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Tolerable Tests

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

Bibliographic Data

ID5338310
AuthorsA Street (0000-0001-7874-0234, School of Social and Political Science, The University of Edinburgh, United Kingdom, corresponding author), Ann H Kelly (0000-0003-4658-2133, King's College London)
Year2025
Volume50
Issue4
Pages744-771
Publication date2025-07-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueScience Technology & Human Values (JOURNAL)
Journal identifiersISSN: 0162-2439 • E-ISSN: 1552-8251
PublisherSAGE Publications Inc (PUBLISHER)
DOI10.1177/01622439241252709
OpenAlexW4398139721
LanguageEN
Citations received3
References cited51

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

Ebola virus · Environmental health · Environmental planning · Global health · Medical emergency · Outbreak · Pathology · Public health · Biomedical Ethics and Regulation · Environmental Science · Ethics in Clinical Research · Medicine · Viral Infections and Outbreaks Research · Virology

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Unique citing works3
Citations per year3
Citation span2025 - 2026 (2)
Citation velocitycurrent
Highly citedNo
Citation typesNeutral: 2

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