Tolerable Tests: Regulating Diagnostic Innovation in a Global Health Emergency, Lessons from Ebola

Abstract

The response to the 2014-2016 West African epidemic was a watershed for emergency research and innovation, forcing a shift in regulatory norms as evidentiary standards were pitted against humanitarian imperatives and biosecurity concerns. This article examines how those ethical and epistemic negotiations unfolded in practice through the development, testing, and use of novel tools for Ebola diagnosis with a focus on Sierra Leone. We track the priorities placed on the accuracy, feasibility, and clinical efficiency of Ebola diagnostic platforms and explore how these varied over the course of the outbreak and for different actors involved in their deployment. The lack of clarity over which tools might be fit for purpose exposed the profound ambiguities around the nature, scope, and purpose of building in-country Ebola diagnostic capacity. Ultimately, we argue that the accelerated regulatory process coordinated by the World Health Organization operated as a liminal procedure that both revealed the scientific, ethical, and political trade-offs and inequalities attendant to an emerging regime of emergency research and development, and provided a tentative, reflexive platform for regulatory experimentation, deliberation, and reform.