@BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values", isbn = "978-0-309-43787-5", abstract = "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.\nGene 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.", url = "https://nap.nationalacademies.org/catalog/23405/gene-drives-on-the-horizon-advancing-science-navigating-uncertainty-and", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academy of Sciences and National Academy of Engineering and Institute of Medicine", editor = "Steve Olson", title = "Biotechnology: An Industry Comes of Age", url = "https://nap.nationalacademies.org/catalog/18677/biotechnology-an-industry-comes-of-age", year = 1986, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Anne Johnson and Lyly Luhachack and Nancy Connell and Carmen Shaw", title = "Engaging Scientists to Prevent Harmful Exploitation of Advanced Data Analytics and Biological Data: Proceedings of a Workshop—in Brief", abstract = "Artificial intelligence (AI), facial recognition, and other advanced computational and statistical techniques are accelerating advancements in the life sciences and many other fields. However, these technologies and the scientific developments they enable also hold the potential for unintended harm and malicious exploitation. To examine these issues and to discuss practices for anticipating and preventing the misuse of advanced data analytics and biological data in a global context, the National Academies of Sciences, Engineering, and Medicine convened two virtual workshops on November 15, 2022, and February 9, 2023. The workshops engaged scientists from the United States, South Asia, and Southeast Asia through a series of presentations and scenario-based exercises to explore emerging applications and areas of research, their potential benefits, and the ethical issues and security risks that arise when AI applications are used in conjunction with biological data. This publication highlights the presentations and discussions of the workshops.", url = "https://nap.nationalacademies.org/catalog/27093/engaging-scientists-to-prevent-harmful-exploitation-of-advanced-data-analytics-and-biological-data", year = 2023, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Safeguarding the Bioeconomy", isbn = "978-0-309-49567-7", abstract = "Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the bioeconomy, presents many opportunities to create jobs, improve the quality of life, and continue to drive economic growth. While the United States has been a leader in advancements in the biological sciences, other countries are also actively investing in and expanding their capabilities in this area. Maintaining competitiveness in the bioeconomy is key to maintaining the economic health and security of the United States and other nations.\nSafeguarding the Bioeconomy evaluates preexisting and potential approaches for assessing the value of the bioeconomy and identifies intangible assets not sufficiently captured or that are missing from U.S. assessments. This study considers strategies for safeguarding and sustaining the economic activity driven by research and innovation in the life sciences. It also presents ideas for horizon scanning mechanisms to identify new technologies, markets, and data sources that have the potential to drive future development of the bioeconomy.", url = "https://nap.nationalacademies.org/catalog/25525/safeguarding-the-bioeconomy", year = 2020, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Joe Alper", title = "Strategies for Effective Improvements to the BioWatch System: Proceedings of a Workshop", isbn = "978-0-309-47174-9", abstract = "BioWatch is the Department of Homeland Security\u2019s (DHS\u2019s) system for detecting an aerosolized biological attack using collectors that are positioned strategically across the country to continuously monitor the air for biological threats. As currently deployed, BioWatch collectors draw air through filters that field technicians collect daily and transport to laboratories, where professional technicians analyze the material collected on the filter for evidence of biological threats.\n\nAs part of the BioWatch program\u2019s efforts to enhance its effectiveness and capabilities, particularly with regard to detecting biological threats in challenging indoor environments, DHS requested the National Academies of Sciences, Engineering, and Medicine hold a workshop to explore alternative and effective biodetection systems for aerosolized biological agents that would meet BioWatch\u2019s technical and operational requirements, integrate into the existing system architecture and public health infrastructure, and be deployable by 2027. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/25014/strategies-for-effective-improvements-to-the-biowatch-system-proceedings-of", year = 2018, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Rapid Response by Laboratory Animal Research Institutions During the COVID-19 Pandemic: Lessons Learned: Proceedings of a Workshop–in Brief", abstract = "The National Academies of Sciences, Engineering, and Medicine convened a workshop to explore lessons learned at animal research institutions in response to SARS-CoV-2, the cause of the COVID-19 pandemic. Expert scientists conducting COVID-19 research, as well as institutional leadership responsible for oversight in areas such as, veterinary medical care, occupational health, risk assessment and biosafety, and public messaging and communications presented and participated in panel discussions. This publication summarizes the presentations and discussion of the workshop.", url = "https://nap.nationalacademies.org/catalog/26189/rapid-response-by-laboratory-animal-research-institutions-during-the-covid-19-pandemic-lessons-learned", year = 2021, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine and National Research Council", title = "Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects", isbn = "978-0-309-09209-8", abstract = "Assists policymakers in evaluating the appropriate scientific methods for detecting unintended changes in food and assessing the potential for adverse health effects from genetically modified products. In this book, the committee recommended that greater scrutiny should be given to foods containing new compounds or unusual amounts of naturally occurring substances, regardless of the method used to create them. \n\nThe book offers a framework to guide federal agencies in selecting the route of safety assessment. It identifies and recommends several pre- and post-market approaches to guide the assessment of unintended compositional changes that could result from genetically modified foods and research avenues to fill the knowledge gaps. \n", url = "https://nap.nationalacademies.org/catalog/10977/safety-of-genetically-engineered-foods-approaches-to-assessing-unintended-health", year = 2004, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "Animal Care and Management at the National Zoo: Final Report", isbn = "978-0-309-09583-9", url = "https://nap.nationalacademies.org/catalog/11212/animal-care-and-management-at-the-national-zoo-final-report", year = 2005, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Erin Hammers Forstag and Lida Anestidou", title = "Advancing Disease Modeling in Animal-Based Research in Support of Precision Medicine: Proceedings of a Workshop", isbn = "978-0-309-47116-9", abstract = "Precision medicine is focused on the individual and will require the rapid and accurate identification and prioritization of causative factors of disease. To move forward and accelerate the delivery of the anticipated benefits of precision medicine, developing predictable, reproducible, and reliable animal models will be essential. In order to explore the topic of animal-based research and its relevance to precision medicine, the National Academies of Sciences, Engineering, and Medicine convened a 2-day workshop on October 5 and 6, 2017. The workshop was designed to focus on the development, implementation, and interpretation of model organisms to advance and accelerate the field of precision medicine. Participants examined the extent to which next-generation animal models, designed using patient data and phenotyping platforms targeted to reveal and inform disease mechanisms, will be essential to the successful implementation of precision medicine. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/25002/advancing-disease-modeling-in-animal-based-research-in-support-of-precision-medicine", year = 2018, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Frances E. Sharples and Micah D. Lowenthal", title = "Developing Norms for the Provision of Biological Laboratories in Low-Resource Contexts: Proceedings of a Workshop", isbn = "978-0-309-48653-8", abstract = "On June 27-28, 2018, the U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies) convened an international workshop in Amsterdam, the Netherlands, on developing norms for the provision of laboratories in low-resource contexts. The U.S. Department of State's Biosecurity Engagement Program requested that the National Academies organize this workshop to engage an international group of organizations that provide funding for construction, upgrades, and maintenance of biological laboratories in countries without the means to build such labs themselves. Twenty-one people from 19 organizations participated. The intent was to advance the conversation about the identification and application of guiding principles and common norms for use by these organizations in their grants, partnerships, and aid. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/25311/developing-norms-for-the-provision-of-biological-laboratories-in-low-resource-contexts", year = 2019, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Evaluating the Taxonomic Status of the Mexican Gray Wolf and the Red Wolf", isbn = "978-0-309-48824-2", abstract = "Scientists strive to develop clear rules for naming and grouping living organisms. But taxonomy, the scientific study of biological classification and evolution, is often highly debated. Members of a species, the fundamental unit of taxonomy and evolution, share a common evolutionary history and a common evolutionary path to the future. Yet, it can be difficult to determine whether the evolutionary history or future of a population is sufficiently distinct to designate it as a unique species. \n\nA species is not a fixed entity \u2013 the relationship among the members of the same species is only a snapshot of a moment in time. Different populations of the same species can be in different stages in the process of species formation or dissolution. In some cases hybridization and introgression can create enormous challenges in interpreting data on genetic distinctions between groups. Hybridization is far more common in the evolutionary history of many species than previously recognized. As a result, the precise taxonomic status of an organism may be highly debated. This is the current case with the Mexican gray wolf (Canis lupus baileyi) and the red wolf (Canis rufus), and this report assesses the taxonomic status for each.", url = "https://nap.nationalacademies.org/catalog/25351/evaluating-the-taxonomic-status-of-the-mexican-gray-wolf-and-the-red-wolf", year = 2019, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Joe Alper and Lida Anestidou and Jenna Ogilvie", title = "Animal Models for Microbiome Research: Advancing Basic and Translational Science: Proceedings of a Workshop", isbn = "978-0-309-46388-1", abstract = "The surface of the human body and its mucous membranes are heavily colonized by microorganisms. Our understanding of the contributions that complex microbial communities make to health and disease is advancing rapidly. Most microbiome research to date has focused on the mouse as a model organism for delineating the mechanisms that shape the assembly and dynamic operations of microbial communities. However, the mouse is not a perfect surrogate for studying different aspects of the microbiome and how it responds to various environmental and host stimuli, and as a result, researchers have been conducting microbiome studies in other animals. \n\nTo examine the different animal models researchers employ in microbiome studies and to better understand the strengths and weaknesses of each of these model organisms as they relate to human and nonhuman health and disease, the Roundtable on Science and Welfare in Laboratory Animal Use of the National Academies of Sciences, Engineering, and Medicine convened a workshop in December 2016. The workshop participants explored how to improve the depth and breadth of analysis of microbial communities using various model organisms, the challenges of standardization and biological variability that are inherent in gnotobiotic animal-based research, the predictability and translatability of preclinical studies to humans, and strategies for expanding the infrastructure and tools for conducting studies in these types of models. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/24858/animal-models-for-microbiome-research-advancing-basic-and-translational-science", year = 2018, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "The Unique U.S.-Russian Relationship in Biological Science and Biotechnology: Recent Experience and Future Directions", isbn = "978-0-309-26980-3", abstract = "In the fall of 2010, the U.S. National Academies (consisting of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine) and the Russian Academy of Sciences (in cooperation with the Russian Academy of Medical Sciences and the Russian Academy of Agricultural Sciences) initiated a joint study of U.S.-Russian bilateral engagement in the biological sciences and biotechnology (hereinafter collectively referred to as bioengagement). The U.S. Department of State and the Russian Academy of Sciences provided support for the study. The academies established a joint committee of 12 leading scientists from the two countries to assess bioengagement activities since 1996 and to provide recommendations as to collaborative efforts in the near future. The Unique U.S.-Russian Relationship in Biological Science and Biotechnology: Recent Experience and Future Directions summarizes the principal conclusions and recommendations of the study.", url = "https://nap.nationalacademies.org/catalog/18277/the-unique-us-russian-relationship-in-biological-science-and-biotechnology", year = 2013, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Teresa J. Sylvina", title = "Animal Welfare Challenges in Research and Education on Wildlife, Non-Model Animal Species and Biodiversity: Proceedings of a Workshop", isbn = "978-0-309-69015-7", abstract = "Research to advance understanding of the ecology and biology of wildlife species is more important than ever as the world confronts issues ranging from biodiversity loss to the emergence of zoonotic diseases. However, the current understanding of animal welfare in research and education has been based on laboratory work with specific domesticated species. Wildlife research represents a starkly different context and with different implications for animal welfare. Wild species that are the subject of research have extremely diverse physiologies and behaviors and live in diverse habitats. This makes it challenging and sometimes impossible for wildlife researchers to follow the recommendations outlined in the Guide for the Care and Use of Laboratory Animals (NRC 2011) and other guidelines developed for a laboratory-based, biomedically focused research context.\nTo explore issues associated with the unique welfare considerations of wildlife research, the National Academies of Sciences, Engineering, and Medicine (under the auspices of the Roundtable on Science and Animal Welfare in Laboratory Animal Use), hosted a workshop titled Discussing and Understanding Animal Welfare Challenges in Research and Education on Wildlife, Non-Model Animal Species, and Biodiversity on February 9-10, 2022. The event, held virtually, included pre-recorded presentations and overarching discussions to explore this topic in breadth and depth. More than 1,800 participants from academia, industry, government, and nonprofit organizations joined the webcast. This proceedings summarizes key topics covered in the workshop presentations and discussions based on transcripts, recordings, and slides from the event.", url = "https://nap.nationalacademies.org/catalog/26614/animal-welfare-challenges-in-research-and-education-on-wildlife-non-model-animal-species-and-biodiversity", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Joe Alper and Lida Anestidou", title = "Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop", isbn = "978-0-309-37924-3", abstract = "In order to better understand the critical issues pertaining to the concept of performance standards for laboratory animal use, the Institute for Laboratory Animal Research Roundtable on Science and Welfare in Laboratory Animal Use held a public workshop on April 20-21, 2015. The purpose of the workshop was to promote the appropriate and responsible care of animals in research, to provide a balanced and civil forum for discussion and collaboration, and to help build transparency and trust among stakeholders. Participants addressed the challenges of defining, developing, implementing, assessing, and validating performance standards to ensure \"optimal practices, management, and operations.\" This report summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/21820/design-implementation-monitoring-and-sharing-of-performance-standards-for-laboratory-animal-use", year = 2015, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "Field Testing Genetically Modified Organisms: Framework for Decisions", isbn = "978-0-309-04076-1", abstract = "Potential benefits from the use of genetically modified organisms\u2014such as bacteria that biodegrade environmental pollutants\u2014are enormous. To minimize the risks of releasing such organisms into the environment, regulators are working to develop rational safeguards.\nThis volume provides a comprehensive examination of the issues surrounding testing these organisms in the laboratory or the field and a practical framework for making decisions about organism release.\nBeginning with a discussion of classical versus molecular techniques for genetic alteration, the volume is divided into major sections for plants and microorganisms and covers the characteristics of altered organisms, past experience with releases, and such specific issues as whether plant introductions could promote weediness. The executive summary presents major conclusions and outlines the recommended decision-making framework.", url = "https://nap.nationalacademies.org/catalog/1431/field-testing-genetically-modified-organisms-framework-for-decisions", year = 1989, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs", isbn = "978-0-309-04382-3", abstract = "Federal law now requires that institutions provide training for anyone caring for or using laboratory animals. This volume provides the guidelines and resources needed to coordinate a quality training program, as well as to meet all legal requirements.\nA core module for all personnel takes no more than four hours to present. Most staff then proceed to one or more additional skills-development modules including the species-specific module that can be customized to any species in use at the institution, the pain management module, and the surgery module.\nThe volume provides content information for required topics\u2014from ethics to record keeping\u2014and lists sources of additional publications, audiovisual programs, and computerized teaching aids.\nIncluded are:\n\n Ready-to-use teaching outlines, with detailed instructions for presenting material.\n Practical guidelines on logistics, covering scheduling, budgeting, and more.\n Guidelines on how to design training for adults and how to work with investigators who may resist taking training courses.\n\nThis practical guidebook will be necessary for research institutions, particularly for staff members responsible for training coordination.", url = "https://nap.nationalacademies.org/catalog/1592/education-and-training-in-the-care-and-use-of-laboratory-animals", year = 1991, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council and National Research Council", title = "Genetic Engineering of Plants: Agricultural Research Opportunities and Policy Concerns", isbn = "978-0-309-03434-0", abstract = "\"The book...is, in fact, a short text on the many practical problems...associated with translating the explosion in basic biotechnological research into the next Green Revolution,\" explains Economic Botany. The book is \"a concise and accurate narrative, that also manages to be interesting and personal...a splendid little book.\" Biotechnology states, \"Because of the clarity with which it is written, this thin volume makes a major contribution to improving public understanding of genetic engineering's potential for enlarging the world's food supply...and can be profitably read by practically anyone interested in application of molecular biology to improvement of productivity in agriculture.\"", url = "https://nap.nationalacademies.org/catalog/10/genetic-engineering-of-plants-agricultural-research-opportunities-and-policy-concerns", year = 1984, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "James Revill and Jo Husbands and Katherine Bowman", title = "Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight: Proceedings of a Workshop", isbn = "978-0-309-47799-4", abstract = "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 \u2013 research that may have beneficial applications but that also could be misused to cause harm.\n \nBetween 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.", url = "https://nap.nationalacademies.org/catalog/25154/governance-of-dual-use-research-in-the-life-sciences-advancing", year = 2018, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine and National Research Council", editor = "Diana E. Pankevich and Theresa M. Wizemann and Anne-Marie Mazza and Bruce M. Altevogt", title = "International Animal Research Regulations: Impact on Neuroscience Research: Workshop Summary", isbn = "978-0-309-25208-9", abstract = "Animals are widely used in neuroscience research to explore biological mechanisms of nervous system function, to identify the genetic basis of disease states, and to provide models of human disorders and diseases for the development of new treatments. To ensure the humane care and use of animals, numerous laws, policies, and regulations are in place governing the use of animals in research, and certain animal regulations have implications specific to neuroscience research.\nTo consider animal research regulations from a global perspective, the IOM Forum on Neuroscience and Nervous System Disorders, in collaboration with the National Research Council and the Institute for Laboratory Animal Research, held a workshop in Buckinghamshire, UK, July 26-27, 2011. The workshop brought together neuroscientists, legal scholars, administrators, and other key stakeholders to discuss current and emerging trends in animal regulations as they apply to the neurosciences. This document summarizes the workshop.", url = "https://nap.nationalacademies.org/catalog/13322/international-animal-research-regulations-impact-on-neuroscience-research-workshop-summary", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" }