The Culture of Biosafety, Biosecurity, and Responsible Conduct in the Life Sciences: A Comprehensive Literature Review

Abstract

Introduction: Managing biological risks requires an organizational culture that holistically ensures the biosafety, biosecurity, and biocontainment of infectious disease agents and toxins, in addition to conducting science in a responsible manner, complying with relevant laws, regulations, guidelines, and policies, as well as emphasizing norms, values, and beliefs of the entire life sciences profession. Methods: Drawing upon the Federal Experts Security Advisory Panel's (FESAP's) 2014 recommendation to "strengthen a culture that emphasizes biosafety, laboratory biosecurity, and responsible conduct in the life sciences," we undertook a comprehensive literature review of the culture of biosafety, biosecurity, and responsible conduct in the life sciences, including metrics by which to evaluate interventions at the organizational level. Results: We identified 4031 unique citations published from January 2001 to January 2017 by searching the MEDLINE/PubMed, Scopus, Web of Science, and Global Health databases. In addition, a subset of 326 articles was reviewed in full. Discussion: We found that while there were discussions in the literature about specific elements of culture (management systems, leadership and/or personnel behavior, beliefs and attitudes, or principles for guiding decisions and behaviors), there was a general lack of integration of these concepts, as well as limited information about specific indicators or metrics and the effectiveness of training or similar interventions. Conclusion: We concluded that life scientists seeking to foster a culture of biosafety and biosecurity should learn from the substantial literature in analogous areas such as nuclear safety and security culture, high-reliability organizations, and the responsible conduct of research, among others.

Management System Approach for Addressing Biosafety and Biosecurity of Emerging Pathogens in a Biosafety Level-3 Core Facility

“…Implementing and maintaining a BRM system require an organizational culture that ensures biosafety and biosecurity, in addition to complying with relevant legal requirements and policies, and most importantly strong leadership support. 34 Rules and procedures have no worth if people do not follow them; a culture of responsibility is also essential for ensuring that people follow safety and security procedures and that they act responsibly even in new or unfamiliar scenarios. 34 With the support of efficient and knowledgeable personnel and using the well-established BRM system, the cycle of continual improvement can be well maintained in containment laboratories.…”

“…34 Rules and procedures have no worth if people do not follow them; a culture of responsibility is also essential for ensuring that people follow safety and security procedures and that they act responsibly even in new or unfamiliar scenarios. 34 With the support of efficient and knowledgeable personnel and using the well-established BRM system, the cycle of continual improvement can be well maintained in containment laboratories. A laboratory that has implemented a robust BRM system is prepared to address risks associated with emerging pathogens, and its personnel will have necessary knowledge, skills, and abilities required to deal with unknown risks.…”

Assessing the Benefits of Research

“…Perhaps the largest issue is the general lack of awareness of biosecurity issues in the life science community (National Academies 2017a). It has been suggested the culture of safety in the life sciences could be most quickly improved by replicating the established models and hard-earned lessons of other fields (e.g., nuclear engineering) to create 'high-reliability organizations' (Trevan 2015;Perkins, Danskin & Rowe 2017).…”

Promoting Scientific Transparency to Facilitate the Safe and Open International Exchange of Biological Materials and Electronic Data

“…Similarly, related topics such as new technology, especially gain of function or dual use research of concern, which have BS&S concerns but are not part of GHSA, could be addressed. Inculcating an organizational culture of BS&S systems and responsible conduct of research at the local level would further reinforce activities, especially when international organizations and professional societies that further promote international norms are engaged [ 40 ].…”