3 Guiding Principles for Emergency Research Response

Abstract

AbstractAccelerated 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: Research should be an integral part of preparedness and emergency response. Response research must align with the three primary goals of an emergency response to: (a) save lives, (b) accelerate the end of the outbreak, and (c) develop measures to prevent and mitigate future outbreaks. Response research should be implemented quickly and efficiently based on preparedness plans. Scientific and ethical standards for human subject research do not change during a health emergency. Research response should be led by the government of the country experiencing the health emergency. Good participatory practice (GPP) applies to research in health emergencies. 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.