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TCPS 2 - Chapter 2

Scope and Approach

Introduction

A. Scope of Research Ethics Review

B. Approach to Research Ethics Board Review

Introduction

The purpose of this Policy, as set out in Chapter 1, is to establish principles to guide the design, ethical conduct and ethics review process of research involving humans. This chapter outlines the scope of application of the Policy and the approach to research ethics review that flows from the core principles – Respect for Persons, Concern for Welfare, and Justice. The preferred approach to research ethics review is a proportionate approach. The research ethics board (REB) tailors the level of scrutiny by an REB to the level of risk presented by the research, and assesses the ethical acceptability of the research through consideration of the foreseeable risks, the potential benefits and the ethical implications of the research, both at the stage of the initial REB review and throughout the life of the project (continuing ethics review). The establishment, governance, jurisdiction and composition of REBs, and operational issues related to their functioning are addressed in Chapter 6.

A. Scope of Research Ethics Review

The following article defines the general categories of research that require REB review in accordance with this Policy, subject to the exceptions set out further on in this Policy. These exceptions are distinct from research that is exempt from REB review, as described in Articles 2.2 to 2.4.

Article 2.1 The following requires ethics review and approval by an REB before the research commences:

  1. research involving living human participants;
  2. research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

Application The scope of this Policy is restricted to the review of the ethical conduct of research involving humans. The scope of REB review is limited to those activities defined in this Policy as “research” involving “human participants.”

For the purposes of this Policy, “research” is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation. 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. For example, a study seeking to explore the narratives of teens coping with mental illness would be evaluated by the established standards of studies employing similar methods, technologies and/or theoretical frameworks.

A determination that research is the intended purpose of the undertaking is key for differentiating activities that require ethics review by an REB and those that do not (see Article 2.5). In some cases it can be difficult to make this distinction, underscoring the need to have reviewers or ad hoc advisors (see Article 6.4 and Article 6.5) who can assist with this determination. It is important to note that choice of methodology and/or intent or ability to publish findings are not factors that determine whether or not an activity is research requiring ethics review.

For the purposes of this Policy, “human participants” (referred to as “participants”) are those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question.

Human participants are unique among the many parties involved in research, because they bear the primary risks of the research. These individuals are often referred to as “research subjects.” This Policy prefers the term “participant” because it better reflects the spirit behind the core principles: that individuals who choose to participate in research play a more active role than the term “subject” conveys. As well, it reflects the range of research covered by this Policy, and the varied degree of involvement by participants – including the use of their data or human biological materials – that different types of research offer. The core principles of this Policy – Respect for Persons, Concern for Welfare, and Justice – help to shape the relationship between researchers and participants.

Where researchers seek to collect, use, share and access different types of information or data about participants, they are expected to determine whether the information or data proposed in research may reasonably be expected to identify an individual. For the purposes of this Policy, researchers and REBs shall consider whether information is identifiable or non-identifiable. Information is identifiable if it may reasonably be expected to identify an individual, when used alone or combined with other available information. Information is non-identifiable if it does not identify an individual, for all practical purposes, when used alone or combined with other available information. The term “personal information” generally denotes identifiable information about an individual. The assessment of whether information is identifiable is made in the context of a specific research project. Guidance on the assessment of the potential for information to identify an individual is addressed in this Policy in Chapter 5, Section A.

In some cases, research may involve interaction with individuals who are not themselves the focus of the research in order to obtain information. For example, one may collect information from authorized personnel to release information or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or statistical reports. Such individuals are not considered participants for the purposes of this Policy. This is distinct from situations where 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, are considered participants.

For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine, saliva and other body fluids. Materials related to human reproduction include embryos, fetuses, fetal tissues and human reproductive materials. Embryo means a human organism during the first 56 days of its development following fertilization or creation, excluding any time during which its development has been suspended, and includes any cell derived from such an organism that is used for the purpose of creating a human being. Fetus means a human organism during the period of its development beginning on the 57th day following fertilization or creation, excluding any time during which its development has been suspended, and ending at birth. Fetal tissue includes membranes, placenta, umbilical cord, amniotic fluid and other tissue that contains genetic information about the fetus. Human reproductive materials mean a sperm, ovum or other human cell, or a human gene, as well as a part of any of them. The term “human biological materials” may be considered, for the purposes of this Policy, to include materials related to human reproduction. The last section of Chapter 12 discusses ethical issues specific to these materials.1

When in doubt about the applicability of this Policy to a particular research project, the researcher shall seek the opinion of the REB. The REB makes the final decision on exemption from research ethics review.

Research Exempt from REB Review

Some research is exempt from REB review where protections are available by other means. This Policy allows the following exemptions from the requirement for REB review, as outlined below.

Article 2.2 Research that relies exclusively on publicly available information does not require REB review when:

  1. the information is legally accessible to the public and appropriately protected by law; or
  2. the information is publicly accessible and there is no reasonable expectation of privacy.

Application For the purposes of this Policy, publicly available information is any existing stored documentary material, records or publications, which may or may not include identifiable information. Some types of information are legally accessible to the public in a certain form and for a certain purpose, as specified by law or regulations: registries of deaths, court judgments, or public archives and publicly available statistics (e.g., Statistics Canada public use files), for example. In Canada, all publicly available archives (national, provincial or municipal) have policies governing access to their records. An archival record or database that is subject to restrictions, such as those under access to information and privacy legislation or contractual restrictions imposed by the donor of the records, may also be considered publicly available for the purposes of this Policy.

Research that relies exclusively on information that is publicly available, or made accessible through legislation or regulation, does not require REB review. Exemption from REB review for research involving information that is legally accessible to the public is based on the presence of a legally designated custodian/steward who protects its privacy and proprietary interests (e.g., an access to information and privacy coordinator or a guardian of Canadian census data).

REB review is also not required where research uses exclusively publicly available information that may contain identifiable information, and for which there is no reasonable expectation of privacy. For example, identifiable information may be disseminated in the public domain through print or electronic publications; film, audio or digital recordings; press accounts; official publications of private or public institutions; artistic installations, exhibitions or literary events freely open to the public; or publications accessible in public libraries. Research that is non-intrusive, and does not involve direct interaction between the researcher and individuals through the Internet, also does not require REB review. Cyber-material such as documents, records, performances, online archival materials or published third party interviews to which the public is given uncontrolled access on the Internet for which there is no expectation of privacy is considered to be publicly available information.

Exemption from REB review is based on the information being accessible in the public domain, and that the individuals to whom the information refers have no reasonable expectation of privacy. Information contained in publicly accessible material may, however, be subject to copyright and/or intellectual property rights protections or dissemination restrictions imposed by the legal entity controlling the information.

However, there are situations where REB review is required.

There are publicly accessible digital sites where there is a reasonable expectation of privacy. When accessing identifiable information in publicly accessible digital sites, such as Internet chat rooms, and self-help groups with restricted membership, the privacy expectation of contributors of these sites is much higher. Researchers shall submit their proposal for REB review (see Article 10.3).

Where data linkage of different sources of publicly available information is involved, it could give rise to new forms of identifiable information that would raise issues of privacy and confidentiality when used in research, and would therefore require REB review (see Article 5.7).

When in doubt about the applicability of this article to their research, researchers should consult their REBs.

Article 2.3 REB review is not required for research involving the observation of people in public places where:

  1. it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
  2. individuals or groups targeted for observation have no reasonable expectation of privacy; and
  3. any dissemination of research results does not allow identification of specific individuals.

Application For the purposes of this article, observational research is used to study acts or behaviour in a natural environment. It does not refer to observational methods used in epidemiological studies.

When designing their research, researchers shall pay attention to the environment in which observation takes place, the expectation of privacy that individuals in public places might have, and the means of recording observations. Researchers shall also determine whether the use of this information in the dissemination of research results (e.g., through publications, photographs, audio recordings, or video footage of groups or particular individuals) will allow the identification of individuals observed in public places. When in doubt, researchers should consult the REB prior to the conduct of such research. Article 10.3 addresses observational studies in qualitative research.

Article 2.4 REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.

Application Secondary use refers to the use in research of information or human biological materials originally collected for a purpose other than the current research purpose. Anonymous information and human biological materials are distinct from those that have been coded, and also from those that have been anonymized (see Section A of Chapters 5 and 12).

Rapid technological advances facilitate identification of information and make it harder to achieve anonymity. These activities may heighten risks of identification and possible stigmatization where a dataset contains information about or human biological materials from a population in a small geographical area, or information about individuals with unique characteristics (e.g., uncommon field of occupational specialization, diagnosis with a very rare disease). Where the researcher seeks data linkage of two or more anonymous sets of information or human biological materials and there is a reasonable prospect that this could generate identifiable information, then REB review is required.

Guidance related to other categories of identifiable and non-identifiable information and human biological materials and their possible secondary use is provided in Chapters 5 and 12.

Activities Not Requiring REB Review

The following distinguishes research requiring REB review from non-research activities that have traditionally employed methods and techniques similar to those employed in research. Such activities are not considered “research” as defined in this Policy, and do not require REB review. Activities outside the scope of research subject to REB review (see Articles 2.5 and 2.6), as defined in this Policy, may still raise ethical issues that would benefit from careful consideration by an individual or a body capable of providing some independent guidance, other than an REB. These ethics resources may be based in professional or disciplinary associations, particularly where those associations have established best practices guidelines for such activities in their discipline.

Article 2.5 Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review.

Application Article 2.5 refers to assessments of 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. Those activities are normally administered in the ordinary course of the operation of an organization where participation is required, for example, as a condition of employment in the case of staff performance reviews, or an evaluation in the course of academic or professional training. Other examples include student course evaluations, or data collection for internal or external organizational reports. Such activities do not normally follow the consent procedures outlined in this Policy.

If data are collected for the purposes of such activities but later proposed for research purposes, it 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. Refer to Section D of Chapter 5 for guidance concerning secondary use of identifiable information for research purposes.

Article 2.6 Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review.

Application Creative practice is a process through which an artist makes or interprets a work or works of art. It may also include a study of the process of how a work of art is generated. Creative practice activities do not require REB review, but they may be governed by ethical practices established within the cultural sector.

Relationship between Research Ethics Review and Scholarly Review

Article 2.7 As part of research ethics review, the REB shall review the ethical implications of the methods and design of the research.

Application The primary test to be used by REBs in evaluating a research project should be ethical acceptability and, where appropriate, relevant disciplinary scholarly standards.

Traditions for scholarly review vary among disciplines or fields of research, including the stage at which scholarly review occurs, and this needs to be taken into account by REBs. The extent of the scholarly review that is required for biomedical research that does not involve more than minimal risk will vary according to the research being carried out. Research in the humanities and the social sciences that poses, at most, minimal risk shall not normally be required by the REB to be peer reviewed.

REBs should normally avoid duplicating previous professional peer-review assessments unless there is a good and defined reason to do so. It is to be noted that for specific types of research (e.g., clinical trials) REBs should respect the relevant guidelines2 that require REBs to evaluate the scientific aspects of the research as part of their research ethics review.

Researchers have a role to play in demonstrating to their REB whether, when and how appropriate scholarly review has been or will be undertaken for their research. REBs may request that the researcher provide them with the full documentation of scholarly reviews already completed.

Where scholarly review is required,

  • an REB should consider what scholarly review has been applied to a particular research project (e.g., by a funder or sponsor, or for student research by the research supervisor or thesis committee, or by a permanent peer review committee where it exists);
  • if scholarly review as indicated by the relevant disciplinary tradition has not yet been done, and there is no body available to do it, the REB should consider the following mechanisms in satisfying itself that scholarly review of the research is completed:
    • establish an ad hoc independent peer review committee;
    • if the REB has the necessary scholarly expertise, assume complete responsibility for the scholarly review. In assuming this responsibility, the REB should not be driven by factors such as personal biases or preferences, and should not reject proposals because they are controversial, challenge mainstream thought, or offend powerful or vocal interest groups.

REB Review Shall Be Continuing

Article 2.8 Following initial REB review and approval, research ethics review shall continue throughout the life of the project in accordance with Article 6.14.

Application The primary goal of REB review is to ensure the ethical acceptability of research involving humans that falls within the scope of this Policy. Following the initial REB review and approval, the ethics review shall continue to ensure that all stages of a research project are ethically acceptable in accordance with the principles of this Policy.

Continuing ethics review by an REB provides those involved in the research process (in particular, researchers and REBs) with multiple opportunities to reflect on the ethical issues surrounding the research. This reflection can show whether the stated risks, or other unknown risks, were incurred and how they affected the individual and collective welfare of participants. This reflective practice is intended to enable both researchers and REBs to be more effective in protecting participants in current and future research. This practice is especially important in new and emerging fields, where the ethical implications are not yet well understood. Here, reflection should involve an ongoing dialogue among REBs and researchers, as appropriate, to enable the practices surrounding research ethics to evolve as needed to comply with the principles of this Policy.

In the conduct of their approved research, should unanticipated issues arise that may increase the level of risk or have other ethical implications, researchers shall report them to their REB in a timely manner. Researchers shall also submit to their REBs in a timely manner requests for changes to their approved research. Further details are provided in Articles 6.14 to 6.16.

B. Approach to REB Review

Concepts of Risks and Potential Benefits

Potential Benefits

Research involving humans may produce benefits that positively affect the welfare of society as a whole through the advancement of knowledge for future generations, for participants themselves or for other individuals. However, much research offers little or no direct benefit to participants. In most research, the primary benefits produced are for society and for the advancement of knowledge.

Risks

Because research is a step into the unknown, its undertaking can involve harms to participants and to others. Harm is anything that has a negative effect on the welfare of participants, and the nature of the harm may be social, behavioural, psychological, physical or economic.

Risk is a function of the magnitude or seriousness of the harm, and the probability that it will occur, whether to participants or to third parties (as outlined below). A proper ethical analysis of research should consider both the foreseeable risk and the available methods of eliminating or mitigating the risk.

  • The magnitude or seriousness of the harm

    Potential harms in research may span the spectrum from minimal (e.g., inconvenience of participation in research) to substantial (e.g., a major physical injury or an emotional trauma). Harms may be transient, such as a temporary emotional reaction to a survey question, while other types of harm may be longer lasting, such as the loss of reputation following a breach of confidentiality, or a traumatic experience. The perspective of the participants regarding harm may vary from that of researchers. Participants themselves may vary in their reaction to the research. Researchers and REBs should attempt to assess the harm from the perspective of the participants to the extent possible. Research in certain disciplines, such as epidemiology, genetics, sociology or cultural anthropology, may present risks that go beyond the individual and may involve the interests of communities, societies or other defined groups.

  • The probability of occurrence of the harm

    This refers to the likelihood of participants actually suffering the relevant harms. An assessment of such probability may be based on the researcher’s past experience conducting such studies, the review of existing publications that provide rates of the relevant harms in similar issues, or on other empirical evidence. And while researchers should attempt to estimate the occurrence of the relevant harms, this may be more difficult, or not possible, for new or emerging areas of research where no prior experience, comparable research or publications exist.

Certain accepted research paradigms bring inherent limitations to the prior identification of risk. For example, when research in the social sciences employs emergent design, the manner in which the research project will proceed and any associated risks may be known only as it unfolds (see Chapters 3 and 10).

Minimal Risk

Minimal risk research that falls within the scope of this Policy requires REB review. It is generally eligible for delegated review – described in Article 6.12.

For the purposes of this Policy, “minimal risk” research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.

In their assessment of the acceptable threshold of minimal risk, REBs have special ethical obligations to individuals or groups whose situation or circumstances make them vulnerable in the context of a specific research project, and to those who live with relatively high levels of risk on a daily basis. Their inclusion in research should not exacerbate their vulnerability (see Article 4.7).

The analysis, balance, and distribution of risks and potential benefits are critical to the ethics of research involving humans. The principle of Concern for Welfare imposes an ethical obligation to design, assess and conduct research in a way that protects participants from any unnecessary or avoidable risks. In their review, REBs should be concerned with an assessment that the potential research outcomes and potential benefits merit the risks.

Risks and potential benefits may be perceived differently by different individuals and groups in society. Researchers and REBs should take this into account in designing and reviewing research. They should also recognize that researchers and participants may not always see the risks and potential benefits of a research project in the same way. In assessing risks and potential benefits for specific populations, researchers and REBs should understand the role of the culture, values and beliefs of the populations to be studied. In this regard REBs may consult ad hoc advisors as needed. Researchers and REBs may also consult guidelines that exist for conducting research with these populations (see Chapters 8, 9 and 10). Researchers shall demonstrate to their REBs that they have a reasonable understanding of the culture, values and beliefs of the population to be studied, and the likely effects of their research upon them. This could be demonstrated, for example, by referring to previous experience with conducting research with a similar population, or to published research on the effects of that type of research on the population being studied, or by presenting feedback from a community advisory group.

Article 2.9  The REB shall adopt a proportionate approach to research ethics review such that, as a preliminary step, the level of review is determined by the level of risk presented by the research: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). A proportionate approach to assessing the ethical acceptability of the research, at either level of review, involves consideration of the foreseeable risks, the potential benefits and the ethical implications of the research.

Application The proportionate approach to REB review encompasses both the initial assessment of the level of risk to participants posed by a research project – used to determine the level of review (i.e., delegated or full REB review [see Articles 6.11 to 6.17]) – and the approach to the actual review of the research project itself. While all research shall be reviewed in light of the core principles of this Policy, the proportionate approach to REB review is intended to direct the most intensive scrutiny, time and resources, and correspondingly, the most protection, to the most ethically challenging research.

A proportionate approach to research ethics review starts with an assessment of the magnitude and probability of harms. Minimal risk research should normally receive delegated review and above-minimal risk research shall receive full REB review. Whether the review is delegated, full-board, initial or continuing, foreseeable risks and potential benefits should be considered as well as the ethical implications of the research. The proportionate approach to REB review requires that a project have a favourable balance of risks and benefits in order to receive REB approval. The REB should make this assessment in light of the context of the research – that is, elements of the research that may produce benefits or harms, or otherwise have an impact on the ethics of research. Regardless of the level of review selected, the review should include the necessary expertise.

Both risks and potential benefits may span the spectrum from minimal to substantial. The concept of minimal risk (described above) provides a foundation for the proportionate approach to REB review. The various applications of the proportionate approach to REB review are addressed in Article 6.12.

Risks to Researchers

Risks in research are not limited to participants. In their conduct of research, researchers themselves may be exposed to risks that may take many forms (e.g., injury, incarceration). Risks to researchers may become a safety concern, especially for student researchers who are at a learning stage regarding the conduct of research, and who may be subject to pressures from supervisors to conduct research in unsafe situations.

While it is not a formal part of its responsibilities, an REB may raise concerns about the safety of student researchers as part of its communication to the student researchers, and to their supervisors. Based on the level of risk, the REB may consider referring these concerns for review by an appropriate body within the institution.

Endnotes

[1] The definitions of embryo, fetus and human reproductive materials are taken from the Assisted Human Reproduction Act (2004, c. 2) at http://laws.justice.gc.ca/en/A-13.4 and Guidelines for Human Pluripotent Stem Cell Research at www.cihr-irsc.gc.ca/e/34460.html.[Back]

[2] See guidance 3.2.1 of the International Conference on Harmonisation (ICH), Guidance for Industry – Good Clinical Practice: Consolidated Guideline, ICH Topic E6: Technical Requirements for the Registration of Pharmaceuticals for Human Use (1996, adopted by Health Canada in 1997). [Back]

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