Online tutorials
Canada - Research Ethics Training (RET)
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2): CORE-Tutorial (Course on Research Ethics)
- This is a free online tutorial. A certificate of completion is available for printing.
- It is recommended that all persons involved in research ethics involving humans follow it.
United-States - National Institutes of Health (NIH)
Tutorial In human subject protection:
- This online tutorial is free. A certificate of completion is provided.
- This training is about protecting human subjects in NIH research. It is required for all applications for federal funding for research involving human subjects in the United States (in English only).
Québec - Research Ethics Tutorial
Ministry of Health and Social Services.
- 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 - Ethics of health research
TRREE is headed by a consortium of interested persons from Northern and Southern countries. It aims to provide basic training, while building capacities, on the ethics of health research involving humans so that research meets highest standards of ethics and promotes the welfare of participants.
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
This site offers training and certification on biobanks.
Key documents
- TCPS 2 (2022)
- International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2003)
- Guidance for industry: Good clinical Practice Consolidated guideline – International Conference on Harmonization Topic E6
- The Nuremberg Code (1947)
- World Medical Association Declaration of Helsinki (updated Oct. 2013)
- 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.
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
Ressources by geographic areas
Federal Regulations
- Canadian Charter of Rights and Freedoms, Part I, Annexe B 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
Quebec Regulations (in French only)
Information on the governance of ethics of research in Québec:
Health Canada
- Health Canada Inspectorate: “The Inspectorate is responsible for clinical trial inspection and investigation activities”
- 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 and Public Health Agency of Canada
- Medical Devices
- Natural Health Products
- Biologics and Gene Therapy Directorate (BGTD).
Other reglementations
- 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)
- 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
Ressources en anglais seulement
Europe
-
Council of Europe : Convention on Human Rights and Biomedicine (CETS No. 164) (Council of Europe, 1997)
International
- The Universal Declaration on Bioethics and Human Rights (UNESCO, 2005)
- The Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997)
- The International Declaration on Human Genetic Data (UNESCO, 2003)
Council for International Organizations of Medical Sciences (CIOMS)
World Medical Association (WMA)
World Health Organization (WHO)
OECD