Non-Research Activities (e.g., Quality Improvement, Program Evaluation)

  • Research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. “Disciplined inquiry” refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.

Overview

There are some activities that involve human participants that are not considered “Research” as defined by TCPS. It can be difficult to determine what is considered Research, and what is not considered Research. If there is any doubt, please contact HiREB for a determination prior to undertaking the work.

The Toronto Metropolitan University has a helpful guidance document on their website:
https://www.torontomu.ca/content/dam/research/documents/ethics/guiding-questions-to-determine-whether-your-research-requires-ethics-approval.pdf.  This can inform individuals as to the considerations between Research and not Research.

In general, quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute Research and do not require HiREB review.

If data are collected for a non-Research use and then reused for Research, REB review and approval is required for the Research use. Similarly, if a project contains both Research and non-Research activities, the Research activities require REB review and approval.

The REB cannot ‘retroactively’ approve a Research project.  It is important that you seek confirmation prior to beginning the work. However, if you have collected data for non-research activities and now intend to use that data for research, it may be possible to obtain REB approval at that point in time – after the data has been collected, but before you begin the research use e.g., analysis. 

Publication of non-research activities:
The choice of methodology and/or intent or ability to publish findings are not factors that determine whether an activity is Research requiring ethics review. However, the nature of the publication/dissemination of results and the information that it contains is critical to the assessment of whether a project is research or not research.

Example:

  • Future dissemination describes the process that was followed and a general description of the impact (not Research)
  • Future dissemination describes the way in which a project was designed and implemented (not research)
  • Future dissemination includes participant data, or analyses based on that data, in a research publication (Research)
  • Future dissemination intends to demonstrate effectiveness of a tool/pathway/educational module/etc. (Research)

For explicit clarity, a determination that a project is not research means that participant data, or analyses based on that data, cannot be used in a research publication.

Research includes activities that are conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.  The inclusion of participant data, or analyses based on participant data, suggests that the work has gone beyond the non-research scope and is now Research.

Research Involving Human Participants:
Most research involving human participants requires REB review.  For explicit clarity, we wish to remind researchers that this includes (but is not limited to):

There are some limited exceptions in the TCPS for Research activities that do not require REB review.  These can be nuanced, so we highly recommend that all researchers who think their Research may be exempt confirm with HiREB prior to proceeding.

Reminder to researchers receiving US federal funding: While the US Common Rule may exempt certain research activities from REB review, many (if not all) of these activities still require REB review in Canada. Please ensure you are following the Canadian requirements when assessing whether REB review is required for your project.  Please contact HiREB if in doubt.

Requesting Confirmation:

Researchers can email HiREB@hhsc.ca to request an assessment of their project.  If there is an existing project plan/protocol then please include this with the email as it will often contain the information needed.

Key details needed include:

  • The objective/aim of the project
  • Why is the project being done (e.g., requested by person or unit who is implementing or overseeing a program/product/service, being done for academic purposes, being done because research funding has been received)
  • How the data will be used (e.g., to determine the need for change in a local program/ service/ product, to contribute to a larger body of knowledge)
  • Who the data will be shared with (e.g., communicated back to the person or unit responsible for the program/product/service, shared more broadly to the academic or hospital community)

It is important to note that projects can have both Research and non-Research components.  If you think this may be the case, it is helpful if you can indicate what the primary and secondary purposes may be as this will help us provided more efficient guidance on how to proceed.

Frequently Asked Questions:

Q: I am doing a research project but the participants are not patients.  Do I need ethics approval?
A: Yes.  Participants are those individuals whose data, biological materials, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question(s).  It does not matter whether your participants are patients or not.

Q: I am doing a survey, not a clinical trial.  Do I need ethics approval?

A: If your survey is being done for research purposes then you need ethics approval. If you are not sure if your project is Research, please contact HiREB for an assessment.

Q: My research project involves collecting anonymous information from participants.  Do I need ethics approval?
A: Yes.  Collection of anonymous information for research purposes requires ethics approval – unless you are observing individuals in a public place in a way that does not require their active participation (example observing how many people obey traffic signals)

Q: I’m doing research but I don’t have any funding (it’s self-funded).  Do I need ethics approval?
A: Yes. The funding status does not impact whether or not you need ethics approval; ethics approval is required before the research begins.

Key Terms used on this page:

  • Participants are those individuals whose data, biological materials, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question(s).
  • Pilot studies are smaller versions of the main study (e.g., fewer participants, shorter duration). The purpose of pilot studies is to assess the feasibility and/or inform the design of a subsequent study intended to address a research question. They are not intended to produce definitive results with regard to the research question, but they can facilitate the successful conduct of the main study
  • Research is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. “Disciplined inquiry” refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.