Organizational culture and risk in high-stakes life sciences research

Introduction Contemporary governance increasingly relies on precautionary regulation to address uncertain future harms, yet such rules often leave significant room for interpretation. This article examines how organizations operationalize precautionary mandates using high-risk life science oversight as an empirical case. Methods Drawing on qualitative transcripts from a multi-institution deliberative workshop involving biosafety professionals, biosecurity experts, compliance personnel and researchers, we examine how participants interpreted and implemented policies governing dual use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPP). Results The findings show that precautionary governance is institutionally mediated through professional discretion, organizational culture, accountability infrastructures, and local interpretations of policy. Oversight decisions were shaped by scientific and technical considerations, liability concerns, reputational risks, organizational priorities, and expertise limitations rather than formal regulatory requirements alone. Discussion We conceptualize this process as regulatory translation: the organizational work through which precautionary mandates become actionable decisions. We also identify a compliance-discretion paradox in which accountability systems seek standardization while effective governance depends upon professional expertise and judgment. The article contributes to scholarship on risk and regulation by showing how precautionary governance is translated into practice through institutional mediation.

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Publication Details

Journal
Frontiers in Political Science
Published
2026-10-28
DOI
https://doi.org/10.3389/fpos.2026.1945896
Primary Topic
Regulation and Compliance Studies
Type
article
Field-Weighted Citation Impact
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article

Organizational culture and risk in high-stakes life sciences research

David R. Gillum, Kathleen Margaret Vogel
4 links
Frontiers in Political Science
Regulation and Compliance Studies
article

Organizational culture and risk in high-stakes life sciences research

David R. Gillum, Kathleen Margaret Vogel
article en

Abstract

Introduction Contemporary governance increasingly relies on precautionary regulation to address uncertain future harms, yet such rules often leave significant room for interpretation. This article examines how organizations operationalize precautionary mandates using high-risk life science oversight as an empirical case. Methods Drawing on qualitative transcripts from a multi-institution deliberative workshop involving biosafety professionals, biosecurity experts, compliance personnel and researchers, we examine how participants interpreted and implemented policies governing dual use research of concern (DURC) and pathogens with enhanced pandemic potential (PEPP). Results The findings show that precautionary governance is institutionally mediated through professional discretion, organizational culture, accountability infrastructures, and local interpretations of policy. Oversight decisions were shaped by scientific and technical considerations, liability concerns, reputational risks, organizational priorities, and expertise limitations rather than formal regulatory requirements alone. Discussion We conceptualize this process as regulatory translation: the organizational work through which precautionary mandates become actionable decisions. We also identify a compliance-discretion paradox in which accountability systems seek standardization while effective governance depends upon professional expertise and judgment. The article contributes to scholarship on risk and regulation by showing how precautionary governance is translated into practice through institutional mediation.

Frontiers in Political ScienceVol. 8
Arizona State University (US)
Peace, justice, and strong institutions
Openalex Percentile: Top 9%
Regulation and Compliance Studies
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