Landscape of Dual-Use Research Governance in Malaysia.

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Learn more: PMC Disclaimer | PMC Copyright Notice Appl Biosaf . 2025 Jun 5;30(2):189–197. doi: 10.1089/apb.2024.0054 Landscape of Dual-Use Research Governance in Malaysia Saarani Vengadesen 1 , Lay Ching Chai 2 , De-Ming Chau 3, * Author information Article notes Copyright and License information 1 University of Malaya, Kuala Lumpur, Malaysia. 2 Sunway University, Bandar Sunway, Malaysia. 3 Universiti Putra Malaysia, Serdang, Malaysia. * Address correspondence to: De-Ming Chau, Universiti Putra Malaysia, Serdang 43400, Malaysia, deming@upm.edu.my Collection date 2025 Jun. Copyright 2025, ABSA International 2025 PMC Copyright notice PMCID: PMC12179350  PMID: 40548080 Abstract 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. Keywords: dual-use research, dual-use research of concern, biosafety, biosecurity, biorisk management Introduction In recent years, the intensification of international collaborations and open science has fueled unprecedented rapid advancement in science, technologies, and innovations in infectious disease research. This highlighted the need for global biorisk management, an important framework to counter the risk associated with research involving pathogens and potentially infectious agents. In response to this need, the World Health Organization (WHO) recently introduced the global biorisk framework to mitigate these risks to protect human health and the environment. 1 Biorisk management relies on three key pillars, which are biosafety, biosecurity, and the governance of dual-use research (DUR). Biosafety is implemented to mitigate risk associated with accidental release or exposure to potentially harmful biological agents. 2 Biosecurity addresses the risk associated with the intentional breach of access to and misuse of biological agents, pathogens, and other potentially infectious materials. In 2014, the U.S. government issued its Dual-Use Research of Concern (DURC) policy to mitigate another form of biorisk, which is a potential risk arising from research with dual-use potential. DURC are “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.” 3 This policy was established partly in response to several controversial gain-of-function research, such as the H5N1 gain-of-function studies. 4 , 5 The U.S. DURC policy outlines specific oversight measures for research involving 15 high-risk agents and toxins, and 7 categories of experiments that require additional institutional review. Countries such as Japan, Israel, Canada, Pakistan, Germany, and the Netherlands have developed their guidelines or policies to mitigate the risks associated with DUR. 6–11 While the U.S. DURC policy is focused primarily on life sciences research, it also acknowledges that nonlife science research with dual-use potential should be carefully considered under a broader umbrella of DUR, which is defined as “research conducted for legitimate purposes that generates, knowledge, information, technologies, and/or products that could be utilized for both benevolent and harmful purposes.” 3 As DUR continues to grow in importance with global biorisk management framework, the WHO has integrated DUR into its latest biorisk management guidance framework. 1 On May 6, 2024, the U.S. National Institutes of Health released a new policy called the “U.S. Government Policy for Oversight of Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential” (DURC/PEPP Policy). This policy, which will take effect on May 6, 2025, supersedes several related policies including the 2012 Federal DURC policy, the 2014 Institutional DURC Policy, and the 2017 HHS PC3O Framework. 12 This new DURC/PEPP provides a “unified framework” to enhance the regulation of research stipulated in the policy. It also significantly increased the number of agents and toxins that need to be regulated from the original 15 high-risk agents and toxins. Furthermore, this policy updated the roles of various stakeholders such as researchers, research institutions, and government agencies. Malaysia, as a signatory of the Cartagena Protocol on Biosafety, introduced the Biosafety Act of 2007, which provides the regulatory framework for activities involving living modified organisms (LMOs). 13 Under the framework of this act, two key governing bodies were established: the National Biosafety Board and the Genetic Modification Advisory Committee. These bodies are responsible for overseeing activities involving LMOs including their use, release, importation, and exportation. In conjunction with these regulatory efforts, the Department of Biosafety was established under Malaysia’s Ministry of Natural Resources, Environmental and Climate Change to ensure the implementation and enforcement of the Biosafety Act. Collectively, these entities are created to protect “human, plant and animal health, the environment and biological diversity.” 14 , 15 While global frameworks such as the WHO’s biorisk management guidelines have provided a foundation for international governance, the implementation of these measures at the national level remains inconsistent. In the context of Malaysia, biosafety and biosecurity measures are in place to various degrees but the governance of DUR is less well understood. The absence of a comprehensive and integrated biorisk management system poses challenges in overseeing research that may have harmful applications. Effective governance must prioritize safety and security in research while addressing risks associated with DUR. To contribute to this effort, this study was conducted to: 1) evaluate the scope of existing DUR policies in Malaysia, 2) assess the level of awareness and perception of DUR among scientists in Malaysia, and 3) propose recommendations for enhancing DUR governance in Malaysia. Materials and Methods This research employed a qualitative approach, utilizing a combination of document analysis (desktop study) and semi-structured interviews. This goal was to assess the current state of DUR governance in Malaysia through the lens of biosecurity and biosafety. This study reviewed institutional biosafety and biosecurity policies from various universities and research institutes across Malaysia, including public, private, and government-affiliated institutions, to provide a comprehensive overview of the biorisk management landscape in Malaysia. To facilitate the analysis, targeted keyword searches were performed within the obtained documents. Keywords such as “dual-use research” and “dual-use research of concern” were used to determine whether and how these concepts are addressed in the institutions’ biosafety and biosecurity frameworks. The interview questions were designed to evaluate the subjects’ existing knowledge and awareness of DUR, their perception of its governance in Malaysia, and their views on potential strategies for improving DUR oversight in Malaysia. The interviews were conducted between January to April 2023 via the Zoom virtual meeting platform. In total, six experts were interviewed, as the number of local experts working in biosafety and biosecurity are limited in Malaysia. The sample size is small because this is the first study conducted in Malaysia about DURC, and thus it is designed as an exploratory study. Moreover, because the subject matter experts were carefully chosen based on their experience, their viewpoints can represent the larger picture in Malaysia. Finally, the recruitment of interviewees was stopped when data saturation was reached, which is a point whereby clear patterns emerged from the interviews and subsequent interviewees provided only repetitive information. 16 The interviews were transcribed and analyzed to identify recurring ideas and patterns across the responses. This entailed a comparison of their insights and enabling the extraction of valuable insights and quotes that they collectively provided during the interviews. These quotes serve to highlight key issues discussed during the interviews. Institutional Review Board approval was obtained from the Sunway University Research Ethics Committee before commencing this portion of the study (SUREC 2021/062). In accordance with ethical standards, informed consent was obtained from each interviewee before the interview process. The interviewees also gave their permission to record the interviews, and they were assured that their names and affiliations would be anonymized in the final reporting. Results Demographic of Interviewees A total of six interviewees were recruited for this study. Their years of experience contributing to the field of biosafety and biosecurity ranges between 4 years and 17 years. Five of the interviewees are employees of public universities, while one of the interviewees works for a government agency. These interviewees currently hold various positions in biosafety and biosecurity, such as biosafety officers and members of Institutional Biosafety and Biosecurity Committees. Biosafety Governance: The Role of Institutional Biosafety Committees The Department of Biosafety mandates the establishment of Institutional Biosafety Committees (IBC) in institutions engaged in activities involving LMOs. IBC is established under the Biosafety (Approval and Notification) Regulations 2010, to monitor and report LMO-related activities to the Department of Biosafety, promote biosafety awareness within their respective institutions, and ensure researchers working on LMO comply with the biosafety regulations. IBCs act as a key link between institutional practices and national biosafety governance, ensuring that biosafety protocols are consistently implemented and maintained. Under the Malaysia Biosafety Act, institutions engaged in Living Modified Organism (LMO) research are legally required to establish an Institutional Biosafety Committee (IBC). One of the IBC’s key responsibilities is to conduct briefings and raise awareness about biosafety guidelines.—Interviewee 2 Along with regulatory oversight, interviewees emphasized that biosafety training plays a crucial role in applying biosafety practices. The purpose of these training programs is to ensure that researchers are well-versed in the guidelines and protocols for handling LMOs. In my university, we conduct biosafety briefings for all the new students at least twice a year. We want to make these training routine, so that all the students who enroll into our university know about biosafety and biosecurity.—Interviewee 2 A few of my colleagues and I were trained to handle organisms in Biosafety Level 3 (BSL-3) labs, so we conduct biosafety training every semester. While the IBC at my institution also provides training, we lack the budget to offer it on a regular basis.—Interviewee 4 Besides that, IBCs appoint biosafety officers (BSOs), whose role is to carry out and support the functions of the IBC. The IBC carries out tasks mandated by the Department of Biosafety, including conducting lab inspections and reviewing LMO-related research. The biosafety officer (BSO) supports the IBC by providing expertise, offering advice, and contributing input during the review and inspection processes.—Interviewee 3 Biosecurity Governance As a signatory of the Biological Toxins and Weapons Convention (BTWC), Malaysia is committed to establishing strong oversight mechanisms to manage biosecurity risks. Malaysia’s commitment to strengthening biosecurity governance and adhering to international regulations is exemplified by the drafting of its Biological Weapons Convention implementation bill in 2012. The Science and Technology Research Institute (STRIDE), operating under the Ministry of Defence, is responsible for developing and implementing the national framework for biosecurity governance. 17 Currently, the Ministry of Defence is working on the Malaysian BTWC bill to govern biosecurity issues in Malaysia. This bill has already been drafted and is currently in the review process, awaiting approval from Parliament. Once enacted, it will be an Act similar to the Biosafety Act, and the two Acts will complement each other.—Interviewee 5 Although the biosecurity bill is not yet approved, some research institutions in Malaysia have incorporated biosecurity oversight into their existing biosafety frameworks. This approach allows for the simultaneous management of both biosafety and biosecurity risks, enhancing the overall governance of biological research. The following are the responses provided by interviewees when asked whether biosecurity measures are being practiced, even in the absence of the bill’s approval: STRIDE requires all laboratories in Malaysia that work with pathogens to submit annual Confidence-Building Measures (CBM) reports, which will then be forwarded to the Biological Weapons Convention’s Implementation Support Unit (ISU).—Interviewee 2 In my institution, we originally had an IBC, but due to the importance of biosecurity, we renamed it the Institutional Biosafety Biosecurity Committee (IBBC). This new structure covers both biosafety and biosecurity regulations, overseeing not only LMOs but also non-LMO pathogens.—Interviewee 2 Challenges in Biosafety and Biosecurity Governance in Malaysia Despite the progress in biosafety and biosecurity governance in Malaysia, the interviewees encountered challenges in implementing these regulations in their institutions. The challenges are insufficient institutional support, limited staffing of BSOs, low awareness and negative perception among selected researchers, and fragmented coordination and communication ( Table 1 ). Table 1. Challenges in biosafety and biosecurity governance in Malaysia Challenges Interviewees response Insufficient institutional support “We are required to conduct site visits to labs involved in LMO or pathogen research, but we haven’t received sufficient support from university management to carry out this task. We are also supposed to have a list of research groups in the university that have received grants for this research, which would allow us to conduct the necessary site visits.”—Interviewee 4 “The most crucial aspect of biosafety and biosecurity governance is securing top management support. If institutional leadership does not recognize the importance of biosafety, it will have a trickle-down effect, hindering the effectiveness of governance. Without the motivation from top management, researchers will be less inclined to implement these measures themselves.” —Interviewee 1 Limited staffing of Biosafety Officers (BSOs) “Our IBBC has only one biosafety officer, and it’s not feasible for one person to manage the entire university’s biosafety and biosecurity needs. Furthermore, this individual also has other responsibilities within the university. In contrast, overseas institutions often have dedicated biosafety departments to handle these issues.”—Interviewee 2 “BSOs need to be empowered. Often, they face challenges in carrying out their duties because they are typically in middle management positions. They frequently have to consult with experienced researchers, such as professors, who have many more years of research experience, which can be intimidating.”—Interviewee 1 Low awareness and negative perception “There has always been resistance towards biosafety governance because the researchers often question the need to overcome and jump over another hurdle.”—Interviewee 1 “In Malaysia, awareness of biosafety and biosecurity is low because researchers are not directly impacted by the severe consequences of lab outbreaks or accidental pathogen releases into the environment. Many researchers struggle to understand the rationale behind biosafety and biosecurity regulations, often viewing them as a hassle or a tedious process that complicates their work.” —Interviewee 2 Fragmented coordination and communication with different agencies overseeing biosafety and biosecurity governance “While the governance of biosafety and biosecurity is well-established, with the Ministry of Natural Resources, Climate Change, and Environment overseeing biosafety and the Ministry of Defence handling biosecurity, other agencies are also involved in certain aspects of governance. Depending on the situation, ministries such as the Ministry of Health, the Ministry of Agriculture and Food Security, and the Ministry of Investment, Trade and Industries may also play a role.”—Interviewee 6 “There was a perception that different ministries in Malaysia did not communicate effectively on biosafety issues. However, since the COVID-19 pandemic, I have noticed improvements and increased collaboration between various agencies.”—Interviewee 2 Open in a new tab Scope of DUR Policies and Regulations in Malaysia While biosafety governance is well-established in Malaysia, and biosecurity governance is becoming more mainstream, the scope of DUR policies and regulations in Malaysia remains unclear. To elucidate this, we accessed the websites of more than 15 public universities, private universities, and government-linked research institutions. Our findings consistently showed that biosafety and biosecurity policies are not available at the majority of these institutions. Instead of listing all the institutions that we explored, we only showed a representation of institutions, which include some of the largest universities in Malaysia. When available, these documents were downloaded and further analyzed. During the analysis, we searched for specific keywords—“Dual-Use,” “Dual-Use Research,” and “Dual-Use Research of Concern”—to determine whether these concepts were explicitly addressed in the institutions’ regulatory framework. A representative list of institutions is presented in Table 2 . Among these institutions, only four institutions—University of Malaya, Universiti Putra Malaysia, International Islamic University Malaysia, and the Institute for Medical Research—published their own biosafety/biosecurity guidelines. 18–22 However, a keyword search revealed that none of these institutional guidelines mentions DUR or DURC. Other institutions in the representative list do not have their own biosafety/biosecurity guidelines. Instead, these institutions refer to national-level policies and guidelines, such as the User’s Guide to the Biosafety Act and Regulations 23 and the Guidelines for IBC, 24 both published by the Department of Biosafety, as well as the Malaysia Laboratory Biosafety and Biosecurity Policy and Guideline published by the Ministry of Health (MOH). 25 Since the Biosafety Act 2007 of Malaysia specifically addresses LMOs, it does not include provisions for DUR or DURC. Similarly, the Malaysia Laboratory Biosafety and Biosecurity Policy and Guideline also does not mention these concepts. Table 2. List of Malaysian institutions’ guidelines on biosafety and biosecurity Institution Does the institution publish its own biosafety and biosecurity guidelines? Name of institutional guidelines on biosafety and biosecurity Universiti Sains Malaysia No Universiti Teknologi MARA No University of Malaya Yes Universiti Malaya Policy And Procedure On Laboratory Biosafety And Biosecurity (2015) Universiti Putra Malaysia Yes Laboratory Biosafety And Biosecurity Policy And Procedure (2020) Universiti Teknologi Malaysia No Institute for Medical Research Yes Regulating Research in IMR in Accordance with Biosafety Act 2007, Act 678 and Biosafety Regulations 2020 International Islamic University Malaysia Yes IIUM Biosafety Policy IIUM Biosafety Guideline Universiti Kebangsaan Malaysia No Universiti Terengganu Malaysia No Open in a new tab Although the universities and research institutions we analyzed lack DUR governance policies, the Academy of Sciences Malaysia published the Malaysian Educational Module on Responsible Conduct of Research in 2018, which explicitly discusses the implications of conducting research with dual-use potential. 26 This module defines DUR in accordance with the international definition, provides examples of research with dual-use potential, and outlines steps that researchers need to take to identify and mitigate risks associated. While this module is not a formal institutional or national policy, it is the only published document in Malaysia that identified and addressed DUR. DUR Awareness and Perception in Malaysia Based on the findings, it was noted that none of Malaysia’s institutional and national policies and guidelines address the concept of DUR. Therefore, we sought insights from interviewees on the perceptions and level of awareness of DUR among researchers in Malaysia. The subject matter experts we interviewed were familiar with the concept of DUR. However, based on the perception of the interviewees, the overall level of awareness in Malaysia remains low. While DUR has emerged as an important component of biosecurity, it is still a relatively new concept compared to more established concepts like biosafety and biosecurity. In Malaysia, the understanding of the DUR concept is still in its infancy. Most researchers do not know what DUR is. If you ask the researchers around you if they know what DUR is, chances are they have heard of it, but they don’t know what it is or whether it concerns them.—Interviewee 6 Our IBC is receiving more and more applications to modify organisms, but most researchers in my institution are unaware of DUR. One potential issue with educating researchers about DUR is that they might not be aware of how technologies can be misused.—Interviewee 4 The low awareness of DUR concepts in Malaysia, based on the findings of the interviews, is consistent with findings from similar studies in other countries. For instance, research conducted in Pakistan showed that 58.2% of postgraduate students surveyed were not aware of DURC concepts. 9 Similarly, a global study by Vinke et al. involving 192 respondents from 29 countries and 74 universities also reported low levels of awareness regarding DUR. 27 The recently published Global BioLabs Report, 2023, noted that many countries still lack sufficient dual-use governance framework. 28 Despite the current low awareness of DUR in Malaysia, the subject matter experts emphasized the importance of raising awareness among researchers, as it is an increasingly important element in biorisk management. It is crucial that DURC is included in discussions on biosafety and biosecurity. For instance, when researchers engage in gain-of-function research to enhance the pathogenicity of pathogens, and intend to publish their findings, they must be mindful of the fact that this information could potentially be replicated by others. There is a risk that individuals might be able to synthesize the gene and create the pathogens themselves—Interviewee 6 It is beneficial to create awareness about DUR since it benefits the researchers who conduct this research. Having such awareness requires researchers to change their actions when they conduct research, such as having stricter control of their research—Interviewee 3 Way Forward to Improve DUR Governance in Malaysia The enactment of the Malaysia Biosafety Act 2007, along with the oversight provided by the Department of Biosafety, has been instrumental in promoting awareness and ensuring the implementation of biosafety measures among researchers engaged in LMO research. Through a combination of reporting and accountability procedures, safety assessments and monitoring are carried out in accordance with requirements. In the meantime, the discourse on biosecurity is steadily gaining momentum through the efforts of STRIDE and Malaysia’s MOH. The growing dialogue reflects an increasing recognition that biosecurity is a critical issue and it is helping to lay the groundwork for stronger biosecurity governance at both the national and institutional levels. As previously highlighted, the concept of DUR is a relatively novel concept within the broader framework of biorisk management, which includes biosafety and biosecurity. Understanding and awareness of DUR in Malaysia remain in their early stages, despite the gradual recognition of DUR as an important concept in global research. Therefore, DUR governance needs to be improved to mitigate potential risks arising from research with dual-use potentials. Our analysis of the interviews identified four broad recommendations to enhance DUR governance in Malaysia: Integrate DUR governance into existing biosafety and biosecurity governance According to subject matter experts, one effective way to enhance DUR governance is to integrate it into existing biosafety and biosecurity frameworks. The oversight of DUR should be placed under the purview of IBC or IBBC. Maybe we just need to add some additional procedures to review projects with potential dual-use elements. To achieve this, institutions need to put their biosafety and biosecurity governance in place first.—Interviewee 3 I think integration between government agencies or regulatory agencies is extremely important. For example, if a researcher wants to import certain GMO plants for research, they need to inform other agencies such as the Department of Biosafety and the Department of Agriculture. All the existing laws and regulations in this aspect are supposed to work together.— Interviewee 1 This approach is seen in Canada, whereby the governance of research with dual-use potential is incorporated into the governance of biosafety. 8 Moreover, “institution committees trained in risk management, as well as research ethics committees, could offer guidance to researchers and provide an additional layer of oversight.” In Pakistan, their DUR guidelines also recommend that “awareness raising and capacity building for the IBCs for the institutional review and oversight of DURC is a more practical and sustainable approach.” 9 The Pakistani guideline further recommends that IBC members should be knowledgeable in management strategies related to biosafety, biosecurity, and DURC. By integrating DUR governance into existing frameworks, institutions can reduce redundancies and enhance efficiency in biorisk management. It also provides a more complete and comprehensive approach to address many complex issues in biorisk management. This integration will ensure that the efforts to promote DUR governance are aligned with other efforts to promote better biorisk management. Enhance education to create more awareness of DUR Since the DUR concept is relatively new and there is a need to raise its awareness to enhance biorisk management, DUR should be included in existing institutional biorisk management education. This integration of training programs aligns with the recommendation to integrate biorisk governance. We need to actively promote DUR awareness. Existing courses on biosafety and biosecurity need to be improved, and competency assessment should be included. These courses should be sustainable and have continuity so that the training is not done for just a year.—Interviewee 3 Many universities have existing courses on research methodology. We can talk to lecturers who are teaching these courses, whether at the undergraduate or postgraduate level, to include biosafety, biosecurity, and DUR concepts. When we conduct seminars on biosafety and biosecurity, we can add a slot to talk specifically about DUR.—Interviewee 6 This type of education integration is also demonstrated by the Canadian DUR policy which recommends that “awareness can be promoted through high schools, colleges and universities, and in science and engineering competition” and “informally through mentorship by senior researchers.” 8 Raising awareness is a “key requirement in the avoidance, or at least control, of research risks.” 10 Increase institutional support for DUR governance While the integration of biosafety, biosecurity and DUR governance, alongside efforts to enhance DUR education, are important, the subject matter experts view strong institutional support as a necessary ingredient to govern DUR properly. Institutions can support by providing necessary resources such as financial or human capacity. For the governance of biosafety, biosecurity and DUR to work well, there must be a group of passionate people who are willing to commit their time because these processes are very long. If we were to include the DUR policy in our university’s governance, we would need the support from our university’s management to launch it.—Interviewee 4 Many overseas universities have biosafety departments, and the people there have time to manage the whole university. It would be good to have a dedicated office that hires professionals to manage biosafety and biosecurity solely.—Interviewee 2 According to the Canadian DUR policy, “risk mitigation is most effective when all impacted stakeholders are engaged,” and these stakeholders include senior management of institutions. 8 As Miller and Selgelid proposed, a dual system involving institutional and governmental control as a basis for DUR governance is perhaps the most optimum option. With the government’s support, institutions can foster better DUR governance by having a regulatory system that mandates personnel security, education, and training. 29 Foster a culture of self-regulation One of the key mechanisms for governing DUR is fostering a culture of self-regulation. As research institutions and universities in Malaysia progress toward enhancing awareness of DUR and governance of DUR, self-governance should become a pivotal aspect of DUR governance. Self-governance, self-monitoring and self-surveillance are the best ways for researchers to enforce and govern biorisk. The researchers are the ones who conduct the research, and they are the ones who know best.—Interviewee 5 Knowledge is very powerful. Researchers need to have the attitude to want to care about these issues and to learn something new or extra. They must have the individual attitudes to treat biorisk as something very important. It is for their own good, the good of the people around them and for the good of the environment.—Interviewee 2 As Drew and Mueller-Doblies proposed, self-regulation and self-assessment should be included as one of the important measures to govern DUR in addition to legislation (i.e., laws and policies) or mechanical (i.e., infrastructures and facilities). 30 The self-governance approach requires scientists to be trained in ethics so that they are aware of potential misuse of their research and committed to using their knowledge and skills for beneficial purposes. The Canadian DUR policy suggests that the principal investigators carry the most responsibilities, as “the principal investigators are the most knowledgeable about their work and should be the first to recognize dual-use potential from the planning stage through to completion.” 8 It is imperative for researchers to “draw on their knowledge and experience to make a personal decision about what is responsible in their research.” 10 Furthermore, it is the responsibility of the researchers to evaluate if their research “complies with legal provisions, self-regulatory measures and ethical principles” 10 and “it is the scientists themselves who are in the best position to recognize the potential misuses of their work” and to know how biological sciences can be governed properly. 31 Discussion and Conclusion Malaysia has made significant strides in biosafety and biosecurity governance through the enactment of the Biosafety Act 2007. Universities and research institutions have also begun to emphasize biosafety and biosecurity regulations as part of their research governance. However, the governance of DUR in Malaysia remains lacking, with almost no mention of this concept in all the biosafety and biosecurity policies that we reviewed. This lack of institutional DUR governance poses potential risks and institutions should address this gap to mitigate these risks. Our study identified several challenges in DUR governance, including low awareness of DUR and the perceived burden of implementing DUR governance. This lack of awareness is consistent with the lack of DUR governance framework in research institutions. In addition, the perceived burden of implementing DUR governance affects both researchers as well as those responsible in governing biorisk, such as the BSOs. Based on the responses from interviewees, this study suggests that DUR governance should be integrated into existing biorisk management frameworks. In addition, institutional support is needed for DUR governance to be implemented effectively. Moreover, a bottom-up approach driven by researchers’ self-governance will complement top-down institutional governance led by policymakers. Together, these measures can address Malaysia’s current gaps in DUR governance and strengthen its capacity to manage the risks associated with DUR. Acknowledgments The authors thank Drs. Wo Su Woan and Lin Mei-Hua, Sunway University, for giving their input on conducting desktop studies and in-depth interviews. Authors’ Contributions S.V.: Conceptualization, investigation, formal analysis, writing—original draft, review and editing; L.C.C.: Conceptualization, writing—review and editing; D.M.C.: Conceptualization, investigation, formal analysis, supervision, writing. Authors’ Disclosure Statement S.V., L.C.C., and D.M.C. declare no conflicts of interest. Funding Information This study was supported by CRDF Global’s Catalyst Initiative Grant Competition. 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