Human Subjects Research in Bioemergencies

Bioemergencies present unique ethical and operational challenges to performing clinical research with human subjects. Patient care, public health protection, and responder safety are paramount in these situations, which often involve high biosafety level pathogens and containment conditions. While working to halt the spread of disease, research is necessary to understand the ongoing outbreak as well as increase response capabilities in the face of future threats. Research in bioemergencies has novel and unexpected challenges that vary greatly depending on the type of studies being conducted and data being collected. This chapter will provide an understanding of basic principles, challenges, and regulatory components of human subjects research during bioemergencies, as well as ongoing practical components of these studies.