Ethical Review and Oversight of Human Research

One of the primary ethical justifications for conducting human research is to benefit society. Because human research seeks to understand something not yet known, participation in human research is not without risks. Given the fundamental importance of human research, society must ensure that research is conducted ethically, scientifically, safely, and in a manner that safeguards the rights and welfare of research participants. The ethical oversight of human research in Canada lies with ethics boards or committees. These are commonly referred to research ethics boards (REBs) or independent review boards (IRBs) and can exist in public institutions or in the private sector. Canada’s Food and Drugs Act and applicable Regulations incorporate an internationally-accepted good clinical practice guideline that stipulates that interventional (clinical) research on humans cannot be initiated without the review and approval by a properly constituted REB or IRB. However, the regulations only apply to interventional (clinical) research and do not include policies or standards pertaining to how REBs or IRBs determine a favourable outcome. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) is a joint policy of Canada’s three federal research agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). As a policy, the TCPS informs and provides guidance to Canadian researchers on what is important and why regarding the ethical conduct of research involving humans. Currently, REBs and IRBs use the guidance of the TCPS in their determination of ethical favourability of human research. The TCPS does not apply to all REBs and IRBs in Canada, and because the TCPS is a policy, interpretation of it varies from one organization to another, or from one province to another, creating barriers to harmonization, collaboration, and growth of this industry sector within Canada and internationally. In the absence of Canadian regulations governing human research, the necessity for a national standard governing the ethical review and oversight of research in humans is paramount.