Ethics Resources

This section includes a limited annotated 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 where possible. Although not addressed here, researchers should also be aware of Codes of Ethics specific to their field of research or profession.
  • CIHR Best Practices for Protecting Privacy in Health Research, 2005: These Privacy Best Practices are intended to provide guidance for the health research community in Canada on the application of fair information principles to research involving personal information, and to assist in the interpretation of the Tri-Council Policy Statement: Ethical Conduct for Research involving Humans (TCPS) by offering additional detail and practicality.
  • CIHR Open Access Policy: This document outlines the Canadian Institutes of Health Research Policy on access to research outputs and data and aims to increase diffusion and availability of research results.
  • CIHR Updated Guidelines for Human Pluripotent Stem Cell Research: This document, updated in 2010, outlines the CIHR guidelines for the use of pluripotent stem cells in research. It presents the guiding principles for such research, oversight for this research including the role of the Stem Cell Oversight Committee (SCOC), and specific research ethics issues that must be considered and addressed in planning and conducting research in this area.
  • Guidance for Industry: Health Canada Addendum to ICH Guidance Document E11: Clinical Investigation of Medicinal Products in the Pediatric Population: In recognition that the ICHFootnote 1 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 REB: 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.
  • 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 Protection: This 2011 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.
  • 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.
  • 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 Ethics at the CDC: The Centers for Disease Control and Prevention (CDC) provides an overview of public health ethics issues and links to relevant resources on their website.
  • 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.
  • 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 Framework: Responsible Conduct of Research: This 2011 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 Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2): 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). TCPS2 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.
  • Uniform Requirements for Manuscripts Submitted to Biomedical Journals: This website of the International Committee of Medical Journal Editors provides advice about various ethical issues associated with the conduct and reporting of research including conflicts of interest, and peer review.
  • U.S. Office for Human Research Protections (OHRP): This office provides ethical guidance (including links to regulations and policies) for research with human subjects conducted in the United States.

Footnotes

Footnote 1

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

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