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Revised Draft 2nd Edition of the TCPS (December 2009)

Chapter 2

SCOPE AND APPROACH

The purpose of this Policy, as set out in Chapter 1, 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 – respect for persons, concern for welfare, and justice. 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.

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 Policy.

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

(a) research involving living human participants;

(b)  research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells.

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 as “research” in this Policy, involving “human participants” as defined in this Policy.

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

A determination that research is the intended purpose of the undertaking is key for differentiating activities that require review by an REB and those that do not.

For the purposes of this Policy, “human participants” (also referred to as “research participants,” or simply, “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 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 research participants.

Where researchers seek to collect, use, share and access different types of information or data about research participants, they are expected to determine whether the information or data proposed in research is identifiable or non-identifiable. Privacy concerns are strongest in regard to information that identifies a specific individual. For the purposes of this Policy, information is identifiable if it, alone or when combined with other information available to the person who receives it, can reasonably be expected to identify an individual. The term “personal information” generally denotes identifiable information about an individual. For further details about the types of information and the spectrum of identifiability, refer to Section A in Chapter 5 of this Policy.

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 in the ordinary course of their employment about organizations, policies, procedures, professional practices or statistical reports. Such individuals are not considered research participants for the purposes of this Policy.

For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, and other body fluids. 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, and includes a part of any of them. Further details on the above are provided in Chapter 12 of this Policy.

Where 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 exceptions from 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:

(a) the information is legally accessible to the public and appropriately protected by law; or,

(b ) 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, and that the law treats as publicly accessible or legally accessible to the public with appropriate protections.

Some types of information are legally accessible to the public in a certain form and for a certain purpose, often specified by law or regulations. For example, registries of deaths, court judgements, or public archives and publicly available statistics (e.g. Statistics Canada public use files). 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, for example those under access to information and privacy legislation or contractual restrictions imposed by the donor of the records, may nevertheless be considered publicly available for the purposes of this Policy.

To the extent that researchers use this information that is publicly available or legally made publicly accessible REB review is not required. Exemption from REB review is based on the “exclusive” reliance of research on the publicly available information, and where the information is legally accessible to the public a legally designated custodian/steward appropriately guards this information and protects its privacy and proprietary interests.

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, does not involve direct interaction between the researcher and individuals through the Internet medium, is not required to obtain 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.

There are, however, publicly accessible digital sites where there is a reasonable expectation of privacy.When accessing identifiable information in publicly accessible digital sites, such as Internet chatrooms, 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 Articles 10.3 and 10.4).

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).

Where 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:

(a) it does not involve any intervention staged by the researcher or direct interaction with the individuals or groups;

(b) it does not involve collecting personal information that will be disseminated through photographic, film or video footage in the research results; and

(c) where individuals or groups targeted for observation have no reasonable expectation of privacy.

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 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.

Refer to Chapter 10, Articles 10.3 and 10.4, that address the use of observational methods in qualitative research, including projects involving digital data collection on the Web.

Article 2.4 REB review is not required for research that relies exclusively on secondary use of anonymous information.

Application Secondary use refers to the use in research of information originally collected for a purpose other than the current research purpose. For the purposes of this Policy, anonymous information is a form of non-identifiable information that never had identifiers associated with it (e.g. anonymous surveys).

Rapid technological advances facilitate identification of information and make it harder to achieve anonymity. Where the researcher seeks data linkage of two or more anonymous sets of information and there is a reasonable prospect that this can generate identifiable information, then REB review is required.

Guidance related to other categories of identifiable and non-identifiable information and secondary use of identifiable information is provided in Chapter 5.

Activities Not Requiring REB Review

The following distinguishes research requiring REB review from activities that have traditionally employed similar methods and techniques. 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, as defined in this Policy, may still raise ethical issues that would benefit from careful consideration by a person 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, and performance reviews or testing within normal educational requirements when used exclusively for program review, 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, 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.

Data collected from such activities but used later as part of a research project would be considered secondary use of information not originally intended for research. 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.

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 governed by ethical practices established within the cultural sector.

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

Relationship between Ethics Review and Scholarly Review

Article 2.7 As part of 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 probity 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. 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 provides them with the full documentation of 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 by a permanent peer review committee where it exists);
  • if the scholarly review has not yet been undertaken and is indicated by the relevant disciplinary tradition, the REB should consider the following mechanisms in satisfying itself that scholarly review of the research has been undertaken:
    • 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 REB review shall start with an initial review of research that falls within the scope of this Policy. Ethics review shall continue throughout the life of the project.

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 review, the REB 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, REBs, and participants) 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 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 should involve a continuing dialogue between the participants, REBs and researchers, as appropriate, to enable the principles and practices surrounding research ethics to evolve.

In the conduct of their approved research, researchers shall report to their REB, in a timely manner, departures from the initially approved research, and events or issues that have ethical implications or that change the risk to participants.

Further details related to the application of continuing ethics review and the REB review of departures to approved research are outlined in Articles 6.14 and 6.15.

B. Approach to REB Review

This section introduces the concepts of risks and potential benefits of research (including a definition of minimal risk), as well as their balance in the conduct and ethics review of research. It addresses the preferred approach where the degree of scrutiny applied to ethics review should be proportionate to the level of risk that the research presents.

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 advancements 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 research participants and to others. Harm is anything that has a negative effect on the welfare of participants, and the nature of the harm may take a social, behavioural, psychological, physical or economic form.

Risk is a function of the magnitude or seriousness of the harm and the probability that it will occur, whether to participants or third parties (as outlined below). A proper ethical analysis of research should consider both the risk and the available methods of 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) through 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. 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, or the review of existing publications that provide rates of the relevant harms in similar issues. 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 study will proceed and any associated risks may be known only as the study 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, a “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 the participant in those aspects of his or her 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 makes 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.

Balancing Risks and Potential Benefits

The analysis, balance and distribution of risks and potential benefits are critical to the ethics of human research. The principle of concern for welfare of participants imposes an ethical obligation to design, assess and conduct research in a way that protects research 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 research 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, as well as any guidelines that exist for conducting research with these populations. (See Chapters 8, 9 and 10). Researchers should demonstrate to their REBs that they have a reasonable understanding of the likely effects of their research on the population being studied. This could be demonstrated, for example, by referring to previous experience with conducting research with a similar population, or published research on the effects of that type of research on the population being studied, or the presence of a community advisory group where it exists.

REBs should also be aware that some research, particularly in the social sciences, when conducting critical assessments of, for example, political or corporate institutions, may be legitimately critical and/or opposed to the welfare of those who are the focus of the research, and may cause them some harm. Such research should be carried out according to professional standards of the relevant discipline(s) or field(s) of research, but it should not be blocked through the use of risk-benefit analysis. In such cases, the balance of risks to those who are the focus of the research is mainly weighed against the potential benefit of new knowledge to society and the indirect benefits to the population to which the participant belongs.

Article 2.9 The REB shall adopt a proportionate approach to ethics review such that the lower the level of risk, the lower the level of scrutiny; the higher the level of risk, the higher the level of scrutiny. The expertise involved in the ethics review process should be proportionate to the risk of research to participants.

Application While all research shall be reviewed in adherence with the core principles, proportionate 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 ethics review starts with an assessment of the magnitude and probability of harms, and potential 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.

Both risks and potential benefits may span the spectrum from minimal through substantial. The concept of minimal risk (described above) provides a foundation for proportionate 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 research participants. In their conduct of research, researchers themselves may be exposed to risks that may take many forms (e.g. injury, incarceration, etc.) 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 such 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 flagging such concerns for review by an appropriate body within the institution.