Ethics Resources
This section includes a limited bibliography of relevant ethics guidelines, policies, regulatory documents, and websites that users may find helpful. Items are presented in alphabetical order and include a brief description as well as a link to the resource . Although not addressed here, researchers should also be aware of Codes of Ethics specific to their field of research or profession.
Guidance for Industry: Health Canada Addendum to International Conference on Harmonisation Guidance Document E11: Clinical Investigation of Medicinal Products in the Pediatric Population: In recognition that the ICH guidance documents are not intended to be fully comprehensive, Health Canada developed an addendum to the ICH guidelines for research in pediatric populations. This document clarifies the Canadian regulatory considerations for clinical trials in the pediatric population, as well as providing further guidance on the ethical issues that may be encountered in such research.
- Health Canada/Public Health Agency of Canada Research Ethics Board (REB): This REB reviews all research involving human participants that is:
- Carried out by Health Canada or the Agency (intra-mural);
- Performed by Health Canada or the Agency in collaboration with external researchers;
- Carried out on Health Canada or the Agency premises;
- Conducted under contract to Health Canada or the Agency; and/or
- Funded by Health Canada or the Agency through grants and contributions to external researchers.
Researchers seeking to apply to this board for ethics review should familiarise themselves with the guidance documents available on their website. The website also provides links to important Canadian and international ethics resources.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline: Clinical Trials E7-E11: The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (known as ICH) provides guidance on the design, conduct, safety, and reporting of clinical trials. Their recommendations provide specific guidance on vulnerable populations in clinical trial research, such as the pediatric and geriatric populations.
International Compilation of Human Research Standards: This 2017 document provides a recent and comprehensive list of international human research protections. It was compiled by the U.S. Department of Health and Human Services, Office for Human Research Protections. The document is updated frequently;— the link below corresponds to the 2017 edition.
International Ethical Guidelines for Biomedical Research Involving Human Subjects: These 2002 guidelines were created by the Council for International Organizations of Medical Sciences (CIOMS), which is an international organization established by WHO and UNESCO. The document discusses a wide range of research ethics issues including research with vulnerable people and the harms and benefits of participating in research.
Laboratory Biosafety and Biosecurity: Principles of Laboratory Biosafety e-Learning Course: This modular course has been developed by the Public Health Agency of Canada and the Canadian Food Inspection Agency to help strengthen biosafety and biosecurity principles.
Nuremberg Code: This code provides directives for human experimentation.
Ownership, Control, Access, and Possession (OCAP) or Self-Determination Applied to Research: A Critical Analysis of Contemporary First Nations Research and Some Options for First Nations Communities: This paper was first prepared for the First Nations Information Governance Committee (2004).
Public Health Agency of Canada (PHAC): Core Competencies for Public Health in Canada: Core competencies are the essential knowledge, skills and attitudes necessary for the practice of public health. They transcend the boundaries of specific disciplines and are independent of program and topic. They provide the building blocks for effective public health practice, and the use of an overall public health approach. Generic core competencies provide a baseline for what is required to fulfill public health system core functions. These include population health assessment, surveillance, disease and injury prevention, health promotion and health protection
Science and Technology for Canadians. Access to Research Results: Guiding Principles: On this website the Government of Canada presents principles intended to make “research results as widely available and accessible as possible” including advancing knowledge, minimizing duplication, maximizing research benefits, and promoting accomplishments.
The Belmont Report: The Belmont Report is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.
Three R’s Alternatives of Animal Research: The Canadian Council on Animal Care (CCAC) provides ethical guidance for research involving animal subjects including an explanation of how to employ the guiding principles of Replacement, Reduction, and Refinement
Tri-Agency Statement of Principles on Digital Data Management: In 2016, the Tri-Agencies adopted a Statement of Principles on Digital Data Management as an important step towards strengthening research data management in Canada. The Statement outlines the agencies' overarching expectations for research data management and the roles of researchers, research institutions, research communities, and research funders in supporting data management.
Tri-Agency Framework: Responsible Conduct of Research: This 2016 document, created by Canada’s three federal research agencies - the Natural Sciences and Engineering Research Council of Canada (NSERC), the Canadian Institutes of Health Research (CIHR), and the Social Sciences and Humanities Research Council of Canada (SSHRC), outlines the various responsibilities of those involved in the research endeavour and ways to foster a “positive research environment.”
Tri-Agency Open Access Policy on Publications: This document outlines the policy on access to research outputs and data and aims to increase diffusion and availability of research results.
Tri Council Policy Statement: Ethical Conduct for Research Involving Humans 2nd Edition (TCPS 2): This document is the joint research policy created by Canada’s three federal research agencies - the Natural Sciences and Engineering Research Council of Canada (NSERC), the Canadian Institutes of Health Research (CIHR), and the Social Sciences and Humanities Research Council of Canada (SSHRC). TCPS 2 promotes the ethical conduct of research involving humans, and is used throughout Canada as a guide for University Research Ethics Boards and other institutions that receive funding from one of the three federal granting agencies.
Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (ICMJE Recommendations): This website of the International Committee of Medical Journal Editors (ICMJE) provides advice about various ethical issues associated with the conduct and reporting of research including conflicts of interest, and peer review.
World Medical Association Declaration Of Helsinki – Ethical Principles For Medical Research Involving Human Subjects: The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.
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