The effort to understand and combat infectious diseases has, during the centuries, produced many key advances in science and medicine-including the development of vaccines, drugs, and other treatments. A subset of this research is conducted with agents that, like anthrax, not only pose a severe threat to the health of humans, plants, and animals but can also be used for ill-intended purposes. Such agents have been listed by the government as biological select agents and toxins. The 2001 anthrax letter attacks prompted the creation of new regulations aimed at increasing security for research with dangerous pathogens. The outcome of the anthrax letter investigation has raised concern about whether these measures are adequate. Responsible Research with Biological Select Agents and Toxins evaluates both the physical security of select agent laboratories and personnel reliability measures designed to ensure the trustworthiness of those with access to biological select agents and toxins. The book offers a set of guiding principles and recommended changes to minimize security risk and facilitate the productivity of research. The book recommends fostering a culture of trust and responsibility in the laboratory, engaging the community in oversight of the Select Agent Program, and enhancing the operation of the Select Agent Program.

Select Agents are defined in regulations through a list of names of particularly dangerous known bacteria, viruses, toxins, and fungi. However, natural variation and intentional genetic modification blur the boundaries of any discrete Select Agent list based on names. Access to technologies that can generate or 'synthesize' any DNA sequence is expanding, making it easier and less expensive for researchers, industry scientists, and amateur users to create organisms without needing to obtain samples of existing stocks or cultures. This has led to growing concerns that these DNA synthesis technologies might be used to synthesize Select Agents, modify such agents by introducing small changes to the genetic sequence, or create entirely new pathogens. Amid these concerns, the National Institutes of Health requested that the Research Council investigate the science and technology needed to replace the current Select Agent list with an oversight system that predicts if a DNA sequence could be used to produce an organism that should be regulated as a Select Agent. A DNA sequence-based system to better define when a pathogen or toxin is subject to Select Agent regulations could be developed. This could be coupled with a 'yellow flag' system that would recognize requests to synthesize suspicious sequences and serve as a reference to anyone with relevant questions, allowing for appropriate follow-up. Sequence-Based Classification of Select Agents finds that replacing the current list of Select Agents with a system that could predict if fragments of DNA sequences could be used to produce novel pathogens with Select Agent characteristics is not feasible. However, it emphasized that for the foreseeable future, any threat from synthetic biology and synthetic genomics is far more likely to come from assembling known Select Agents, or modifications of them, rather than construction of previously unknown agents. Therefore, the book recommends modernizing the regulations to define Select Agents in terms of their gene sequences, not by their names, and called this 'sequence-based classification.'

During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State's Biosecurity Engagement Program sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The international workshop examined biosafety and biosecurity issues related to the design, construction, maintenance, and operation of high-containment biological laboratories- equivalent to United States Centers for Disease Control and Prevention biological safety level 3 or 4 labs. Although these laboratories are needed to characterize highly dangerous human and animal pathogens, assist in disease surveillance, and produce vaccines, they are complex systems with inherent risks. Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories summarizes the workshop discussion, which included the following topics: Technological options to meet diagnostic, research, and other goals; Laboratory construction and commissioning; Operational maintenance to provide sustainable capabilities, safety, and security; and Measures for encouraging a culture of responsible conduct. Workshop attendees described the history and current challenges they face in their individual laboratories. Speakers recounted steps they were taking to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many also spoke about physical security, access controls, and monitoring pathogen inventories. Workshop participants also identified tensions in the field and suggested possible areas for action.

Learn how to assess and prevent biosecurity threats to protect public health and national security With contributions from experts in all facets of biosecurity, this book explains the fundamental elements of biosecurity as well as the related concepts of biosafety and biosurety, detailing how all three concepts fit within the framework of biodefense. Readers are then given the tools needed to assess and prevent biosecurity threats and vulnerabilities. The book explores the nature of biosecurity threats to research laboratories as well as to agriculture, food, and mass transit. Moreover, readers will learn how to apply principles of biosecurity to assess epidemics and protect public health. Biosecurity takes a detailed look at today's biosecurity policy, explaining how it is likely to evolve given current and potential threats to national security. The authors stress the importance of education and advocacy, helping readers develop effective programs to build public awareness and preparedness. The book also presents a novel tool to assess the effectiveness of laboratory biosafety and biosecurity programs. Biosecurity is divided into four parts: Part I: An Introduction to Biosecurity Part II: Elements of Biosecurity Part III: Biosecurity in Various Sectors Part IV: Biosecurity Policy, Bioterrorism, and the Future This book will instill a deep understanding of what biosecurity is and what it is not. It urges readers to think about the importance of biosecurity as it relates to national security, safety, and health. By exposing major flaws in global biosecurity thinking, Biosecurity sets forth a clear pathway to correct those errors and build stronger biosecurity programs.

Ensuring National Biosecurity: Institutional Biosafety Committees reviews the various responsibilities and associated challenges Institutional Biosafety Committees (IBCs) face and proposes changes that may help improve this system and increase national biosecurity and worker safety. In recent years IBCs in academic and other institutions have been tasked with increasing levels of responsibility, overseeing work with recombinant genetic material and hazardous agents. IBC members often lack the training to effectively ensure that the work performed is truly safe for scientists and the general community, and so increasingly rely upon the expertise of the researchers themselves. With the proposed US dual-use research policies soon to be implemented, this strain may increase. This book provides readers with the necessary information to be able to enhance national biosecurity within the US, EU, Australia, New Zealand, Japan and more. Ensuring National Biosecurity is as an invaluable reference for biosafety professionals or for researchers who need to understand the regulatory landscape that impacts their research. - Examines and assesses the current state of Institutional Biosafety Committees (IBCs) - Collates contributions from world-renowned experts in fields as diverse as research compliance, law and astrobiology - Reflects an international perspective on regulatory biosecurity and biosafety

Katz provides a comprehensive guide for understanding and managing public health emergencies in an increasingly interconnected world. The globalization of the world's food supply and the speed and volume of international travel have increased communities' vulnerability to infectious disease, biological weapons, and new agents anywhere in the world.

This book gathers original, empirical and conceptual papers that address the complex challenges of conducting responsible research in the business and management professions. It includes contributions related to, and reflecting on, the vision of the Responsible Research in Business and Management (RRBM) network, which proposes that business can help provide a better world if it is informed by responsible research. The responsible research agenda requires new methods of scholarly assessment that include criteria for measuring impact, systemic solutions and practitioner relevance. Theories greatly influence business and management practices, and as the late Sumantra Ghoshal warned, bad management theories are destroying good management practices. The authors of this book believe that good management theories can help to create new and better business practices.

This important volume covers ethics and integrity in health and life sciences research. It addresses concerns in gene editing, dual use and misuse of biotechnologies, big data and nutritional science in health and medicine, and covers attempts at ensuring ethical practices in such fields are shared internationally.

Cover -- Contents -- List of Tables -- Acknowledgments -- Abbreviations -- Introduction -- PART I. PROTECT OR PROLIFERATE -- 1. Biodefense and the Security Dilemma -- 2. Vertical Proliferation and Threats from Within -- PART II. SECURE OR STIFLE -- 3. Laboratory Biosecurity -- 4. Export and Publication Controls -- PART III. REMEDY OR OVERKILL -- 5. Social Distancing and National Security -- 6. Border Security and Transnational Contagion -- PART IV. ATTENTION OR NEGLECT -- 7. The Agenda of Global Health Security -- 8. Public Health and Biodefense Priorities -- Conclusion -- Selected Bibliography -- Index -- A -- B -- C -- D -- E -- F -- G -- H -- I -- J -- K -- L -- M -- N -- O -- P -- Q -- R -- S -- T -- U -- V -- W -- Z -- About the Author