HRSO). These standards were developed in direct accordance with the normative references listed below, all of which are publicly available. Informative references also aided in the conceptual understanding of the standards.

Health Canada Food and Drugs Act

Personal Information Protection and Electronic Documents Act (PIPEDA)

Health Canada Food and Drugs Regulations, Part C, Division 5

Health Canada Natural Health Products Regulations, Part 4

Health Canada Medical Device Regulations, Part 3

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

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

US Code of Federal Regulations Title 21

US Code of Federal Regulations Title 45

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

Canada’s Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines (2012) – Standing Senate Committee on Social Affairs, Science and Technology

Canadian governance of human research involving human subjects: is anyone minding the store? – authored by Michael McDonald, BA, MA, PhD

CARE Principles for Indigenous Data Governance

 

National Council on Ethics in Human Research (NCEHR): Options for the Development of an Accreditation System for Human Research Protection Programs, 2005

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 Experts Committee for Human Research Participant Protection in Canada (2008) Moving Ahead: Final Report, Ottawa.

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

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.

Ethics on Trial: Protecting Humans in Canada’s Broken Research System, authored by Parente JE (2025), Dundurn Press.

Institute of Medicine – Preserving Public Trust: Accreditation and Human Research Participant Protection Programs

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