Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB
Research involving humans can greatly benefit human society, but it must be done in a way that protects and respects the research participants. The Health Canada and Public Health Agency of Canada (PHAC) Research Ethics Board (REB) was created to provide this oversight. It reviews all research from Health Canada and PHAC that involves humans (including living individuals, human biological materials and information from or about humans) to ensure that it meets the highest ethical standards, and that the greatest protection is provided to research participants. Specifically, the Health Canada-PHAC REB reviews all research involving humans that is:
- Carried out by Health Canada or PHAC (intramural);
- Performed by Health Canada or PHAC in collaboration with external researchers;
- Carried out on Health Canada or PHAC premises; or
- Conducted under contract to Health Canada or PHAC.
The REB may also review research that is funded by Health Canada or PHAC through grants and contributions to external researchers who do not have access to another research ethics board.
The Health Canada-PHAC REB does not review research that is not carried out by, funded by, or otherwise undertaken in association with Health Canada or PHAC. Research projects not associated with Health Canada or PHAC should be referred to the REB at the lead investigator's institution and/or the REB at the institution(s) where the research is being conducted.
In addition, the Health Canada-PHAC REB does not oversee or regulate other REBs in Canada. Like other Canadian REBs, the Health Canada-PHAC REB is guided by the principles of the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). TCPS 2 is the official human research ethics policy of the three federal research funding agencies (the Canadian Institutes of Health Research, the Natural Sciences and Engineering Council of Canada, and the Social Sciences and Humanities Research Council of Canada). The Agencies have mandated the Secretariat on Responsible Conduct of Research (SRCR) and the Panel on Research Ethics (PRE) with the evolution, education and interpretation of the policy. Questions about the interpretation of TCPS 2 should be directed to the SRCR at firstname.lastname@example.org.
Human clinical trials are also subject to Health Canada regulatory requirements. For further information regarding these regulatory requirements, researchers may contact the relevant Health Canada clinical trials office as appropriate.
On this page
- Applying for ethics review
- Maintaining ethics approval
- Closing a study
- Annual reports of REB activities
- Contact us
Applying for ethics review
Researchers must obtain ethics approval in writing from the Health Canada-PHAC REB before the research begins. Research approved by another Canadian REB must also be reviewed by the Health Canada-PHAC REB if it involves researchers from Health Canada or PHAC or if it meets any of the other criteria described above.
Full details on the application process can be found in the Apply for ethics review section of the website. Key elements of the application process include:
- Pre-submission consultation with the Health Canada-PHAC Privacy Management Division for a privacy risk assessment
- PHAC departmental approval (for PHAC researchers only)
- Independent scientific peer reviews of the research protocol
- The application form and all required supporting documents (as described in the application form instructions)
The application deadline for initial REB ethics review is 3 weeks before each monthly REB meeting. If an application is deemed to represent minimal risk to participants, it may be sent at the discretion of the REB chair to delegated review (consisting of the Chair or Deputy Chair and one other REB member) rather than full REB review. Note that the application requirements and review process are the same, regardless of the level of risk. However, because delegated review meetings are held more frequently, minimal risk applications are accepted at any time and may be reviewed more quickly.
Applicants are encouraged to contact the REB Secretariat before submitting their proposal to determine the level of risk associated with the study. The REB Secretariat can also provide advice on whether a study meets the definition of research involving humans and therefore requires REB review.
Maintaining ethics approval
All research approved by the Health Canada-PHAC REB is subject to continuing ethics review by the REB throughout the life of the project. To maintain a valid ethics certificate, applicants are required to submit annual progress reports to the REB, seek approval for amendments to the research protocol, and report any unanticipated issues or events.
Submissions for continuing ethics review are accepted at any time and are normally reviewed within one to two weeks at a delegated review meeting. Information and forms for continuing ethics review are available on the Research Ethics Board: Continuing ethics review forms web page.
Closing a study
Researchers must notify the REB upon completion or termination of their project by submitting a Completion/termination report form (PDF format, 8 pages). Submissions are accepted at any time and are normally reviewed within one to two weeks.
Annual reports of REB activities
The REB Secretariat produces an annual report for the Deputy Minister of Health and the President of PHAC, summarizing the activities of the Board and the Secretariat during the fiscal year. The reports include details on the number and profile of submissions, outcome of REB reviews, and approval times.
Health Canada-PHAC Research Ethics Board Secretariat
70 Colombine Driveway, Room 941C, PL: 0909C
Brooke Claxton Building, Tunney's Pasture
Ottawa, ON K1A 0K9
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