Ethic Board Useful Links
Canada: 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 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.
- 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 (BRC):
- Canada. TCPS 2 (2018)
- CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS, 2002)
- Guidance for industry: Good clinical Practice Consolidated guideline - International Conference on Harmonization Topic E6
- The Nuremberg Code
- 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.
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
- Office of the Information and Privacy Commissioner of Ontario
- Fact sheet, Encrypting Personal Health Information on Mobile Devices, Information and Privacy Commissioner of Ontario
- Freedom of Information and Protection of Privacy Act
- 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:
- Ministère de la santé et des services sociaux du Québec
- Framework governing multicentre research in Québec
- 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.”
- 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.”
“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
“The Panel develops, interprets and implements the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).”
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
- U.S. Department of Health & Human Services (DHHS)
- U.S. Office of Human Research Protections (OHRP)
- U.S. Food and Drug Administration (FDA)
- FDA Regulations Relating to Good Clinical Practice (GCP) and Clinical Trials
- 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)
- The Impact of the New EU Device Regulations for Regulatory Affairs Professionals
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)
- The Declaration of Helsinki (updated Oct. 2008)
The Declaration of Ottawa on child health (adopted Oct. 1998, amended Oct. 2009)
World Health Organization (WHO)
OECD