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Past Interpretations of the TCPS

Subject Survey Research by University Administrators: Requirement of REB Review
Keywords Surveys/questionnaires, quality assurance studies, quality assessment, performance review, proportionate review, administrative survey, exemptions, research conducted by administrators vs. researchers, role of REB, requirement for REB review
TCPS Articles 1.1, 3.2
Date January 2005

PDF Survey_Research_by_University_Administrators_January_2005.pdf

1. Thank you for your question regarding ethics review of survey studies under the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). You asked whether proposed research surveys of university students by university administrators need ethics review, since similar surveys by academic researchers do. If the answer turns out to be no, you asked for an explanation of the difference. The key to the answer is whether the survey constitutes research, as we will discuss below.

2. Your question raises two issues: (1) Do administrative surveys require research ethics review? (2) Should such ethics review follow the same procedure in every instance? Your questions have been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice.1 As elaborated below, the TCPS indicates that academic or administrative surveys that concern research involving humans are generally subject to REB review, unless particular exceptions apply. Administrative quality assessment studies do not normally fall under REB review, though they may if they involve elements of research on human subjects.

Research Surveys and Ethics Review

3. The TCPS defines research as involving “a systematic investigation to establish facts, principles or generalizable knowledge” (TCPS, page 1.1). The project you refer to would seem to involve administrators conducting research surveys of students. If the primary purpose, design, content and/or function of such surveys is to conduct “research”2 involving humans, then it would generally require REB review, under TCPS Article 1.1(a): “All research that involves living human subjects requires review and approval by an REB … before the research is started ..."

4. The requirement of REB review is not absolute, however. The TCPS allows some exemptions and exceptions. For instance, Article 1.1(d) exempts “Quality assurance studies, performance reviews or testing within normal educational requirements.” The article’s commentary adds that “performance reviews or studies that contain an element of research in addition to assessment may need ethics review.” [emphasis added, TCPS page 1.2]

5. These TCPS standards thus distinguish two classes of research surveys that require ethics review: (1) those whose design, content and function mean that they are “research” that requires ethics review; and (2) those that contain elements of “research” that “may need ethics review”(TCPS, page 1.2).

Research Surveys by Administrators or Researchers: Similar Review?

6. The general TCPS standard of REB review of research does not outline a differential approach based on who conducts the research: article 1.1(a), refers to “All research that involves human subjects.” Moreover, an exception for survey research based on who is doing it would defeat the basic purposes of REB review: interdisciplinary and independent review to identify and address ethics issues in the design and conduct of research, and to protect participants.

7. Does all survey research thus require similar ethics review? Imagine that an administrator and a researcher propose the same quality assurance study with a “research” element in it. As noted, this kind of research survey may be subject to REB review under the TCPS. This discretionary approach may appear to allow for differential treatment. General principles of justice within the TCPS, however, indicate that discretionary review by a body other than an REB should be exercised reasonably and with due process: differential treatment requires a reasonable and principled rationale. The spirit of the TCPS seems to indicate that any such bodies be constituted according to the norms, principles and practices of the TCPS. This ensures consistency of review.

8. The TCPS also indicates that “The opinion of the REB should be sought whenever there is any doubt about the applicability of this Policy to a particular research project” (page 1.2). Thus, the TCPS’s default position is to consult an REB if there is uncertainty whether a project requires research ethics review. In this context, the REB functions differently in its consultative role than in its ethics review role. In the consultative role, the REB provides its opinion. If it believes that a proposal requires research ethics review and it identifies the appropriate review body, the institution should implement this recommended review. In its other role, when a project is submitted for regular REB review, the REB does not have the authority to delegate this responsibility.3

Proportionate Review

9. Survey research that undergoes ethics review should be reviewed under the proportionate approach to ethics review. This “starts with an assessment, primarily from the viewpoint of the potential subjects, of the character, magnitude and probability of potential harms inherent in the research” (TCPS, page 1.7). As such, research surveys in which subjects remain anonymous or that have adequate mechanisms for guarding confidentiality normally undergo expedited review, because respondents to well-designed surveys are rarely put at more than minimal risk.4 Article 3.2 of the TCPS specifies factors REBs should consider in assessing research proposals that involve identifiable personal information. These include appropriate safeguards for security and confidentiality, as well as the accessibility of collected and stored data.5

10. Because issues such as the definitions of “research,” “quality assurance” and “performance review” may warrant potential procedural clarification or reform, PRE has begun studying them as part of its mandate to advise on evolving the TCPS.

We hope that this information proves helpful to your TCPS research deliberations.

Sincerely,


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

************

Appendix

Is it Research, Quality Assurance, etc.?

11. The TCPS defines some terms, but is silent on others. It defines “research” as involving “a systematic investigation to establish facts, principles or generalizable knowledge” (TCPS, page 1.1). As with national research ethics documents in many other countries, however, the TCPS offers no explicit definition “quality assurance.” Indeed, 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.”6 This silence may be partly explained by the overlap between the concepts of “research” and “quality assurance.”

12. To distinguish between the two, some analysts differentiate the primary purposes of the inquiry, while others differentiate the functions of quality assurance from those of research.7 Such distinctions may prove helpful to case-by-case analysis. The literature also provides what might be considered working definitions 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.8

13. In terms of performance evaluations, the commentary of Article 1.1 of the TCPS helps define the concept:

. . . studies related directly to the assessment of the performance of an organization, its employees or students, within the mandate of the organization or according to terms and conditions of employment or training, should not be subject to REB review. However, such studies may include an element of research and may need ethics review [emphasis added].

14. In the context of the TCPS, PRE understands 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, which are a normal requirement within academic institutions and do not require REB review.

15. 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 or not and thus whether it should be reviewed by an REB. It is the intent behind the survey which is crucial to understand. If the intent of the survey is to gather information as part of the research process, for which the analysis results will contribute to the advancement of knowledge as currently defined in the TCPS, then Research Ethics Board review as per the TCPS guidelines will be required; if the intention behind administering the survey is not research related, then REB ethics review as per the TCPS guidelines is not required. Such a survey, although it still must respect ethical norms, is not subject to REB review.


  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. See the Appendix below on the distinction between “research,” “quality assurance” and “performance reviews.”
  3. However, this does not preclude the REB from delegating the review through its expedited review process and reporting requirement to full REB.
  4. See American Association for Public Opinion Research. “Protection of Human Participants in Survey Research: A Source Document for Institutional Review Boards” (May 2003).
    (http://www.aapor.org/)
  5. See also the Council of American Survey Research Organizations (CASRO): “It is essential that Survey Research Organizations be responsible for protecting from disclosure to third parties—including Clients and members of the Public—the identity of individual Respondents as well as Respondent-identifiable information, unless the Respondent expressly requests or permits such disclosure.” Council of American Survey Research Organizations, “CASRO Code of Standards and Ethics for Survey Research.”
    (www.casro.org/codeofstandards.cfm)
  6. Australian Health Ethics Committee of the Australian National Health and Medical Research Council (AHEC). Revised Draft: When Does Quality Assurance in Health Care Require Independent Ethical Review? (Dec. 2002), page 18. See also the final report: When Does Quality Assurance in Health Care Require Independent Ethical Review? (Feb. 2003). (http://www.nhmrc.gov.au/publications/synopses/e46syn.htm)
  7. National Council on Ethics in Human Research. Audit versus Research NCBHR Communiqué (Sept. 1995). See also AHEC 2003, page 3.
  8. Compare this with AHEC, 2003, page 3: “An activity where the primary purpose is to monitor, evaluate or improve the quality of health care delivered by a health care provider (an individual, a service or an organisation) is a quality assurance study.” Canadian Psychiatric Association definition of quality assurance: “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 improvement means both measuring the level of care provided and, when necessary, improving it.”
    (http://publications.cpa-apc.org/media.php?mid=195).