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What is a research ethics board (REB)? | What is health research? | What if my project is not considered health research? What are my ethical responsibilities? |
What are the ethical requirements of my study? What types of studies require a research ethics board review and approval? | Which Research Ethics Board should I apply to?
An independent body (not affiliated with the sponsor) that ensures research involving human participants is ethical and that the safety, well-being, and rights of the participants are protected (definition adapted from ACRC Glossary of Common Terminology and MyHealth Alberta).
Health research involves human subjects, their health information, and/or research involving their biological samples, such as blood or tissue.
According to the TCPS2, quality assurance, program improvement initiatives, or any other systematic investigation meant to inform change in only local practice or policy is not considered research and is not subject to REB review. That, however, doesn't mean these types of projects are without ethical risk.
If you are unsure whether your project is considered research it is recommended that researchers/project leads consult with their designated Research Ethics Board or complete the ARECCI Ethics Screening Tool that will help to assess whether a project is research or non-research. Of note, studies which involve both clinical research and Quality Improvement (QI) or program evaluation must have the clinical research portion reviewed by the relevant REB.
For projects that are confirmed to be QI or program evaluation, researchers/project leads can use the ARECCI Ethics Guideline Tool to help identify and integrate the appropriate ethics consideration into the project and/or consult with expertise in project ethics prior to involving participants as ethics approval cannot be granted for research already undertaken. This expertise may include:
The type of research project proposed will determine the ethical requirements of the study. Not all studies involving humans require ethical review, although many clinical health research studies do require ethical review.
The Minister of Health designates which REB have authority under the Health Information Act of Alberta (HIA Designation Regulation 69/2001). There are three REB in the province that are able to review studies that involve human subjects or the use of their health information and/or samples. Each of these boards has specific requirements for submission of an application for ethics approval and each provide guidance and templates to aid in your submission process.
If a study is AHS-led, this should be noted in the ethics application to ensure applicability of appropriate institutional policies. Ethics for AHS-led studies should be submitted as follow:
For a detailed list of eligibility requirements associated with each REB, view the Where to Apply document.