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Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.
Evaluation of Safety and Environmental Metrics for Potential Application at Chemical Agent Disposal Facilitiesby National Research Council of the National Academies
By the end of 2009, more than 60 percent of the global chemical weapons stockpile declared by signatories to the Chemical Weapons Convention will have been destroyed, and of the 184 signatories, only three countries will possess chemical weapons-the United States, Russia, and Libya. In the United States, destruction of the chemical weapons stockpile began in 1990, when Congress mandated that the Army and its contractors destroy the stockpile while ensuring maximum safety for workers, the public, and the environment. The destruction program has proceeded without serious exposure of any worker or member of the public to chemical agents, and risk to the public from a storage incident involving the aging stockpile has been reduced by more than 90 percent from what it was at the time destruction began on Johnston Island and in the continental United States. At this time, safety at chemical agent disposal facilities is far better than the national average for all industries. Even so, the Army and its contractors are desirous of further improvement. To this end, the Chemical Materials Agency (CMA) asked the NRC to assist by reviewing CMA's existing safety and environmental metrics and making recommendations on which additional metrics might be developed to further improve its safety and environmental programs.
A nuclear attack on a large U.S. city by terrorists--even with a low-yield improvised nuclear device (IND) of 10 kilotons or less--would cause a large number of deaths and severe injuries. The large number of injured from the detonation and radioactive fallout that would follow would be overwhelming for local emergency response and health care systems to rescue and treat, even assuming that these systems and their personnel were not themselves incapacitated by the event. The United States has been struggling for some time to address and plan for the threat of nuclear terrorism and other weapons of mass destruction that terrorists might obtain and use. The Department of Homeland Security recently contracted with the Institute of Medicine to hold a workshop, summarized in this volume, to assess medical preparedness for a nuclear detonation of up to 10 kilotons. This book provides a candid and sobering look at our current state of preparedness for an IND, and identifies several key areas in which we might begin to focus our national efforts in a way that will improve the overall level of preparedness.
NASA maintains a planetary protection policy to avoid the forward biological contamination of other worlds by terrestrial organisms, and back biological contamination of Earth from the return of extraterrestrial materials by spaceflight missions. Forward-contamination issues related to Mars missions were addressed in a 2006 National Research Council (NRC) book, Preventing the Forward Contamination of Mars. However, it has been more than 10 years since back-contamination issues were last examined. Driven by a renewed interest in Mars sample return missions, this book reviews, updates, and replaces the planetary protection conclusions and recommendations contained in the NRC's 1997 report Mars Sample Return: Issues and Recommendations. The specific issues addressed in this book include the following: The potential for living entities to be included in samples returned from Mars; Scientific investigations that should be conducted to reduce uncertainty in the above assessment; The potential for large-scale effects on Earth's environment by any returned entity released to the environment; Criteria for intentional sample release, taking note of current and anticipated regulatory frameworks; and The status of technological measures that could be taken on a mission to prevent the inadvertent release of a returned sample into Earth's biosphere.
Despite a strong commitment to delivering quality health care, persistent problems involving medical errors and ineffective treatment continue to plague the industry. Many of these problems are the consequence of poor information and technology (IT) capabilities, and most importantly, the lack cognitive IT support. Clinicians spend a great deal of time sifting through large amounts of raw data, when, ideally, IT systems would place raw data into context with current medical knowledge to provide clinicians with computer models that depict the health status of the patient. Computational Technology for Effective Health Care advocates re-balancing the portfolio of investments in health care IT to place a greater emphasis on providing cognitive support for health care providers, patients, and family caregivers; observing proven principles for success in designing and implementing IT; and accelerating research related to health care in the computer and social sciences and in health/biomedical informatics. Health care professionals, patient safety advocates, as well as IT specialists and engineers, will find this book a useful tool in preparation for crossing the health care IT chasm.
The U.S. Environmental Protection Agency (EPA) is one of several federal agencies responsible for protecting Americans against significant risks to human health and the environment. As part of that mission, EPA estimates the nature, magnitude, and likelihood of risks to human health and the environment; identifies the potential regulatory actions that will mitigate those risks and protect public health1 and the environment; and uses that information to decide on appropriate regulatory action. Uncertainties, both qualitative and quantitative, in the data and analyses on which these decisions are based enter into the process at each step. As a result, the informed identification and use of the uncertainties inherent in the process is an essential feature of environmental decision making. EPA requested that the Institute of Medicine (IOM) convene a committee to provide guidance to its decision makers and their partners in states and localities on approaches to managing risk in different contexts when uncertainty is present. It also sought guidance on how information on uncertainty should be presented to help risk managers make sound decisions and to increase transparency in its communications with the public about those decisions. Given that its charge is not limited to human health risk assessment and includes broad questions about managing risks and decision making, in this report the committee examines the analysis of uncertainty in those other areas in addition to human health risks. Environmental Decisions in the Face of Uncertainty explains the statement of task and summarizes the findings of the committee.
New Directions in Climate Change VULNERABILITY, IMPACTS, AND ADAPTATION ASSESSMENT: SUMMARY OF A WORKSHOPby National Research Council of the National Academies
With effective climate change mitigation policies still under development, and with even the most aggressive proposals unable to halt climate change immediately, many decision makers are focusing unprecedented attention on the need for strategies to adapt to climate changes that are now unavoidable. The effects of climate change will touch every corner of the world's economies and societies; adaptation is inevitable. The remaining question is to what extent humans will anticipate and reduce undesired consequences of climate change, or postpone response until after climate change impacts have altered ecological and socioeconomic systems so significantly that opportunities for adaptation become limited. This book summarizes a National Research Council workshop at which presentations and discussion identified specific needs associated with this gap between the demand and supply of scientific information about climate change adaptation.
The Small Business Administration issued a policy directive in 2002, the effect of which has been to exclude innovative small firms in which venture capital firms have a controlling interest from the SBIR program. This book seeks to illuminate the consequences of the SBA ruling excluding majority-owned venture capital firms from participation in SBIR projects. This book is part of the National Research Council's study to evaluate the SBIR program's quality of research and value to the missions of five government agencies. The other books in the series include: http://www.nap.edu/catalog.php?record_id=11989 An Assessment of the SBIR Program (2008) http://www.nap.edu/catalog.php?record_id=11929 An Assessment of the SBIR Program at the National Science Foundation (2007) http://www.nap.edu/catalog.php?record_id=11964 An Assessment of the Small Business Innovation Research Program at the National Institutes of Health (2009) http://www.nap.edu/catalog.php?record_id=12052 An Assessment of Small Business Innovation Research Program at the Department of Energy (2008) http://www.nap.edu/catalog.php?record_id=12441 An Assessment of the Small Business Innovation Research Program at the National Aeronautics and Space Administration (2009) http://www.nap.edu/catalog.php?record_id=11963 An Assessment of the Small Business Innovation Research Program at the Department of Defense (2009).
Sustainable development--meeting human needs while nurturing and restoring the planet's life support systems--requires a continuous process of scientific innovation, new knowledge and learning, and collaborative approaches to implementing technologies and policies. To address these challenges, different stakeholder groups are increasingly seeking to ally themselves through partnership, in order to implement projects, deliver services, establish secure funding mechanisms, and achieve on the ground results. Advocates of this collaborative approach point to the failure of governmental regulations, international commitments, or business as usual. However, skeptics often question the effectiveness of partnerships at achieving sustainable development goals and, in the absence of demonstrated results, wonder where partnerships are adding value. A symposium held in June 2008 and summarized in this volume, attempted to advance the dialogue on partnerships for sustainability in order to catalyze existing knowledge and inform future efforts. Ideas that came out of discussions at the symposium will help leaders in government, the private sector, foundations and NGOs, and universities, both in the United States and internationally, as they develop and participate in new partnerships for sustainability.
Strengthening High School Chemistry Education Through Teacher Outreach Programs: A Workshop Summary To The Chemical Sciences Roundtableby National Research Council of the National Academies
A strong chemical workforce in the United States will be essential to the ability to address many issues of societal concern in the future, including demand for renewable energy, more advanced materials, and more sophisticated pharmaceuticals. High school chemistry teachers have a critical role to play in engaging and supporting the chemical workforce of the future, but they must be sufficiently knowledgeable and skilled to produce the levels of scientific literacy that students need to succeed. To identify key leverage points for improving high school chemistry education, the National Academies' Chemical Sciences Roundtable held a public workshop, summarized in this volume, that brought together representatives from government, industry, academia, scientific societies, and foundations involved in outreach programs for high school chemistry teachers. Presentations at the workshop, which was held in August 2008, addressed the current status of high school chemistry education; provided examples of public and private outreach programs for high school chemistry teachers; and explored ways to evaluate the success of these outreach programs.
The mission of the NIST Physics Laboratory is to support U.S. industry, government, and the scientific community by providing measurement services and research for electronic, optical, and radiation technology. In this respect, the laboratory provides the foundation for the metrology of optical and ionizing radiations, time and frequency, and fundamental quantum processes, historically major areas of standards and technology. The Panel on Physics visited the six divisions of the laboratory and reviewed a selected sample of their programs and projects. This book finds that the overall quality and productivity of the Physics Laboratory are comparable to or better than those of other peer institutions, an accomplishment that is being achieved with an infrastructure that is smaller in both size and funding than the size and funding of most national and agency laboratories in the United States.
An Assessment Of The National Institute Of Standards And Technology Building And Fire Research Laboratory: Fiscal Year 2008by National Research Council of the National Academies
A panel of experts appointed by the National Research Council assessed the scientific and technical work of the Building and Fire Research Laboratory (BFRL) of the National Institute of Standards and Technology (NIST). The scope of the assessment included the following criteria: (1) the technical merit of the current laboratory programs relative to the current state of the art worldwide; (2) the adequacy of the laboratory facilities, equipment, and human resources, as they affect the quality of the laboratory technical programs; and (3) the degree to which the laboratory programs in measurement science and standards achieve their stated objectives and desired impact. The book finds that, overall the technical merit of the programs reviewed within the BFRL is very high and generally at a state-of-the-art level. The programs have clear ties to the overall BFRL Strategic Priority Areas and are well aligned with the mission of NIST, which is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life.
An Assessment of the National Institute of Standards and Technology Manufacturing Engineering Laboratoryby National Research Council Division on Engineering and Physical Sciences Laboratory Assessments Board Panel on Manufacturing Engineering
The mission of the Manufacturing Engineering Laboratory (MEL) of the National Institute of Standards and Technology (NIST) is to promote innovation and the competitiveness of U.S. manufacturing through measurement science, measurement services, and critical technical contributions to standards. The MEL is organized in five divisions: Intelligent Systems, Manufacturing Metrology, Manufacturing Systems Integration, Precision Engineering, and Fabrication Technology. A panel of experts appointed by the National Research Council (NRC) assessed the first four divisions. Overall, this book finds that the four individual divisions are performing to the best of their ability, given available resources. In many areas in all four divisions, the capabilities and the work being performed are among the best in the field. However, reduced funding and other factors such as difficulty in hiring permanent staff are limiting (and are likely to increasingly limit) the degree to which MEL programs can achieve their objectives and are threatening the future impact of these programs.
An Assessment of the National Institute of Standards and Technology Materials Science and Engineering Laboratoryby National Research Council Division on Engineering and Physical Sciences Laboratory Assessments Board Panel on Materials Science and Engineering
The Materials Science and Engineering Laboratory (MSEL) of the National Institute of Standards and Technology (NIST) works with industry, standards bodies, universities, and other government laboratories to improve the nation's measurements and standards infrastructure for materials. A panel of experts appointed by the National Research Council (NRC) assessed the four divisions of MSEL, by visiting these divisions and reviewing their activities. This book concludes that, for the selected portion of the MSEL programs reviewed, the staff, the projects, and many facilities are outstanding. The projects are clearly focused on the mission of MSEL. The facilities and equipment are rationally upgraded within budget constraints, with several facilities being unique; the funding provided through the America COMPETES Act of 2007 is being used effectively. Division chiefs and staff evinced high morale, attributable to several factors: clear definitions of expectations and of the processes for realizing them, strong support of the MSEL from NIST leadership and of NIST generally from the President and from the Congress (through the American Competitiveness Initiative and the America COMPETES Act), and positive feedback from customers.
Many economic models exist to estimate the cost and effectiveness of different policies for reducing greenhouse gas (GHG) emissions. Some approaches incorporate rich technological detail, others emphasize the aggregate behavior of the economy and energy system, and some focus on impacts for specific sectors. Understandably, different approaches may be better positioned to provide particular types of information and may yield differing results, at times rendering decisions on future climate change emissions and research and development (R&D) policy difficult. Reliable estimates of the costs and benefits to the U.S. economy for various emissions reduction and adaptation strategies are critical to federal climate change R&D portfolio planning and investment decisions. At the request of the U.S. Department of Energy (DOE), the National Academies organized a workshop to consider these issues. The workshop, summarized in this volume, comprised three dimensions: policy, analysis, and economics. Discussions along these dimensions were meant to lead to constructive identification of gaps and opportunities. The workshop focused on (1) policymakers' informational needs; (2) models and other analytic approaches to meet these needs; (3) important economic considerations, including equity and discounting; and (4) opportunities to enhance analytical capabilities and better inform policy.
Dual loyalties exist in many medical fields, from occupational health to public health. Military health professionals, as all health professionals, are ethically responsible for their patients' well-being. In some situations, however, military health professionals can face unique ethical tensions between responsibilities to individual patients and responsibilities to military operations. This book summarizes the one-day workshop, Military Medical Ethics: Issues Regarding Dual Loyalties, which brought together academic, military, human rights, and health professionals to discuss these ethical challenges. The workshop examined two case studies: decisions regarding returning a servicemember to duty after a closed head injury, and decisions on actions by health professionals regarding a hunger strike by detainees. The workshop also addressed the need for improvements in medical ethics training and outlined steps for organizations to take in supporting better ethical awareness and use of ethical standards.
Assessing the Research and Development Plan for the Next Generation Air Transportation System: Summary of a Workshopby National Research Council of the National Academies
The U.S. aviation industry, airline passengers, aircraft pilots, airports, and airline companies are all facing challenges. The air transportation system is experiencing unprecedented and increasing levels of use. The federal government understands the critical need to update the U.S. air transportation system, and plans to implement the Next Generation Air Transportation System (NextGen) by 2025. This system is an example of active networking technology that updates itself with real-time shared information and tailors itself to the individual needs of all U.S. aircraft, stressing adaptability by enabling aircraft to immediately adjust to ever-changing factors. On April 1-2, 2008, a workshop was held at the National Academies to gather reactions to the research and development aspects of the Joint Planning and Development Office’s baseline Integrated Work Plan (IWP), which is designed to increase the efficiency of airport and air space use in the United States. This book provides a summary of the workshop, which included presentations on the following topics: Airport operations and support; Environmental management; Air navigation operations, Air navigation support, and flight operation support; Positioning, navigation, and timing services and surveillance; Weather information services; Safety management; Net-centric infrastructure services and operations; and Layered adaptive security.
Federal agencies have taken steps to include the public in a wide range of environmental decisions. Although some form of public participation is often required by law, agencies usually have broad discretion about the extent of that involvement. Approaches vary widely, from holding public information-gathering meetings to forming advisory groups to actively including citizens in making and implementing decisions. Proponents of public participation argue that those who must live with the outcome of an environmental decision should have some influence on it. Critics maintain that public participation slows decision making and can lower its quality by including people unfamiliar with the science involved. This book concludes that, when done correctly, public participation improves the quality of federal agencies' decisions about the environment. Well-managed public involvement also increases the legitimacy of decisions in the eyes of those affected by them, which makes it more likely that the decisions will be implemented effectively. This book recommends that agencies recognize public participation as valuable to their objectives, not just as a formality required by the law. It details principles and approaches agencies can use to successfully involve the public.
In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. As it did in 2007, the Committee identified issues that warranted revision, and this book addresses those issues in a second set of amendments. Most importantly, this book addresses new scientific developments in reprogramming of somatic cells to pluripotency by adding a new section and revising other relevant sections of the Guidelines.
Since 1992, the Committee on National Statistics (CNSTAT) has produced a book on principles and practices for a federal statistical agency, updating the document every 4 years to provide a current edition to newly appointed cabinet secretaries at the beginning of each presidential administration. This fourth edition presents and comments on four basic principles that statistical agencies must embody in order to carry out their mission fully: (1) They must produce objective data that are relevant to policy issues, (2) they must achieve and maintain credibility among data users, (3) they must achieve and maintain trust among data providers, and (4) they must achieve and maintain a strong position of independence from the appearance and reality of political control. The book also discusses 11 important practices that are means for statistical agencies to live up to the four principles. These practices include a commitment to quality and professional practice and an active program of methodological and substantive research. This fourth edition adds the principle that statistical agencies must operate from a strong position of independence and the practice that agencies must have ongoing internal and external evaluations of their programs.
In order to ensure effective military operations and continued warfighter safety, the functionality and integrity of the equipment used must also be ensured. For the past several years, the Nondestructive Evaluation Branch at the Air Force Research Laboratory (AFRL) has focused actively on the development of embedded sensing technologies for the real-time monitoring of damage states in aircraft, turbine engines, and aerospace structures. These sensing technologies must be developed for use in environments ranging from the normal to the extreme, confronting researchers with the need to understand issues involving reliability, wireless telemetry, and signal processing methods. Additionally, there is a need to develop science and technology that will address the sensing of a material state at the microstructure level, precursor damage at the dislocation level, and fatigue-crack size population. To address these issues, the National Research Council convened a workshop at which speakers gave their personal perspectives on technological approaches to understanding materials state and described potential challenges and advances in technology. This book consists primarily of extended abstracts of the workshop speakers’ presentations, conveying the nature and scope of the material presented.
On March 3-4, 2008, the Institute of Medicine (IOM) Forum on Medical and Public Health Preparedness for Catastrophic Events hosted a workshop titled “Medical Countermeasures Dispensing.” The overall objective was to discuss a range of solutions to rapidly provide medical countermeasures to protect large numbers of people prior to or during a public health emergency, such as a bioterrorist attack or infectious disease outbreak. The United States is currently unprepared to confront the range of threats it is facing, such as an intentional anthrax release, severe acute respiratory syndrome (SARS), or pandemic influenza, and it must plan aggressively to counteract the threat of these and other future public health emergencies. Countermeasure dispensing must harness all types of imaginative partnerships between public and private institutions, working together in ways tailored to meet individual community needs. This workshop summary highlights the presentations and subsequent discussion that occurred at the workshop.
Neuroscience has made phenomenal advances over the past 50 years and the pace of discovery continues to accelerate. On June 25, 2008, the Institute of Medicine (IOM) Forum on Neuroscience and Nervous System Disorders hosted more than 70 of the leading neuroscientists in the world, for a workshop titled "From Molecules to Minds: Challenges for the 21st Century." The objective of the workshop was to explore a set of common goals or "Grand Challenges" posed by participants that could inspire and rally both the scientific community and the public to consider the possibilities for neuroscience in the 21st century. The progress of the past in combination with new tools and techniques, such as neuroimaging and molecular biology, has positioned neuroscience on the cusp of even greater transformational progress in our understanding of the brain and how its inner workings result in mental activity. This workshop summary highlights the important issues and challenges facing the field of neuroscience as presented to those in attendance at the workshop, as well as the subsequent discussion that resulted. As a result, three overarching Grand Challenges emerged: How does the brain work and produce mental activity? How does physical activity in the brain give rise to thought, emotion, and behavior? How does the interplay of biology and experience shape our brains and make us who we are today? How do we keep our brains healthy? How do we protect, restore, or enhance the functioning of our brains as we age?
Since the first commercial introduction of transgenic corn plants in 1995, biotechnology has provided enormous benefits to agricultural crop production. Research is underway to develop a much broader range of genetically engineered organisms (GEOs), including fish, trees, microbes, and insects, that could have the potential to transform fields such as aquaculture, biofuels production, bioremediation, biocontrol, and even the production of pharmaceuticals . However, biotechnology is not without risk and continues to be an extremely controversial topic. Chief among the concerns is the potential ecological effects of GEOs that interact with wildlife and habitats. The U.S. Geological Survey (USGS) is charged with providing scientific advice to inform federal agencies that manage wildlife and their habitats. USGS has identified biotechnology as one of its major challenges for future research. Seeing an opportunity to initiate a dialogue between ecologists and developers of GEOs about this challenge, the USGS and the National Research Council (NRC) held a two-day workshop in November of 2007, to identify research activities with the greatest potential to provide the information needed to assess the ecological effects of GEOs on wildlife and habitats. The workshop, designed to approach the research questions from a habitat, rather than transgenic organism, perspective, is summarized in this book.
Many developing countries are exploring whether biotechnology has a role in addressing national issues such as food security and environmental remediation, and are considering whether the putative benefits of the technology—for example, enabling greater agricultural productivity and stability in the food supply—outweigh concerns that the technology might pose a danger—to biodiversity, health, and local jobs. Some policy leaders worry that their governments are not prepared to take control of this evolving technology and that introducing it into society would be a risky act. Others have suggested that taking no action carries more risk, given the dire need to produce more food. This book reports on an international workshop held to address these issues. Global Challenges and Directions for Agricultural Biotechnology: Mapping the Course, organized by the National Research Council on October 24-25, 2004, in Washington, DC, focused on the potential applications of biotechnology and what developing countries might consider as they contemplate adopting biotechnology. Presenters at the workshop described applications of biotechnology that are already proving their utility in both developing and developed countries.
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