Emergency Preparedness in Clinical Research

We live in a destabilizing world, where natural disasters, wars, pandemics, and other disruptive events are becoming more common. In clinical research, such disruption is detrimental to research participants and to the advances in scientific knowledge that will benefit future patients. Emergency responses, however, can be fragmented and inefficient. The COVID-19 pandemic has impressed this point on the research community, raising awareness of the need to plan ahead and adapt in response to disaster. To date, most of the attention has focused on actual responses to the pandemic – primarily setting up new, pandemic-focused trials, or calling for changes to clinical trial infrastructure in anticipation of the next pandemic. However, other types of emergencies are often left out of these discussions.

At this meeting of the MRCT Center Bioethics Collaborative, we hope to explore sponsors’ and investigators’ ethical obligations to plan for emergencies in advance. What obligations do they have to participants? How much preparation is necessary? How much is realistic? What obligations do research teams on the ground in disruptive and potentially dangerous situations have to research participants and to maintaining research protocols? Answering these questions and more will allow the clinical research community to develop the guidelines and infrastructure necessary to prepare for future emergency situations.

Deliverables