Governing Dual-Use Research of Concern in the Life Sciences: United States and Canada Policy Comparative Analysis and Recommendations.

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Learn more: PMC Disclaimer | PMC Copyright Notice Appl Biosaf . 2025 Jun 5;30(2):157–166. doi: 10.1089/apb.2024.0046 Governing Dual-Use Research of Concern in the Life Sciences: United States and Canada Policy Comparative Analysis and Recommendations Riya Manas Sharma 1, * , Yasmin Cürük 2 , Kirke Joamets 3 , Kurdo Araz 1 , Conrad Kunadu 4, ✉ Author information Article notes Copyright and License information 1 School of Medicine, Royal College of Surgeons in Ireland, Dublin, Ireland. 2 Institute for Peace Research and Security Policy at the University of Hamburg, Hamburg, Germany. 3 Independent Scholar, London, United Kingdom. 4 Department of Politics and International Relations, University of Oxford, Oxford, United Kingdom. * Address correspondence to: Riya Manas Sharma, School of Medicine, Royal College of Surgeons in Ireland, 123 St. Stephen’s Green, Dublin 2, D02 YN77, Ireland, riyasharma23@rcsi.com i ORCID ID ( https://orcid.org/0009-0003-8117-0879 ). ii ORCID ID ( https://orcid.org/0009-0006-8919-8835 ). ✉ Corresponding author. Collection date 2025 Jun. Copyright 2025, ABSA International 2025 PMC Copyright notice PMCID: PMC12179360  PMID: 40548094 Abstract Introduction: This study examines and compares dual-use research of concern (DURC) policies in the United States and Canada, two countries with advanced biosafety frameworks, to identify strengths, weaknesses, and areas for improvement in DURC governance. Methods: The study conducts a comprehensive review of current DURC policies, regulatory frameworks, and oversight mechanisms in the United States and Canada, analyzing key policy documents, including the 2024 U.S. Government Policy for Oversight of DURC and Canada’s Human Pathogens and Toxins Act. Results: Both U.S. and Canadian DURC policies require principal investigators (PIs) to conduct continuous project reviews throughout the research duration and maintain dedicated advisory agencies for biosecurity. Their approaches are notably multi-layered, integrating policymaking with educational initiatives and surveillance systems. However, important differences exist in their governance strategies. The United States has specific DURC policies primarily for federally funded research, while Canadian regulations apply to all facilities handling human pathogens and toxins. Notably, Canada also employs more detailed pathogen classification and quantity specifications than the United States and requires designated biological safety officers for oversight. Conclusion: While both countries maintain robust DURC oversight frameworks, they differ in their approach to governance, scope, and implementation. Based on this analysis, five key recommendations were developed. This includes establishing an international minimum standard for DURC regulation, extending U.S. DURC legislation to non-federally funded research, developing detailed risk-benefit analysis guidelines, and strengthening policies for responsible scientific communication. Keywords: dual-use research of concern, biosecurity policy, comparative policy analysis, research governance, North American biosecurity Introduction Life sciences research and global health security are inextricably linked. With controversial research studies that alter pathogens to better understand them, the revision and standardization of ethical frameworks on local, national, and international levels has been extensively debated in scientific communities, as the products of these studies can potentially fall into the wrong hands. 1 One of the most cited cases igniting such substantive discussion was the 2001 mousepox case in Australia. 2 In the study, researchers inserted an interleukin-4 gene into the mousepox virus to control the rodent population through sterilization. To their surprise, they had inadvertently created a new strain so virulent that it could kill all infected mice, despite natural or vaccine-induced immune mechanisms. This case serves as a quintessential example of dual-use research of concern (DURC), where the creation of a more pathogenic or virulent strain holds the potential for both beneficial and detrimental applications. The research presents multiple potential outcomes. On one side, there are constructive applications such as eradicating unwanted pests such as rodents using mousepox. Alternatively, the research could contribute to developing prophylactic measures against vaccine-resistant smallpox, given its close relationship to mousepox. However, a critical concern remains the potential for nefarious misuse, where malicious actors might reverse engineer these findings to weaponize smallpox against human populations. 2 Other such cases include a 2005 article detailing the reconstruction of the influenza virus responsible for the 1918 Spanish flu through reverse genetics, 3 a 2012 article describing specific mutations enabling the deadly H5N1 avian influenza to become transmissible in mammals, 4 and a 2002 study involving the creation of a synthetic poliovirus using a map of the poliovirus genome obtained on the internet. 5 “Dual-use” research refers to scientific investigations and technological advancements that, while pursued for legitimate purposes, possess the inherent potential to pose significant risks if misapplied. It highlights the understanding that the manner in which research outcomes are utilized is influenced not only by the nature of the research itself but also by the intentions and actions of individuals or entities who may leverage the findings. 1 DURC is a subset of dual-use research that is defined as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.” 6 In other words, DURC is research that has the greatest potential of posing a biorisk, defined as a risk associated with biological materials and/or infectious agents. Although there have been rapid developments in pharmaceutical research and genetic engineering of infectious diseases over the past 20 years, it is evident that the management of biorisks is lagging and has not been prioritized to a higher degree. Internationally, the life sciences community is ill-equipped to deal with the harm posed by DURC. 7 The World Health Organization (WHO) has created a global guidance framework for the responsible use of the life sciences, 8 which, given the complexities of biorisk management, does not intend to be “prescriptive or to provide specific standards for governance.” The Biological Weapons Convention, the first multilateral disarmament treaty outlawing biological and toxin weapons signed by all but six countries, does not contain explicit prohibitions for research activities and does not have a verification mechanism to ensure compliance of member states, hence it is not sufficient to regulate DURC. 9–11 Although there are proposed guidelines to address these issues, they have not been implemented on a global scale. 11 , 12 Due to significant gaps in international governance frameworks addressing biorisks, relying on national regulation and oversight is the most practical policy approach due to the differing governing bodies and research focuses in each country requiring specific regulations for each respective nation. National-level regulation allows countries to align their policies with their unique scientific capabilities, infrastructure, legal systems, and societal values, enabling them to take swift action to mitigate biorisk threats. The United States and Canada have developed robust, multidisciplinary review policies on identifying and mitigating risks of DURC. 6 , 13 These robust frameworks reflect their high rankings on the Global Health Security Index, although it is important to note that DURC policies are just one component of their overall biosafety strategies. 14 This article argues that effective DURC governance requires striking a delicate balance between oversight mechanisms and the flexibility to pursue scientific advancements. A comparative analysis of the U.S. and Canadian frameworks reveals shared principles and critical divergences. Based on this analysis, the article proposes recommendations to harmonize international DURC governance and strengthen national frameworks. U.S. Policies for Oversight of DURC The U.S. policy governing DURC has been updated several times since its first iteration in 2012, most recently in May 2024 with the “United States Government Policy for Oversight of Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential.” 15 This policy, which will take into effect May 6, 2025, a year after its first publication, replaces the three preceding policies: The 2012 United States “Government Policy for Oversight of Life Sciences Dual-Use Research of Concern,” 16 the 2014 “United States Government Policy for Institutional Oversight of Life Sciences Dual-Use Research of Concern,” 17 and the 2017 “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight.” 18 The first of these was established a few months after the H5N1 publishing controversy. This policy, along with the following policies, were, in part, a response to increased U.S. interest in biosecurity following bioterrorist events such as the deadly anthrax letters that were disseminated via U.S. mail and claimed the lives of five individuals in 2001. 19 Researchers have raised concerns about the efficacy and transparency of the 2012 and 2014 policies, with the National Science Advisory Board for Biosecurity (NSABB) asked to revisit them in 2020. However, this process was delayed by the COVID-19 pandemic, which once again brought the topic to prominence following the debate over whether the virus could have leaked from a laboratory in China, ultimately leading to this comprehensive overhaul in 2024. 20 While prior policies were often criticized for lax oversight, ambiguous wording, and lack of transparency, 21 the 2024 policy is an attempt to consolidate the oversight framework into a single, unified process, balancing genuine concerns for risks with the importance and potential value of dual-use research. Contrary to prior policies, the framework covers both DURC and research related to enhanced potential pandemic pathogens. Thus, research subject to this oversight is distinguished along these lines into two separate categories with research that fits into both being designated to Category 2, which is subject to slightly more stringent oversight. Category 1 involves research that: 1. Uses specific biological agents and toxins listed under Select Agent regulations; 2. Is reasonably anticipated to result in particular experimental outcomes, such as enhancing the harmfulness, transmissibility, or resistance of pathogens, among others; and 3. Is assessed by research institutions and/or Federal funding agencies to pose DURC risks, meaning the research could provide knowledge, products, or technologies that may be misapplied to cause harm. Category 2 research refers to research that: 1. Involves pathogens with pandemic potential (PPP), or is expected to result in a PPP. 2. Is reasonably anticipated to result in specific experimental outcomes that may pose a significant threat, such as enhancing a pathogen’s transmissibility, virulence, or immune evasion; and 3. May involve the development, use, or transfer of eradicated or extinct pathogens, such as variola major or the 1918 H1N1 influenza virus. The oversight framework further defines responsibilities for three distinct groups: PIs, who shall assess, notify, and continuously monitor research for DURC risks; research institutions, who need to establish institutional review entities (IREs) and ensure compliance with oversight requirements; and Federal funding agencies, who shall review and approve risk assessments, mitigation plans, and maintain oversight of research. Figure 1 provides an overview of the workflow for reviewing and assessing research under this framework. Figure 1. Open in a new tab Overview of the Review Process for Category 1 or 2 Research. 6 According to this framework, all federally funded research must first be assessed by a PI to determine if it falls into the scope of either Category 1 or Category 2 based on the three respective criteria summarized above. If it does, the Federal funding agency and IRE have to be notified, after which the Federal funding agency will notify the research institution. The IRE then provides its own assessment of whether the research meets the three-step criteria for Category 1 or 2 oversight. Suppose the research falls into Category 1 or 2. In that case, the IRE and PI are to conduct thorough risk-benefit assessments and a risk mitigation plan according to the respective category, as outlined in the Implementation Guidelines, and submit this to the funding agency, with the PI and research institution continuing oversight of the research as it is ongoing. Suppose the research also falls within the scope of Category 2 oversight. In that case, the Federal department funding the research shall convene an additional multidisciplinary review entity to evaluate the research and conduct an additional risk-benefit assessment and risk mitigation plan to inform the funding decision, thus adding an additional layer of oversight for Category 2 oversight. Along with the policy document itself, the White House also published an accompanying document titled “Implementation Guidance for the United States Government Policy for Oversight of Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential,” 6 which outlines the review process in more detail in an effort to improve understanding of the policy and increase the ease of its implementation for affected institutions. Although the policy primarily targets federally funded research, the U.S. government is the largest funder of academic research, 22 and institutions that do not receive Federal funding are encouraged to adopt these oversight practices for non-federally funded work as well. The oversight mechanisms for non-federally-funded research are much less streamlined, and regulation is governed by a combination of the respective research institution’s Institutional Review Boards (IRBs), Institutional Biosafety Committees (IBCs), and the Federal Select Agent Program (FSAP). The FSAP is jointly managed by the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture (USDA) and regulates the possession, use, and transfer of certain biological agents and toxins, termed select agents, which pose a severe threat to public health, animal and plant health, or national security. It requires that any facility that handles select agents must register with the CDC or USDA and demonstrate they can meet stringent security, safety, and reporting requirements to prevent the misuse or accidental release of these agents. 23 While Category 1 research under the new DURC policy and the FSAP now employ the same list of select agents, the latter is more narrowly focused on specific pathogens. The DURC policy also considers experimental outcomes and the creation of new, potentially dangerous pathogens, especially regarding Category 2 research, which is not list-based. While the new policy still has potential shortfalls, such as lacking a unified oversight mechanism for federally-funded and non-federally-funded research, experts highlighted its key improvements. A more holistic governance approach, clearer oversight protocols, more frequent reviews of the policy, and expanded, more appropriate lists of covered pathogens 24 are generally seen as a step in the right direction. However, the true effectiveness of the new framework will only become clear after its implementation in May 2025. Canadian Policies for Oversight of DURC Similarly to the United States, Canada saw an increased interest in DURC regulation following 2001, ultimately leading to the establishment of the Public Health Agency of Canada (PHAC) in 2004. Building on this, the Human Pathogens and Toxins Act (HPTA), 26 which remains the most fundamental piece of regulation governing biosecurity and biosafety in Canada, was passed in 2009. The complementary Human Pathogens and Toxins Regulations (HPTR), 27 which provides specific details on the implementation of HPTA, was published in 2015. The HPTA and HPTR, alongside the Health of Animals Act (HAA) and Health of Animals Regulations (HAR), are enabling legislation at the top of the pyramid in the Government of Canada’s biosafety and biosecurity document hierarchy, depicted in Figure 2. Figure 2. Open in a new tab The Government of Canada’s Biosafety and Biosecurity Document Hierarchy. 25 Under the HPTA, human pathogens and toxins are classified into four different risk groups (RGs 1 to 4) based on their potential to cause harm to individuals and the community. A list of all classified pathogens can be found online on the ePATHogen database. 28 The main rules set out by HPTA 26 and HPTR 27 are: 1. All facilities, both in the public and private sectors, where Risk Group 2, 3, and 4 human pathogens (including zoonotic pathogens) or toxins are handled and stored, must obtain a Pathogen and Toxin License from the PHAC to conduct their activities with the pathogens or toxins unless they are exempt. The facilities must also comply with the requirements specified in the Canadian Biosafety Standard 29 (CBS), which is the national standard in Canada for facilities handling or storing human and terrestrial animal pathogens and toxins. CBS provides specific standards for the physical containment of pathogens and operational practices. To help with following the requirements of the CBS, a companion handbook (Canadian Biosafety Handbook has also been published). 2. Licensed labs must have a biological safety officer (BSO). 3. Mandatory reporting of laboratory incidents to the Laboratory Incident Notification Canada (LINC) surveillance system. This includes exposure incidents, non-exposure incidents, and other events requiring notification. 30 4. Mandatory reporting of incidents and “of any activities that could result in the creation of a human pathogen with increased virulence, pathogenicity, or communicability, that is resistant to preventative or therapeutic treatments or produces a toxin with increased toxicity.” 25 5. Facilities where scientific research is conducted are required to submit a plan (i.e., the Plan for Administrative Oversight [PAO]) that describes how they administratively manage and control biosafety and biosecurity risks, including risks from research with dual-use potential. PHAC published a technical guidance document, the “Canadian Biosafety Guideline—Dual-Use in Life Science Research,” 25 to offer guidance on implementing regulations specifically related to DURC. In Canada, the pathogens and toxins that have been explicitly identified as having dual-use potential are referred to as security sensitive biological agents (SSBAs). They are given as a frequently updated list 28 (the overlap between risk groups 3–4, and the Australia Group list, 31–33 a set of controlled items, including chemicals, biological agents, and related equipment and technologies, which could be used in the development of chemical or biological weapons). Although having a list-based system for identifying dual-use potential pathogens can mean that the system is rigid and constrained, the Canadian system mitigates this in two ways. First, each pathogen needs to be classified into a risk group before the start of a research project involving the pathogen. Second, the Minister of Health is granted powers to add and subtract items from the list of SSBAs. This design reflects the need for stringent oversight over high-risk research while maintaining adaptability to evolving scientific knowledge and emerging threats. There are additional requirements for handling SSBAs, including: 1. Any individual working with or having access to SSBAs requires an HPTA Security Clearance. 2. There are stricter access controls for areas containing SSBAs. The aforementioned policies apply to all research facilities in Canada. As part of the requirement to submit a PAO, 34 risk assessments of planned research projects must be carried out. “The Biosafety Handbook” 35 includes guidance for what kinds of risk assessments should be done and what these should contain, including a review of dual-use potential. Before research is conducted and throughout the course of the project, the project concept should be reviewed by PIs to assess dual-use potential, followed by discussions between institutional collaborators and stakeholders such as funders, senior management at the university, and the voluntary IBC to give the project final approval. An example of more specific guidance on how to decide whether a research project has dual-use potential is given in Figure 3 . Figure 3. Open in a new tab Canada Institutional Review Decision Tree for Identification of DURC. 25 The oversight of dual-use potential pathogens in Canada is thus achieved by requiring licenses and security clearances for the researchers based on a list of pathogens and their risk classifications, combined with review processes and risk assessments. U.S. and Canadian DURC Policy Convergences Most importantly, both the United States and Canada explicitly govern DURC, although Canada employs a more unified approach to federally and non-federally-funded research. Both countries recognize the dual-use dilemma in life sciences research and emphasize the need to balance scientific advancement and mitigation of biorisks. They each define and identify DURC as research that holds immense promise for societal benefits, while also posing potential risks if misused. Therefore, the governance frameworks in both countries are built around managing these risks without unduly stifling scientific inquiry. For example, the U.S. Presidential Commission for the Study of Bioethical Issues suggests that “While many emerging technologies raise ‘dual-use’ concerns—when new technologies intended for good may be used to cause harm—these risks alone are generally insufficient to justify limits on intellectual freedom.” 36 The Canadian Biosafety Guidelines similarly state, “In research, a balance must be achieved between the pursuit of innovation, and the protection of public health through regulation. In Canada, a risk-based approach is used to support innovative research with human pathogens and toxins, while protecting the health and safety of Canadians.” 25 In terms of definitions, the U.S. Institutional DURC Policy defines DURC as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. 6 The Canadian Biosafety Standard defines research as having the potential for dual-use if “the qualities of a pathogen or toxin, scientific method, intellectual property, or other related assets […] allow it to be either used for legitimate scientific applications (e.g., commercial, medical, or research purposes) or intentionally misused to cause harm or disease.” 29 These definitions imply an analogous core understanding of the concept of dual-use research. Both countries employ lists to identify and classify dangerous pathogens and consider several categories of experiments and outcomes, which is a common approach also employed by the WHO, which publishes a regularly updated list of priority pathogens that pose significant risks to public health. 37 While these lists are not identical, they have large overlaps in terms of pathogens that fall under the respective regulations. Other important considerations in the Canadian system include determining whether the research involves creating, recreating, or modifying a new or existing pathogen, such as anticipating any new potential hazards that the pathogen may acquire through experimental procedures, considering factors including transmissibility, pathogenicity, ecological fitness, immune system evasion, toxin production, and an assessment of the threats posed if the pathogen or research information were to be released. 25 Similarly, the U.S. policy requires an experiment to be reasonably anticipated to result in particularly risky experimental outcomes, such as enhancing transmissibility or virulence, to fall under either oversight category, demonstrating that both countries show a degree of flexibility, allowing for the incorporation of relevant information and avoiding the limitations of a strictly list-based approach. 6 The United States 6 and Canada 25 each require the PIs to review the research project for dual-use potential throughout its duration, including the planning stages, during the course of the research, and after its completion, thus ensuring that initially approved research remains safe as the research progresses. In addition, both countries employ institutional review entities, though they differ slightly in how these are composed. In the United States, an IRE consists of at least five members, including members that have knowledge of institution policies, authority to request research changes as part of a risk mitigation plan from researchers, familiarity with United States Government biosecurity and biosafety policies, and expertise in dual-use assessment (virologists, microbiologists, etc.) 14 In Canada, an IBC is recommended to have at least four members 25 (with many universities having around 10), including a management representative, research or technical staff, a medical advisor, and a BSO. Both the United States and Canada also have advisory agencies for biosecurity—NSABB in the United States and the Centre for Biosecurity at PHAC in Canada—that address DURC, necessitated by their high research output and dual-use research. Both countries also have similar structures for managing biorisk, with the United States requiring an IRE 15 and a designated Institutional Contact for Dual-Use Research and Canada having voluntary IBCs and BSOs to oversee the facility’s biosecurity practices. 25 In addition, both provide risk-benefit analysis tools in their respective technical risk mitigation handbooks to guide research modification and publication practices. The rapid dissemination of information requires responsible scientific communication and the creation of stronger social norms around dual-use research. 38 Thus, both countries take a multi-layered approach to dual-use research governance, combining policy making with education, awareness, and surveillance to build capacity. Although scientists often favor self-regulation, national and international frameworks remain crucial for accountability and guidance. Strengthening social norms around responsible scientific communication is key to effective DURC governance. These convergences show that both countries consider the trade-off between freedom for scientific innovations and the potential dangers of DURC very thoughtfully, exemplified by both countries’ use of risk-benefit analyses, institutional oversight, and responsible communication guidance. U.S. and Canadian DURC Policy Divergences Despite these convergences, the two countries still differ in some key aspects of their DURC governance strategies as well as terminology, with the United States referring to dual-use potential pathogens as “enhanced potential pandemic pathogens” 6 and Canada referring to them as “security-sensitive biological agents.” 25 The central difference in governance is the applicability of their policies. The United States has specific DURC policies that apply for federally funded and government-conducted research projects. In addition, the FSAP applies to all research facilities but its list-based approach is more rigid and does not specifically consider experimental outcomes or the creation of new, potentially dangerous pathogens. 6 In Canada, its HPTA and HPTR legislation, as well as other guiding documents and standards, apply to all facilities in Canada where human pathogens or toxins are handled or stored, 26 leading to a more streamlined approach to DURC governance. Canada has also implemented a comprehensive nationwide Laboratory Incident Notification Canada (LINC) surveillance system, launched in 2015. LINC is one of the first national surveillance systems reporting laboratory-acquired infections (LAIs) and exposures involving RG2 HPTs and above across private, public, hospital, and academic sector laboratories. All licensed laboratories in Canada are required to submit a notification report detailing exposure and non-exposure laboratory incidents, including LAIs, via the PHAC’s Biosecurity Portal. 31 Although under-reporting of laboratory incidents is a possible limitation, this centralized and mandatory system, coupled with real-time identification of causes of incidents in laboratories, is highly effective, yielding 42 exposure incident reports in 2020 and 43 in 2021. 39 The United States, meanwhile, has multiple systems for reporting and no overarching legal requirement to report all LAIs. 40 However, laboratories must notify Animal and Plant Health Inspection Service or CDC in case of the release, theft or loss of a select agent. 23 While not specifically designed for DURC, Canada’s robust incident reporting system provides a strong foundation for identifying and mitigating risks associated with dual-use research, demonstrating a more integrated approach to biosafety and biosecurity governance, whereas the U.S. system is less streamlined. Canada’s review bodies have the unique feature of designating a member of the review body as the BSO. The BSO is appointed part-time or full-time to oversee a facility’s biosafety practices and liaise with the IBC. The BSO must have appropriate knowledge of the risks associated with research conducted, the HPTA, HPTR, HAA, and HAR, and other relevant Federal legislation, facility containment levels, and biosecurity and biosafety policies. Having a designated BSO is a valuable practice. BSOs assist scientific and technical staff in implementing biosafety guidelines and regulations, and they are identified during the facility's application process for handling human pathogens and toxins. While BSOs have distinct responsibilities from the occupational health and safety committee, it's recommended they participate in the committee to ensure proper safety coordination. 25 While the U.S. approach displays adaptability within the DURC-specific governance, its limited scope raises concerns about oversight gaps, particularly in non-federally funded research. At the same time, the FSAP, which applies to all research, seems needlessly rigid and there is significant overlap between the two policies which could benefit from streamlining. By contrast, Canada’s framework offers a more unified approach. The Way Forward A unified U.S.–Canada approach could leverage the strengths of both systems. For example, Canada’s comprehensive oversight of all research facilities, regardless of funding source, could inform U.S. policies to ensure consistency across federally and non-federally funded research. Conversely, the United States’ emphasis on experimental outcomes, procedures and case-by-case risk assessments within DURC governance could enhance Canada’s list-based regulatory model, fostering flexibility without compromising safety. DURC risks transcend national borders, as pathogens or sensitive research findings can easily cross jurisdictions through international collaborations or scientific publications. Aligning these frameworks would reduce oversight gaps, streamline collaboration between institutions and researchers in both countries, and set a strong precedent for international governance. A harmonized North American framework could serve as a model for establishing global minimum standards under an organization like the WHO. As life sciences research continues to grow, so does the need for further advancement of DURC governance. To this end, this article proposes five recommendations that could benefit either one or both countries, and serve as a blueprint for other countries. Further research and development into their applicability on a country-by-country basis would be necessary: 1. Establishing an internationally recognized minimum standard for DURC regulation in the life sciences and implementing a global DURC database would address key challenges in the field such as the divergences outlined between the U.S. and Canada DURC policies. This would promote collaboration among researchers in countries with different biosafety policies and provide a unified framework for safeguarding and assessing dual-use potential. Presently, only a few countries such as the United States and Canada have comprehensive frameworks in place to regulate DURC. However, many countries that operate Biosafety Level-3 and Biosafety Level-4 laboratories lack similar frameworks. An international standard would ensure all countries adhere to common generalized regulations, mitigating dual-use research risks. A centralized database for high-risk DURC projects is also essential. Such a database would track and monitor dual-use research globally, providing crucial information during pandemics and enabling the reporting of suspicious activities. The WHO’s current guidelines are suggestive, not mandatory. A minimum standard under the WHO could introduce authoritative protocols, including risk-benefit analyses and specific guidelines for handling pathogens. 2. Expanding the U.S. DURC oversight to non-federally research would be beneficial to extend the recent overhaul of federally funded research governance to also cover non-federally funded research. The new U.S. policy for federally funded research has been praised for simplifying a previously complex system, making it more transparent and easier to navigate. However, similar clarity and efficiency are still lacking for research funded by other mechanisms. To address this, it would be logical to harmonize oversight by applying a consistent set of guidelines to both federally and non-federally funded research, simplifying compliance while ensuring safety and ethical standards across the board. 3. Initiating international discussions, consultation, and cooperation, leading to stronger global regulatory frameworks between science and security sectors. Stakeholders from different countries should develop collaborative mechanisms to promote a culture of shared scientific responsibility. In the United States and Canada, fostering systematic discussions among stakeholders and raising awareness of DURC through education and capacity-building would help promote social cohesion and trust. Encouraging a safety-by-design approach in life sciences research, where risks and consequences are integral considerations when constructing a research methodology and proposal, would help identify pitfalls and potential accidents early on. This approach should be promoted through educational programs, workshops, and awareness campaigns targeting scientists, researchers, and institutions in order to educate the research community on how to best mitigate risks of DURC. 4. Detailing guidelines for risk-benefit analyses and responsible scientific communication is suggested , as vague indicators in national policies can leave room open for interpretation. Both U.S. and Canadian policymakers should increase specificity in their scientific dissemination policy for DURC and include explicit risk categories. Evaluation of risk as well as probability and consequences of insider diversion or theft by rogue actors needs to be taken into account. To ensure early identification of high risk DURC, evaluation of risk-benefit should be done at the initial design of experiments when reviewed by ethics research boards and during peer-review before a manuscript is published. 5. Determining the level of public engagement on a country-by-country basis is needed to mitigate disinformation, misinformation, and infodemics surrounding dual-use life sciences research. 38 Appraising the risks and benefits of awareness raising and advocacy would be valuable. Due to the sensitivity of DURC, identifying information hazards that would have inadvertent consequences such as motivating agents to misuse such research or inciting undue fear of biorisks is an ethical obligation to ensure a more secure future. Scientists liaising with policymakers and civil society to promote a broader understanding of DURC with a balance of its potential positive and negative effects should be encouraged in national policies. Limitations to these recommendations include financial resources and differing governance goals between countries that may make it challenging to coordinate harmonizing different DURC approaches. Conclusion Dual-use research is an evolving area. The threats posed by the potential and growing accessibility of DURC scientific material, such as methodology, code, and data, cannot be overlooked. There is an ongoing need for critical and continual evaluation of incumbent biosecurity policies on a country-by-country basis. This article compared U.S. and Canadian DURC policies and recommended measures to create more robust dual-use frameworks. While the United States and Canada have some similar approaches such as biosecurity regulatory agencies, they have key differences in their governance structures, innovation focuses, and public agendas. Decision-makers need to be cognizant of these differences to guide discussions and collaborations on DURC policies in North America. Authors’ Contributions R.M.S. conceived the original article and wrote the initial draft. Y.C., K.J., and K.A. each contributed to updating two sections in light of the 2024 policy changes and provided substantive editorial suggestions. C.K. reviewed the article and offered critical comments and editorial recommendations. Disclaimer This research was completed in the United Kingdom, Ireland, and Germany and did not require IRB approval. Authors’ Disclosure Statement The authors declare that there are no conflicts of interest. Funding Information This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. References 1. Duprex WP, Fouchier RAM, Imperiale MJ, et al. Gain-of-function experiments: Time for a real debate. Nat Rev Microbiol 2015;13(1):58–64; doi: 10.1038/nrmicro3405 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 2. Jackson RJ, Ramsay AJ, Christensen CD, et al. 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