Organizational culture and risk in high-stakes life sciences research

Abstract

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. 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). 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. 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.