Is your proposed activity research, quality assurance (QA), or quality improvement (QI)? All three are systematic investigations that involve data, use scientific methods, and can be broadly considered science.
The Tri-Council Policy Statement 2 (TCPS2) governing research ethics in Canada suggests that while research must undergo ethical review, program evaluation and qualitative improvements studies do not fall under the auspices of the TCPS2 or institutional Research Ethics Boards (REBs).
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, program evaluation and quality improvement. An incorrect determination, whether intentional or otherwise, may result in a violation of the UAPPOL Research and Scholarship Integrity Policy and where applicable, the Health Information Act of Alberta. It is equally important to understand the distinction prior to initiating the project. The REB cannot issue retroactive ethics approval.
Some projects are not easily characterized, nor is there any simple rule or single characteristic that differentiates QI, QA and research. The Research Ethics Office views these as existing on a continuum. Quality improvement and program evaluation activities that contain additional research components may need ethics review. Intent to publish results does not distinguish an activity as research; findings of QI and QA are often published.
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.”
If a researcher knows at the outset that a study will serve two purposes – it is intended both as QI/QA and research – then the study 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 study 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.”
It is when inquiry is primarily intended for QA/QI, but results and/or process will be disseminated beyond the institution, that it is most difficult to distinguish research from QA/QI. It is the responsibility of the individual engaging in data gathering to use good judgment with regard to the requirement for REB review. This document is intended to help researchers with that decision-making. Think through the questions within the document with respect to the project, to see if the proposed inquiry falls mostly/entirely in the QA or QI columns, or mostly/entirely in the research column. If the latter, it probably requires REB review.
Projects deemed to be quality improvement or program evaluation and therefore outside of REB mandate, should still be conducted with respect for human dignity adhering to ethical standards as well as any professional or practice standards of conduct.
After reviewing the Guidelines document, if you are still unsure whether your activities require ethics review, please contact Charmaine Kabatoff, REB Consultant 492-0302 or email@example.com. Depending on the nature of the study, the REB will either request the completion of an ethics application or provide a determination that the study is exempt from REB consideration. If you require a written determination, please include the following in your email request; a brief summation of the project, indicating where the findings will be disseminated, a copy of the full proposal (if available), and copies of any data collection instruments (if available).
Please note that the REB is the final authority as to whether or not a project requires ethics review and approval. “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.” (TCPS2 – Article 2.1).