Ethical Review and Oversight of Human Research During Publicly-Declared Emergencies

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 as research ethics boards (REBs) or independent review boards (IRBs) and can exist in public institutions or in the private sector. Publicly-declared emergencies are extraordinary events that arise suddenly or unexpectedly, pose an enormous risk to the population, and require urgent response in order to minimize harm. Declaration of the emergency is done by authorized public officials in accordance with legislation and/or public policy. Publicly-declared emergencies include natural disasters, outbreaks of communicable diseases, humanitarian emergencies, and environmental disasters. Publicly-declared emergencies have the potential to present significant risks to research participants in ongoing research. For example, research participants who may not normally be considered in a situation of vulnerability, may become so by the very nature of the emergency, while other research participants already in a situation of vulnerability, may become more acutely so. Additionally, new research may emerge as a direct result of a publicly-declared emergency that may require a temporary modification of normal practices and procedures. The existence of an emergency does not override established norms regarding research participant protection and ethical oversight of research. A national standard is required to guide REBs and IRBs in the development of procedures for publicly-declared emergencies that are proportionate to the complexity and urgency of the emergency, and the risks posed by the research under review.