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Draft 2nd Edition of the TCPS (December 2008)

Chapter 2

SCOPE AND APPROACH

The purpose of this Policy, as set out in Chapter 1 (“Ethics Framework”), is to establish principles to guide the design, conduct and review of research involving human participants. This chapter outlines the scope of application of the Policy and the approach to ethics review that flows from the core principles: welfare, autonomy and equal moral status of all humans. It sets out the preferred approach to ethics review by a research ethics board (REB) - a proportionate approach, which tailors the level of scrutiny by an REB to the level of risk presented by the research, both at the stage of the initial review and throughout the period the research is active, to ensure the continued ethical acceptability of research. The establishment, governance, jurisdiction, composition and operational issues related to the functioning of REBs are addressed in Chapter 6 (“Governance of Research Ethics Review”).

A. Scope of Ethics Review

Research Requiring REB 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 chapter.

Article 2.1

  1. All research that involves human participants requires review and approval by a research ethics board (REB) in accordance with this Policy before the research commences, except as stipulated below.
  2. Research involving human remains, cadavers, tissues, biological fluids, embryos or fetuses shall also be reviewed by an REB.
  3. Researchers who intend to secure identifiable personal information about participants shall secure REB approval.

Application REB review is limited to those activities defined as “research” in this Policy, and involving “human participants” as defined in this Policy. There are many activities outside the scope of these definitions that may raise ethical issues requiring some form of review or guidance. REBs are not the sole forum for ethics guidance, however. Their role should be restricted to the scope of research involving human participants as set out below.

For the purpose of this Policy, “research” is defined as an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.

A determination of the intended purpose of the undertaking, as distinct from the use of potentially similar methods, is key for differentiating activities that require review by an REB and those that do not.

For the purpose of this Policy, “research participants” (or simply, “participants”) are those living individuals whose data or responses to questions, stimuli or interventions by the researcher are material to the research question. They are unique among the many parties involved in research, because they bear the primary risks of the research. The focus of this Policy is to ensure respect for their welfare, autonomy and equal moral status. 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. In particular, it reflects the range of research covered by this Policy, as well as the varied degree of involvement by participants that different types of research offer.

Article 2.1(b) describes the scope of REB review beyond living individuals. This includes research involving human materials such as biological fluids, tissues and gametes, and human remains. Note that this covers only research involving the physical remains of a deceased person, and not deceased persons themselves. For further information regarding what type of research is exempt from REB review, see Article 2.2.

The use of human tissues for the purpose of research is further elaborated on in Chapters 12 and 13 (“Human Tissue” and “Human Genetic Research”).

For the purposes of this Policy, “identifiable personal information” means information relating to an individual that could be used to identify or re-identify that individual through a combination of indirect identifiers (such as date of birth, place of residence, or a unique personal characteristic). It includes information about personal characteristics such as age, culture, educational background, employment history, health care, life experiences, religion, social status and other matters where an individual has a reasonable expectation of privacy. (See Chapter 5 [“Privacy and Confidentiality”] regarding types of information and Chapter 3 [“Free and Informed Consent”] regarding consent procedures specific to securing identifiable personal information.)

Subject to the exceptions in this chapter, research based exclusively on publicly available information requires REB review only if the participant is approached directly for interviews or for access to private papers, and then only to ensure that such approaches are conducted according to professional protocols and to Articles 3.1 and 3.2 (free and informed consent). Where the research involves interaction with an individual in public life or an artist as a research participant by way of a request for an interview or for access to private papers, the REB review should focus only on whether these requests will be made in accordance with appropriate ethical and professional standards. Similarly, REBs should ensure that interviews with third parties are conducted according to a professional interview protocol and to Articles 3.1 and 3.2 (free and informed consent), and that the potential interviewees be fully informed about publication of the interview and their identity. REBs should not require such third-party interviews to be controlled in any way by the person who is the primary focus of the research.

Research based on critical inquiry - focusing, for example, on public policy issues, modern history, or literary or artistic criticism - may involve interaction with living individuals, notably through interviews. Where the aim of the researchers is to engage in a critical examination of a body of artistic work, a public policy, other comparable types of work, the role of the REB should be limited to ensuring that researchers conduct their work respecting the professional standards of their discipline(s) or field(s) of research. The need to ensure freedom of inquiry and to protect the ability of researchers to criticize the work (or organization, political party, corporate enterprise, etc.) they are examining takes precedence over the need to protect individual parties from harm.

Research Not Requiring REB Review

The requirement for REB review is not absolute. This Policy allows some exemptions and exceptions, as outlined below and complemented in the Appendix by examples of activities that do not require ethics review by an REB.

Beyond the exceptions listed below, others may arise. Because principles are designed to guide ethical reflection and conduct, they require flexibility and admit exceptions. To preserve the values, purpose and protection that they attempt to advance, the onus for demonstrating a reasonable exception to a principle should fall on those claiming the exception. The opinion of the REB should be sought whenever there is any doubt about the applicability of this Policy to a particular research project.

Community processes may apply to research beyond the scope of REB responsibilities. For example, research on the interface between environmental and human systems that does not involve individual participants does not require REB review. In these cases, the guidelines of this Policy can be used as a model to help fill gaps, accommodate overlap and resolve other types of ethical conflicts between community and institutions.

Article 2.2 Research that relies exclusively on publicly available information does not require research ethics board review. This includes research on living individuals and research on organizations such as governments or corporations, so long as the research is based entirely on material to which the public has access.

Application Archival materials and records conserved by libraries, documentation centres and archival services (public and private) that are open to the general public on the basis of transparent procedures, including consultation policies, are considered to be publicly available for the purposes of this Policy. An archival document or a database that is subject to restrictions under access to information and privacy legislation may nevertheless be considered publicly available for the purposes of this Policy, insofar as it meets the criteria set out in this definition.

Research about a living individual involved in the public arena (politicians, artists, public figures, business or labour leaders, etc.) or about organizations and institutions (governments, corporations, criminal organizations, political parties, etc.) based exclusively on publicly available information such as documents, records, material from public archives, performances, archival materials, third-party interviews, public policy documents, published works and the like, available in print, electronic or other media, to which the public is granted access, is not required to undergo REB review, because such research involves no interaction with the person or organization who is the subject of the public records. In these cases, there is no presumption of privacy. The safeguard for those in the public arena is through public debate and discourse or, in extreme cases, through action in the courts for libel.

Article 2.3 Research ethics board review is usually not required for research involving public policy issues, the writing of modern history, or literary or artistic criticism.

Application While all the areas of research noted in Article 2.3 may involve interaction with living individuals, this exception is based on the fact that the research relies either on published or publicly available information, including performances, archival materials, or on information derived from publicly available third-party interviews. This exception could, for example, cover research about a living individual with a public profile, or criticism of a living artist, so long as the research involves no interaction with the person who is the subject of the publicly available information.

Article 2.4 Quality assurance and quality improvement studies, program evaluation, and performance reviews or testing within normal educational requirements are not subject to research ethics board review.

Application Studies related directly to assessing 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, do not require REB review.

Activities other than research as defined in this Policy may still raise ethical issues that would benefit from careful consideration by a body capable of providing some independent guidance, other than an REB. Such issues may include, for example, the potential for real or perceived coercion in certain quality assurance or evaluation studies. Bodies capable of providing such guidance may be based in professional or disciplinary associations, particularly where those associations have established best-practices guidelines for research in their discipline.

Article 2.5 Research involving observation of people in public places that does not allow for the identification of the individuals in research material and that is not staged by the researchers does not require research ethics board review.

Application Observational research is a form of qualitative research. The exemption of observational research that meets the specific criteria set out in this article is addressed more fully in Article 10.2 of Chapter 10 (“Qualitative Research”).

Article 2.6 Creative practice activities in and of themselves do not require research ethics board 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 review by an REB, but they may be appropriately governed by ethical practices established within the cultural sector. As a form of artistic expression, creative practice does not fall within the definition of research in this Policy. It is therefore not subject to REB review.

Research that employs creative practice to obtain responses from human participants that will be analyzed to generate or to address a research question is, however, subject to REB review.

B. Approach to Research Ethics Board Review

REB Review Shall be Proportionate

Article 2.7 The research ethics board should adopt a proportionate approach to ethics review, based on the principle that as the risk to participants increases, so should the level of scrutiny in assessing the research and the level of expertise involved in the review process.

Application The concept of proportionate review gives practical expression to the core principle of concern for the welfare of participants in research, such that the more potentially invasive or harmful is the proposed and ongoing research, the higher the level of scrutiny and expertise that should be applied to the ethics review process. While all research must be reviewed adequately, proportionate review is intended to direct the most intensive scrutiny, time and resources, and correspondingly the most protection, to the most ethically challenging or high-risk research.

A proportionate approach to ethics review starts with an assessment of the character, magnitude and probability of potential harms and benefits inherent in the research. 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.

The concept of minimal risk (described below) provides a foundation for proportionate review. The various applications of the proportionate approach to REB review are addressed in Chapter 6 (“Governance of Research Ethics Review”).

Concept of Potential Risks and Benefits

Applying the principles of concern for welfare and respect for autonomy of research participants requires an assessment of foreseeable risks and benefits to research participants and to others. The ethical acceptability of research is dependent on a judgment as to whether the potential benefits justify the risks, thus ensuring that research involving humans is designed and conducted in such a way as to answer as well as possible the question posed by the research, while ensuring that the participant is not unduly or unnecessarily exposed to risk. It is the responsibility of the REB in reviewing a research proposal to decide whether the research presents an ethically acceptable balance of risks and potential benefits. The subsequent decision to participate in approved research is one that potential participants make based on their own appreciation of whether it serves their welfare to do so. Participants should share both the burdens and the benefits of research.

Potential Risks

Three considerations (informed by the principle of concern for welfare) are relevant to the assessment and categorization of risks to research participants and of the possible risks to third parties:

  • The nature of the harm;
  • The magnitude or seriousness of the harm; and
  • The probability of occurrence of the harm.

Potential harms are usually understood in relation to risks, which are defined in terms of the magnitude of harm and the probability of its occurrence. Both potential harms and potential benefits may span the spectrum from minimal through substantial. An explanation of “risk” should clarify risk as the combination of the probability of harm and the magnitude of harm. For example, the various kinds of harms that a participant might incur, the likelihood of participants’ actually incurring harms, and the available methods of ameliorating the harms all need to be considered. 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.

For the purpose of this Policy, a “minimal risk” situation is defined as one in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by the participant in those aspects of his or her everyday life that relate to the research.

Above the threshold of minimal risk, research warrants a higher degree of scrutiny and greater provision for the protection of the interests of prospective participants.

Because research involves advancing the frontiers of knowledge, its undertaking often involves uncertainty about the precise magnitude and kind of harms that attend proposed research. 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 study will proceed and any associated risks will be known only as the study unfolds. (See Chapter 3 [“Free and Informed Consent”] and Chapter 10 [“Qualitative Research”].) In cases in which patients participate in research on interventions undertaken for purposes of therapy for that individual, the concept of minimal risk raises special issues in clinical research, especially clinical trials. (See Chapter 11 [“Clinical Trials”].)

Risk may be perceived differently by different groups in society. Researchers and REBs should take this into account in designing and reviewing research. In assessing risks for specific populations, researchers and REBs should understand the role of the culture, values and beliefs of the populations to be studied, as well as any guidelines that exist for conducting research with these populations. (See Chapter 8 [“Multi-jurisdictional Research”], Chapter 9 [“Research Involving Aboriginal Peoples’] and Chapter 10 [“Qualitative Research”].)

Potential Benefits

Research involving humans is intended to produce benefits for participants themselves, for other individuals, or for society as a whole through the advancement of knowledge. Just as there are uncertainties concerning the risks of research, so there is uncertainty about its expected benefits. In most research, the primary benefits produced are for society and for the advancement of knowledge.

Balancing Risks and Benefits

Risks and benefits must be evaluated in the context of research and, to the extent possible, from the perspective of participants, because both risks and benefits may be perceived differently by different individuals.

The analysis, balance and distribution of risks and benefits are critical to the ethics of human research. Modern research ethics, for instance, requires a favourable risk-benefit balance - that is, the anticipated benefits should outweigh the foreseeable harms.

The uncertainty of research outcomes often makes it difficult to reliably predict the precise nature and magnitude of the resulting benefits and harms. This reality, coupled with the principle of concern for welfare, imposes an ethical obligation to design, assess and conduct research in a way that protects research participants from any unnecessary or avoidable harm. This is particularly true in the areas of biomedical research, where the physical well-being of participants may be at stake.

These considerations do not apply in the same way in certain areas of research in the social sciences and humanities, such as political science, economics or modern history (including biographies), where the purpose of the research may be to cast a critical eye on organizations, political institutions, or systems or individuals in public life. The outcome of these types of research may harm the reputation of public figures or institutions in politics, business, labour, the arts, or other walks of life. Such harm may, however, be an unavoidable outcome of research that seeks to shed light on or to critically assess the work of a public figure or institution. Where the purpose of the research is to advance knowledge about the workings, for example, of a public office or a public figure, the risk-benefit analysis by the REB should focus on whether the approach they have adopted respects the professional standards of the researcher’s discipline or fields of research. Just as a bruise is an unavoidable risk of research that requires a needle-stick, so harm to reputation is an unavoidable risk of certain types of social science inquiry, and it must be treated as such.

Requirement of Continuing REB Review

Article 2.8 Further to the initial review of research that falls within the scope of this Policy, research ethics boards shall review ongoing research throughout the life of the project. This includes review of departures from approved research that result in a change in the level of risk of research, or other ethical implications that have an impact on the welfare, autonomy and equal moral status of all humans. As with initial review, continuing ethics review should be based on a proportionate approach.

Application The primary goal of continuing ethics review is to ensure that all stages of a research project are conducted in accordance with the guiding principles outlined in this Policy, thus ensuring the continued ethical acceptability of research. At the time of initial review of the research, the REB has the authority to determine the level at which continuing ethics review occurs (for example, the frequency of reports and the type of information to be provided in reports). The level of review and reporting schedule may be adjusted throughout the life of the project if the need arises in situations where the risk level increases because of the discovery of new information or changes in procedures.

Continuing ethics review by an REB provides those involved in the research process (in particular, researchers, REBs, participants or participant groups) 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 or participant groups. This reflective practice enables both researchers and REBs to be more effective in protecting research 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 is characterized as a continuing dialogue between the participants or participant groups, REBs and researchers to enable the principles and practices surrounding research ethics to evolve.

In the conduct of their approved research, researchers should be cognizant of the requirement to report to their REB, in a timely manner, events or issues that have ethical implications or that change the risk to participants. The level of REB review required to assess these changes shall follow a proportionate approach to ethics assessment.

Further details related to the application of continuing ethics review and the REB review of departures to approved research are outlined in Chapter 6 of this Policy.

Scholarly Review as Part of REB Review

Article 2.9 The research ethics board should satisfy itself that research posing more than minimal risk has undergone scholarly review.

Application Scholarly review (referred to as peer review or scientific review in clinical research) is generally understood as a review of the importance of the research question and the validity of the methodology. When research poses more than minimal risk, exposing participants to research that has not been subject to scholarly review may be considered unethical.

Scholarly review is assessed by those familiar with the disciplines or methods of the proposed research. REBs may themselves assume the responsibility for scholarly review in the rare circumstances where there is no other more appropriate body to do so. In these cases, the REB will review research approaches and methodologies to the extent necessary to determine that the approach or methodology adopted is capable of answering the research question in a manner appropriate to the discipline or disciplines in question.

Traditions for scholarly and ethical review undertaken vary between disciplines or fields of research. The tradition for biomedical research is that it undergoes peer review prior to or as part of the REB review process. The extent of peer review required for minimal-risk biomedical research will vary according to the research being carried out. The tradition in the humanities and the social sciences for researchers is to undergo peer review at the grant application or publication stage. REBs therefore shall not require peer review for research in the humanities and the social sciences that poses, at most, minimal risk.

The possible mechanisms for REBs to seek evidence of scholarly review of more-than-minimal-risk research are detailed in Article 6.14 of Chapter 6 (“Governance of Research Ethics Review”).

Nothing in this section, however, shall be interpreted to mean that other relevant parts of this Policy - such as the need for REB review, interview protocols, free and informed consent and privacy - are not applicable to their research.

Balance of Ethics and Law

Article 2.10 In ethics review and the conduct of research, research ethics boards and researchers have an obligation to be aware of applicable laws.

Application The law establishes principles and rules that affect and regulate the conduct of research involving humans. These include legal rules about privacy, confidentiality, competence of research subjects, intellectual property, and many other topics. Researchers should be aware of applicable laws. For research conducted in multiple jurisdictions or research outside Canada (addressed in Chapter 8 [“Multi-jurisdictional Research”]), this may require knowledge of laws in multiple jurisdictions. REBs may satisfy this obligation through expertise among their memberships or through wider consultation.  

Legal rules and ethical principles are not always consistent. Researchers may face situations where they experience a tension between the requirements of law and the guidance of ethical principles. In such situations, researchers should do their best to uphold ethical principles while complying with the law. Consultation with colleagues, the REB or any relevant professional body will help resolve any conflicts between law and ethics and guide an appropriate course of action. This may include providing the researcher with access to legal advice, if needed.

Appendix

Examples of Research that does not Require Research Ethics Board Review

The following are examples of activities that do not require review by a research ethics board (REB). These may, nevertheless, raise ethical issues that would benefit from careful consideration outside of the REB.

  • Scholarship based on personal reflections and self-study where no one other than the researcher is involved in the research (e.g., autoethnography).
  • Occasions when individuals other than the researcher provide information, but are not themselves the focus of the research; for example:
    • data collection about organizations, policies, procedures, professional practices or statistical reports (e.g., information provided by authorized personnel in the ordinary course of their employment); or
    • consultation to frame or develop the research (e.g., a graduate student interviews an agency manager to determine if the data he or she is interested in can be accessed, and how the information from the interview will inform planning decisions about the research).
  • Program evaluation, quality assurance, quality improvement, or the review and assessment of the program or service; for example:
    • student course evaluations;
    • staff performance reviews;
    • website usability testing;
    • discussion with stakeholders and consultants; or
    • data collection for internal or external organizational reports.
  • Public health surveillance that is legally mandated.
  • Secondary use of information in research that does not involve identifying or identifiable information (see Chapter 5 [“Privacy and Confidentiality”] for a definition of identifying or identifiable information).
  • Analysis or scrutiny of material in the public domain:
    • studies of people's writings that appear in the public domain (e.g., letters to the editors of newspapers; postings to public websites); or
    • studies of public figures (e.g., politicians or celebrities) based on material such as interviews with a journalist or broadcast on television; biographical profiles based on materials in a public archive.
    • research for a critical biography not involving living participants (i.e., based exclusively on published or publicly available material) (see Article 2.2).
  • Student assignments that pose minimal risk; teach about the design, conduct and process of research; and might involve “practice” data collection.