Tri-Council Policy Statement on

Ethical Conduct for Research Involving Humans

Some key points from the NCEHR

Guidelines edited by P. McLeod for Psychology 2013 / 2023

Some context for the guidelines:

A. The Need for Research

B. A Moral Imperative: Respect for Human Dignity

C. Guiding Ethical Principles

1. Respect for Human Dignity:

2. Respect for Free and Informed Consent:

3. Respect for Vulnerable Persons:

4. Respect for Privacy and Confidentiality:

5. Respect for Justice and Inclusiveness:

6. Balancing Harms and Benefits:

7. Minimizing Harm:

8. Maximizing Benefit:

D. A Subject-Centred Perspective

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A. The Need for Research

Research involving human subjects is premised on a fundamental moral commitment to advancing human welfare, knowledge and understanding, and to examining cultural dynamics.

B. A Moral Imperative: Respect for Human Dignity

An ethic of research involving human subjects should include two essential components: (1) the selection and achievement of morally acceptable ends, and (2) the morally acceptable means to those ends.

C. Guiding Ethical Principles

Respect for Human Dignity: The cardinal principle of modern research ethics, as discussed above, is respect for human dignity.

Respect for Free and Informed Consent: Individuals are generally presumed to have the capacity and right to make free and informed decisions.

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.

Respect for Privacy and Confidentiality: Respect for human dignity also implies the principles of respect for privacy and confidentiality.

[* Be aware of the important distinction between confidential and anonymous.]

Respect for Justice and Inclusiveness: Justice connotes fairness and equity. Procedural justice requires that the ethics review process have 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.

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.

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 risk

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.

D. A Subject-Centred Perspective

Research subjects contribute enormously to the progress and promise of research in advancing the human condition. In many areas of research, subjects are participants in the development of a research project and collaboration between them and the researcher in such circumstances is vital and requires nurturing. Such collaboration entails an active involvement by research subjects, and ensures both that their interests are central to the project or study, and that they will not be treated simply as objects.

… Hence, researchers and REBs must strive to understand the views of the potential or actual research subjects.

… However, researchers and REB should also be aware that some research may be deliberately and legitimately opposed to the interests of the research subjects.

E. Academic Freedoms and Responsibilities

Researchers enjoy, and should continue to enjoy, important freedoms and privileges. To secure the maximum benefits from research, society needs to ensure that researchers have certain freedoms. It is for this reason that researchers and their academic institutions uphold the principles of academic freedom and the independence of the higher education research community. These freedoms include freedom of inquiry and the right to disseminate the results thereof, freedom to challenge conventional thought, freedom from institutional censorship, and the privilege of conducting research on human subjects with public monies, trust and support. However, researchers and institutions also recognize that with freedom comes responsibility, including the responsibility to ensure that research involving human subjects meets high scientific and ethical standards.

F. Ethics and Law

The law affects and regulates the standards and conduct of research involving human subjects in a variety of ways, such as privacy, confidentiality, intellectual property, competence, and 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.

G. Putting Principles into Practice

For meaningful and effective application, the foregoing ethical principles must operate neither in the abstract, nor in isolation from one another. Ethical principles are sometimes criticized as being applied in formulaic ways. To avoid this, they should be applied in the context of the nature of the research and of the ethical norms and practices of the relevant research discipline. Good ethical reasoning requires thought, insight and sensitivity to context, which in turn helps to refine the roles and application of norms that govern relationships. Thus, because principles are designed to guide ethical reflection and conduct, they admit flexibility and exceptions.

A. Research Requiring Ethics Review

Article 1.1

a. All research that involves living human subjects requires review and approval by an REB in accordance with this Policy Statement, before the research is started, except as stipulated below.

Article 1.1(a) includes the basic elements that determine whether research involving human subjects should undergo ethics review by an REB before the research begins. First, the undertaking must involve "research," which involves a systematic investigation to establish facts, principles or generalizable knowledge. This concept of research parallels those employed in other research ethics norms in Canada and abroad. Secondly, the research must involve humans as "research subjects," for which the potential scope is evidently very wide and requires further elaboration.

C. Analysis, Balance and Distribution of Harms and Benefits

C1. Minimal Risk

The standard of minimal risk is commonly defined as follows: if potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research then the research can be regarded as within the range of minimal risk. Above the threshold of minimal risk, the research warrants a higher degree of scrutiny and greater provision for the protection of the interests of prospective subjects. There is a similar threshold regarding undue or excessive offers of benefit. As an offer of payment in relation to research participation exceeds the normal range of benefits open to the research subject, it is increasingly likely to amount to an undue incentive for participation

C2. Scholarly Review as Part of Ethics Review

Article 1.5

a. The REB shall satisfy itself that the design of a research project that poses more than minimal risk is capable of addressing the questions being asked in the research.

b. The extent of the review for scholarly standards that is required for biomedical research that does not involve more than minimal risk will vary according to the research being carried out.

c. Research in the humanities and the social sciences which poses, at most, minimal risks shall not normally be required by the REB to be peer reviewed.

Section 2

Free and Informed Consent

Requirement for Free and Informed Consent

Article 2.1

a. Research governed by this Policy (see Article 1.1) may begin only if (1) prospective subjects, or authorized third parties, have been given the opportunity to give free and informed consent about participation, and (2) their free and informed consent has been given and is maintained throughout their participation in the research.

b. Evidence of free and informed consent by the subject or authorized third party should ordinarily be obtained in writing. Where written consent is culturally unacceptable, or where there are good reasons for not recording consent in writing, the procedures used to seek free and informed consent shall be documented.

c. The REB may approve a consent procedure1 which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent, provided that the REB finds and documents that:

i. The research involves no more than minimal risk to the subjects;

ii. The waiver or alteration is unlikely to adversely affect the rights and welfare of the subjects;

iii. The research could not practicably be carried out without the waiver alteration;

iv. Whenever possible and appropriate, the subjects will be provided with additional pertinent information after participation; and

v. The waivered or altered consent does not involve a therapeutic intervention.

d. In studies including randomization and blinding in clinical trials, neither the research subjects nor those responsible for their care know which treatment the subjects are receiving before the project commences. Such research is not regarded as a waiver or alteration of the requirements for consent if subjects are informed of the probability of being randomly assigned to one arm of the study or another.