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Past Interpretations of the TCPS

Subject Definition of Quality Assurance Studies, Performance Review and Research
Keywords quality assurance, performance review, assessment, evaluation, research
TCPS Articles 1.1
Date April 2003

PDF Definition of Quality Assurance Studies Performance Review and Research April 2003.pdf

1. This is in response to your questions regarding the definition of quality assurance studies and performance review to determine the ethics review requirements for a proposed study. You also seek requested examples and details on quality assurance studies and performance reviews. Your questions have been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice1.

Ethics Review and Exceptions

2. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of 1998 (with 2000, 2002 amendments) generally provides that all "research involving living human subjects" must undergo prospective research ethics review (TCPS, article. 1.1[a]). The TCPS exempts from such review "quality assurance studies, performance reviews or testing within normal educational requirements." (TCPS, article 1.1[d]). As your inquiry reveals, the general rule and its exceptions raise questions about the definition of "research, " "quality assurance" and "performance review."

Definitions

3. The TCPS provides some definitions, but is silent on others. It defines "research" as "a systematic investigation to establish facts, principles or generalizable knowledge" (TCPS, page 1.1). However, the TCPS offers no explicit definition of quality assurance. Neither do national research ethics documents in many other countries. A recent report from Australia notes that "no national or international body appears to have established and promulgated separate guidelines to assist individual institutions in determining whether a proposed course of investigation is to be treated as quality assurance or research."2 This silence may be partly explained by the overlap between the concepts of "research" and "quality assurance" (QA). To distinguish between the two, some analysts differentiate the primary purposes of the inquiry, while others differentiate the functions of QA from those of research.3 Such distinctions may prove helpful in case-by-case analysis. The literature also provides what might be considered a working definition of quality assurance: the systematic monitoring and evaluation of the various aspects of a project, service or facility to ensure that standards of quality are being met.4

4. In terms of performance evaluations, the commentary of TCPS article 1.1 helps define the concept:

Studies related directly to assessing the performance of an organization or its employees or students, within the mandate of the organization or according to the terms and conditions of employment or training, should also not be subject to REB review. However, performance reviews or studies that contain an element of research in addition to assessment may need ethics review. [emphasis added for this interpretation]

5. PRE understands TCPS article 1.1(d) to cover, in a very narrow manner, evaluations regarding performance of professors, testing of students, or assessment of quality of curriculum or program. These normal requirements within academic institutions do not require Research Ethics Board (REB) review. Institutions may, however, determine that such administrative assessments and evaluations need to be reviewed by another entity within the institution.

6. Although quality assurance studies, performance review and testing within the normal educational requirements of institutions or organizations all share some characteristics with research (such as data collection and data analysis), the a priori intent and objectives of the data collection, as well as the further use of the collected data, may be a determining factor for establishing whether it is research and thus whether it should be reviewed by an REB.

7. Norms from other organizations may help to clarify some of the definitional concepts. For instance, the Canadian International Development Agency (CIDA) regards performance review as encompassing all functions and instruments used by managers and staff to assess the agency's development and operational results. This may include evaluation, international audit, and monitoring of programs, projects and institutions. Similarly, the United Nations Development Programme (UNDP) has defined evaluation as a "time-bound exercise that attempts to assess systematically and objectively the relevance, performance and success of ongoing and completed programs and projects" (see www.undp.org/eo/documents/mec1-3.htm for its comparison of evaluation, audit and research). As a management function, performance review provides a basis for decision-making, enabling an organization to respond to needs for accountability and to define future objectives and activities. It is result-oriented. It assesses relevance, performance and success of an organization and its programs, projects or services. Results of quality assurance studies or performance review are not generally for public release.

8. Based on the forgoing, we suggest that researchers resolve doubts about ethics review of QA or performance reviews by consulting their local REB. You might make your decision based on these questions:

  • Is the study's goal to contribute to generalizable knowledge or to correct or enhance a service, program or project?
  • Do its other essential elements correspond to those of QA or performance review (as noted above)?
  • Will the result of the study be published?
9. For further information, you may also refer to university Web sites that provided guidelines on quality assurance, performance review, etc. (e.g., http://umanitoba.ca/admin/vp_admin/media/bulletin79.pdf and www.hreb.ualberta.ca/qa&pe.htm).

10. Please note that if the elements correspond to QA, the proposal may nonetheless raise ethical issues (e.g., consent, voluntariness and confidentiality) that at least warrant an expedited research ethics review. This might result in, for example, the anonymizing of personal identifying information.

11. We would also like to inform you that the issue of defining quality assurance studies, performance review and research will be forwarded to PRE's Subgroup on procedural issues for the TCPS.

We hope you find this information helpful to your human research ethics deliberations.

Sincerely,

Secretariat on Research Ethics
on behalf of
The Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


  1. PRE provides advice on such interpretation questions to assist the research ethics community in applying the TCPS to the ethical issues it faces. While responses to TCPS interpretation questions may address ethical dimensions of legal issues in research ethics, PRE does not provide legal advice. Nor does it act as an appeal body on REB or institutional decisions.
  2. Australian Health Ethics Committee (AHEC) of the Australian National Health and Medical Research Council, When Does Quality Assurance in Health Care Require Independent Ethical Review? (revised consultation draft), December 2002, p. 18. http://www.nhmrc.gov.au/publications/synopses/e46syn.htm
  3. National Council on Ethics in Human Research, "Audit versus Research,"NCEHR Communique, Sept. 1995. See also AHEC, p. 25.
  4. See, by way of comparison: AHEC: "An activity where the primary purpose is to monitor, evaluate or improve the quality of health care delivered by a health-care provider ..is a quality assurance study." The Canadian Psychiatric Association's definition of quality assurance: a "comprehensive endeavour to deliver patient care that is optimal with available resources and consistent with achievable goals; it is a systematic scrutiny of patient care which deliberately finds and corrects meaningful problems, and for which documentation is visible, objective and communicated. Quality assurance means both measuring the level of care provided and, when necessary, improving it." http://publications.cpa-apc.org/media.php?mid=195.