Research Ethics Board: Policies, guidelines and resources
The Health Canada-PHAC REB reviews applications in accordance with the considerations set out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) as the minimum standard. TCPS 2 is the foundation for the REB’s operational and guidance documents (which include the Operational Policy Framework, evaluation criteria and requirements for informed consent). The REB also takes into account to relevant federal laws and regulations, such as the Privacy Act and clinical trial regulations, where applicable.
On this page
- TCPS 2 and related ethics resources
- REB evaluation criteria
- Clinical trial regulations
- REB Operational Policy Framework
TCPS 2 and related ethics resources
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) 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). Recognizing that TCPS is the prevailing Canadian standard for ethical research, Health Canada and PHAC have adopted TCPS to guide the ethical aspects of the design, review and conduct of research involving humans. Related links:
The Declaration of Helsinki is an official policy document of the World Medical Association, the global representative body for physicians, developed as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
The Belmont Report was the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It identifies three basic principles underlying the ethics of human research: respect for persons, beneficence and justice.
The Canadian Association of Research Ethics Boards (CAREB) is a grassroots national membership organization intended to represent the interests of all Canadian REBs and to reflect REB perspectives and concerns.
REB evaluation criteria
Research involving humans can be ethically justified only when:
- The research is scientifically sound;
- The potential benefit significantly outweighs the potential for harm;
- There is an adequate process for informed consent, and assent where applicable; and
- There is justice or fairness in selection of participants.
Thus, when assessing whether a proposal meets the ethical requirements for research involving humans, the REB focuses on the following five elements:
- Selection and recruitment
- Informed consent process
- Potential harms and benefits
- Privacy and confidentiality
Applicants should ensure that their research protocols provide sufficient detail so that the REB can appropriately assess the proposal against these criteria. The research protocol instructions on the REB website provide additional information relevant to each of these elements. Applicants are advised to follow these instructions closely when drafting their protocols.
Clinical trial regulations
Health Canada regulates the sale and importation of certain drugs, medical devices and natural health products that will be used in human clinical trials. This includes health products not authorized/licenced in Canada, as well as Canadian market authorized drugs and licensed medical devices and natural health products that are being investigated for potential use outside their approved indication. Health Canada requires that the drug sponsor (individual, corporate body, institution or organization) and medical device manufacturer/importer undertaking the clinical study obtain institutional Research Ethics Board approval prior to opening the clinical trial in Canada, in accordance with Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Product Regulations or Part 3 of the Medical Devices Regulations.
The Health Canada-PHAC REB only reviews clinical trials being undertaken and conducted by investigators from Health Canada or PHAC. The REB does not provide advice to external researchers.
For further information regarding the regulatory requirements, investigators may contact:
- For pharmaceutical drugs: Office of Clinical Trials, Therapeutic Products Directorate. Email: email@example.com
- For biologics and radiopharmaceuticals: Office of Regulatory Affairs, Biologic and Radiopharmaceutical Drugs Directorate. Email: firstname.lastname@example.org
- For medical devices: Bureau of Investigational Testing Authorization, Special Access Program and Post-Market Surveillance, Medical Devices Directorate. Email: email@example.com
- For natural health products: Natural and Non-prescription Health Products Directorate. Email: firstname.lastname@example.org
For more information, please see:
- Clinical trials and drug safety
- Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications
- Clinical Trials For Natural Health Products
- Applications for Medical Device Investigational Testing Authorizations Guidance Document
- Guidance document for Preparation of an Application for Investigational Testing - In Vitro Diagnostic Devices
- ICH Guidelines
- ICH Guidance E6(R2): Good Clinical Practice
REB Operational Policy Framework
The REB Operational Policy Framework provides information about the REB’s authorities, mandate and scope, committee structure and review process.
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