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Past Interpretations of the TCPS

Subject REB Jurisdiction and Research Involving Humans Requiring Ethics Review
Keywords REB jurisdiction, requirement for REB review, researchers’ multiple affiliations, student activities and research, co-op programs, reach of the TCPS
TCPS Articles 1.1, 1.2, 1.4, 1.14
Date October 2005

PDF REB Jurisdiction and Research Involving Humans Requiring Ethics Review October2005.pdf

1. This is in response to your question in which you raise three scenarios and inquire whether each would require an institutional Research Ethics Board (REB) review in accordance with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).

2. In the first scenario, you indicate that some faculty members at your institution have multiple organizational affiliations. You seek advice on criteria to determine the requirement to submit their project for research ethics review by your REB, if they engage in research involving humans mainly under the auspices of their other organizational affiliations.

3. The second issue is in regard to students registered at your institution who do co-op or field placements as part of their educational programs and are involved in collecting information about clients for their placement agencies. You inquire whether student’s institution requires REB review when the student is involved in such projects during the work term/co-op placement.

4. The third scenario you raise is in regard to whether research ethics review is required for activities undertaken by students in journalism, as well as other similar programs, where students are required to conduct interviews to gain insight into the professional practice of their field of study. You inquire about criteria to make such a determination, including how the definition of research as defined by the TCPS may be used or applied.

5. Your questions have been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice1.

(1) Local REB review of research involving humans conducted by faculty under the auspices of another institution

6. The reach of the TCPS is broad and inclusive. It applies to research conducted under the auspices of institutions funded, or eligible for funding, by the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, or the Social Sciences and Humanities Research Council of Canada. It is in effect regardless of the source of funding or of the location of the conducted research. According to TCPS article 1.2:

The institution …shall mandate the REB to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects which is conducted within, or by members of, the institution, using the considerations set forth in this Policy as the minimum standard. [emphasis added]

7. This reach is extended to other jurisdictions or countries by means of TCPS article 1.14,2 which requires ethics review for research done outside the researcher’s institution. There are complementary rationales for the broad reach of the TCPS: it enables institutions to consistently apply the same ethical standards to research conducted within and across institutions. The TCPS thus enables consistent application of participant protections, and furthers public trust and accountability in the ethics of research involving humans.

8. Consistent with the TCPS, researchers—as members of the institution—should obtain REB ethics approval if they engage in research involving humans related to one of their other organizational affiliations. Should the institution assess that some exceptions may apply, and therefore wish to extend or limit the scope of the institutional research ethics policy to researchers’ other activities on a case-by-case basis, the policy determination should be clearly documented in the institutional policies.

9. These are factors to consider in making this decision on case-by-case exceptions:

  • Consider the degree to which the faculty member’s affiliation with the institution is his/her “primary” professional affiliation. In an extreme example, some adjunct faculty members at the institution may be employed full-time in industry, government or some other entity; the research activities they conduct wholly within the auspices of that other entity—and without any reference to the institution in question—would not normally be subject to that institution’s policies.
  • Consider the practicality of distinguishing the capacity in which the researcher is conducting his/her research.
  • Consider the availability of other avenues through which the researcher may address the TCPS guidelines extramurally, and consider the possibility of sharing responsibility of research ethics review, as outlined on page 1.3 of the TCPS, “Each institution is accountable for the research carried out in its own jurisdiction or under its auspices. An institution can authorize its REB(s) to accept the review of other REBs constituted under the Tri-Council Policy Statement if it so wishes. This might involve specific agreements between institutions for sharing the work.”
  • Consider methods to address the potential conflict-of-interest issues and research subjects’ reasonable perceptions.

10. In considering the above factors, from the perspective of a participant or objective community, it may prove difficult to distinguish or categorize the status and capacity in which researchers conduct research. For instance, a researcher undertaking research in the community may not easily disassociate research as an affiliate of one institution from research undertaken in another capacity. Researchers carry with them the reputation of their institution in many of the capacities in which they elect to conduct their research. If research participants cannot easily distinguish researchers as affiliates of their primary institution from other affiliations, they may reasonably presume that the research has undergone ethics review from the primary institution’s REB.

(2) REB review of “research” activities of students in co-op or field placements

11. Students are members of the academic institution and are governed by the various policies of their institution, including the institutional policy for research involving humans. As discussed above, according to TCPS article 1.2 and the commentary to article 1.14:

An institution is responsible for the ethical conduct of research undertaken by its faculty, staff or students regardless of the location where the research is conducted. Thus, review of research by that institution’s REB is required in addition to review by any agency having jurisdiction over the site of the research. [emphasis added]

12. This equally applies to research dimensions of student co-op work or field placements3 that are part of, and credited to, educational programs to provide exposure to the field and allow application of the knowledge and skills acquired from those programs. Does the co-op or field placement involve activities whose intent and objectives qualify as “research involving humans” (that is, “a systematic investigation to establish facts, principles or generalizable knowledge”)? TCPS article 1.1(d) provides a list of activities that may resemble research but are not necessarily such. To help you analyze the issues, we have provided an appendix that discusses distinctions between research and such activities as quality assurance, and program evaluation.

13. Presuming that the co-op placements involve components of research, institutions and organizations hosting co-op student researchers may consider specifying in advance, in policies, agreements or contracts for co-op student placements, the roles and responsibilities pertaining to ethics review of research involving humans.

14. These are some options for consideration:

Option 1: The institution may decide to take responsibility for the review of all research (including co-op) in which the student is involved, irrespective of who initiates the research.

Option 2: The institution may implement a policy under which there is case-by-case distinguishing of the responsibilities of the institution from that of the host organization. Under this option, the institution would have the onus of ethics review only where the project is initiated by the student as part of his/her academic program (e.g., required co-op term, course requirement, or thesis). In the case of projects that are initiated by the host organization, the agreement may put the onus on the host organization to submit the project to its own REB (or equivalent entity) for ethics review before the student is engaged in the project. Or, both the institution and the host organization may agree to share responsibility as per TCPS page 1.3.

15. When in doubt, the host organization should be advised to consult the institution.

(3) REB review of course-based student research activities

16. The intent and objectives of the activity, which may include data collection, as well as the further use of the collected data, are among the determining factors for establishing whether an activity is “research,” whether it requires REB review, and, if so, at what level. As noted under (2) above, some activities are geared more to providing students with exposure to their field of study, rather than to carry out actual research. In the latter case, the conduct of “research involving humans” as part of an undergraduate research assignment within course or co-op requirements may undergo ethics review at a departmental level4. You may wish to consult the guidelines that some Canadian institutions have developed to help instructors distinguish “research” from professional skills development.5 These may help you to establish criteria for determining whether course-based activities are subject to ethics review.

We hope you will 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


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Appendix

Is it Research, Quality Assurance, etc.?

17. 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.”

18. 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

19. In terms of performance evaluations, the commentary of Article 1.1 of the TCPS 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 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].

20. 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.

21. 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. “Research to be performed outside the jurisdiction or country of the institution which employs the researcher shall undergo prospective ethics review both (a) by the REB within the researcher’s institution; and (b) by the REB, where such exists, with the legal responsibility and equivalent ethical and procedural safeguards in the country or jurisdiction where the research is to be done” (TCPS article 1.14).
  3. A co-op or field placement involves students in practical work experience while they are attending university programs.
  4. See Commentary to TCPS article 1.4: “An institution may decide that ethics review of research that is carried out by undergraduate students as part of their course work may be delegated to a departmental level process that complies with this Policy Statement.”
  5. See examples: http://www.mcmaster.ca/ors/ethics/download/course%20guidelines.doc and http://www.ucalgary.ca/UofC/research/documents/coursebased_research.pdf.
  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 (Dec. 1996). 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 assurance means both measuring the level of care provided and, when necessary, improving it.” (http://publications.cpa-apc.org/media.php?mid=195).