Conducting 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. Publicly-declared emergencies are extraordinary events that arise suddenly or unexpectedly, pose an enormous risk to the population, and require an 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. 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, data integrity, the preservation of biological specimens, as well as the preservation, availability, and administration of interventional products. A national standard is required to guide researchers 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 ongoing research.