Use Research Of Concern Research Articles

Bridging biosafety and biosecurity gaps: DURC and ePPP policy insights from U.S. institutions.

This study provides empirical data on the knowledge and practices of biosafety and biosecurity professionals and researchers involved in research on enhanced Potential Pandemic Pathogens (ePPPs) and Dual Use Research of Concern (DURC) within various U.S. sectors. The goal is to improve public health interventions and oversight for DURC and ePPP, contributing valuable insights for policy development. A notable finding was the association between larger biosafety/biosecurity teams and a higher likelihood of conducting high-risk biological research. A survey of 541 biosafety and biosecurity professionals was conducted between March 8 and 10 April 2024, with results analyzed using SAS at a significance level of 0.05. The study received approval from the Institutional Review Boards (IRBs) at Arizona State University and the University of Nevada, Reno. Government organizations were more likely to conduct DURC compared to other sectors (e.g., Academic, Commercial, Consulting). Public institutions reviewed more experiments outside the scope of the U.S. DURC Policy than private for-profit institutions. Institutions with larger biosafety/biosecurity teams reported greater research activity and more effective non-compliance reporting mechanisms (e.g., anonymous hotlines, reporting forms). Additionally, financial support and the challenges of policy implementation varied significantly across sectors. The findings emphasize the need for appropriate staffing and resource allocation for high-risk biosafety and biosecurity research. A differentiated regulatory approach and equitable distribution of resources are essential for effective oversight. Moreover, robust non-compliance reporting systems are critical to mitigating the risks associated with DURC and ePPP research.

Assessing dual use risks in AI research: necessity, challenges and mitigation strategies

This article argues that due to the difficulty in governing AI, it is essential to develop measures implemented early in the AI research process. The goal of dual use considerations is to create robust strategies that uphold AI’s integrity while protecting societal interests. The challenges of applying dual use frameworks to AI research are examined and dual use and dual use research of concern (DURC) are defined while highlighting the difficulties in balancing the technology’s benefits and risks. AI’s dual use potential is discussed, particularly in areas like NLP and LLMs, and the need for early consideration of dual use risks to ensure ethical and secure development is underscored. In the section on shared responsibilities in AI research and avenues for mitigation strategies the importance of early-stage risk assessments and ethical guidelines to mitigate misuse is emphasized, accentuating self-governance within scientific communities and structured measures like checklists and pre-registration to promote responsible research practices. The final section argues that research ethics committees play a crucial role in evaluating the dual use implications of AI technologies within the research pipeline. The need for tailored ethics review processes is articulated, drawing parallels with medical research ethics committees.

Dual use concerns of generative AI and large language models

ABSTRACT We suggest the implementation of the Dual Use Research of Concern (DURC) framework, originally designed for life sciences, to the domain of generative AI, with a specific focus on Large Language Models (LLMs). With its demonstrated advantages and drawbacks in biological research, we believe the DURC criteria can be effectively redefined for LLMs, potentially contributing to improved AI governance. Acknowledging the balance that must be struck when employing the DURC framework, we highlight its crucial political role in enhancing societal awareness of the impact of generative AI. As a final point, we offer a series of specific recommendations for applying the DURC approach to LLM research.

Establishing a national biosafety and biosecurity agency for the United States.

The rapid advancement of biological research and biotechnology requires a novel and robust regulatory agency to ensure uniform biosafety and biosecurity governance in the United States. The current fragmented regulatory landscape needs to be refocused to address the complexities of modern biological research, including risks associated with accidental, inadvertent, and deliberate biological incidents. An independent government agency, which we call the National Biosafety and Biosecurity Agency (NBBA), that is devoted to biosafety and biosecurity could effectively address these challenges. The NBBA would consolidate various regulatory functions, streamline processes, and enhance oversight. This oversight would encompass life sciences research in the United States, regardless of the source of funding or level of classification. The agency could also contribute to the bioeconomy by streamlining requirements to safeguard public health and the environment while fostering scientific and commercial progress. The proposed agency would govern high-risk biological pathogens, manage the Federal Select Agent Program, enforce policies related to dual use research of concern, pathogens with enhanced pandemic potential, and nucleic acid synthesis screening, administer regulations on the use and care of laboratory animals, as well as regulate other relevant biosafety and biosecurity activities. The goal would be to provide one-stop shopping for the biomedical research and biotechnology sectors subject to oversight by the Federal government. To ensure leadership in global biosafety and biosecurity, the agency's mission would include international collaboration, applied research, education, workforce development, and coordination with national security initiatives. Creating an agency like the NBBA will be politically challenging but presenting a comprehensive vision and engaging stakeholders early and frequently, and being transparent in the process, will be essential for garnering support. Creating a unified biosafety and biosecurity governance system in the United States will ensure the safe and secure advancement of biological research while sustaining innovation and maintaining international competitiveness.

Improved understanding of biorisk for research involving microbial modification using annotated sequences of concern.

Regulation of research on microbes that cause disease in humans has historically been focused on taxonomic lists of 'bad bugs'. However, given our increased knowledge of these pathogens through inexpensive genome sequencing, 5decades of research in microbial pathogenesis, and the burgeoning capacity of synthetic biologists, the limitations of this approach are apparent. With heightened scientific and public attention focused on biosafety and biosecurity, and an ongoing review by US authorities of dual-use research oversight, this article proposes the incorporation of sequences of concern (SoCs) into the biorisk management regime governing genetic engineering of pathogens. SoCs enable pathogenesis in all microbes infecting hosts that are 'of concern' to human civilization. Here we review the functions of SoCs (FunSoCs) and discuss how they might bring clarity to potentially problematic research outcomes involving infectious agents. We believe that annotation of SoCs with FunSoCs has the potential to improve the likelihood that dual use research of concern is recognized by both scientists and regulators before it occurs.

Assessing dual use research of concern (DURC)-lessons learned from the United States government institutional DURC policy.

Life science research was analyzed for potential misuse in the 2004 report "Biotechnology Research in an Age of Bioterrorism". However, it was not until 2015 that the United States Government (USG) Institutional Dual Use Research of Concern (DURC) policy went into effect. Institutions receiving USG funding for life science research are required to scan their research portfolios for research involving one of 15 agents and subsequent 7 experimental effects described in the policy. In practice, this policy was implemented in a variety of ways with varying outcomes and lessons learned. First and foremost, reviewing research for potential DURC is a highly subjective process that differs depending on the risk tolerance, experience, and training of the individuals charged with reviewing research for an institution as well as the review process itself. The information being reviewed also lends to the subjectivity of the process, that is, the experimental data provided. It is difficult to determine whether research is potential DURC without experimental data. Any review process is hypothetical until there is data. Lastly, reviewers of the research should look beyond the research proposals, like how compounding existing research information can create new risks, potential use in other organisms or systems, or the creation of a roadmap that, for example, shows how to create a concerning organism or could be used in a pathogen.

Proceedings of the Dual Use Research of Concern Panel Discussion: challenges and perspectives.

To address real and perceived emerging risks originating from the ever-accelerating breakthroughs in life science research, the Dual Use Research of Concern (DURC) Panel Discussion, organized by Synbio Canada and the Alberta RNA Research and Training Institute (ARRTI), took place on June 23rd, 2021. It brought together six stakeholders from different levels of academic research, administration, governance, and science publishing to explore the current and future challenges in addressing DURC. Technological advancements within the life sciences, especially within the field of omics technology, make it difficult to apply a simple checklist for dual-use assessment and require continuous and integrated effort. Bottom-up approaches from within the scientific community are suggested by all stakeholders to enable efficient governance and address the true risks resulting from DURC, not just the alleged risks. To address such alleged risks, open and broadscale communication of DURC and its oversight policies may be required. At the same time, any form of open communication also contains the risk of information hazards, defined as potentially creating public fear or informing malicious actors. Here, an overview of the DURC panel and its outcomes is provided.

Evaluation of animal biosafety webinar series for professionals working in animal facilities across Pakistan during the COVID-19 pandemic

Experimental research with animals can help the prevention, cure, and alleviation of human ailments. Animal research facilities are critical for scientific advancement, but they can also pose a higher risk than other biomedical laboratories. Zoonosis, allergic reactions, bites, cuts, and scratches by animals are all substantial concerns that can occur in animal facilities. Furthermore, human error and unexpected animal behavior pose a risk not just to humans, but also to the environment and the animals themselves. The majority of biosafety and biosecurity training programs focus on clinical and biomedical laboratories dealing with human safety factors, with little emphasis on animal biosafety. The current virtual training was designed to improve biosafety and biosecurity capabilities of animal laboratory personnel, researchers, and veterinarians from different regions of Pakistan. The results revealed that understanding was improved regarding triggers for risk assessment in addition to annual and regular reviews (56% to 69%), biosecurity (21% to 50%), decontamination (17% to 35%), safe handling of sharps (21% to 35%), Dual Use Research of Concern (DURC) (17% to 40%), Personal Protective Equipment (PPE) usage by waste handlers (60.9% to 75%), waste management (56% to 85%), animal biosafety levels (40.57% to 45%), and good microbiological practices and procedures (17% to 35%). To bring human and animal laboratories up to the same level in terms of biosafety and biosecurity, it is critical to focus on areas that have been overlooked in the past. Training programs focusing on animal biosafety should be conducted more frequently to strengthen bio risk management systems in animal research facilities.

Stakeholder Engagement Workshop on the Implementation of the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern: Workshop Report

This report documents the discussions of the 2017 Stakeholder Engagement Workshop on the Implementation of the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. It is not an official record of the Stakeholder Engagement Workshop. It was compiled to assist the research and policy communities as they consider updating U.S. Government policies on Dual Use Research of Concern (DURC). Neither the National Institutes of Health nor the National Science Advisory Board for Biosecurity (NSABB) produced a report out of the workshop, and it is hoped that this summary of the discussion, based on analysis of the videos of the workshop, will be useful for those interested in the development of the United States Policies on dual use research of concern.

Information for Contributors

Information for Contributors

DUAL-USE TECHNOLOGIES OF CONCERN IN CONTEXT OF BIOSAFETY (review)

One of the main prerequisites for creation and dissemination of bioethics in the world was the concept of dual use in medical and biological sciences, which is defined as the direction of unintentional creation of biological threats in research or implementation of new biotechnologies. To determine the range of dual-use research that could potentially generate products, technologies, or knowledge whose misuse could harm large numbers of people or the environment and that are biosafety-relevant, the international term Dual Use Research of Concern (DURC) is used. Actualization of the debate on the dilemma of dual use in biomedical sciences is due to, on the one hand, the international community's attempt to minimize the potential for destructive use of biomedical research, on the other hand, the active search for effective ways to raise awareness of their social and moral responsibility for implementation of the results of scientific developments in the field of life. This article considers the definition of terms that define the field of DURC in the context of biosafety, which in recent decades have undergone a number of semantic changes. The article also outlines the modern general concept of DURC, defines the categories by which DURC is defined, and outlines the scope of policy on the implementation of control over DURC. Informing the scientific community engaged in biomedical research about the problem issues of DURC biotechnology is a key component of biosafety. Modern biotechnology and related biosafety issues should be applied to society needs, but without compromising human and environmental safety. Systematic consideration of all these disputable questions of the dual-use dilemma with the involvement of all stakeholders will allow to form a rational biosafety policy for biotechnology.

Dual Use Research of Concern: Perspective of Clinicians from a Training Viewpoint.

The field of Dual use research of concern (DURC) has been rapidly expanding in the last decade. Though this has led to unprecedented breakthroughs in Life sciences and Technology, it is also associated with significant risks. These risks are enormous, transcend local and national boundaries and have the potential of catastrophic effects. Some of these include the release of highly infectious pathogens capable of sparking unnatural outbreaks, with resultant widespread illness and deaths. Yet Clinicians who are significant first responders involved in the management of cases in outbreaks, often lack relevant training on DURC and its associated risks. We propose that the World Health Organization (WHO) should develop global guidelines on the integration of relevant DURC training into undergraduate and postgraduate medical curricula. In addition, country-level national policy should be developed by each member country in line with their specific context.

Dual use in the 21st century: emerging risks and global governance.

Dual use research of concern (DURC) is defined by the World Health Organization as "life sciences research that is intended for benefit, but which might easily be misapplied to do harm." Ethical and policy discussions on DURC span the past three decades. Today, however, new and emerging technologies and associated sociocultural transformations within the scientific community are reshaping the current risk scenario. This paper identifies three major trends that are likely to characterise dual use dilemmas in the near future: the diversification of dual use domains, the digitalisation of potential threats and the proliferation of actors. This analysis illustrates an increasingly heterogeneous and fragmented risk scenario, which can hardly be effectively governed top-down from a centralised authority. We propose that in order to meet the critical challenges of dual use in the 21st century, a global and distributed governance is needed. In contrast to globally binding sets of legal mechanisms administered by a central and hierarchical authority supported by leading powers, we suggest a global and decentralised governance architecture encompassing multilevel, multipolar and bottom-up strategies that can stretch across a spectrum of stakeholders and scientific domains in an agile, proactive and adaptive manner. Finally, we discuss how Switzerland can take a leading role in the promotion and development of this global governance architecture.

‘Dual Use Research of Concern’ and ‘Select Agents’

AbstractCreating a suspect community is a time-consuming task and requires persistence. Once achieved, it is difficult to undo. In security terms, inspiring fear of dual use is one of many successful methods used to create suspicion. The concept of dual use research of concern (DURC) is the idea that scientific knowledge can be created by the worthy, stolen by the malevolent and used to make war on the innocent. On campus, ideas about Islam are currently often viewed as if Islam epitomisesDURC. By this means, a Derridean binary opposition springs up between Islam and the rest, whereby that-which-is-Islam is demeaned and the ‘rest’ is privileged. This emanates from political intervention on campus and creates a risk-averse ‘othering’ approach to students’ interaction with Islam and Muslims and the Western world. In order to demonstrate how this political intervention influences the university curriculum and university life on campus, the termdual usewill function here as a heuristic: the ‘metaphor’ ofDURCshows how certain government ideologies are being used on campus to ‘weaponise’ ideas about Islam as if they are malevolent. Using a complementary and mutually enhancing combination of philosophy, empirical research and policy analysis, three positive solutions are proposed that show how important it is that academics be aware of national policy: first, in order to make people cognisant of the urgent need to offer alternatives to the British counter terrorism programme ‘Prevent’ and the work of the Charity Commission with student societies; second, to support the work of academic subject associations; and third, to create a useful debate about free speech.

The dual use of research ethics committees: why professional self-governance falls short in preserving biosecurity

BackgroundDual Use Research of Concern (DURC) constitutes a major challenge for research practice and oversight on the local, national and international level. The situation in Germany is shaped by two partly competing suggestions of how to regulate security-related research: The German Ethics Council, as an independent political advisory body, recommended a series of measures, including national legislation on DURC. Competing with that, the German National Academy of Sciences and the German Research Foundation, as two major professional bodies, presented a strategy which draws on the self-control of science and, inter alia, suggests expanding the scope of research ethics committees (RECs) to an evaluation of DURC.Main bodyThis situation is taken as an occasion to further discuss the scope and limits of professional self-control with respect to security-related research. The role of RECs as professional bodies of science is particularly analyzed, referring to the theoretical backgrounds of professionalism. Two key sociological features of professionalism – ethical orientation and professional self-control – are discussed with respect to the practice of biomedical science. Both attributes are then analyzed with respect to the assessment of DURC by RECs.ConclusionIn conclusion, it is stated that issues of biosecurity transcend the boundaries of the scientific community and that a more comprehensive strategy should be implemented encompassing both professional self-control and legal oversight.

A New Approach to Evaluating the Risk-Benefit Equation for Dual-Use and Gain-of-Function Research of Concern.

In the twenty-first century, biology faces a problem that has previously vexed other disciplines such as physics, namely the prospect that its knowledge domain could be used to generate biological agents with altered properties that enhanced their weapon potential. Biological weapons bring the additional dimension that these could be self-replicating, easy to manufacture and synthesized with commonly available expertise. This resulted in increasing concern about the type of research done and communicated, despite the fact that such research often has direct societal benefits, bringing the dual-use dilemma to biology. The conundrum of dual use research of concern was crystallized by the so-called “gain-of-function” type of experiments in which avian influenza viruses were endowed with new properties in the laboratory such as increased virulence and the capacity for mammalian transmission. After more than a decade of intensive discussion and controversy involving biological experiments with dual-use potential, there is no consensus on the issue except for the need to carry out such experiments in the safest conditions possible. In this essay, we review the topic with the hindsight of several years and suggest that instead of prescribing prohibitions and experimental limitations the focus should be on the importance of scientific questions at hand. We posit that the importance of a scientific question for medical and scientific progress provides a benchmark to determine the acceptable level of risk in biological experimentation.

From Healthcare to Warfare and Reverse: How Should We Regulate Dual-Use Neurotechnology?

Recent advances in military-funded neurotechnology and novel opportunities for misusing neurodevices show that the problem of dual use is inherent to neuroscience. This paper discusses how the neuroscience community should respond to these dilemmas and delineates a neuroscience-specific biosecurity framework. This neurosecurity framework involves calibrated regulation, (neuro)ethical guidelines, and awareness-raising activities within the scientific community.

How to Balance the Risk and Benefit of Dual Use Research of Concern

Dual use research on H5N1 Influenza is a big debate topic as technologies in research improve. Once DURC research is published, these studies could be misused by bioterrorist and considered a potential risk for public health with individual ill intent. There are many risks and benefits of performing and publishing of H5N1 studies in the United States. Some restriction in DURC are needed to take place to make sure the benefits outweigh the risks, so research could be performed to ensure the global health.

Biosafety Oversight and Compliance: What do you Mean, I have to Fill Out Another Form?!

This unit is an overview of biosafety compliance and oversight in the United States. Specific attention is given to the oversight of the Institutional Biosafety Committee (IBC) and how the purview of the IBC may overlap with other local committees, such as the Institutional Animal Care and Use Committee (IACUC) for animal research and the Institutional Review Board (IRB) for research on human subjects. Requirements for the Federal Select Agent Program and Dual Use Research of Concern (DURC) are also briefly reviewed for those working with materials and experiments covered under these regulations. This unit serves as a guide for new and established investigators who are navigating the regulatory world and how regulatory oversight applies to their research.

A New Synthesis for Dual Use Research of Concern

Michael Imperiale and Arturo Casadevall propose a path forward for life sciences research whose results could be misused to cause harm.