Quality Assurance Activities and Case Studies
The Distinction between Quality Assurance and Research
The REB overseas all human research conducted at or through the hospital. In defining its scope, the REB adheres to Tri-Council definition of research as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation. This is distinct from quality assurance activities that are intended to assess the performance of an organization or its staff, within the mandate of the organization. Recognizing that there can be overlap between these two concepts, the REB should be consulted to determine whether or not a specific activity constitutes research.
The Interagency Advisory Panel on Research Ethics PRE has provided guidance on the distinction between quality assurance and research. The Panel states that quality assurance studies may share characteristics with research and in fact, may use scientific methods. In quality assurance, however, the data are used to advance the needs and functioning of the organization. By contrast, in research, data are used to answer a scientific question. The primary distinction between research and quality assurance is therefore, in their respective objectives, rather than the methods used.
The REB recommends using the ARECCI Ethics Screening Tool to assist in determining whether or not your project is human research requiring review and approval by REB.Case StudiesThe REB does not review case studies. This is because case studies are generally not considered research & as such, do not fall under the jurisdiction of the Board. That being said, informed consent for this type of publication is generally required. The CMAJ has implemented such a requirement ('Written consent from patients for publication of their story is a necessity and should accompany submissions'). Clinical Case SeriesClinical case series may fall under the jurisdiction of the Board. The Chair should be consulted on these projects.