The potential misuse of advances in life sciences research is raising concerns about national security threats. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies examines the U.S. strategy for reducing biosecurity risks in life sciences research and considers mechanisms that would allow researchers to manage the dissemination of the results of research while mitigating the potential for harm to national security.

Based on a series of regional meetings on university campuses with officials from the national security community and academic research institutions, this report identifies specific actions that should be taken to maintain a thriving scientific research environment in an era of heightened security concerns. Actions include maintaining the open exchange of scientific information, fostering a productive environment for international scholars in the U.S., reexamining federal definitions of sensitive but unclassified research, and reviewing policies on deemed export controls. The federal government should establish a standing entity, preferably a Science and Security Commission, that would review policies regarding the exchange of information and the participation of foreign-born scientists and students in research.

Continuing advances in science and technology offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances have the potential to challenge the oversight systems for responsible conduct of life sciences research with dual use potential â€" research that may have beneficial applications but that also could be misused to cause harm. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, to promote global dialogue and increased common understandings of the essential elements of governance for such research. Hosted by the Croatian Academy of Sciences and Arts in Zagreb, Croatia, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop.

In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.

Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.

When, in late 2011, it became public knowledge that two research groups had submitted for publication manuscripts that reported on their work on mammalian transmissibility of a lethal H5N1 avian influenza strain, the information caused an international debate about the appropriateness and communication of the researchers' work, the risks associated with the work, partial or complete censorship of scientific publications, and dual-use research of concern in general. Recognizing that the H5N1 research is only the most recent scientific activity subject to widespread attention due to safety and security concerns, on May 1, 2012, the National Research Council's Committee on Science, Technology and Law, in conjunction with the Board on Life Sciences and the Institute of Medicine's Forum on Microbial Threats, convened a one-day public workshop for the purposes of 1) discussing the H5N1 controversy; 2) considering responses by the National Institute of Allergy and Infectious Diseases (NIAID), which had funded this research, the World Health Organization, the U.S. National Science Advisory Board for Biosecurity (NSABB), scientific publishers, and members of the international research community; and 3) providing a forum wherein the concerns and interests of the broader community of stakeholders, including policy makers, biosafety and biosecurity experts, non-governmental organizations, international organizations, and the general public might be articulated. Perspectives on Research with H5N1 Avian Influenza: Scientific Enquiry, Communication, Controversy summarizes the proceedings of the workshop.

What Is the Dual-Use Dilemma? The so-called “dual-use dilemma” arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of sci- tific research sometimes has the potential to be used for harm as well as for good. A dual-use dilemma is an ethical dilemma, and an ethical dilemma for the researcher (and for those who have the power or authority to assist or impede the researcher’s work, e. g. , governments). It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e. g. , the p- motion of health in the context of providing the wherewithal for the killing of in- cents. It is an ethical dilemma for the researcher not because he or she is aiming at anything other than a good outcome; typically, the researcher intends no harm, but only good. Rather, the dilemma arises for the researcher because of the potential actions of others. Malevolent non-researchers might steal dangerous biological agents produced by the researcher; alternatively, other researchers—or at least their governments or leadership—might use the results of the original researcher’s work for malevolent purposes. The malevolent purposes in question include bioterrorism, biowarfare and blackmail for financial gain.

Recent advances in disciplines such as biotechnology, nanotechnology, and neuropharmacology entail a "dual-use dilemma" because they promise benefits for human health and welfare yet pose the risk of misuse for hostile purposes. The emerging field of synthetic genomics, for example, can produce custom DNA molecules for life-saving drugs but also makes possible the creation of deadly viral agents for biological warfare or terrorism. The challenge for policymakers is to prevent the misuse of these new technologies without forgoing their benefits . Innovation, Dual Use, and Security offers a systematic approach for managing the dual-use dilemma. The book presents a "decision framework" for assessing the security risks of emerging technologies and fashioning governance strategies to manage those risks. This framework is applied to fourteen contemporary case studies, including synthetic genomics, DNA shuffling and directed evolution, combinatorial chemistry, protein engineering, immunological modulation, and aerosol vaccines. The book also draws useful lessons from two historical cases: the development of the V-series nerve agents in Britain and the use and misuse of LSD by the U.S. Army and the CIA. Innovation, Dual Use, and Security offers a comprehensive, multifaceted introduction to the challenges of governing dual-use technologies in an era of rapid innovation. The book will be of interest to government officials and other practitioners as well as to students and scholars in security studies, science and technology studies, biology, and chemistry.

Biomedical advances have made it possible to identify and manipulate features of living organisms in useful ways-leading to improvements in public health, agriculture, and other areas. The globalization of scientific and technical expertise also means that many scientists and other individuals around the world are generating breakthroughs in the life sciences and related technologies. The risks posed by bioterrorism and the proliferation of biological weapons capabilities have increased concern about how the rapid advances in genetic engineering and biotechnology could enable the production of biological weapons with unique and unpredictable characteristics. Globalization, Biosecurity, and the Future of Life Sciences examines current trends and future objectives of research in public health, life sciences, and biomedical science that contain applications relevant to developments in biological weapons 5 to 10 years into the future and ways to anticipate, identify, and mitigate these dangers.

Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as malaria and dengue, which disproportionately impact low and middle income countries. However, due to their intrinsic qualities of rapid spread and irreversibility, gene drive systems raise many questions with respect to their safety relative to public and environmental health. Because gene drive systems are designed to alter the environments we share in ways that will be hard to anticipate and impossible to completely roll back, questions about the ethics surrounding use of this research are complex and will require very careful exploration. Gene Drives on the Horizon outlines the state of knowledge relative to the science, ethics, public engagement, and risk assessment as they pertain to research directions of gene drive systems and governance of the research process. This report offers principles for responsible practices of gene drive research and related applications for use by investigators, their institutions, the research funders, and regulators.