What is Research?
Research is defined in TCPS2 as “An undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation.”
“Human 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).
Research Requiring Review
In accordance with TCPS2, research requiring review includes all types of research conducted with human participants. Specifically, prior ethics review and approval is required for research involving:
- living human participants;
- human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.
For clarity, ethics review is required for the following categories of research that may be overlooked or raise questions about the necessity for such a review:
- Pilot projects and feasibility projects, even those involving only one human participant, require the same scrutiny as full-scale research projects involving many participants.
- Projects that involve the secondary use of data on human participants gathered in earlier projects.
Special Note Regarding International Research
For research projects being conducted with human participants outside of Canada, TCPS2 Article 8.3 requires local ethics board approval and approval by an ethics board, where such exists, in the country where the research will be conducted. Extra time should be factored in for obtaining ethics approval from international ethics bodies, often known as Institutional Review Boards (IRBs) or Research Ethics Committees (RECs).
Guidelines for Distinguishing between Research, Quality Assurance, and Quality Improvement
For some projects, it may be difficult to distinguish between what is research and what is Quality Assurance (QA) or Quality Improvement (QI). In accordance with TCPS2, QA and QI projects are exempt from Research Ethics Board (REB) review.
TCPS2, Article 2.5: ”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 for the purposes of this Policy, and do not fall within the scope of REB review.”
Because of this, it is important to distinguish the differences between research, QA and QI prior to initiating a project. An incorrect determination, whether intentional or otherwise, may result in ethical and/or privacy violations. In addition, REBs and privacy committees cannot issue retroactive approvals.
TCPS2, Article 2.1 Application: ”For the purposes of this Policy, ‘research’ is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.”
As mentioned above, some projects are not easily characterized, nor is there any simple rule or single characteristic that differentiates QI, QA and research. QA or QI activities that contain additional research components may need ethics review. If a researcher knows at the outset that a project will serve two purposes – it is intended both as QI/QA and research – then the project must undergo research ethics review before it commences. If information collected for QI or QA is later used for research purposes, the research falls within the scope of TCPS2 as secondary use of data, and at that time the project would normally require REB review.
TCPS2 Article 2.5: ”If data are collected for the purposes of such activities but later proposed for research purposes, it would be considered secondary use of information not originally intended for research, and at that time may require REB review in accordance with this Policy.”
The table below lists common descriptions and characteristics associated with research and QA/QI projects. Please use the description in the table to help with your determination. If your project falls mostly/entirely in the research column it likely requires ethics review.
| Project Design Element | Human Participants Research Project | Quality Improvement/Quality Assurance Project |
|---|---|---|
| Purpose | Gather facts to test a hypothesis and develop or contribute to generalizable knowledge. | Improve and understand specific, local processes or practices commonly related to cost, productivity, operations, quality, or patient experience. |
| Starting point | Answer a question or test a hypothesis that can be applied to a more general population. | Improve performance in a specific unit or population (patient or provider) in an organization. |
| Design | Systematic design with strict adherence to a protocol that does not change throughout the process. May involve randomization. | Iterative and adaptive design that may or may not be systematic. Usually does not involve randomization. |
| Beneficiaries | Clinician, researcher, scientific community, and occasionally the participant benefit. Results do not directly benefit institutional practice or programs. | Patients, staff, providers, and institution benefit. |
| Mandate | Institutions do not mandate research activities or programs. | Activities are usually mandated by institutions or clinics as part of clinical operations. |
| Impact | Designed to contribute to generalizable knowledge and may or may not benefit participants. | Findings are expected to directly impact institutional processes or practices. |
| Measures | Measurement instruments must have estimates of reliability, validity, specificity, and sensitivity. Instruments are often complex and have a significant time burden. Protocols are followed closely, and confounding variables are measured or controlled for. Projects may occur over long periods of time (years). | Measurement instruments are generally limited, simple, easy to administer, and not overburdensome to the provision of care. Iterative, rapid cycles are followed, and confounding variables are acknowledged but not measured. Timeline is commonly weeks to months. |
| Adoption of results | Little urgency to disseminate results quickly. | Results rapidly adopted into local care delivery. |
| Participants | Subset of a population without an obligation to participate. Participants must meet strict inclusion and exclusion criteria. Researcher will calculate a sample size to determine how many participants are needed. | Most or all of the population involved in the process or practice. The responsibility to participate is a component of care, and the expectation is that most individuals participate. |
| Benefits | Participants may or may not benefit directly. | Direct benefit to system, program, or process is expected although participants may not receive direct benefit. |
| Risk | Participants may be placed at risk, and risks are stated in the informed consent document. | By design, does not increase patients’ risk, with the exception of possible privacy/confidentiality concerns. Consent is implied as part of care. |
| Analysis | An a priori hypothesis is developed by the researcher to be statistically proved or disproved. | A program, process, or system is compared to an established set of standards, outcomes, or targets. |
The table above is based on information adapted from “How to Determine if a Project Is Human Subjects Research, a Quality Improvement Project, or Both” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122260/)
When is Research Not Subject to Ethics Review?
Prior ethics review and approval will not normally be required for a limited type of research most often found within the humanities, fine arts, and in some historical research which involves:
(a) a public database where aggregated data that cannot be associated with any individual are obtained; and/or
(b) information already in the public domain (for example, autobiographies, biographies or public archives). Nevertheless, it is the responsibility of the researcher to ascertain that any information used from these sources is presented in an accurate fashion.
(c) Class research projects which involve human participants and which are conducted by students on other members of the class as exercises to learn how to conduct research.
Consultations
After reviewing these guidelines, if you are still unsure whether your activities require ethics review, you may seek the written opinion of a CHIPER Chair by sending a RITHIM Consultation within the Harmony system. The RITHIM Consultation can be accessed by selecting:
and then answering the Routing questions in the Get Started Form. Depending on the nature of the project, CHIPER will either request the completion of an application or provide a determination that the project is exempt from CHIPER consideration. Please note that CHIPER is the final authority as to whether or not a project requires ethics review and approval.
TCPS2 – Article 2.1: “When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the opinion of the REB. The REB makes the final decision on exemption from research ethics review.”