Landscape of Dual-Use Research Governance in Malaysia

Introduction: Biosafety and biosecurity are critical elements of biorisk management, designed to mitigate the risk associated with intentional or unintentional release or exposure to potentially harmful biological agents. Dual-use research (DUR), research conducted with beneficial intentions but also carries the potential for misuse, has recently emerged as a form of biorisk that requires mitigation. Objectives: While biosafety and biosecurity governance already exist in Malaysia, the governance of DUR remains unexplored. The objective of this study is to assess the current state of DUR governance in Malaysia, with a focus on identifying existing gaps in institutional policies. The goal is to explore strategies and recommendations to enhance DUR governance in Malaysia. Methods: This study used a combination of desktop research and semi-structured interviews. The desktop study involved reviewing policies and guidelines related to biosafety, biosecurity, and DUR. The documents were analyzed to assess whether DUR governance is mentioned or integrated within existing biorisk frameworks. In addition, semi-structured interviews were conducted to gain insights into the current understanding and governance of DUR in Malaysia. The qualitative data collected through these interviews were analyzed to identify common themes and challenges. Discussion and Conclusions: This study identifies significant gaps in DUR governance in Malaysia. None of the institutional guidelines that we reviewed contain DUR elements and this contributes to low researcher awareness of DUR. Experts suggest integrating DUR into existing biosafety frameworks, enhancing institutional support, and fostering a culture of self-regulation to improve governance and strengthen biorisk management.