Research Ethics Boards (REBs) evaluate research projects involving human subjects, including genetic research. Quebec and Canadian institutions where such research takes place or that finance such research require prior REB approval.

An REB is composed of at least five people: two experts in evaluated research; one ethics expert; one legal expert; and a representative of the public.

REBs evaluate the scientific and ethical aspects of research projects. Ethical evaluation involves balancing the interests of participants, society, and science and draws on principles to do this, including the following three key principles: respect for persons, beneficence, and justice.

Examples of some of the questions that REBs address include: Will free and informed consent be obtained? Will the confidentiality of personal information be protected? Do the anticipated benefits of the research exceed the risks, or vice versa? Is the proposed population for the research over-recruited?

• The World Medical Association (WMA), in its Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2008), establishes general ethical guidelines. To begin, the well-being of the subject prevails over the interests of science and society (Art. 5). Furthermore, the WMA requires the protection (or respect) of rights and dignity, as well as the protection of vulnerable subjects. Researchers should take into account the relevant ethical norms within their jurisdiction as well as international norms. Finally, the principle requiring that the expected benefits of research outweigh inherent risks is brought forth (Art. 18).
• UNESCO’s Universal Declaration on Bioethics and Human Rights (2005) contains a section that addresses REBs (Article 19). This section articulates the importance of the independence of research ethics committees and specifies that the role of REBs includes facilitating public education on the social, legal, and ethical issues surrounding research involving human subjects.
• The World Health Organization’s (WHO) Operational Guidelines for Ethics Committees that Review Biomedical Research (2000) contains provisions addressing the membership and role of ethics committees, in addition to providing guidance on the evaluation process.
• The Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO) created International Ethical Guidelines for Biomedical Research Involving Human Subjects (2003). These guidelines emphasize the three pillars of ethical research: “respect for the person, beneficence and justice.” They also contain specific provisions addressing consent, conflicts of interest, and compensation for research participants.

• The Canadian Institutes of Health Research Act (2000) specifies that research must “take into consideration ethical issues”. The law delegates to the Canadian Institutes of Health Research (CIHR) the role of ensuring that international norms are respected in research, and encouraging the discussion of ethical questions within the scientific community.
• The Tri-Council Policy Statement (1998, 2000, 2005) applies to all research projects financed or carried out in an institution that is receiving funding from one of the following federal funding agencies: Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC) or the Social Sciences and Humanities Research Council of Canada (SSHRC). The Statement includes provisions on REB membership, conflicts of interest and confidentiality, amongst others. It also provides guidance for the evaluation of research, including: respect for human dignity, and vulnerable people, consent, confidentiality and the need to balance the advantages and disadvantages of research.

• The Fonds de recherche en santé du Québec’s (FRSQ) Guide d'éthique de la recherche et d'intégrité scientifique (2003) address REB membership and require REBs to be independent of all financial or material advantages and to maintain administrative independence. The Guidelines also provide requirements relative to confidentiality, consent and risks of research.
• It is important to underline that individual institutions, such as hospitals, may have internal governance frameworks for research evaluation and REBs. Such frameworks must respect provincial and national law.

REB members may find themselves in a conflict of interest when their judgment of a research project may be influenced by a secondary interest, such as financial gain or prestige. Institutions may also find themselves in a conflict of interest when financial or administrative independence is at risk of compromise depending on the outcome of an REB decision.

To address conflict of interest problems, the immediate disclosure of real and potential conflicts is recommended. In 2003, the Canadian Institutes of Health Research (CIHR) created a committee to specifically address conflict of interest situations. The committee has drafted the Policy on Conflict of Interest and Confidentiality in the context of Merit, Relevance and Peer Review.

Some argue that the research ethics process, with overly restrictive requirements, slows down the progress of research. The argument is that complicated informed consent forms and in-depth evaluation of even minimal risks slows the grant and research approval process, and ultimately slows the progress of research. This burdening of research is itself considered unethical.

The Sponsors’ Table for Human Research Participant Protection in Canada proposed mechanisms to ensure that ethical review is proportionate to risks faced by research participants. Further information is available at: http://www.hrppc-pphrc.ca

A debate is currently underway about the possibility of establishing a national or provincial system of accreditation for REB membership. Such training could address the role of REBs and the decision-making process.

People in favour of this initiative argue that the standardization of REB expertise, and consequently of ethical evaluation are advantageous. Those who oppose this initiative worry about an increase in bureaucracy and that standardization will undermine the diversity of viewpoints in ethics deliberations that are valuable on REBs. According to detractors, the appeal of REBs lies in their multidisciplinarity.