A Project-Management Governance Model for Strengthening Biosafety Oversight in High-Risk Biological Research...

In the United States, there are high-risk biological research facilities with complex and overlapping management structures in an attempt to combat accidental or intentional exposure to dangerous pathogens. Even with numerous regulatory mechanisms and institutions biosafety committees, the recent evaluation of biosafety management shows that there are still a lot of gaps in governance, accountability fragmentation and inconsistency in the enforcement of biosafety management practices. The process of enhancing these oversight mechanisms needs to be organized, which is based on uniting the operational, institutional, and federal duties and control under a common system of governance. This narrative review will suggest a project-management governance model that is more integrative to facilitate better oversight of biosafety in the case of high-risk biological research in the United States. The model aims at enhancing stakeholder coordination, accountability and transparency in biosafety management by implementing project-management concepts in biosafety governance. A focused literature search was undertaken to locate peer-reviewed articles, governmental documents, and policy brochures within the past five years (2020-2025) with the help of PubMed, Scopus, and Google Scholar being used. Literature covering the issue of biosafety oversight, biosecurity governance and project-management systems were captured. The data were compiled in terms on the theme in order to determine governance aspects that are flexible to manage biosafety. The proposed model was informed by comparison of key concepts in the Project Management Body of Knowledge (PMBOK), ISO 21500, and the rest of governance standards to existing biosafety and biosecurity standards. The review reported four consistent challenges associated with biosafety governance, including: (1) lack of inter-agency coordination; (2) weak institutional accountability; (3) failure to communicate risk and performance reports/monitoring; and (4) lack of standard projects-governance organization. Project-management principles, which include the stakeholder mapping, the risk registers, the performance measures and the governance boards, can be incorporated to reinforce decision making and accountability. The model suggested is based on the three levels of governance consisting of strategic, operational, and project layer of governance, and the initiative of keeping the feedback and performance loop cycles. The implementation of the bio-safety regulation with the help of the project-management governance framework is an organized way to integrate the policy implementation, improve the risk treatment, and promote ongoing improvement in the high-risk researches. Put differently, the implementation of this model can strengthen national resiliency in biosafety, facilitate inter-agency partnerships, and develop an organizational culture of accountability and safety in the field of biological research.