Safeguard the world's worst pathogens.

More people in more places are researching the world's most dangerous pathogens. This work helps prepare against future pandemics, but it's not without danger. Pathogens could escape from research facilities, so it is vital for countries to assess potential hazards and have procedures in place to manage the risks. This doesn't happen enough.

The Dual-Use Education Gap: Awareness and Education of Life Science Researchers on Nonpathogen-Related Dual-Use Research.

With the rise of synthetic biology, dual-use research risks are not confined to pathogen-related research. However, existing measures to mitigate the risks of dual-use research, such as export control, are still designed to hinder access to pathogens and do not address the risks of nonpathogen-related dual-use research. The current self-regulatory approach requires scientists to be aware of their responsibility and know how to assess risks and establish countermeasures. The purpose of this study was to examine the state of knowledge about dual-use research among life science students and to test an alternative teaching approach on the importance of considering biosecurity risks for teams participating in the International Genetically Engineered Machine (iGEM) competition. We conducted an international survey from July 18 to September 13, 2018, which was completed by 192 respondents from 29 countries and 74 universities. Based on the results of the survey, we designed and tested a learning workshop on dual-use research within the iGEM community. Results from the workshop and the survey show that educational machinery so far have failed to integrate teaching about dual-use research issues.

iGEM and Gene Drives: A Case Study for Governance.

Gene drives have already challenged governance systems. In this case study, we explore the International Genetically Engineered Machine (iGEM) competition's experiences in gene drive-related research and lessons in developing, revising, and implementing a governance system. iGEM's experiences and lessons are distilled into 6 key insights for future gene drive policy development in the United States: (1) gene drives deserve special attention because of their potential for widescale impact and remaining uncertainty about how to evaluate intergenerational and transboundary risks; (2) an adaptive risk management approach is logical for gene drives because of the rapidly changing technical environment; (3) review by individual technical experts is limited and may fail to incorporate other forms of expertise and, therefore, must be complemented with a range of alternative governance methods; (4) current laboratory biosafety and biosecurity review processes may not capture gene drive research or its components in practice even if they are covered theoretically; (5) risk management for research and development must incorporate discussions of values and broader implications of the work; and (6) a regular technology horizon scanning capacity is needed for the early identification of advances that could pose governance system challenges.

Implementing adaptive risk management for synthetic biology: Lessons from iGEM's safety and security programme.

Synthetic biology offers exciting possibilities to deal with local and global challenges over the coming decades. As we make greater use of biological engineering, it will be increasingly important to balance potential risks and benefits. The rate, scale, and diffusion of relevant capabilities will make this challenging. There will be a growing need for flexible risk management approaches, which can be rapidly adapted as technology and societal needs change. This study details efforts by the International Genetically Engineered Machine (iGEM) competition in creating and implementing an adaptive risk management approach. It concludes with key lessons and challenges: working with hazardous materials, such as dangerous pathogens, toxins and chemicals; managing risks to plants, animals and the environment; use of samples from people, animals, and the environment; improving the hazards identified; variations in risk perception and tolerance; variation in terminology that complicates interpretation of risk management plans; and connections with broader societal or ethical questions, such as animal use, gender and sexuality, or benefit sharing.

The biosecurity benefits of genetic engineering attribution.

Biology can be misused, and the risk of this causing widespread harm increases in step with the rapid march of technological progress. A key security challenge involves attribution: determining, in the wake of a human-caused biological event, who was responsible. Recent scientific developments have demonstrated a capability for detecting whether an organism involved in such an event has been genetically modified and, if modified, to infer from its genetic sequence its likely lab of origin. We believe this technique could be developed into powerful forensic tools to aid the attribution of outbreaks caused by genetically engineered pathogens, and thus protect against the potential misuse of synthetic biology.

COVID-19, SARS-CoV-2, and Export Controls.

Export controls are intended to prevent the proliferation of materials that could be misused to make biological weapons. They are not intended to stifle critical research and development in the midst of a pandemic. This article explores how and why export controls might apply to severe acute respiratory syndrome coronavirus 2, the virus that causes coronavirus disease 2019. It outlines the taxonomic and genetic factors associated with the current approach to export control lists and discusses how they lead to unnecessary ambiguity. The authors describe ways in which the current export control systems might be revised in the short, medium, and long term, including sequence, disease, and function-based approaches.

Bioengineering horizon scan 2020.

Horizon scanning is intended to identify the opportunities and threats associated with technological, regulatory and social change. In 2017 some of the present authors conducted a horizon scan for bioengineering (Wintle et al., 2017). Here we report the results of a new horizon scan that is based on inputs from a larger and more international group of 38 participants. The final list of 20 issues includes topics spanning from the political (the regulation of genomic data, increased philanthropic funding and malicious uses of neurochemicals) to the environmental (crops for changing climates and agricultural gene drives). The early identification of such issues is relevant to researchers, policy-makers and the wider public.

Cyber-Biosecurity Risk Perceptions in the Biotech Sector.

The expanding digitization of the biological sciences places greater value on the data generated, information extrapolated and knowledge gained. Failing to protect data will affect a company or country's ability to position itself optimally in the forthcoming fourth industrial revolution. Further, more reliance on automation, distribution, and outsourcing in biotechnology makes its infrastructure a target. The equipment and service providers that drive physical research and development are also all connected online. Failing to protect these resources from intrusion increases the risk of accidental or deliberate harm, for example by the loss of control over biological products. Robust cybersecurity measures are therefore critical for both securing the data generated by the biotechnology sector as well as securing key infrastructure. Cyber-biosecurity is emerging multidisciplinary field that combines cybersecurity, biosecurity, and cyber-physical security as relates to biological systems (Murch et al., 2018). To better identify the perceived risks at the interface between cybersecurity and biosecurity, Biosecure conducted a pilot study that surveyed the opinions of a discrete set of international field leaders in biotechnology and cybersecurity. The survey was carried out online from October-November 2017. Key findings of the survey showed that cyber-biosecurity risks were considered to be difficult to characterize due to variations in types of threats, targets and potential impacts, and compounded by a notable variation between the level of sophistication or maturity of mitigation and response measures. Further research is therefore necessary bringing together the different communities focusing on these issues to develop a common language, better define the threats and discuss potential ways forward in addressing risks.

Developing a Comprehensive, Adaptive, and International Biosafety and Biosecurity Program for Advanced Biotechnology: The iGEM Experience.

Introduction: The international synthetic biology competition iGEM (formally known as the international Genetically Engineered Machines competition) has a dedicated biosafety and biosecurity program. Method: A review of specific elements of the program and a series of concrete examples illustrate how experiences in implementing the program have helped improved policy, including an increasing diversity of sources for genetic parts and organisms, keeping pace with technical developments, considering pathways toward future environmental release, addressing antimicrobial resistance, and testing the efficacy of current biosecurity arrangements. Results: iGEM's program is forward-leaning, in that it addresses both traditional (pathogen-based) and emerging risks both in terms of new technologies and new risks. It is integrated into the technical work of the competition-with clearly described roles and responsibilities for all members of the community. It operates throughout the life cycle of projects-from project design to future application. It makes use of specific tools to gather and review biosafety and biosecurity information, making it easier for those planning and conducting science and engineering to recognize potential risks and match them with appropriate risk management approaches, as well as for specialists to review this information to identify gaps and strengthen plans. Discussion: Integrating an increasingly adaptive risk management approach has allowed iGEM's biosafety and biosecurity program to become comprehensive, be cross-cutting, and cover the competition's life cycle.

Information Hazards in Biotechnology.

With the advance of biotechnology, biological information, rather than biological materials, is increasingly the object of principal security concern. We argue that both in theory and in practice, existing security approaches in biology are poorly suited to manage hazardous biological information, and use the cases of Mousepox, H5N1 gain of function, and Botulinum toxin H to highlight these ongoing challenges. We suggest that mitigation of these hazards can be improved if one can: (1) anticipate hazard potential before scientific work is performed; (2) consider how much the new information would likely help both good and bad actors; and (3) aim to disclose information in the manner that maximally disadvantages bad actors versus good ones.

The WHO R&D Blueprint: 2018 review of emerging infectious diseases requiring urgent research and development efforts.

The Research and Development (R&D) Blueprint is a World Health Organization initiative to reduce the time between the declaration of a public health emergency and the availability of effective diagnostic tests, vaccines, and treatments that can save lives and avert a public health crisis. The scope of the Blueprint extends to severe emerging diseases for which there are insufficient or no presently existing medical countermeasures or pipelines to produce them. In February 2018, WHO held an informal expert consultation to review and update the list of priority diseases, employing a prioritization methodology which uses the Delphi technique, questionnaires, multi-criteria decision analysis, and expert review to identify relevant diseases. The committee determined that, given their potential to cause a public health emergency and the absence of efficacious drugs and/or vaccines, there is an urgent need for accelerated R&D for (in no order of priority) Crimean-Congo haemorrhagic fever, Ebola virus and Marburg virus disease, Lassa fever, Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), Nipah and henipaviral diseases, Rift Valley fever and Zika virus disease. The experts also included "Disease X," representing the awareness that a previously unknown pathogen could cause a major public health emergency. This report describes the methods and results of the 2018 prioritization review.

World Health Organization Methodology to Prioritize Emerging Infectious Diseases in Need of Research and Development.

The World Health Organization R&D Blueprint aims to accelerate the availability of medical technologies during epidemics by focusing on a list of prioritized emerging diseases for which medical countermeasures are insufficient or nonexistent. The prioritization process has 3 components: a Delphi process to narrow down a list of potential priority diseases, a multicriteria decision analysis to rank the short list of diseases, and a final Delphi round to arrive at a final list of 10 diseases. A group of international experts applied this process in January 2017, resulting in a list of 10 priority diseases. The robustness of the list was tested by performing a sensitivity analysis. The new process corrected major shortcomings in the pre-R&D Blueprint approach to disease prioritization and increased confidence in the results.

A transatlantic perspective on 20 emerging issues in biological engineering.

Advances in biological engineering are likely to have substantial impacts on global society. To explore these potential impacts we ran a horizon scanning exercise to capture a range of perspectives on the opportunities and risks presented by biological engineering. We first identified 70 potential issues, and then used an iterative process to prioritise 20 issues that we considered to be emerging, to have potential global impact, and to be relatively unknown outside the field of biological engineering. The issues identified may be of interest to researchers, businesses and policy makers in sectors such as health, energy, agriculture and the environment.

Existential Risk and Cost-Effective Biosecurity.

In the decades to come, advanced bioweapons could threaten human existence. Although the probability of human extinction from bioweapons may be low, the expected value of reducing the risk could still be large, since such risks jeopardize the existence of all future generations. We provide an overview of biotechnological extinction risk, make some rough initial estimates for how severe the risks might be, and compare the cost-effectiveness of reducing these extinction-level risks with existing biosecurity work. We find that reducing human extinction risk can be more cost-effective than reducing smaller-scale risks, even when using conservative estimates. This suggests that the risks are not low enough to ignore and that more ought to be done to prevent the worst-case scenarios.

Proliferation of biological weapons: challenges and responses.

The threat posed by the proliferation of biological weapons (BW) confronts all strata of our society, from the individual, the nation, or the region to the truly international. The history of state-run offensive BW programmes and the attacks in the United States with powdered anthrax demonstrate that existing measures fall short of addressing this threat. This article examines the current regime and the concerns that confront it in order to suggest possible responses across the social strata that may mitigate future proliferation of BW.

The Biological Weapons Convention after November 2002.

The Fifth Review Conference of the Biological Weapons Convention, in November 2002, was the first to fail to produce a Final Document. It saw heated debate on non-compliance with the spirit of the prohibitions that it enshrines and marked the collapse of almost ten years of negotiations attempting to create a Protocol to strengthen the Convention. What was to emerge was a new process, very different from the traditional tools of arms control. This article examines the events that culminated in this drastic new approach, details the nature of this new process and discusses the possible short-, medium- and long-term impact of these events on the norm against the weaponization of disease.