1. Does TCPS 2 apply to any organization or individual who plans to carry out research involving humans?
As indicated in the introduction to the Policy, TCPS 2 applies to all research conducted under the auspices of any institution that is eligible to receive and administer research funds from any of the three federal Agencies (the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada). Eligible institutions are those that have entered into the Agreement on the Administration of Agency Grants and Awards by Research Institutions with the Agencies.
An eligible institution is responsible for the ethical conduct of research undertaken by its faculty, staff or students, regardless of where the research is conducted. This means that TCPS 2 applies to Agency and non-Agency-funded research, as well as non-funded research, that takes place under the auspices of the eligible institution and its affiliates. Typically, eligible institutions include Canadian universities, colleges and affiliated hospitals.
Other organizations have chosen to adopt the TCPS to guide the ethical conduct of research involving humans that falls within their institutional jurisdictions. For example, some private REBs and other federal government entities such as Health Canada, the National Research Council, and the Department of National Defence have done so. In academic and other settings where TCPS 2 applies, it is often one of several norms that complement applicable legal, institutional and professional standards.
2. Does program evaluation require REB review?
REB review would be required only if program evaluation falls within the definition of research or serves as a component of a research project. Although program evaluation may share some methods and techniques with those employed in research (such as data collection and data analysis), the intent and objectives of the data collection, as well as the further use of the collected data, may be determining factors for establishing whether it is research and whether it should be reviewed by an REB. The determination of whether an evaluation study is research and therefore requires REB review should be made on a case-by-case basis, and should be guided by the definition of research in TCPS 2 (see Application to Article 2.1). TCPS 2 exempts from REB review program evaluation activities normally administered in the ordinary course of operation of an organization (see Article 2.5). If the collected data for such activities is later proposed for research purposes, it is considered secondary use of information not originally intended for research, and may require REB review at that time. Where in doubt about the applicability of TCPS 2 or the requirement for REB review of a particular research project, the researcher should consult the REB.
3. When conducting research in Canada, should researchers from abroad be required to obtain REB approval in Canada?
TCPS 2 does not require research conducted by researchers from abroad to undergo REB review in Canada unless at least one of the following is true:
However, even in the absence of these conditions, access to research sites and research participants should be determined on a case-by-case basis. Some institutions have voluntarily adopted TCPS 2 or require ethics review by a private research ethics board. It is the researchers’ responsibility to determine whether access to the research site or its members is subject to research ethics approval from any such body. Even if not subject to TCPS 2, researchers conducting research in Canada would be subject to the applicable laws, regulations and policies in effect, including, but not limited to those concerning the protection of privacy of participants, confidentiality, and the capacity of participants to consent.
4. How do researchers and REBs judge that a space described in a research proposal is a public place qualifying for exemption from REB review as specified in Article 2.3?
The assessment of whether a space is a public place must be made on a case-by-case basis. The first consideration is whether the space in question is open to the public and intended to serve the public (e.g. stadium, planetarium, beach, museums, parks, or library). The second key consideration is whether the proposed research fulfills the three conditions of the exemption in Article 2.3: a lack of researcher involvement/interaction with the individuals or groups concerned, a lack of any reasonable expectation of privacy, and the impossibility of identifying specific individuals in the dissemination of research results. If all conditions are met, the proposed research involving the observation of people in a public place would be exempt from REB review. If there is any doubt as to whether a particular condition has been satisfied, for example whether the people being observed have a reasonable expectation of privacy, then the proposal should be submitted to the REB for consideration.
5. Should surveys conducted by administrators rather than researchers under the auspices of an eligible institution be submitted for REB review?
It is the intended purpose of the survey that determines the requirement for REB review, not the role of the person administering it. TCPS 2 does not provide for any exemption from REB review based on who conducts the research. If it is determined that the intended purpose of administering the survey is research, then it would require REB review (Article 2.1). If the survey is normally administered as an operational requirement for quality assurance, quality improvement, or for program evaluation purposes, then it would not require REB review (Article 2.5), because the survey would not be considered “research” as defined in this policy. Also refer to TCPS 2 Interpretations, Scope # 2.
6. What is the meaning of “disciplined inquiry” in the definition of research in TCPS 2?
TCPS 2 defines “research” as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation” (Application of Article 2.1). The term “disciplined inquiry” refers to an inquiry that is conducted with the expectation that the method, results, and conclusions will be able to withstand the scrutiny of the relevant research community.
7. Does publishing the results of a quality assurance study in a journal determine whether it is research, and whether it requires REB review?
Publishing or otherwise disseminating the results of an activity is not a factor that determines whether the activity is research or not. Publishing the results of a quality assurance study or another activity in a relevant journal (e.g., quality assurance and program evaluation journals) may inform other studies, but does not alter that the main purpose for which the study was conducted is for quality assurance/another activity. To qualify as research as defined in TCPS 2, the study must seek to address a research question that may extend knowledge to other programs. TCPS 2 exempts from REB review quality assurance activities on the basis that such studies do not meet the TCPS 2 definition for research when those activities are “used exclusively for assessment, management or improvement purposes” (Article 2.5). Such activities may, however, raise ethical issues that would benefit from careful consideration by an individual or a body, other than the REB, capable of providing some independent guidance e.g., in professional or disciplinary associations. Some entities have designed tools to help determine whether an activity is research or quality assurance. See, for example, the Alberta Research Ethics Community Consensus Initiative (ARECCI) .
8. Is it ethically acceptable to recruit participants for a dual purpose: a quality improvement study and research?
It would be ethically acceptable to recruit participants for the purpose of both quality improvement and research if the relevant guidelines of both activities are respected. Article 2.5 describes activities (e.g., quality improvement, program evaluation, performance reviews) that may use methods and techniques similar to research but are not considered research as defined by TCPS 2. The same activities, when conducted for the purposes of research, require REB review prior to recruitment and/or data collection. If the researcher plans to use data collected for both a research and a non-research activity, this must be made clear in the consent process, and other distinguishing elements should be managed – such as the voluntariness of consent (Article 3.1). If individuals are mandated to participate in the non-research activity (as a condition of admission to an educational program, for example), the researcher must provide the prospective participants with the option of either consenting or refusing to allow their data to be used for research purposes.
9. Is it ethically acceptable to use information for the purpose of research if it was originally collected for another purpose?
Information originally collected for a purpose other than the current research purposes is considered secondary use of information and its use is acknowledged in TCPS 2. Secondary use of information has the potential to avoid duplication of primary data collection and the associated burdens on participants (Section D, Chapter 5). An REB must review the ethical acceptability of the research involving secondary use of information; including issues of privacy (see Articles 5.5A, 5.5B and 5.6). For example, data collected from students by institutions for program evaluation or quality improvement purpose but later proposed for research purposes 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” (Application of Article 2.5). Similarly, the requirement for REB review applies to information that may have been collected for a specific research purpose and is later proposed for a new research purpose.