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Draft 2nd Edition of the TCPS (December 2008)

Chapter 1

ETHICS FRAMEWORK

A. The Importance of Research and Research Ethics

Research is a distinctly human enterprise, a natural extension of our desire to understand and to improve the world in which we live. The search for knowledge about ourselves and the world around us has been an aspect of human endeavour throughout recorded history. We observe, we question, and then we test our observations and theories. Over time, these instinctive activities have developed into disciplined inquiry to extend knowledge.

The scope of research is vast. On the purely physical side it ranges from seeking to understand the origins of the universe, down through 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.

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 society. But research is, by any definition, a step into the unknown: it seeks to understand something not yet revealed. Because we do not know where it will lead us, research may entail risks. These risks can be trivial or profound, physical or emotional - but they do exist.

History offers unfortunate examples where participants in research have been needlessly and at times profoundly harmed by research. It offers many more examples where people have been gratified and their lives enriched by their participation in research and the sense that they have contributed to the expansion of knowledge. Given the fundamental importance of research and of human participation in research, we must do all we can as a society to ensure that research proceeds in an atmosphere of public confidence and trust. By promoting and guiding the ethical conduct of research involving humans, this Policy seeks to contribute tangibly to that essential public confidence and trust.

Respect for human dignity has been a founding value of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (“the Policy”) since its inception. The term lends itself to a wide variety of interpretations. At its most basic, it requires that research involving humans be conducted ethically - ­ that is, in accordance with an agreed-on set of principles. This Policy takes human dignity as the foundation for three core principles that transcend disciplinary boundaries and are therefore relevant to the full range of research covered by this Policy. The intent is that the three core principles will collectively constitute a functional definition of human dignity, one that will provide clarity and guidance for the purposes of this document.

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 sets out guiding principles for the design, conduct and oversight of ethical research. Its aim is 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

Article 1.1 The three core principles that are the basis for the guidelines developed in the Policy are:

  • Concern for welfare;
  • Respect for autonomy; and
  • Respect for the equal moral status of all humans.

These principles are not absolute. They may, at times, conflict. They do not apply in all circumstances, to all types of research, as is set out in the following chapters. How they apply and the weight to be accorded to each one will depend on the nature and context of the research being undertaken.

Welfare

Welfare is a broad concept that encompasses the full range of concerns that form the basis of an individual’s decisions. It includes the individual’s own well-being, such as his or her physical and mental health, but it is broader. It also involves all concerns regarding the individual’s physical, social, economic and cultural environments, including the welfare of those who are important to the participant. One key aim of this Policy is not only to safeguard the well-being of the individual research participant, but to do so in a way that preserves and respects the broader values with which that individual identifies.

The researcher is responsible for considering welfare when designing and conducting a research project. However, concern for a participant’s welfare does not imply that research must present no risk. Welfare must be assessed in light of the aims and the methodology of the research. Some risks are legitimate and necessary if the researcher is to gain the desired knowledge.

Researchers must be conscious of the impact their research can have, not only on those who participate in it, but also on others not directly involved. Just as the benefits of research can be enjoyed by larger groups, it is also possible that the knowledge gained from research can have negative effects, such as the stigmatization of groups. Consultation during the design of the research with groups who may be affected can help clarify the potential impact of the research and may provide the best assurance that any negative impact of the research is minimized.

Prior to the research’s being presented to prospective participants, the REB is responsible for ensuring that the risks of research are reasonable. It is the assessment of the relative risks and potential benefits (the “risk-benefit ratio”) that should determine whether the research risks are proportionate to the potential contribution of the research to the advancement of knowledge. Researchers should then explain to prospective participants the known or expected risks their research presents. In the end, since they bear the risks, it is the research participants themselves who must judge whether the risks and benefits of participating are acceptable. This imperative follows from the next core principle, autonomy.

Autonomy and the Decision to Participate in Research

Respect for autonomy implies that participation in research should usually be voluntary - a matter of choice. To be meaningful, that choice should be informed. This means it should be based on as complete an understanding as reasonably possible of the purpose of the research, what it entails, and its foreseeable risks and benefits, both to the participant and to others.

How researchers obtain and maintain consent for participation in their projects will differ according to the nature of the research and the circumstances and capacity of the potential participants. While research ethics policies traditionally refer to autonomy as a condition for participation in research, we must consider the reality that:

  • Not all research participants are capable of exercising their autonomy;
  • Even those with the capacity to express their autonomy may experience constraints on how they do so; and
  • In certain research contexts, incomplete disclosure of relevant information or deception is necessary for the successful conduct of the research.

Autonomy is not always the paramount consideration. Indeed, for some types of research, free and informed consent is not even required. The real inquiry, therefore, is the extent to which the exercise of autonomy is possible, and whether it can be validly exercised: either directly, by the prospective participant, or by an authorized third-party decision maker. Beyond the decision of an individual participant or an individual’s authorized third-party decision-maker, the exercise of autonomy is influenced by an individual’s various connections: to family; to community; and to cultural, social, linguistic, religious and other groups. The individual’s decision can have an impact on and be constrained by any of these. Under some conditions, the views of the groups affected may have to be considered by the researcher and the REB in approving the research. The weight given to it will depend on the nature of the research being undertaken and the individuals or groups in question. This does not, however, imply that group consent is a condition of ethics approval.

The ethical recruitment of participants in human research goes beyond an evaluation of autonomy, which often seems to focus primarily on whether an adult person has signed a consent form. It is a more complex consideration of whether the recruitment of participants has been carried out on a basis that is ethically legitimate and methodologically justified. It should be a process that respects and reflects, wherever possible, the values and preferences of the individual participants and, where necessary, engages the groups that may be affected by the research.

Equal Moral Status of All Humans

Equal moral status means that all human beings should be accorded the same level of respect and concern in the conduct of research. This means that, for example, researchers may not be arbitrarily discriminatory in the recruitment of participants and that participants should share the burdens and the benefits of research equitably. Researchers may choose particular groups as the focus of their research, so long as the selection criteria for those to be included in the research are germane to answering the research question.

Respect for the equal moral status of all individuals is also important because the relationship between researcher and participant is often marked by an imbalance of power. The participant will generally not understand the research in the same way and in the same depth as does the researcher. In some cases, historically, this power imbalance has been a source of harm or abuse. Participants must have the assurance that they will be treated fairly and not be exploited. Researchers should conduct themselves in a way that earns the trust of participants. Respect for the equal moral status of all individuals is an important element in establishing that trust.

A special problem of according equal treatment to all emerges with regard to research populations that may be particularly vulnerable. In light of a few notorious cases of abuse, there has been a tendency to try to afford extra protection to certain categories of participants. While some such measures may be warranted, equal moral regard for all requires that the protection not be so comprehensive as to deny the groups access to participation in ethical research.

In designing and conducting research, researchers should consider their relationship to participants as a form of collaboration, even in fields where participants do not (indeed cannot) contribute to the design of the research. The touchstone for the researcher should be to respect the welfare, autonomy and equal moral status of all participants. That will engender trust, and the trust of individual participants, as well as public trust, is necessary for 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 forces both researchers and REB members to navigate a sometimes difficult course between insufficient protection and overprotection of research participants. The three core principles, which characterize respect for human dignity, provide the compass for that journey.

C. A Guide to this Policy

To be effective, a research ethics policy should provide guidance for the interpretation of the principles of research ethics. This Policy aims to strike an appropriate balance between recognizing the potential benefits of research and the need to protect participants from research-related risks. Given that research involving humans covers the full spectrum from minimal to high risk, the first 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 level of risk that the research presents.

Proportionality is the key to ensuring that those who volunteer to participate in research are not exposed to unnecessary risks, while at the same time avoiding the creation of unnecessary barriers or delays to research. Those involved in the design and the review of research should keep ethical considerations in mind. For any given research question, the design should be structured so that research risks are minimized. Equally, those involved in reviewing research (both initial and continuing review) should do so with an appreciation of the level of review that is appropriate to the risks of the project. The scope and intensity of ethics review should be proportionate to the level of risk involved. When those involved in the review of research tailor their level of scrutiny to the level of risk, they reduce unnecessary impediments and facilitate the progress of worthwhile and ethical research. This is the crux of proportionality, and it is a message that recurs throughout this Policy.

It is equally 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.

Finally, it is not enough to say that ethics review must be approached from the perspective of the participant. It is necessary to consider the context - social, economic, cultural or other - that shapes the participant’s life.

Together, the core principles and proportionality form the basis of a sound approach to research ethics - one that recognizes the value of research, while respecting, valuing and protecting research participants.

Members of REBs should view the Policy’s guidelines, not as rules to be applied, but as principles to be interpreted. This requires a thorough understanding of the principles in this Policy. It also requires the exercise of sound judgment in deciding how to apply those principles. Because the principles are intended to cover a wide variety of approaches to research and types of research, they may and should be interpreted differently in different circumstances. The use of discretion in the exercise of interpretation will be necessary. A certain variability of decisions among REBs may therefore be inevitable. These should not be so great, however, as to result in fundamental conflicts among the decisions of REBs.

This Policy is designed to provide general guidance with respect to the ethical conduct of research involving humans. It is divided into chapters, each of which focuses on a different aspect of the ethics of research and research ethics review. The chapters are divided into articles that provide targeted guidance on specific issues. Each article is followed by an explanatory section - “Application” - that describes in more detail considerations relevant to interpreting the article. In some cases, illustrative examples are provided, and in some sections other sources - “References” - are provided for more detailed guidance on particular topics.

Where the articles and their applications do not address an ethical issue in question, the researcher or REB should return to the core principles in order to resolve their dilemma.

This Policy, which provides a distinctive, comprehensive approach to considering research ethics, will continue to evolve as new issues emerge.