Introduction: Naturally occurring or man-made pathogens can be transmitted to humans through zoonotic spillovers and accidental or deliberate release. These scenarios present a public health threat, highlighting the importance of implementing robust biosafety and biosecurity measures in both the field and laboratory, where the risks of pathogen spread are highest. Significance: The Lao People’s Democratic Republic (PDR) faces considerable public health challenges due to extensive human–animal interfaces, limited resources, and underdeveloped laboratory capacities. Repeated disease outbreaks have revealed critical gaps in local capabilities for effective diagnosis, surveillance, and emergency response. In addition, high-consequence pathogens from the region may spill over into Lao PDR and vice versa, underscoring the urgent need to strengthen biosafety, biosecurity, and public health preparedness. Methodology: The Institut Pasteur du Laos (IPL) serves as a research hub for (re)emerging pathogens and provides technical support for public health initiatives in Lao PDR. Since 2021, Global Affairs Canada has helped strengthen the biosafety and biosecurity framework at IPL through the Weapons Threat Reduction Program. Results and Conclusions: Workforce training, such as the nomination of a biosafety officer, training staff on good laboratory/field practices and biobanking, modernizing standard-operating protocols, and upgrading support infrastructure, have been crucial for enhancing preparedness and resilience against high-consequence biological threats, providing a foundation for IPL to conduct research while upholding the highest standards for biosafety and biosecurity.
Introduction: While scientist-led calls for moratoria are not uncommon, there is little consensus on when a moratorium is appropriate and little guidance on the topic: training, education, and professional guidance for life scientists do not specify when a moratorium might be justified. Guidance on ethical moratoria is needed. We conducted a thematic analysis of key publications in which life science researchers publicly advocated for a moratorium on specific lines of research. Methods: Articles were identified through citation tracing, review of the secondary literature on scientific research governance, news articles, and a targeted literature search of PubMed and Google Scholar. Articles were included if they were (a) published in a scientific journal, (b) (co-)authored by a practicing scientist, and (c) called for a temporary ban or pause on a line of research. Two researchers coded and then thematically analyzed the articles. Results: Twenty publications and six themes were identified: (1) the research is potentially very risky; (2) there is an unclear immediate or urgent societal or clinical need; (3) regulations and consensus are presently lacking; (4) there is societal pressure to pause or a lack of societal buy-in; (5) there are serious ethical and social concerns; and (6) impact on science. Conclusion: Calls for scientific moratoria reveal several recurring themes, but they lack consistently applied criteria. Biosafety professionals have an important role to play in risk communication, the development and dissemination of best practices, and the cultivation of trust in the governance of potentially risky scientific research.
Institutional Biosafety Committees (IBCs) play a critical role in overseeing biosafety risks associated with clinical research involving human gene transfer, a field that has expanded rapidly in scale and complexity. As part of the National Institutes of Health (NIH) Biosafety Modernization Initiative, proposals have been advanced to modify biosafety oversight frameworks in the United States, including the potential reduction or elimination of IBC review for clinical research conducted under the purview of the Food and Drug Administration (FDA). To inform these discussions, we conducted an anonymous survey of voting members serving on IBCs administered by our organization in 2025 to assess perceptions of the value and importance of IBC oversight. Survey responses demonstrated strong support for maintaining IBC review of clinical research, with nearly all respondents indicating that IBC oversight increases confidence in the safe conduct of studies at participating institutions. Only a small minority supported eliminating IBC oversight for FDA-regulated clinical trials. Respondents also emphasized the importance of IBC-provided guidance for safe investigational product handling, staff training and education, and prevention of needlesticks and other exposure incidents. These findings highlight the unique, site-specific role of IBCs in addressing biosafety considerations that are not fully encompassed by FDA regulatory oversight. Reducing or eliminating IBC oversight of clinical research could create significant biosafety gaps, particularly at smaller or non-academic institutions, and may undermine confidence in biosafety practices as emerging biomedical technologies continue to advance.
Background: The global community faces growing risks from emerging infectious diseases and bioterrorism, driven by shifts in national security, globalization, and advances in biotechnology. Biosafety plays a vital role in fostering international collaboration to counter terrorist threats, promote shared benefits, and enhance biosecurity. This study explores global biosecurity challenges and suggests strategies to enhance global biosecurity against bioterrorism. Methods: A comprehensive search strategy was designed to identify English-language literature across Scopus, PubMed, and Web of Science. Gray literature was additionally gathered via Google and other relevant websites. The databases were exhaustively searched for articles up to April 20, 2025, irrespective of the publication period. The Preferred Reporting Items for Systematic Review and Meta-Analysis Statement 2020 checklist was applied to screen articles, extract information, and synthesize related findings. This protocol is registered in the PROSPERO database with the number CRD42023445914. Results: In total, 25 out of 676 records met the inclusion criteria for the systematic review. The information obtained from the studies was organized and summarized into five sections and 24 subsections. The main categories were biosafety defense, biosafety issues and challenges, health sector challenges, legal frameworks, and solutions to deal with bioterrorism. Conclusion: This research systematically reviews biosafety concerns related to bioterrorism, proposing solutions and countermeasures. It offers a roadmap for decision-makers to enhance community preparedness by improving surveillance, strengthening laboratories, enforcing restrictive laws, and promoting international cooperation.
Introduction: Most high-speed cell sorters rely on droplet generation technology to create statically charged, particle containing droplets triaged at high throughput based on distinct characteristics of the targets. Normally, aerosols generated through the droplet breakoff process are constantly removed as waste or pulled away from the operator by the negative pressure dynamics created by an Aerosol Evacuation System (AES). However, if the AES integrity has been compromised, aerosols produced by a stream diversion event may potentially expose the environment and the operator to any potentially hazardous material that is being sorted. Standard methods to validate the integrity of the AES rely on the collection of aerosolized beads that escape the front of a sorter during a simulated stream diversion event. Although much improved compared with previous versions, the assay still requires 1-2 h to perform. Methods: We use a simple airflow meter in conjunction with an original set of 3D printed holders and a hot wire anemometer to measure vacuum created by the AES at two locations within the flow cytometer. Results: Here, we describe Air-VELoCheck, an airflow velocity assay to monitor AES integrity. The assay was validated against the standard aerosol containment assay and takes <15 min to perform, representing an approximate 75-88% reduction in assay time. Conclusions: Our findings support the need to accelerate efforts toward the integration of real-time monitoring of AES performance, particularly for laboratory operations requiring biosafety containment, to quickly diagnose alterations in aerodynamics that can be confirmed using other orthogonal assays.
Introduction: Sharps safety is critical in preventing injuries such as cuts, lacerations, and needlestick wounds, particularly in research environments where sharp instruments are frequently used and there is a risk of exposure to biological hazards. The aim of this study was to assess how effectively implemented control measures reduce sharp-related injuries in research environments. This study examines the implementation of best practices aimed at preventing sharp-related injuries in research settings through a combination of substitution, engineering controls, administrative controls, and employee education via workshops and training. Methods: The Abigail Wexner Research Institute (AWRI) adopted a multi-faceted safety program focused on equipment redesign, engineering controls, staff education, and engagement. Injury data from 2019 through 2025 were analyzed to evaluate the development and impact of targeted initiatives. Initiatives included implementation of a revised cryostat/microtome policy, hands-on workshops, and provision of safer engineering controls or alternatives. Results: A 35% reduction in overall sharps injuries was observed from 2022 to 2023 (from 20 to 13 incidents), alongside a 70% drop in Occupational Safety and Health Administration (OSHA)-recordable injuries (from 10 to 3 incidents). From 2024 to 2025, a 28% reduction in overall sharps injuries was observed (from 21 to 15 incidents), alongside a 67% reduction in OSHA-recordable injuries (from 3 to 1 incidents). Notably, injuries related to cryostats and microtomes dropped to zero in 2023. Conclusion: Implementation of targeted, comprehensive sharps safety initiatives led to significant injury reduction at AWRI. This demonstrates the effectiveness of combining administrative policy, training, and equipment improvements in fostering a culture of safety.
Background: Cyberbiosecurity addresses vulnerabilities at the intersection of biological and cyber systems, yet implementation guidance for laboratories remains limited. This scoping review examines cyberbiosecurity implementation in laboratory settings. Methods: A systematic search across five databases (PubMed, Web of Science, EBSCO, Google Scholar, ArXiv) identified 47 unique records since 2010. Following PRISMA guidelines, 30 articles met the inclusion criteria. Data extraction focused on publication type, funding source, country focus, private or public sector laboratory, mention of high-containment laboratory (biosafety level [BSL]-3 or BSL-4), laboratory sector focus, topics covered, and cybersecurity attack vectors. Results: Of 30 articles, 57% were literature reviews and 20% were conference/policy papers. Only two (6.7%) were primary implementation studies. Merely 2.6% mentioned high-containment laboratories (BSL-3/BSL-4), while 77% focused on biomanufacturing/medtech sectors (medtech refers to facilities equipped with technology that analyze biological specimens for clinical use, such as surgical, implant, and suture devices). Geographic bias was evident, with 63% focusing on high-income countries. Clinical and diagnostic laboratory guidance was underrepresented (23% coverage). This review revealed no standardized approaches for assessing or implementing cyberbiosecurity capacities in laboratory facilities. Conclusions: Critical gaps exist in cyberbiosecurity implementation for laboratory settings, particularly in the Global South, where significant and growing life sciences research occurs. The absence of laboratory-specific guidance and oversight mechanisms represents significant vulnerabilities. Recommendations include (1) development of enforceable norms and standards by policymakers; (2) integration of cyberbiosecurity safeguards into research funding mechanisms; and (3) mandatory capacity building and training programs for relevant laboratory personnel.
Introduction: Biosafety and biosecurity play increasingly important roles in global health security. Although many countries have established national policies to govern these practices, the existence of regulation does not guarantee its application or stronger biosecurity in practice. Methods: We analyzed survey data collected from biosafety and biosecurity practitioners in > 40 countries. An institutional-level biosecurity implementation index was developed and aligned with country-level Global Health Security (GHS) Index scores to construct a policy-practice gap (PPG) index. Descriptive analyses and multivariable regression models were used to assess variation in implementation and to identify factors associated with implementation scores. Results: High-income countries had policy development outpacing institutional implementation (PPG mean = 23.5). In contrast, low- and middle-income countries obtained higher implementation scores than their national policy frameworks (PPG mean = -35.7). The study also identified areas requiring greater attention to implementation, including psychological programs for personnel vetting, cross-border transfer, end-use transfer, and cybersecurity. Multivariable analyses showed that experience working in high-containment laboratories, engagement in international collaboration (beta = 6.9, p < 0.05), access to high-quality training (beta = 2.3, p < 0.05), and adequate institutional financial support (beta = 3.51, p < 0.05) were positively associated with implementation index. The magnitude and significance of these associations varied between U.S.-based and non-U.S. respondents. Conclusions: These findings help to understand the differences between national biosecurity policies and implementation across many countries. It shows the limitations of policy-only approaches to strengthening global biosecurity and informs future efforts to address some specific biosecurity practices.
Introduction: Behavioral assays, such as those evaluating memory, motor coordination, balance, pain response, and anxiety, are valuable tools for studies of neuropsychological function when applied to rodent models. Most behavioral research focuses on non-infectious models of altered neurocognitive states such as dementia, drug addiction, and stroke. Behavioral assays are often large, costly, and challenging to disinfect, resulting in safety concerns when considering the translation of these techniques to infectious models of disease. As more infections are recognized for their potential to cause long-term neurological complications, we must make behavioral research accessible to infectious settings. Objective: We aimed to develop and verify a behavioral arena suitable for biohazardous settings. Methods: We used open-source software to create low-cost versions of four common behavioral platforms: elevated plus maze, novel object recognition, von Frey test, and tail flick test. Leveraging 3D printing and widely available, cost-effective materials, we constructed durable and easily disinfected testing arenas. To facilitate data collection under containment conditions, we incorporated a sealed wireless camera and tablet. Key Findings: We successfully executed an inexpensive animal behavioral arena for use in safe containment settings. Each apparatus is modular, easily disinfected, does not disrupt BSC airflow, and is low cost. Conclusions: The arena of behavioral assays is readily available for use in studying long-term sequelae of infectious agents in mouse models of disease. These provide a safe tool for advancements in the disciplines of infectious disease and biosafety.
Background: Sharps injuries pose a significant occupational risk for healthcare and laboratory workers, with hundreds of thousands of incidents reported annually. While protocols for blood-borne pathogens like HIV and hepatitis viruses are well-established, the risk of traumatic inoculation with Mycobacterium tuberculosis (M. tuberculosis) is under-recognized. Methods: This case series reviews six separate instances of healthcare and laboratory personnel across multiple academic health systems in a northeastern U.S. metropolitan region who developed cutaneous tuberculosis following sharps injuries in environments where M. tuberculosis was present. This series was used to identify gaps in current sharps safety guidelines and to propose improved and standardized safety protocols. Results: All patients were previously nonsensitized to M. tuberculosis and presented with tuberculous chancre at the inoculation site. Diagnosis was delayed in several cases, resulting in prolonged morbidity and unnecessary exposure to ineffective treatments. Treatment regimens varied considerably across the cases, reflecting a lack of standardized guidelines for managing this rare form of the disease. Furthermore, no established post-exposure prophylaxis (PEP) protocols for M. tuberculosis exist for direct inoculation, in stark contrast to guidelines for airborne TB exposure. Conclusion: This review highlights critical gaps in occupational health and biosafety policy. We conclude that awareness of primary cutaneous tuberculosis as a potential sequela of sharps injuries is essential for early diagnosis and effective management. These findings support the development of standardized diagnostic algorithms and evidence-based PEP recommendations to better protect workers from this preventable hazard.
Introduction: Infectious disease research conducted in the Duke Regional Biocontainment Laboratory, a biosafety level-3 facility, often includes work with mice. Infected carcasses must be properly decontaminated at the completion of each study and prior to removal from the facility. Working with Select Agents requires validated methods for complete inactivation of the agent before carcasses can be removed from registered spaces. Methods: Biological indicators were implanted into the abdomen of unfrozen mouse carcasses, then autoclaved using different cycle parameters and packaging strategies to determine the best approach to ensure complete sterilization. Results: Both 20-min and 30-min autoclave cycles at 122 degrees C, with three pre-vacuum pulses, failed to consistently sterilize unfrozen mouse carcasses. A 45-min autoclave cycle with the same parameters did result in the successful sterilization of carcasses when packaged at two or four carcasses in an 8" & times; 12" autoclave bag. Conclusions: This study supports the utilization of an autoclave cycle (122 degrees C sterilization temperature, 45-min sterilization time, three pre-vacuum pulses) to sterilize unfrozen mouse carcasses, up to four per bag.
Introduction: Biosafety and biosecurity principles and practices were introduced to Indonesia over the last two decades, with the Avian influenza outbreak serving as the main catalyst. Both have been implemented in parallel following the establishment of Biosafety Level 3 laboratories in Indonesia for handling highly pathogenic agents. A national standard for biorisk management was initiated by a group of expert panelists from the government and universities, who adopted the CEN Working Agreement 15793 standard. This standard was then endorsed by the Indonesian National Standardization Body as Indonesian National Standard (SNI) 8340 in 2016. The Laboratory Assessment Tool (LAT) for the Biorisk Management System was developed based on the SNI 8340 standard and is used to assess laboratory compliance and performance.Methods: The LAT for the Biorisk Management System has been developed based on the SNI 8340 standard and used in assessing the laboratory current condition and compliance. This assessment tool consists of 16 elements and 54 questions.Results: The LAT has been used as a basis to assess different laboratories in broader fields where biological hazardous materials are present. The LAT assesses laboratories according to their degree of conformity with the established standard, and the level of compliance is reported as a percentage. Various charts are used to present detailed results, allowing for comparisons to monitor future progress.Conclusion: This LAT outlines laboratory achievements in biorisk management. It has been proven to be an effective, easy-to-use, and practical tool that supports laboratories in meeting the Indonesian standards for laboratory biorisk management.
Introduction: In the United States, vaccine development is a complicated and multifaceted process governed by a myriad of regulatory authorities and structures. In addition to industry laboratory, clinical, and manufacturing best practices, biosecurity restrictions are also placed on vaccine development for "select agents," those agents that are considered to pose the greatest risk to public health. Regulations imposed on select agent vaccine development must necessarily be adaptable in consideration of the opinions and experiences of practitioners, but, to date, those involved in vaccine development for select agents have not been specifically represented in published studies assessing researcher viewpoints. The perspectives of this community thus represent a gap in our knowledge of the effects of regulations on biosecurity preparedness infrastructures.Objectives: In this study, we sought to capture personal experiences of scientists working on select agent vaccines, who face unique technical considerations that differ from other vaccine research.Methods: We interviewed U.S. Government researchers and independent contractors who are directly involved in creating vaccines to assess how the select agent regulations (SARs) affect vaccine development in the United States. These personal narratives were transcribed and compiled thematically, covering topics of financial and governmental incentives, administrative and regulatory challenges, subcontracting, personnel security measures, and safety and efficacy testing.Results: Across eight interviews, there was a consensus that the SARs, while burdensome, are fair provisions that mitigate the inherent risk of conducting select agent work. Their perspectives exhibited how the SARs are primarily relevant during the preclinical stage of vaccine development and generally restrict progression to later stages of development typical of nonselect agent vaccines. In addition, lacking government financial incentives, the need for subcontracting, and the limited availability of validated animal models, while not exclusive to SAR work, all serve as significant obstacles to researcher involvement and overall progress in select agent vaccine development.Conclusions: Collectively, these perspectives provide valuable insight into the strengths, weaknesses, and potential areas for improvement in the implementation of the SARs for select agent vaccine development. In addition, these accounts were complimentary of the SARs in ways not currently represented in the literature, which merits further evaluation by larger-scale studies of this subgroup as well as select agent researchers as a whole. These insights provide important context for future discussions of regulatory oversight and its impact on biosecurity preparedness.
Introduction: Effectively managing biological risk in a research setting requires a strong organizational commitment to promoting safe practices and adhering to established protocols, a concept known as a "culture of biosafety." Although a sound culture of biosafety is critical for responsible conduct of research, its assessment remains challenging, relying on self-reporting and qualitative and subjective evaluations.Methods: To determine if a laboratory's culture of biosafety could be evaluated objectively, we examined historical biosafety violation data at three U.S. universities, including biosafety cabinet recertification violations at one university and a range of violations at two other universities. These data were analyzed to determine the distribution of violations among investigators.Results: At all three institutions, we found that a majority of investigators operate laboratories with low rates of biosafety violations and few repeat violations; however, a minority of investigators operate laboratories that are repeatedly in violation of established biosafety guidelines and standards. Repeat violations were unequally distributed amongst laboratories, with only 20% of laboratories accounting for 70-90% of total repeat violations.Discussion: We found that a vast majority of investigators operate laboratories with commendable cultures of biosafety that manifest as low rates of violations and repeat violations.Conclusion: This research establishes metrics for evaluating a laboratory's culture of biosafety with an objective evidence basis and transparent approach, laying the foundation for future research to understand the drivers of biosafety culture, create interventions to improve biosafety culture, and creating a near-term mechanism to promote biosafety culture at institutions via data-driven retention and recruitment strategies.
Introduction: Building on risk communication scholarship, this study examines the effectiveness of communication efforts of the National Bio and Agro-Defense Facility through a survey of community residents living near the facility.Methods: An online survey (n = 478) was conducted in summer of 2024 with residents living within 20 miles of the National Bio and Agro-Defense Facility.Results: Results indicate that sufficient and consistent communication efforts by the facility, though directly relating to knowledge levels and information seeking behaviors, were also directly associated with the community's risk and preparedness perceptions, circumventing knowledge and information seeking behaviors. Misinformation frequency led to increased knowledge and information seeking behaviors. While knowledge was not associated with risk or preparedness perceptions, it increased information seeking behaviors, which in turn led to higher risk perceptions.Conclusion: Findings imply the importance of leveraging local partners, like the local university, to increase knowledge about the science conducted at the National Bio and Agro-Defense Facility, while at the same time pointing to the fact that information consistency and sufficiency are more important in increasing community preparedness than knowledge itself.
Introduction: Self-driving laboratories (SDLs) are rapidly transforming the scientific enterprise by integrating artificial intelligence (AI), robotics, and automated experimentation to accelerate discovery with greater speed, autonomy, and precision. These intelligent platforms enable researchers to efficiently explore vast experimental spaces, reducing human error and increasing reproducibility. However, they introduce new and complex safety and security risks that demand proactive attention.Methodology: Here we discuss SDLs and how their utility in biotechnology can be harvested to drive scientific change. We also assess the security risks associated with integrating AI into SDL operations in research environments and provide mitigation strategies to address them.Results: We present an assessment of the vulnerabilities related to AI-driven SDLs and provide targeted, actionable mitigation strategies. These strategies are designed to help researchers and institutions address emerging risks related to system autonomy, data governance, and automation in experimental workflows.Conclusion: We argue that safeguarding SDLs cannot fall to any single actor; instead, it requires coordinated action among researchers, institutions, and policymakers. By grounding SDL development in principles of security, ethics, and collaborative governance, the scientific community can ensure that these powerful platforms advance research in a responsible manner. This work lays a critical foundation for secure and ethical SDL integration, supporting innovation while protecting against misuse and unintended harm.
Introduction: This article presents comprehensive safety guidelines and risk management strategies for conducting research involving bats in laboratory environments, building upon previously established field safety recommendations. With the increasing use of bats in biomedical and ecological research, proper handling, housing, biosafety, and biosecurity measures are critical for protecting researchers, the surrounding community, and animal welfare.Methods: This document discusses essential topics such as institutional review processes, medical surveillance, regulatory compliance, and the transportation of live bats and their biological materials. It also includes a discussion of pathogens of concern that may be found in bats or bat samples, from rabies and other lyssaviruses to filoviruses, henipaviruses, and others. It emphasizes the need for robust risk assessments tailored to various laboratory settings, highlighting procedures for handling potentially infectious tissues and fluids and managing bat housing in vivarium facilities. In addition, it addresses considerations for quarantine, environmental controls, and biosafety and biosecurity protocols that are critical for protecting researchers and the community, specifically the use of personal protective equipment and training requirements for laboratory personnel.Discussion: By detailing these safety practices using a holistic approach from a broad background of expertise, this article aims to equip researchers and biosafety professionals with the tools necessary to establish a safe and ethical framework for bat-related studies, facilitating responsible and effective research while minimizing zoonotic risks and supporting conservation efforts.
Introduction:Public health logic models divide interventions into three categories: inputs, activities, and outcomes. Similarly, biosafety programs can be described using this same logic model by describing inputs in the form of program staffing and budget; program activities in the form of risk assessments, routine surveillance, training, incident response, and other services; and outcomes in the form of reported exposures, injuries, compliance, finances, and client satisfaction. Methods:Described here is a systematic means of collecting and displaying biosafety program activity data monthly so that the organizational leadership and associated safety committees can readily grasp the scope of various activities undertaken by the biosafety program to support the broader organizational goals. Discussion:The simplified public health logic model affords guidance on inputs, activities, and outcomes that biosafety programs can use to their advantage. The importance of succinctly reporting the data describing activities can inform and educate upper management and other stakeholders regarding the resources needed to avoid injuries and illnesses and maintain compliance. Conclusion:Within the biosafety profession, on a good day, "nothing bad happens," so conveying the message of the value of prevention can be challenging. By capturing and readily presenting data that describes the efforts of a biosafety program, individual programs can articulate their needs for staffing and resources more successfully, and the profession stands a better chance of maintaining strong administrative and stakeholder support.
