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

Chapter 1

ETHICS FRAMEWORK

A. The Importance of Research and Research Ethics

The search for knowledge about ourselves and the world around us is a fundamental human endeavour. Research is a natural extension of this desire to understand and to improve the world in which we live.

The scope of research is vast. On the purely physical side, it ranges from seeking to understand the origins of the universe down to the fundamental nature of matter. At the analytic level, it covers mathematics, logic and metaphysics. Research involving humans ranges widely, including attempts to understand the broad sweep of history, the workings of the human body and the body politic, the nature of human interactions and the impact of nature on humans – the list is as boundless as the human imagination. For the purposes of this Policy, research is defined as an undertaking designed to extend knowledge through a disciplined inquiry or systematic investigation.

There can be no doubt that research has greatly enriched and improved our lives. A fundamental premise of this Policy is that research can benefit human society. In order to maximize the benefits of research, researchers must have certain freedoms. These freedoms include freedom of inquiry and the right to disseminate the results of that inquiry, freedom to challenge conventional thought and freedom from institutional censorship. Collectively, these are generally referred to as “academic freedom.” Along with these freedoms comes the responsibility to make sure that research involving human participants meets high ethical standards that respect and protect the research participants.

Research is a step into the unknown. Because it seeks to understand something not yet revealed, research often entails risks to research participants and others. These risks can be trivial or profound, physical or psychological, individual or social. History offers unfortunate examples where research participants have been needlessly and at times profoundly harmed by research, sometimes even dying as a result. Ethical principles and guidelines play an important role in advancing the pursuit of knowledge while protecting and respecting human participants in order to try to prevent such occurrences.

People have also been gratified and have had their lives enriched by their participation in research, either because they may have benefited directly or because their participation has contributed to the expansion of knowledge. Given the fundamental importance of research and of human participation in research, we must do all that we can as a society to ensure that research is conducted in an ethical manner so as to build public confidence and trust. By promoting and guiding the ethical conduct of research involving humans, this Policy seeks to contribute tangibly to these goals.

No single document can provide definitive answers to all ethical issues that may arise in an undertaking as complex as research involving humans. This Policy aims to assist those who use it – researchers, sponsors, members of research ethics boards (REBs), research participants and the public – to identify ethical issues in the design, conduct and oversight of research and to point the way to arriving at reasoned and ethical responses to these issues.

B. Core Principles

Respect for human dignity has been an underlying value of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS or the Policy) since its inception. Despite clear recognition of its centrality in research ethics, the term lends itself to a variety of definitions and interpretations that make it challenging to apply.

Respect for human dignity requires that research involving humans be conducted in a manner that is sensitive to the inherent worth of all human beings and the respect and consideration that they are due. In this Policy, respect for human dignity is expressed through three core principles – respect for persons, concern for welfare, and justice. These core principles transcend disciplinary boundaries and therefore, are relevant to the full range of research covered by this Policy.1

Article 1.1       The guidelines in this Policy are based on the following three core principles:

  • Respect for Persons
  • Concern for Welfare
  • Justice

These principles are complementary and interdependent. How they apply and the weight to be accorded to each will depend on the nature and context of the research being undertaken. Specific applications are addressed in the following chapters.

Respect for Persons

Respect for persons recognizes the intrinsic value of human beings and the respect and consideration that they are due. It encompasses the treatment of persons involved in research directly as participants and those who are participants because their data, or human biological or reproductive materials are used in research. Respect for persons incorporates the dual moral obligations to respect autonomy and to protect those with developing, impaired or diminished autonomy.

Autonomy includes the ability to deliberate about a decision and to act based on that deliberation. Respecting autonomy means giving due deference to a person’s judgement and ensuring that they are free to choose without interference. Autonomy is not exercised in isolation but is influenced by a person’s various connections to family, to community, and to cultural, social, linguistic, religious and other groups. Likewise, a person’s decisions can have an impact on any of these.

An important mechanism for respecting participants’ autonomy in research is the requirement to seek their free and informed consent. This requirement reflects the commitment that participation in research, including participation through the use of one’s data, or biological or reproductive materials, should be a matter of choice and that, to be meaningful, the choice must be informed. An informed choice is one that is based on as complete an understanding as is reasonably possible of the purpose of the research, what it entails, and its risks and potential benefits, both to the participant and to others.

Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequate information or understanding for deliberation, or a lack of freedom to act due to controlling influences or coercion. Such constraints may include the fear of alienating those in positions of authority, such as professional or personal caregivers, researchers, leaders, larger groups or a community to which one belongs. Other constraints may consist of barriers to accessing resources or knowledge outside the research context. Efforts should be made to eliminate or mitigate such constraints on autonomy where possible. However, in certain research contexts, incomplete disclosure of relevant information or deception may be necessary for the successful conduct of the research. (See Chapter 3, Section B for guidance on the ethical use of partial disclosure and deception).

Some people may be incapable of exercising autonomy because of immaturity, illness or certain mental health issues. While autonomy may be considered a necessary condition for participation in research, involving those who lack capacity can be valuable, just and even necessary. For those potential research participants, additional measures are needed to protect their interests and to ensure that their wishes (to the extent that these are known), are respected. These measures will generally include seeking consent from an authorized third party who is entrusted to make decisions on behalf of the prospective participant, based on knowledge of that person and their wishes or, if such wishes are unknown, consideration of their welfare. Even when the requirements of free and informed consent cannot be met, respect for persons requires involving the vulnerable person in decision-making where possible. This may include asking about their feelings regarding participation and/or for their assent. Where it is foreseeable that a participant may lose capacity during a research project, such as when studying dementia, it may be appropriate to ask research participants to express their preferences and ensure that they have authorized a trusted person to make decisions on their behalf should they lose the capacity to provide ongoing consent. (See Article 3.11 for guidance on research directives for individuals who lack capacity).

Concern for Welfare

Welfare is a holistic concept that refers to how a person or group is faring. The welfare of a person is the quality of that person's experience of life in all its aspects. Welfare is constituted of the impact on persons of such factors as their physical, mental and spiritual health, as well as their physical, economic and social circumstances. Thus, determinants of welfare can include housing, employment, security, family life, community membership, and social participation, among other aspects of life. Other contributing factors to welfare are privacy and the control of information about the person, and the treatment of human biological and reproductive materials according to the expressed or reasonably expected wishes of the person who was the source of the information or materials. A person or group's welfare is also affected by the welfare of those who are important to them. Harm includes any negative effects on welfare, broadly construed. (For the relationship between risk and harm, see Chapter 2, Section B).

Concern for welfare means that researchers and REBs should aim to protect the welfare of participants, and, in some circumstances, to promote that welfare. To do so, researchers and REBs must ensure that participants are not exposed to unnecessary risks. Researchers and REBs must attempt to minimize the risks associated with answering any given research question. They should attempt to achieve the best possible balance of risks and potential benefits in a proposed research study. Then, in keeping with the principle of respect for persons, participants or authorized third parties make the final judgement about the acceptability of this balance to them.

The welfare of groups can also be affected by research. Groups may benefit from the knowledge gained from the research, but they may also suffer from stigmatization, discrimination or damage to reputation. Engagement during the design process with groups whose welfare may be affected by the research can help to clarify the potential impact of the research and indicate where any negative impact on welfare can be minimized. Researchers must also consider the risks and potential benefits of their research and the knowledge it might generate for the welfare of society as a whole. Where research on individuals may affect the welfare of a group(s), the weight given to the group’s welfare will depend on the nature of the research being undertaken and the individuals or group in question. This consideration does not imply, however, that the welfare of a group should be given priority over the welfare of individuals.

Justice

Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating all people with equal respect and concern. Equity requires distributing the benefits and burdens of research participation in such a way that no segment of the population is unduly burdened by the harms of research or denied the benefits of the knowledge generated from it.

Treating people fairly and equitably does not always mean treating people in the same way. Differences in treatment or distribution are justified when there are morally relevant differences between persons or groups. One important difference that must be considered for fairness and equity is vulnerability. Vulnerability is often caused by limited capacity or limited access to social goods, such as rights, opportunities and power. Vulnerable persons or groups have traditionally included children, the elderly, prisoners, those with mental health issues, and those with diminished capacity for self-determination. Ethnic and racial minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly and inequitably in research or have been excluded from research opportunities. In order to treat vulnerable or marginalized persons or groups justly, they may need to be afforded special protections.

The recruitment process, both of participants who may become directly involved in research and those who participate as the source of information, or biological or reproductive materials to be used in research, is an important component of the fair and equitable conduct of research. Participants should be chosen based on inclusion criteria that are justified by the research question and not because they are easy to access or manipulate. In addition, inequity is created when particular groups fail to receive fair benefits of research or when groups, or their data, or biological or reproductive materials, are excluded from research arbitrarily or for reasons unrelated to the research question.

An important threat to justice is the imbalance of power that often exists in the relationship between researcher and participant. Participants will generally not understand the research in the same way and in the same depth as does the researcher. Historically, there have been instances in which this power imbalance has been abused, with resulting harm to participants.

Summary

The respectful treatment that flows from the application of these principles can help to engender the trust of participants, as well as of the public, which is integral to the research process. Researchers should also consider the implications of the core principles for sharing the benefits of the research.

In summary, the importance of research and the need to ensure the ethical conduct of research requires both researchers and REB members to navigate a sometimes difficult course between insufficient protection and overprotection of research participants. The three core principles that express the value of human dignity provide the compass for that journey.

C. How to Apply this Policy

Proportionate review

Proportionality is the approach to ethics review recommended throughout this Policy. (See in particular Articles 2.9 and 6.12). This Policy aims to strike an appropriate balance between recognizing the potential benefits of research and the need to protect participants from research-related harms, broadly construed. Given that research involving humans covers the full spectrum from minimal to significant risks, a crucial element of the approach laid out in this Policy is to ensure that the degree of scrutiny applied to ethics review is proportionate to the risks presented by the research. A reduced level of scrutiny of a research project with minimal risks does not imply a lower level of adherence to the core principles. Rather, the intention is to reduce unnecessary impediments and facilitate the progress of ethical research.

Research Ethics and Law

In addition to the principles and guidelines in this Policy, researchers are responsible for ascertaining and complying with all applicable legal and regulatory requirements with respect to consent and the protection of privacy of research participants. (See Chapter 5). These legal and regulatory requirements may vary depending on the jurisdiction in Canada in which the research is being conducted and who is funding and/or conducting the research, and may be comprised of constitutional, statutory, regulatory, common law, and/or international or legal requirements of jurisdictions outside of Canada. Where the research is considered to be a governmental activity, for example, standards for protecting privacy flowing from the Canadian Charter of Rights and Freedoms and federal privacy legislation and regulatory requirements would apply.

The law affects and regulates the standards and conduct of research involving humans in a variety of ways, such as privacy, confidentiality, intellectual property, the capacity of research participants as well as in many other areas. Human rights legislation prohibits discrimination on a variety of grounds. In addition, most documents on research ethics prohibit discrimination and recognize equal treatment as fundamental. REBs should also respect the spirit of the Canadian Charter of Rights and Freedoms, particularly the sections dealing with life, liberty and the security of the person as well as those involving equality and discrimination.

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 strive to comply with the law while complying with ethical principles. Researchers should consult with colleagues, the REB or any relevant professional body to help resolve any conflicts between law and ethics, and guide an appropriate course of action. This may include the institution or professional association providing the researcher with access to legal advice, if needed.

This legal context for research involving humans is constantly evolving and varies from jurisdiction to jurisdiction. For this reason, REBs and researchers should be aware of applicable laws to identify legal issues that may occur in the conduct of research. REBs may satisfy this obligation through expertise among their members or through wider consultation. The researcher may seek independent legal advice where necessary.

The perspective of the participant

In designing and conducting research or reviewing the ethics of research, researchers and REBs must be mindful of the perspective of the participant. It may be necessary to consider the context – social, economic, cultural or other – that shapes the participant’s life, to properly evaluate the implications of the research in terms of the core principles.

Appropriate expertise for review

It is also important that ethics review be appropriate to the disciplines, fields of research and methodologies of the research being reviewed. This means that REBs must understand the discipline and methodology under review and be able to assess the research on its own terms. This Policy provides more direction concerning appropriate expertise in Articles 6.4 and 6.5.

Interpreting this Policy

This Policy contains both guidance for the interpretation of the principles of research ethics, as well as a number of mandatory requirements for researchers, institutions and members of REBs. Mandatory provisions are signalled by the use of the term “shall.” Guidance for the interpretation of the core principles are generally indicated by use of the term “should.”

Evaluating the ethics of human research is not, and cannot be, an exact science. The interpretation and application of the articles and principles to particular circumstances will always be a part of the exercise. The articles in this Policy are intended to provide guidance, and in some cases, to set out certain requirements. The application sections are intended to supplement the articles with further explanation and examples. While they cannot guarantee identical decisions across REBs, they can ensure that researchers and REBs employing this Policy are operating within the same parameters and taking into account the same considerations as they design and evaluate human research.

At the end of certain chapters, a section entitled “References” provides links to documents that contain further guidance on specific topics addressed in the chapter. These references are not meant to be exhaustive, but are offered to assist the reader who wishes to explore certain topics in greater detail.

This Policy will continue to evolve in response to the emerging needs and suggestions of all those whom this Policy is intended to serve, including the research community, participants and the public.

Definitions

The definitions provided in this Policy are intended specifically and solely for the purposes of this Policy.

Endnote

[1] The three core principles incorporate within them the eight principles set out in the 1998 TCPS. Respect for human dignity is expressed through the three core principles. Respect for free and informed consent and respect for vulnerable persons are both reflected in the principle of Respect for Persons, while respect for vulnerable person is also reflected in the principle of Justice. Respect for privacy and confidentiality is an element of Concern for Welfare. Respect for Justice and Inclusiveness is covered in the core principle of Justice. Balancing Harms and Benefits, Minimizing Harm and Maximizing Benefits are in fact not principles, but are the means by which the principle of Concern for Welfare is put into effect. Each of these elements is addressed in greater detail in a chapter or section of this Policy.

By using these broader and more encompassing core principles, this Policy seeks to provide a more focused framework for the ethical guidance that follows. It is also a framework that harmonizes with other national and international ethics policies.