{"title":"Thrown in the Deep End: The Dual-Use Saga.","authors":"Rebecca L Moritz","doi":"10.1089/apb.2024.0062","DOIUrl":"10.1089/apb.2024.0062","url":null,"abstract":"<p><p>This reflection shares insights from a biosafety professional's experience managing dual-use research challenges. It emphasizes the importance of proactive communication, teamwork, and transparency. In responding to high-profile, ethically complex projects involving potential pandemic pathogens, I discuss the evolving role of biosafety professionals in ensuring safety and ethical oversight while supporting scientific progress. Key lessons include the need for a proactive approach to science communication, a resilient mindset, and strategic team collaboration. Managing public scrutiny and navigating confidentiality issues underscored the necessity for transparency to foster public trust. The experience also revealed the value of biosafety professionals as essential partners in research who contribute to policy discussions and should be consulted to shape effective, responsible research practices. These lessons emphasize the need for continuous improvement in biosafety practices, promoting proactive, integrated support systems within research institutions to effectively manage complex biosafety and biosecurity challenges.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"198-203"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Landscape of Dual-Use Research Governance in Malaysia.","authors":"Saarani Vengadesen, Lay Ching Chai, De-Ming Chau","doi":"10.1089/apb.2024.0054","DOIUrl":"10.1089/apb.2024.0054","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion and conclusions: </strong>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.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"189-197"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The World Needs a PEPP Policy that Addresses Biosafety Loopholes Highlighted by the COVID-19 Pandemic.","authors":"Alina Chan","doi":"10.1089/apb.2024.0041","DOIUrl":"10.1089/apb.2024.0041","url":null,"abstract":"<p><p>The new U.S. government policy for oversight of dual-use research of concern and pathogens with enhanced pandemic potential (PEPP) focuses on federally funded research projects that are predicted by the funding applicant to have a nontrivial likelihood of generating a PEPP. This leaves a considerable gap in oversight of nonfederally funded work and research on novel pathogens. The prediction of pandemic risk arising from novel experiments is difficult even for multidisciplinary teams of experts, and a self-reporting system is inadequate as evidenced by past incidents. Creating an independent organization for oversight, inspection, and investigation of research projects regardless of funding source will ensure consistency and transparency in policy implementation and help to build knowledge and best practices for mitigating the risks of accidental outbreaks.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"146-150"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179365/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Virologist Opinions: An Important Component for the Governance of the Convergence of Artificial Intelligence and Dual-Use Research of Concern.","authors":"Matthew E Walsh, Gigi Kwik Gronvall","doi":"10.1089/apb.2024.0060","DOIUrl":"10.1089/apb.2024.0060","url":null,"abstract":"<p><strong>Background: </strong>The convergence of artificial intelligence (AI) and the life sciences has brought in silico research into policy conversations around dual-use research of concern and pathogens with enhanced pandemic potential research. This study considers the expert opinions of virologists on governance of AI and life sciences research.</p><p><strong>Methods: </strong>Semi-structured interviews with virologists were conducted and qualitatively analyzed to explore expert opinions about AI and virology. Interviewees were asked about the risks and benefits of AI, policy development considerations, and about evaluating the capability of AI tools in the field of virology.</p><p><strong>Results: </strong>Interviewed virologists generally expressed similar sentiments in responses to questions, including that benefits and risks of AI use in virology research are still to come, that policy and governance should be a process that includes virologist input, and that it is challenging to predict the capability of AI tools without experimental wet-lab validation.</p><p><strong>Discussion: </strong>Governance should be informed by expert opinions of practitioners, and it is important to consider how such opinions are incorporated. Expert opinions are valuable in understanding the impact of governance measures on beneficial research and development, and ensuring that governance measures are practicable and applicable. Virologists interviewed generally had similar opinions around AI and virology topics and often expressed an expectation that their opinions would develop over time.</p><p><strong>Conclusion: </strong>Given the uncertainty around the capability of AI technologies in the life sciences, it may be better to focus on developing frameworks for how governance measures will be developed, and to monitor developments, than to focus on specific interventions.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"124-131"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ben C Snyder, Joshua M Wentzel, Gerald L Epstein, Robert P Kadlec, Gerald W Parker
{"title":"Trust, but Verify: A \"Just Culture\" Model for Oversight of Potentially High-Risk Life Sciences Research.","authors":"Ben C Snyder, Joshua M Wentzel, Gerald L Epstein, Robert P Kadlec, Gerald W Parker","doi":"10.1089/apb.2024.0053","DOIUrl":"10.1089/apb.2024.0053","url":null,"abstract":"<p><strong>Introduction: </strong>A \"just culture\" balances accountability for misconduct with transparency, collaboration, and proactive engagement to address the root causes of accidents and compliance issues. Fostering a just culture in the oversight of potentially high-risk life sciences research would allow the U.S. government to improve biosafety and biosecurity while promoting beneficial research.</p><p><strong>Discussion: </strong>The authors explore four proposed elements of a just culture approach to oversight: (1) an enforcement continuum with options ranging from cooperative engagement to legal penalties, (2) non-punitive reporting of safety and security incidents, (3) technical assistance for researchers and institutions subject to oversight, and (4) outreach and two-way information sharing across the life sciences research enterprise.</p><p><strong>Conclusion: </strong>Promoting a just culture would support effective risk management by combining bottom-up scientific responsibility with top-down oversight and accountability. Implementing this approach will be challenging and require extensive stakeholder engagement, but adoption in the aviation industry shows it can succeed.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"107-111"},"PeriodicalIF":0.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Evolution of United States Governance Policies for Research Using Pathogens with Enhanced Pandemic Potential.","authors":"Gerald L Epstein","doi":"10.1089/apb.2024.0049","DOIUrl":"10.1089/apb.2024.0049","url":null,"abstract":"<p><strong>Background: </strong>Prompted by publications in 2012 involving the enhancement of a highly virulent but poorly transmissible human pathogen to make it more transmissible, the research community and the U.S. government have implemented policies to oversee research involving enhanced pathogens that pose the risk of causing a pandemic.</p><p><strong>Method: </strong>This article reviews the evolution of policies governing high consequence, government-funded research that has been called \"gain-of-function-research-of-concern,\" research with \"enhanced potential pandemic pathogens\" (ePPPs), and research with \"pathogens with enhanced pandemic potential\" (PEPPs). It analyzes features that these policies share and points out some of their shortcomings, challenges, and ambiguities.</p><p><strong>Results: </strong>These policies, culminating in the 2024 United States Government Policy for Oversight of Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential, all define a set of consequential research activities that trigger the need for additional high-level review, and they all set out principles that must be satisfied before the research can be funded.</p><p><strong>Conclusion: </strong>The 2024 policy, like its predecessors, only applies to government-funded research. Extending it to cover privately funded research would require either new regulations under existing statutory authority or new legislation. Like its predecessors, the 2024 policy requires that the benefits of PEPP research justify its potential pandemic risk. Unlike its predecessors, however, the 2024 policy is missing an important principle that prevents construction of a pandemic pathogen that-were it not for its creation in the proposed research-would have little likelihood of ever causing an actual pandemic.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"79-96"},"PeriodicalIF":0.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Principal Investigator Responsibility for Flagging Research with Dual-Use or Pandemic Risk.","authors":"Marc Lipsitch","doi":"10.1089/apb.2024.0059","DOIUrl":"10.1089/apb.2024.0059","url":null,"abstract":"<p><p>The new United States Government Policy for Oversight of Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential places primary responsibility on the proposing principal investigator to flag potential need for special review. This approach may carry significant risks, given that investigators have incentives to downplay the types of risks the policy aims to address, compounded by substantial opposition to the policy from many virologists. However, this commentary argues that such an approach is much more consistent with proven models of research oversight for protecting human subjects and animals and may be essential in the long run. It identifies the need for several independent but potentially mutually reinforcing preconditions for success-which will require creativity and investment not fully specified in the regulations: researcher training on dual-use and population-level biosafety risks, effective institutional-level support for and scrutiny of investigator evaluation, cultural change, checks and balances, and speedy evaluation of low-risk research.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"139-142"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Dual-Use Research and Publication Policies: A Comparison of Journals in Life Sciences and Artificial Intelligence.","authors":"Daniel J Hurst, Christopher A Bobier","doi":"10.1089/apb.2024.0034","DOIUrl":"10.1089/apb.2024.0034","url":null,"abstract":"<p><strong>Introduction: </strong>Dual-use research (DUR) describes research with potential benefits that could be misapplied for harm. Policy on DUR is often limited to life sciences research. However, recently, there have been demonstrations of how research with dual-use concerns may extend beyond the life sciences to artificial intelligence (AI). One method of ensuring that research with dual-use concerns is not misapplied for harm is by censoring scientific journal articles. Journals may have policy on managing article submissions with potential DUR concerns. This study compared the policies of life science and AI journals toward DUR.</p><p><strong>Methods: </strong>Google Scholar Metrics and Scimago Journal and Country Rank were utilized to identify and select the top 20 publications in fields of life sciences and AI by specific metrics. The publicly accessible websites of each journal were searched to ascertain their publication policies regarding DUR. Journals and/or publishers were contacted if no policy was located.</p><p><strong>Results: </strong>From Google Scholar, 12/20 journals within the \"Life Sciences & Earth Sciences\" category had policies on DUR; from Scimago, 9/16 of the \"Biochemistry, Genetics, and Molecular Biology\" category had policies; and 8/19 of the \"Immunology and Microbiology\" category had policies. For AI journals, 2/13 journals from Google Scholar had policies; 4/15 journals from Scimago had policies.</p><p><strong>Conclusion: </strong>More journals in the life sciences have extant policies on how to handle article submissions with DUR concerns. Very few AI journals have policies.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"97-106"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Incorporating the Intent of the Experiment into Gain-of-Function Oversight.","authors":"Michael J Imperiale","doi":"10.1089/apb.2025.0008","DOIUrl":"10.1089/apb.2025.0008","url":null,"abstract":"<p><p>The U.S. government recently released a new policy for the oversight of research that could lead to the creation of pathogens with increased ability to cause an epidemic or pandemic. While this policy is generally well thought out, some of the criteria are somewhat subjective. I propose a new criterion with which to view these experiments.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"143-145"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478508","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Toward a Collaborative, Collective, and Integrative International Chemical, Biological, Radiological, and Nuclear Security Education.","authors":"Iris Magne, Olivia Ibbotson, Lijun Shang, Malcolm Dando","doi":"10.1089/apb.2024.0048","DOIUrl":"10.1089/apb.2024.0048","url":null,"abstract":"<p><strong>Background: </strong>Despite the entry into force of the 1975 Biological and Toxic Weapons Convention (BTWC) and the 1997 Chemical Weapons Convention (CWC) many years ago, the risk of malign use of chemistry and biology has been a consistently growing threat. Various initiatives have been proposed to address chemical, biological, radiological, and nuclear (CBRN) security issues, particularly on the issue of dual-use research of concern (DURC).</p><p><strong>Methods: </strong>In this article, we first briefly review the history and evolution of chemical and biological security education. Then we discuss the challenges faced among the initiatives developed to strengthen the BTWC and CWC. We further analyze the lessons learned for establishing global biosecurity education, and we conclude that international collaboration and coordination are keys to raising awareness of the necessity for biological security education. In the end, we detail our new initiative entitled the International Biological Security Education Network (IBSEN), which aims to provide this needed global framework through developing resources in biosecurity education in collaboration with international and regional actors using new methodologies and a linguistic plurality.</p><p><strong>Discussion: </strong>We believe that a collaborative, collective, and integrative international CBRN security education is the key to ensuring a broad engagement in biosecurity education and addressing the issue of DURC.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 2","pages":"167-173"},"PeriodicalIF":0.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12179351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144478514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}