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. Should researchers affiliated exclusively with institutions located outside of Canada be required to obtain REB approval in Canada when conducting research involving human participants in Canada? Revised
TCPS 2 does not require researchers affiliated exclusively with institutions located outside of Canada to undergo REB review in Canada unless at least one of the following is true:
- The research is conducted under the auspices of a Canadian institution eligible to receive and administer research funds from one of the three federal research 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) (see TCPS 2 Interpretation Scope 1);
- The funding comes from, or is administered through, an eligible Canadian institution;
- At least one of the research collaborators is affiliated with an eligible Canadian institution.
However, even in the absence of these conditions, access to research sites and research participants should be determined on a case-by-case basis, considering the local context. Some non-eligible institutions have voluntarily adopted TCPS 2 or require ethics review by a private research ethics board. It is the responsibility of researchers to determine whether access to the research site or its members is subject to research ethics approval from any such body. Moreover, even if not subject to TCPS 2, researchers conducting research in Canada are subject to applicable laws, regulations, and policies, 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 and/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 (Application of Article 2.1). 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. REB review is not required for 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. When in doubt about the applicability of TCPS articles to a particular project, researchers shall seek the opinion of the REB for a final determination (see Application of Article 2.1).
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.
10. Are researchers required to follow guidance in TCPS 2 even if their research is exempt from REB review?
The Introduction to the Policy states: "Researchers are expected, as a condition of funding, to adhere to the TCPS." Further, the Introduction to Chapter 2 describes the purpose of the Policy as follows: "to establish principles to guide the design, ethical conduct and ethics review process of research involving humans". Ethics review is therefore only one component of TCPS 2 guidance. Consequently, researchers affiliated to institutions eligible for Agency funding are responsible for complying with all TCPS 2 guidance relevant to their research, even if their research is exempt from REB review. See also an interpretation on Compliance with the Policy under Scope #1.
11. Does public health surveillance require REB review?
Public health surveillance is the systematic collection, analysis and interpretation of health-related data for the planning, implementation and evaluation of public health practice. The TCPS 2 definition of research (Article 2.1) is "an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation." Although public health surveillance 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, are determining factors for establishing whether it is research as defined in TCPS 2. Activity that is conducted in support of a public health program or under the jurisdiction of a public health authority and that does not have research as a primary goal, does not fall within the TCPS 2 definition of research and does not require REB review.
Activities outside the scope of research subject to REB review as defined in this Policy may raise ethical issues that would benefit from careful consideration by an individual or body capable of providing independent guidance. These ethics resources may be based in professional or disciplinary associations.
12. In interviewing staff at an organization for a research project, researchers are collecting both public information and personal opinions from staff members. Does this research require REB review?
Research that relies exclusively on public information that meets the definition and criteria in Article 2.2 (publicly available and protected by law, or in the public domain with no expectation of privacy) does not require REB review. Research that relies only on seeking information that staff normally provide as part of their work duties (e.g. a Parks and Recreation staff member providing lists of parks with hiking trails) does not require REB review, as the staff are not considered participants in research as defined in TCPS 2 (Application of Article 2.1). In this case, the information is the focus of the research, not the views of the staff member.
However, where researchers are collecting public information and also asking staff members to provide personal opinions outside the scope of their job roles, their research must be reviewed by an REB. This follows guidance in TCPS 2 that states that “individuals are considered participants because they are themselves the focus of the research. For example, individuals who are asked for their personal opinions about organizations, or who are observed in their work setting for the purposes of research” (Application of Article 2.1).
13. Does self-study research require Research ethics board (REB) review?
Self-study done for the purpose of research, as defined in the Policy, and involving human participants falls within the scope of TCPS 2, and requires REB review (Application of Article 2.1). Self-study typically involves a scholarly reflection on one’s own experiences in a particular context. Self-study may involve narratives, reflections and/or analyses of experiences based on the researcher’s observations of, interactions with, or information about other individuals or communities. In self-study, at least the researcher is a research participant. See also related interpretation, [REB review #10].
14. When does creative practice require REB review?
TCPS 2 defines ‘research’ and ‘creative practice’. Research is defined as “an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation” (Application of Article 2.1). Creative practice is defined as “a process through which an artist makes or interprets a work or works of art” (Application of Article 2.6). When research incorporates creative practice methods, it requires research ethics board (REB) review. When creative practice activities incorporate research methods, REB review is not required. When the activity has a dual purpose of research and creative practice, REB review is required.
If an activity is being carried out as a form of expression for an artistic purpose, e.g., a theatrical work or video that involves interviewing people, then it is creative practice even if research methods, such as questionnaires, are being used, and even if a form of knowledge is being generated. This type of activity does not require REB review. If the activity is being done for research purposes then it is considered research, even if creative practice methods are being used.
The distinction between research and creative practice is not always clear, and remains a challenging issue in practice. The final assessment of whether an activity is research is the responsibility of the REB, in collaboration with the individual proposing the project, and must be made in the context of the specific project under consideration.
15. Does product testing involving humans require REB review?
Product testing requires REB review if it falls within the definition of research, or serves as a component of a research project, and involves humans as participants in the testing of the product. The TCPS 2 defines research as “an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation” (Application of Article 2.1). Human participants are “those individuals whose data, biological materials, or responses to interventions, stimuli or questions by the researcher are relevant to answering the research question(s)” (Application of Article 2.1).
The purpose of the product testing determines whether it falls within the definition of research. For example, a project designed to understand factors affecting the acceptance of a product that employs a repeatable and rigorous method of investigation, and involves human participants in a process or experiment designed to assess those factors, falls within the definition of research involving humans. However, if the sole purpose of the product testing is to assess or improve its quality, such as improving the design of the product to make it more consumer-friendly, then the intent of the activity is for quality assurance/quality improvement. While the product testing in this case may employ similar methods as those used in research, its intent is for a purpose other than research, and therefore it falls outside the scope of TCPS 2, and does not require REB review (Article 2.5).
Where the product testing activities have a dual purpose – to improve the design of a product, and to answer a research question – the activities fall within the scope of TCPS 2, and REB review is required. If in doubt about the applicability of TCPS 2 or the requirement for REB review, researchers should consult their REB.
16. Is REB review required for research that relies exclusively on information unauthorized for public release, but available in the public domain?
TCPS 2 exempts from research ethics board (REB) review research that “relies exclusively on information that …is in the public domain and the individuals to whom the information refers have no reasonable expectation of privacy” (Article 2.2b). Research involving information that has made its way into the public domain, but has not been authorized for public release must be reviewed by an REB, as it does not meet the second condition set out for this exemption. While the released information may now be in the public domain, the individuals who contributed this information may have had a reasonable expectation of privacy when they provided their data.
In their review of the ethical acceptability of research that relies exclusively on information in the public domain but unauthorized for public release, REBs should weigh the potential benefits to society against the foreseeable new risks that the re-use of this information in research may introduce to the involuntary participants. For example, the re-use of this information for the purpose of research may exacerbate the harm caused by the original privacy breach. REBs should make this assessment on a case-by-case basis, taking into account the nature of the information proposed for use in the research, and the circumstances of the individuals who contributed this information.
REBs should not prohibit research simply because the research is unpopular, looked upon with disfavour by a community or organization in Canada or abroad or because the research involves critical assessments of public, political or corporate institutions and associated public figures. There “may be a compelling public interest in this research” (Application of Article 3.6).
17. Is secondary use of de-identified information stored in a repository exempt from REB review?
Generally, secondary use of de-identified information stored in repositories for new research purposes would not qualify for the exemption from REB review outlined in Articles 2.2 and 2.4.
Applicability of Article 2.2
Article 2.2a specifies two criteria for the exemption from REB review to apply: that the information (i) is “publicly available through a mechanism set out by legislation or regulation”, and (ii) “protected by law”. De-identified information stored in a repository for secondary use would not typically meet the description of “publicly available through a mechanism set out by legislation or regulation”. In addition, those responsible for guarding the data may not meet the definition of a ‘custodian/steward’ in the TCPS. The TCPS clarifies that a custodian/steward is “designated in accordance with access to information and privacy legislation who protects privacy and proprietary interests associated with the information” (Application of Article 2.2).
Article 2.2b also specifies that REB review is not required for research that relies exclusively on information that is (i) in the ‘public domain’, and (ii) “individuals to whom information refers have no reasonable expectation of privacy.” Both criteria must be clearly met in order for the exemption to apply.
The extent to which a repository may be considered to be in the public domain depends on how access to this information is managed. This can range from freely available without any requirement for REB review, or to seek permission to use this information (i.e., no barriers at all), or accessible if a person formally requests and is granted access in accordance with established criteria.
With respect to expectations of privacy, it should be noted that even information that is easily accessed by members of the public may be associated with expectations of privacy, particularly if the terms of consent are unclear. When participants provide informed and voluntary consent to sharing their de-identified information in a repository, this generally suggests that participants have been informed of, and understand, the protections that the researcher will put in place to protect their privacy, and have consented to these measures. If the privacy expectations of individuals to whom the information refers are unclear or contested, however, then research relying on their information would require REB review.
Applicability of Article 2.4
The narrow exemption from REB review in Article 2.4 is limited to the exclusive reliance of the research on secondary use of anonymous information. Anonymous information is defined in the TCPS as, “the information never had identifiers associated with it…” (Ch. 5, A. Key Concepts, Types of Information). Anonymous information is distinct from de-identified information where identifiers existed but were removed. Therefore, the exemption from REB review outlined in Article 2.4 does not apply to the secondary use of de-identified information stored in repositories.
See also related interpretation [REB review #11], and Guidance on Depositing Existing Data in Public Repositories.
18. Do the Agencies require eligible institutions to comply with any research ethics norms other than the TCPS 2? New
Institutions eligible to administer funding from any of the three federal research funding 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 – the Agencies) are required to comply with the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018) for all research involving human participants conducted under the institutions’ auspices or within their jurisdiction (TCPS 2, Introduction). Failure to comply with the requirements of the TCPS 2 by researchers or their institution may result in a recourse by the Agencies, as set out in the Tri-Agency Framework: Responsible Conduct of Research (RCR Framework).
In addition to the requirements of the TCPS 2, researchers and their institutions may be subject to other research ethics norms. For instance, researchers may be subject to professional standards, or consensus guidelines, such as the ICH Consensus Guideline for Good Clinical Practice ICH E6(R2). Private and public organizations may also voluntarily choose to adopt other standards or complementary research ethics norms beyond the TCPS 2. For instance, they may require that their REBs comply with the HRSO standard for Ethical Review and Oversight of Human Research (CAN/HRSO-200.01-2021). However, the Agencies do not require eligible institutions to adopt or comply with such other standards or research ethics norms.
The mandate of the Panel on Research Ethics, an interagency advisory body created by the Agencies, is the interpretation, education, and evolution of the TCPS 2. As a collective body, the Panel does not develop, endorse, or implement research ethics norms beyond the TCPS 2. However, individual members of the Panel may be involved in such work independent of their advisory role to the Agencies. When they do so, they do not represent the Panel or the Agencies.
Compliance with other research ethics norms does not diminish the protections provided by the TCPS 2 and cannot serve as a replacement for compliance with the TCPS 2 by eligible institutions. Where the TCPS 2 appears to be silent on a particular issue, or there is uncertainty about the meaning and significance of the content of the TCPS 2, the research community may seek clarification from the Secretariat on Responsible Conduct of Research.
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