Ethical Conduct for Research Involving Humans

Tri-Council Policy Statement

The three major federal granting councils (CIHR, NSERC and SSHRC) have developed the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2).

The Councils will consider funding only to those universities that certify compliance with this policy statement for all research involving human participants. The ethical conduct of research involving human participants is also a legitimate concern of Saint Mary's University. All research involving human participants at Saint Mary's University, whether funded or unfunded, will be reviewed and approved by the Research Ethics Board (REB).

The 3 Core Ethical Principles

The purpose of the new Tri-Council policy is to protect the interests of people who participate in research studies. The Tri-Council Policy is based on 3 Core Principles: Respect for Persons, Concern for Welfare and Justice. These principles are complementary and independent.  How they apply and the weight accorded to each will depend on the nature and context of the research being undertaken.

1.  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 are incorporated 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 judgment and ensuring that the person is free to choose without interference.  Respect for persons also includes a commitment to accountability and transparency in the ethical conduct of research. Certain factors may diminish a person's ability to exercise their autonomy, such as inadequate information or understanding for deliberation, a lack of freedom to act due to controlling influences or coercion, barriers to accessing resources or knowledge outside the research context, youth, cognitive impairment, mental health issues or illness therefore additional measures are needed to protect their interests and to ensure that their wishes are respected.

2.  Concern for Welfare

The welfare of a person is the quality of that person's experience of life in all its aspects. Welfare consists of the impact on individuals such as their physical, mental and spiritual health, as well as their physical, economic and social circumstances. Other contributing factions to welfare are privacy and the control of information about the person according to free, informed and ongoing consent of the person who was the source of the information or materials. Harm includes any negative effects on welfare. Concern for welfare means that researchers shall aim to protect the welfare of participants and, in some circumstances, to promote that welfare in view of any foreseeable risks associated with the research and to provide participants with enough information to be able to adequately assess risks and potential benefits associated with their participation in the research. 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.

3.  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 knowledge generated from it. 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.  People or groups whose circumstances cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in research.  Participation should be based on inclusion criteria that are justified by the research question. An important threat to justice is the imbalance of power that may exist in the relationship between researcher and participant and there have been instances in which such power imbalance has been abused, with resulting to harm to participants.