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Human Research Protections in Canada

Ethical Codes

• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. November, 2000. Available from (External) http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm
• Helsinki Declaration Ethical Principles for Medical Research Involving Human Subjects. The World Medical Association (1964/2000/2002). Available from (External) http://www.wma.net/e/policy/17-c_e.html
• International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS Council for International Organizations of Medical Sciences. November, 2002. Available from (External) http://www.cioms.ch/frame_guidelines_nov_2002.htm
• The Nuremberg Code: Directives for Human Experimentation. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law. No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office (1949). Available from (External) http://ohsr.od.nih.gov/guidelines/nuremberg.html

Guidelines and Information

• (External) National Council on Ethics in Human Research (NCEHR) (English)
• (External) NCEHR Canadian Research Ethics Boards Database
• (External) NCEHR Resources (Excellent collection of links)
• (External) NCEHR Communique
• (External) The Provincial Health Ethics Network (Alberta, Canada)
• (External) National Placebo Initiative (CIHR and Health Canada)
• (External) Ottawa Statement on Clinical Trial Registration

Professional Information Resources

• CMAJ Collected Resources: Bioethics for Clinicians. Accessed on 2006-10-17 at: (External) http://www.cmaj.ca/cgi/collection/bioethics_for_clinicians_series?page=1
• CMAJ Collected Resources: Clinical Research. Accessed on 2006-10-17 at: (External) http://www.cmaj.ca/cgi/collection/clinical_research
• CMAJ Collected Resources: Informed Consent. Accessed on 2006-10-17 at: (External) http://www.cmaj.ca/cgi/collection/informed_consent
• CMAJ Collected Resources: Research and Publication Ethics. Accessed on 2006-10-17 at: (External) http://www.cmaj.ca/cgi/collection/research_and_publication_ethics
• Canadian Medical Association Canadian Bioethics Report. Accessed on 2006-10-17 at: (External) http://www.cma.ca/cma/common/displayPage.do?pageId=/staticContent/HTML/N0/l2/cbr/index.htm
• Code of Ethics of the Canadian Medical Association (2004 update) Accessed on 2006-10-17 at: (External) http://policybase.cma.ca/PolicyPDF/PD04-06.pdf
• 1996 CMA Code of Ethics Annotated for Psychiatrists. (Canadian Psychiatric Association) Accessed on 2006-10-17 at: (External) http://www.cpa-apc.org/Publications/Position_Papers/annotatedCodeOfEthics/codeOfEthics.html
• (External) Canadian Medical Association
• (External) Nuffield Council on Bioethics (Not Canadian, excellent nonetheless.)
• (External) The Royal College of Physicians and Surgeons of Canada

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Bioethics Organizations and Academic Departments

• (External) Canadian Bioethics Society
• (External) The Canadian Association of Research Ethics Boards
• (External) Dalhousie University Department of Bioethics
• (External) McGill University Biomedical Ethics Unit
• (External) McGill University Clinical Trials Research Group
• (External) University of Alberta Health Law Institute
• (External) University of Alberta John Dossetor Health Ethics Centre
• (External) University of Toronto Joint Centre for Bioethics

Regulations and Guidelines :: Canadian Institutes of Health Research

• (External) Canadian Institutes of Health Research Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards
• (External) CIHR Health Research Results and Related Reports – Publications
• (External) CIHR Policies and Guidelines in Ethics
• (External) Canadian Institutes of Health Research

Regulations and Guidelines :: Health Canada

• Health Canada Clinical Trials Guidance Documents. Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/index_e.html
• Health Canada Guidance for Sponsors: Clinical Trials Manual. (Posted October, 2006) Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_intro_e.html
• Health Canada Notice: To Clinical Trial Sponsors: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties. 2006-07-23. Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/tuberc_notice_avis_e.html
• Health Canada Regulations Amending the Food and Drug Regulations (1024 – Clinical Trials). Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/reg/1024_tc-tm_e.html
• Health Canada Annexe 2 to the Current Edition of the Good Manufacturing Practices Guidelines: Manufacture of Drugs Used in Clinical Trials. (December, 2003) Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/docs/cln_trials-essais_cln_tc-tm_e.html
• ICH Harmonized Tripartite Guideline: Good Clinical Practice International Conference on Harmonization of Technical Requirements For Registration of Pharmaceuticals For Human Use. Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6_e.html
• Clinical Trials for Natural Health Products Guidance Document. 2005-10-30. Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/clini_trials-essais_nhp-psn_e.html
• Natural Health Products Regulations Part 4 Clinical Trials Involving Human Subjects. Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/propose2_regula-regle_doc6_e.html
• Health Canada Acts and Regulations. Accessed on 2006-10-17 at: (External) http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/acts_regs_e.html

For U.S. Food and Drug Administration regulations, see our FDA information page

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Information :: Canadian Institutes of Health Research

• (External) Canadian Institutes for Health Research Ethics Office
• (External) 2005—2006 CIHR Grants and Awards Guide
• (External) Canadian Institutes for Health Research Funding–Related Databases (Search for CIHR-funded research by principal investigator or institution)
• (External) Registration of randomized controlled trials (RCTs) funded by CIHR. 2005-09-01

Information :: Health Canada

• Summary Report of the Inspections of Clinical Trials Conducted in 2003—2004. Health Products and Food Branch Inspectorate, Health Canada. 2004-12-15. Accessed on 2007-08-20 at: (External) http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/report-rapport/2003-2004_tc-tm_e.html
• Summary Report of the Inspections of Clinical Trials Conducted Under Voluntary Phase. Health Products and Food Branch Inspectorate, Health Canada. 2003-07-11. Accessed on 2007-08-20 at: (External) http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/report-rapport/gcp_insp_rep-rap_bpc_insp_tc-tm_e.html
• Health Canada–Regulation of Medical Devices. Report of the Auditor General of Canada. 2004. Accessed on Accessed 2006-05-28 at: (External) http://www.oag-bvg.gc.ca/domino/reports.nsf/html/20040302ce.html
• (External) Canadian Adverse Drug Reaction Monitoring Program (CADRMP) (Information and Terms of Use; link to the online query is at the bottom of the page.)
• (External) MEDeffect Main Page (Index of adverse reaction information.)
• (External) How To Report Adverse Reactions to Health Canada
• (External) Health Canada Drug and Medical Device Recall Listings
• (External) Health Canada Therapeutic Products Directorate Drug Product Database
• (External) Health Canada Therapeutic Products Directorate TPD-Web (Drugs)
• (External) Health Canada Therapeutic Products Directorate Devices (Licensed establishments and devices)
• (External) Health Canada Natural Health Products Directorate
• (External) Health Canada List of Approved Natural Health Products
• (External) Health Canada Online

Law

• (External) Department of Justice Canada Consolidated Statutes and Regulations
• (External) Department of Justice Canada Access to Information Act
• (External) CanLII Canadian Legal Information Institute
• (External) Health and Safety Laws (Lawguru.com)
• (External) Personal Directives Information and instructions from the Provincial Health Ethics Network (Alberta)

Still Looking For Information?
Start with our Index of Information Resources

Reports

• Final Report of the Task Force Established by the National Council on Ethics in Human Research to Study Models of Accreditation for Research Protection Programs in Canada. 2002-03-29. Accessed on 2006-10-17 at: (External) http://ncehr.medical.org/downloads/FIN_TaskForceReport_EN.pdf
• HRIHS The Governance Of Health Research Involving Human Subjects. Law Commission of Canada (1998). Accessed on 2006-10-17 at: (External) http://www.lcc.gc.ca/en/themes/gr/hrish/macdonald/macdonald_main.asp

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Last Updated: 2007-10-10

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