There are activities which may employ “methods and techniques similar to those employed in research”, but that are not considered “research” as defined in the TCPS2 and therefore do not require REB review.
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. [TCPS2(2018) Article 2 [2.5]]
The Application to the above Article goes on to discuss the following as Quality Assurance (QA):
- Performance of an organization or its employees or students
- Activities which must be assessed within the mandate of the organization
- Activities administered in the ordinary course of the operation of the organization
- Participation is required as a condition of employment (e.g. performance reviews)
- Evaluation in the course of academic or professional training
- Student course evaluations
- Data collection for internal or external organizational reports.
Research or Quality Improvement (QA)?
Research: An undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation (See TCPS2(2018) Article 2 [2.1]).
Quality Assurance: Assessments of the performance of an organization or of its employees or students
- Within the mandate (in the ordinary course of operations) of the organization
- Carried out according to the terms and conditions of employment or training
[from PRE Webinar on Scope, December 1, 2011]
Considerations in Determining whether your project is QA or research
It is sometime difficult to discern whether a project falls into the category of research, needing REB review, or QA, which is exempt. To discern which category your project is in, you may consider using the ARECCI Ethics Screening Tool. Note that the ARECCI initiative has informed much of the thinking on QI and research ethics review and is best suited to health research.
What is your intention? To create a ‘Best Practices’ document (QA) or to make a generalizable statement (research)?
It is not the activity but the purpose which may be a deciding factor.
- the purpose is to contribute to a body of knowledge. The results are likely published in a scholarly journal
- generalizable statements result
- benefits a broader community
- The purpose is often to develop better practices
- Site specific rather than generalizable
- Often benefit only the immediate participants
- There may be ethical issues associated with both research and QI
- The language of QA may reflect the site-specific nature of the project.
What may not help you decide between QA and research?
- Dissemination – research will likely be published in peer reviewed journals, but QA can also be published.
- Risk – there can be risks associated with both QA and research
- Ethical issues – both types of activities can raise serious ethical issues.
Program Evaluation and Evaluation Research
Although some Program Evaluation (PE) will fall into the same category as QA, there is a large body of evaluation research which constitutes research and requires ethics approval. Consider the following definitions of program evaluation:
“The use of social research methods to systematically investigate the effectiveness of social intervention programs in ways that are adapted to their political and organizational environments and are designed to inform social action in ways that improve social conditions.” Rossi, P.H., Lipsey, M.W., & Freeman, H.E. (2004). Evaluation: A systematic approach (7th ed.). Sage Publications: Thousand Oaks, CA., p. 431.
“Systematic collection, analysis, and reporting of descriptive and judgmental information about the merit and worth of a program’s goals, design, process, and outcomes to address improvement, accountability, and dissemination questions and increase understanding of the involved phenomena.” Stufflebeam, D.L., & Shinkfield, A.J. (2007). Evaluation theory, models, and applications. Jossey-Bass: San Francisco, CA., p. 710.
“Evaluation can be viewed as a structured process that creates and synthesizes information intended to reduce the level of uncertainty for stakeholders about a given program or policy.” McDavid, J.C., & Hawthorn, L.R.L. (2006). Program evaluation & performance measurement: An introduction to practice. Sage Publications: Thousand Oaks, CA., p. 3.
In deciding whether or not a PE project should be reviewed by the REB, the “Considerations in Determining whether your project is QA or research” should be consulted. In addition, if the PE project is conducted as part of a faculty member’s program of research or as part of a student’s program of studies, then it should be submitted for REB review.. Decisions regarding the necessity of REB review will be made on a case by case basis by the Manager, Research Ethics in consultation with members of the REB with experience in this type of research.
What if QA becomes research?
The TCPS2 states that “[i]f data are collected for the purposes of [QA] 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.”