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Is my Project considered health research?

Health research involves human subjects, their health information, and/or research involving their biological samples, such as blood or tissue.

It's the job of research ethics boards to also ensure that the research projects being considered comply with relevant regulations, guidelines, and ethical principles.

Alberta's research ethics boards have the responsibility of adhering to a piece of legislation called the Health Information Act of Alberta.

Because health research exposes people to risk, at least in part, for the benefit of others, it must show that it lives up to high ethical standards set out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) before it even gets off the ground.

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 research ethics board 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 run their project through 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 QI/program evaluation must have the clinical research portion reviewed by the relevant research ethics board. .

 

What if my project is not considered research? What are my ethical responsibilities?

For projects that are categorized as Quality Improvement (QI) or program evaluation, researchers / project leads can use the ARECCI Ethics Guidelines to help identify and integrate the appropriate ethics consideration into the project.

Consultation with expertise in project ethics is recommended and should be done prior to involving participants as ethics approval cannot be granted for research already undertaken. This expertise may include:

  • An advisor from the relevant REB to confirm if the project falls outside the REB's mandate or should be submitted for REB review, or
  • QI and evaluation consultants with projects ethics review training to confirm if the project requires that type of review. 
  •  See A pRoject Ethics Community Consensus Initiative (ARECCI) for more information.