Bio-risk Management Culture: Concept, Model, Assessment

Abstract

Biorisk Management Culture (BRMC) is a subset of an organizational culture that emphasizes responsible conduct in life sciences, biosafety, and biosecurity. BRMC is further defined as an assembly of beliefs, attitudes, and patterns of behavior of individuals and organizations that can support, complement or enhance operating procedures, rules, and practices as well as professional standards and ethics designed to prevent the loss, theft, misuse, and diversion of biological agents, related materials, technology or equipment, and the unintentional or intentional exposure to (or release from biocontainment of) biological agents. Effective BRMC could also significantly contribute to preventing proliferation of biological weapons as an integral part of a comprehensive WMD non-proliferation strategy including culture. Given the complexity of biosafety/biosecurity oversight systems, the need for evidence-based decision-making (e.g. on staffing, areas for improvement, choice of training programs), and the ability to detect behavioral changes associated with a particular intervention, it is important to periodically assess the strengths and weaknesses of BRMC. The purpose of this paper is to apply the experience in culture assessment and enhancement accumulated in other domains to biorisk management with due regard for its special features. This methodology is not prescriptive and leaves much latitude to its users. With appropriate modifications, the model can be applicable to a wide range of institutions including biological research and public health laboratories, diagnostic facilities, and bioproduction facilities. The BRMC and its systematic assessment (conducted periodically) are critical to understanding inter alia, the role of the human factor, the strengths and weaknesses of the bio-risk management framework, causality of system breakdowns or analysis of incidents, sources of human error or breaches of biosafety/biosecurity, and the effectiveness of training.