3 Guiding Principles for Emergency Research Response

Accelerated clinical research in response to infectious disease health emergencies is a critical element of advancing health security and future freedom from infectious disease threats. An effective research response requires preparedness to ensure an expeditious assessment of candidate medical countermeasures (MCMs) for safety and efficacy through rigorous clinical trials. Ideally, a research response is simply a pivot from ongoing conduct of rigorous clinical trials within a continuously operating global clinical trials network based on national clinical research infrastructure. This chapter identifies and explains six principles that apply throughout an accelerated emergency research response: The first three of these apply specifically to public health emergencies, while the last three are in effect reminders that the fundamental principles of clinical research still hold in an emergency situation, even though the temptation to cut corners may don the cloak of compassion for suffering humanity. These six principles involve both moral and practical considerations for emergency response research to develop and reliably assess MCMs in a public health emergency.