Proportionate Approach to REB Review
This Policy aims to strike an appropriate balance between recognition of the potential benefits of research, and protection of participants from research-related harms, including injustices and breaches of Respect for Persons. Given that research involving humans spans the full spectrum of risk, from minimal to significant, a crucial element of REB review is to ensure that the level of scrutiny of a research project is determined by the level of risk it poses to participants (see Article 6.12). A reduced level of scrutiny applied to a research project assessed as minimal risk does not imply a lower level of adherence to the core principles. Rather, the intention is to ensure adequate protection of participants is maintained while reducing unnecessary impediments to, and facili-tating the progress of, ethical research. This approach is in keeping with the need to respect academic freedom and not to place unwarranted constraints upon it.
In the context of both initial and continuing research ethics review, the REB assesses the ethical acceptability of a research project through consideration of the foreseeable risks, the potential benefits and the ethical implications of the project (see Article 2.9). These two steps constitute the proportionate approach to REB review that is recommended throughout the Policy.
12 TCPS 2
Chapter 1 – Ethics Framework
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 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 they may comprise 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, 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 areas, including, but not limited to privacy, confidentiality, intellectual property and the capacity of participants. In addition, human rights legislation and most documents on research ethics prohibit discrimination on a variety of grounds and recognize equal treatment as fundamental.
REBs and researchers should also respect the spirit of the Canadian Charter of Rights and Freedoms, particularly the sections dealing with life, liberty and 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 the law and the guidance of the ethical principles in this Policy. In such situations, researchers should strive to comply with the law in the application of ethical principles. Researchers should consult with colleagues, the REB or any relevant professional body, and if necessary, seek independent legal advice to help resolve any conflicts between law and ethics, and guide an appropriate course of action.
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 so they can 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 when 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 various contexts (e.g., social, economic, cultural) that shape 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 research ethics review be appropriate to the disciplines, fields of research, and methods of the research being reviewed. This means that REBs must understand the discipline and method 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.
Chapter 1 – Ethics Framework
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 is generally indicated by use of the term “should.”
Evaluating the ethics of research involving humans 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. Although 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 research involving humans.
At the end of some 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
1The three core principles incorporate within them the eight guiding ethical 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 Persons 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 Benefit 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.
Chapter 2
SCOPE AND APPROACH
Introduction
The purpose of this Policy, as set out in Chapter 1, is to establish principles to guide the design, ethical conduct and ethics review process of research involving humans. This chapter outlines the scope of application of the Policy and the approach to research ethics review that flows from the core principles – Respect for Persons, Concern for Welfare, and Justice. The preferred approach to research ethics review is a proportionate approach. The research ethics board (REB) tailors the level of scrutiny by an REB to the level of risk presented by the research, and assesses the ethical acceptability of the research through consideration of the foreseeable risks, the potential benefits and the ethical implications of the research, both at the stage of the initial REB review and throughout the life of the project (continuing ethics review). The establishment, governance, jurisdiction and composition of REBs, and operational issues related to their functioning are addressed in Chapter 6.