Useful links for the Ethics Board

1. Canada. TCPS 2 (2022)
2. CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002)
3. Guidance for industry: Good clinical Practice Consolidated guideline – International Conference on Harmonization Topic E6
4. The Nuremberg Code
5. World Medical Association Declaration of Helsinki (updated Oct. 2013)
6. Belmont Report. Report of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Department of Health, Education, and Welfare. April 18, 1979.

CANADA

Regulations

Federal Regulations

Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982

Canadian Legislation relating to Health Research (several titles):

• Food and Drugs Act (R.S., 1985, c. F-27)
• Food and Drug Regulations (C.R.C., c. 870)
• Medical Devices Regulations (SOR/98-282)
• Natural Health Products Regulations (SOR/2003-196)
• Assisted Human Reproduction Act (2004, c. 2)
• Human Pathogens and Toxins Act (2009, c. 24)
• Privacy Act (R.S., 1985, c. P-21)
• Personal Information Protection and Electronic Documents Act (PIPEDA)

Ontario Regulations

1. Office of the Information and Privacy Commissioner of Ontario
2. Fact sheets, Information and Privacy Commissioner of Ontario
3. Freedom of Information and Protection of Privacy Act 
4. The Personal Health Information Protection Act, 2004, S.O. 2004, c. 3 Sched. A 

Quebec Regulations (in French only)

Information on the governance of ethics of research in Québec:

1. Ministère de la santé et des services sociaux du Québec
2. Framework governing multicentre research in Québec
3. Commission d’accès à l’information du Québec 

Health Canada

• Health Products and Food Branch Inspectorate Compliance and Enforcement

Under ‘Good Clinical Practices’, the “Health Products and Food Branch Inspectorate (Inspectorate) has the responsibility for the inspections and investigations of clinical trials.”

• Clinical Trials Manual
• Registration and disclosure of Clinical Trial information (notice)
• Access to Therapeutic Products: The regulatory Process in Canada

“This publication describes how therapeutic products in Canada make their way from the laboratory to the marketplace.”

• Clinical Trial Application (CTA)

“Sponsors must file a Clinical Trial Application (CTA) to conduct clinical trials in Phases I through III of drug development and comparative bioavailability trials.”

• Management of Applications for Medical Device Licences and Investigational Testing Authorizations
• Health Canada Research Ethics Board
• Medical Devices
• Natural Health Products
• Biologics and Gene Therapy Directorate (BGTD). Regulation of biological and radiopharmaceutical drugs

Other

• Interagency Advisory Panel on Research Ethics

“The Panel develops, interprets and implements the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).”

• Canadian Association of Research Ethics Boards (CAREB)

Major Canadian Federal Granting Agencies:

• Canadian Institutes of Health Research (CIHR)
• CIHR Ethics Office
• Guidelines for Human Pluripotent Stem Cell Research, June 30, 2010
• The Natural Sciences and Engineering Research Council of Canada (NSERC)
• Social Sciences and Humanities Research Council (SSHRC)
• Office of the Privacy Commissioner of Canada

UNITED STATES

1. U.S. Department of Health & Human Services (DHHS)
2. U.S. Office of Human Research Protections (OHRP)
3. U.S. Food and Drug Administration (FDA)
4. FDA Regulations Relating to Good Clinical Practice (GCP) and Clinical Trials
5. Federal Policy for the Protection of Human Subjects (“The common Rule” 45 CFR 46)

EUROPE

Council of Europe

• Convention on Human Rights and Biomedicine (CETS No. 164) (Council of Europe, 1997)
  

INTERNATIONAL

UNESCO

1. The Universal Declaration on Bioethics and Human Rights (UNESCO, 2005)
2. The Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997)
3. The International Declaration on Human Genetic Data (UNESCO, 2003)

Council for International Organizations of Medical Sciences (CIOMS)

World Medical Association (WMA)

The Declaration of Helsinki (updated Oct. 2008)

The Declaration of Ottawa on child health (adopted Oct. 1998, amended Oct. 2009)

Medical Ethics Manual

World Health Organization (WHO)

Ethics and Health

OECD

• Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs)

Public Responsibility in Medicine and Research (PRIM&R)

Canadian Association of Research Ethics Board

The Society of Clinical Research Associates (SOCRA)