Useful Links

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

  • This is a free online tutorial.  A certificate of completion is available for printing.
  • It is recommended that all individuals involved with research involving human subjects complete this tutorial.

United States: National Institutes of Health (NIH). Tutorial In human subject protection:

  • This is a free online tutorial required for NIH human subjects training for obtaining US Federal Funds.
  • A certificate of completion is available for printing.

Québec: Ministry of Health and Social Services. Tutorial in Research Ethics:

  • This tutorial “was developed specifically for research ethics board (REB) members and support staffs who works in the institutions of the Québec health and social services network.”

TRREE is headed by a consortium of interested persons from Northern and Southern countries.

TRREE provides free-of-charge access to:

  • e-Learning: a distance learning program and certification on research ethics evaluation
  • e-Resources: a participatory web-site with international, regional and national regulatory and policy resources

Other:

The Biobank Resource Center (BRC):

  1. Canada. TCPS 2 (2014)
  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):

 

Ontario Regulations
  1. Office of the Information and Privacy Commissioner of Ontario
  2. Fact sheet, Encrypting Personal Health Information on Mobile Devices, 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

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

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

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

 

Other

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

Major Canadian Federal Granting Agencies:

 

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

 

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

Medical Ethics Manual

World Health Organization (WHO)

OECD