Ethics resources

The understanding of ethical issues and application of ethical principles in health research can be complex endeavours. Various materials are available to help in navigating subtle and complex issues. This section provides select relevant Canadian and international ethics oversight policies and guidance documents.

• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2022)

  The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) is a joint policy of Canada's three federal research agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), or "the Agencies." The TCPS expresses the Agencies' continuing commitment to the people of Canada to promote the ethical conduct of research involving humans. Guided by its core principles of Respect for Persons, Concern for Welfare and Justice, the TCPS sets out guidance for institutions, researchers and research ethics boards in the ethical conduct and review of research involving humans.

• Tri-Agency Framework: Responsible Conduct of Research (2021)

  The Tri-Agency Framework: Responsible Conduct of Research (RCR Framework) is a joint framework of Canada's three federal research agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). The RCR Framework sets out the responsibilities and corresponding policies for researchers, Institutions, and the tri-agencies, that together help support and promote a positive research environment.

• TCPS 2: CORE-2022

  The online tutorial CORE-2022 (Course on Research Ethics) is an introduction to the TCPS 2 for the research community. It focuses on the TCPS 2 ethics guidance that is applicable to all research involving human participants, regardless of discipline or methodology.

• Standards and Guidelines of the Canadian Council of Animal Care

  The Canadian Council on Animal Care (CCAC) works to ensure that animal-based science in Canada takes place only when necessary and that the animals in the studies receive optimal care according to high quality, research-informed standards.

  Acting in the interest of the people of Canada, the CCAC advances animal ethics and care in science by:

  • developing science-informed standards that incorporate expert opinion, the values of Canadians, and strategies to reduce the need for, and harm of, animals in science, while promoting their wellbeing;
  • encouraging the implementation of the highest standards of ethics and care for animals in science in collaboration with the animal care community and scientists across Canada;
  • providing assessment and certification programs that empower scientific institutions in achieving high standards of animal ethics and care; and
  • providing education, training, and networking opportunities to support individuals, animal care committees, and institutions in implementing our guidelines and sharing best practices in the oversight of animal ethics and care in science.

International Research Ethics Oversight Policies and Guidelines

• E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (2018)

  U.S. Department of Health and Human Services Food and Drug Administration, in 2018, published the Good Clinical Practice (GCP) guidance. It is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

• International Ethical Guidelines for Health-related Research Involving Humans (2016)

  The Council for International Organisations of Medical Sciences' (CIOMS) International Ethical Guidelines for Health-related Research Involving Humans, is a foundational set of guidelines for a broad range aspects of human health research such as social value, equity, care, collaborative partnerships, community engagement and inclusion in health research. It was first published in 1993 and last revised in 2016.

• Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2013)

  The World Medical Association's Declaration of Helsinki first published in 1964 and last amended in 2013 provides ethical principles for medical research involving human subjects and identifiable human material and data.

• The Belmont Report (1979)

  Hinging on three basic ethical principles of respect for persons, beneficence, and justice, the Belmont Report provides requirement that should guide the conduct of biomedical and behavioural research involving human participants. It was published by the US Department of Health, Education, and Welfare in 1979.

• The Nuremberg Code – Directives for Human Experimentation (1947)

  The modern primary source for the oversight of human experimentation published in 1947, the Nuremberg Code is a ten-point statement on that delimits permissible medical experimentation on human subjects, as summed up in these terms: "humane experimentation is justified only if its results benefit society and it is carried out in accord with basic principles that 'satisfy moral, ethical, and legal concepts.'"

Canadian Acts and Rules Governing Research

A partial list of important Canadian federal and provincial acts directly and indirectly related to technologies and health.

• Human Pathogens and Toxins Act (S.C. 2009, c. 24)
  An Act to promote safety and security with respect to human pathogens and toxins

• Canada Border Services Agency Act (S.C. 2005, c. 38)
  An Act to establish the Canada Border Services Agency

• Assisted Human Reproduction Act (S.C. 2004, c. 2)
  An Act respecting assisted human reproduction and related research

• Canadian Environmental Protection Act (S.C. 1999, c. 33)
  An Act respecting pollution prevention and the protection of the environment and human health in order to contribute to sustainable development

• Controlled Drugs and Substances Act (S.C. 1996, c. 19)
  An Act respecting the control of certain drugs, their precursors and other substances and to amend certain other Acts and repeal the Narcotic Control Act in consequence thereof

• Chemical Weapons Convention Implementation Act (S.C. 1995, c. 25)
  An Act to implement the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction

• Criminal Code (R.S.C., 1985, c. C-46)
  An Act respecting the Criminal Law

• Customs Act (R.S.C., 1985, c. 1 (2nd))
  An Act respecting Customs

• Fertilizers Act (R.S.C., 1985, c. F-10)
  An Act respecting fertilizers and supplements

• Fisheries Act (R.S.C., 1985, c. F-14)
  An Act respecting fisheries

• Food and Drugs Act (R.S.C., 1985, c. F-27)
  An Act respecting food, drugs, cosmetics and therapeutic devices

• Patent Act (R.S.C., 1985, c. P-4)
  An Act respecting patents of invention

Date modified:

2023-10-27