Guiding Principles

Health Canada's Research Ethics Board (REB) follows the ethical principles set out in the Tri-Council Policy Statement (TCPS). These principles have been widely adopted by diverse research disciplines and as such, they express common standards, values and aspirations of the research community.

Respect for Human Dignity
The cardinal principle of modern research ethics, as discussed above, is respect for human dignity. This principle aspires to protect the multiple and interdependent interests of the person -- from bodily to psychological to cultural integrity.
In certain situations, conflicts may arise from application of these principles in isolation from one other. Researchers and REBs must carefully weigh all the principles and circumstances involved to reach a reasoned and defensible conclusion.
Respect for Free and Informed Consent
Individuals are generally presumed to have the capacity and right to make free and informed decisions. Respect for persons thus means respecting the exercise of individual consent. In practical terms within the ethics review process, the principle of respect for persons translates into the dialogue, process, rights, duties and requirements for free and informed consent by the research subject.
Respect for Vulnerable Persons
Respect for human dignity entails high ethical obligations towards vulnerable persons - to those whose diminished competence and/or decision-making capacity make them vulnerable. Children, institutionalized persons or others who are vulnerable are entitled, on grounds of human dignity, caring, solidarity and fairness, to special protection against abuse, exploitation or discrimination. Ethical obligations to vulnerable individuals in the research enterprise will often translate into special procedures to protect their interests.
Respect for Privacy and Confidentiality
Respect for human dignity also implies the principles of respect for privacy and confidentiality. In many cultures, privacy and confidentiality are considered fundamental to human dignity. Thus, standards of privacy and confidentiality protect the access, control and dissemination of personal information. In doing so, such standards help to protect mental or psychological integrity. They are thus consonant with values underlying privacy, confidentiality and anonymity.
Respect for Justice and Inclusiveness
Justice connotes fairness and equity. Procedural justice requires that the ethics review process has fair methods, standards and procedures for reviewing research protocols, and that the process be effectively independent. Justice also concerns the distribution of benefits and burdens of research. On the one hand, distributive justice means that no segment of the population should be unfairly burdened with the harms of research. It thus imposes particular obligations toward individuals who are vulnerable and unable to protect their own interests in order to ensure that they are not exploited for the advancement of knowledge. History has many chapters of such exploitation. On the other hand, distributive justice also imposes duties neither to neglect nor discriminate against individuals and groups who may benefit from advances in research.
Balancing Harms and Benefits
The analysis, balance and distribution of harms and benefits are critical to the ethics of human research. Modern research ethics, for instance, require a favourable harms-benefit balance -- that is, that the foreseeable harms should not outweigh anticipated benefits. Harms-benefits analysis thus affects the welfare and rights of research subjects, the informed assumption of harms and benefits, and the ethical justifications for competing research paths. Because research involves advancing the frontiers of knowledge, its undertaking often involves uncertainty about the precise magnitude and kind of benefits or harms that attend proposed research. These realities and the principle of respect for human dignity impose ethical obligations on the prerequisites, scientific validity, design and conduct of research. These concerns are particularly evident in biomedical and health research; in research they need to be tempered in areas such as political science, economics or modern history (including biographies), areas in which research may ethically result in the harming of the reputations of organizations or individuals in public life.
Minimizing Harm
A principle directly related to harms-benefits analysis is non-maleficence, or the duty to avoid, prevent or minimize harms to others. Research subjects must not be subjected to unnecessary risks of harm, and their participation in research must be essential to achieving scientifically and socially important aims that cannot be realized without the participation of human subjects. In addition, it should be kept in mind that the principle of minimizing harm requires that the research involve the smallest number of human subjects and the smallest number of tests on these subjects that will ensure scientifically valid data.
Maximizing Benefit
Another principle related to the harms and benefits of research is beneficence. The principle of beneficence imposes a duty to benefit others and, in research ethics, a duty to maximize net benefits. The principle has particular relevance for researchers in professions such as social work, education, health care and applied psychology. As noted earlier, human research is intended to produce benefits for subjects themselves, for other individuals or society as a whole, or for the advancement of knowledge. In most research, the primary benefits produced are for society and for the advancement of knowledge.
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