Bøger udgivet af National Academies Press

"Since the early 1960s, the U.S. strategic nuclear posture has been composed of a triad of nuclear-certified long-range bombers, intercontinental ballistic missiles, and submarine-launched ballistic missiles. Since the early 1970s, U.S. nuclear forces have been subject to strategic arms control agreements. The large numbers and diversified nature of the U.S. nonstrategic (tactical) nuclear forces, which cannot be ignored as part of the overall nuclear deterrent, have decreased substantially since the Cold War. While there is domestic consensus today on the need to maintain an effective deterrent, there is no consensus on precisely what that requires, especially in a changing geopolitical environment and with continued reductions in nuclear arms. This places a premium on having the best possible analytic tools, methods, and approaches for understanding how nuclear deterrence and assurance work, how they might fail, and how failure can be averted by U.S. nuclear forces. U.S. Air Force Strategic Deterrence Analytic Capabilities identifies the broad analytic issues and factors that must be considered in seeking nuclear deterrence of adversaries and assurance of allies in the 21st century. This report describes and assesses tools, methods - including behavioral science-based methods - and approaches for improving the understanding of how nuclear deterrence and assurance work or may fail in the 21st century and the extent to which such failures might be averted or mitigated by the proper choice of nuclear systems, technological capabilities, postures, and concepts of operation of American nuclear forces. The report recommends criteria and a framework for validating the tools, methods, and approaches and for identifying those most promising for Air Force usage."--Publisher's description.

The Postdoctoral Experience Revisited builds on the 2000 report Enhancing the Postdoctoral Experience for Scientists and Engineers. That ground-breaking report assessed the postdoctoral experience and provided principles, action points, and recommendations to enhance that experience. Since the publication of the 2000 report, the postdoctoral landscape has changed considerably. The percentage of PhDs who pursue postdoctoral training is growing steadily and spreading from the biomedical and physical sciences to engineering and the social sciences. The average length of time spent in postdoctoral positions seems to be increasing. The Postdoctoral Experience Revisited reexamines postdoctoral programs in the United States, focusing on how postdocs are being guided and managed, how institutional practices have changed, and what happens to postdocs after they complete their programs. This book explores important changes that have occurred in postdoctoral practices and the research ecosystem and assesses how well current practices meet the needs of these fledgling scientists and engineers and of the research enterprise. The Postdoctoral Experience Revisited takes a fresh look at current postdoctoral fellows - how many there are, where they are working, in what fields, and for how many years. This book makes recommendations to improve aspects of programs - postdoctoral period of service, title and role, career development, compensation and benefits, and mentoring. Current data on demographics, career aspirations, and career outcomes for postdocs are limited. This report makes the case for better data collection by research institution and data sharing. A larger goal of this study is not only to propose ways to make the postdoctoral system better for the postdoctoral researchers themselves but also to better understand the role that postdoctoral training plays in the research enterprise. It is also to ask whether there are alternative ways to satisfy some of the research and career development needs of postdoctoral researchers that are now being met with several years of advanced training. Postdoctoral researchers are the future of the research enterprise. The discussion and recommendations of The Postdoctoral Experience Revisited will stimulate action toward clarifying the role of postdoctoral researchers and improving their status and experience.

The Science of Responding to a Nuclear Reactor Accident summarizes the presentations and discussions of the May 2014 Gilbert W. Beebe Symposium titled "The Science and Response to a Nuclear Reactor Accident". The symposium, dedicated in honor of the distinguished National Cancer Institute radiation epidemiologist who died in 2003, was co-hosted by the Nuclear and Radiation Studies Board of the National Academy of Sciences and the National Cancer Institute. The symposium topic was prompted by the March 2011 accident at the Fukushima Daiichi nuclear power plant that was initiated by the 9.0-magnitude earthquake and tsunami off the northeast coast of Japan. This was the fourth major nuclear accident that has occurred since the beginning of the nuclear age some 60 years ago. The 1957 Windscale accident in the United Kingdom caused by a fire in the reactor, the 1979 Three Mile Island accident in the United States caused by mechanical and human errors, and the 1986 Chernobyl accident in the former Soviet Union caused by a series of human errors during the conduct of a reactor experiment are the other three major accidents. The rarity of nuclear accidents and the limited amount of existing experiences that have been assembled over the decades heightens the importance of learning from the past. This year's symposium promoted discussions among federal, state, academic, research institute, and news media representatives on current scientific knowledge and response plans for nuclear reactor accidents. The Beebe symposium explored how experiences from past nuclear plant accidents can be used to mitigate the consequences of future accidents, if they occur. The Science of Responding to a Nuclear Reactor Accident addresses off-site emergency response and long-term management of the accident consequences; estimating radiation exposures of affected populations; health effects and population monitoring; other radiological consequences; and communication among plant officials, government officials, and the public and the role of the media.

"In recent years, patients' out-of-pocket costs for cancer care have been rising rapidly. These costs include health insurance deductibles, coinsurance, and copayments for covered services, as well as services that are not covered by insurance. Many cancer patients are especially vulnerable financially because their illness and/or treatment impedes their ability to work, with some patients losing employment altogether. Even with insurance, cancer patients often experience financial hardships, such as going into debt, depleting all assets to pay for cancer treatment, and personal bankruptcy. Although many elements contribute to the cost of cancer care, one important component is the cost of new cancer drugs, which has been escalating rapidly in recent years. To explore the issue of cancer drug costs and patient access to affordable, appropriate drug therapies, the Institute of Medicine's National Cancer Policy Forum convened a workshop on ensuring patient access to affordable cancer drugs in June 2014. Affordability was considered from both individual and societal perspectives. The workshop featured discussion panels as well as invited presentations from clinicians, researchers, representatives from the health insurance and pharmaceutical industries, and patient advocates. Ensuring Patient Access to Affordable Cancer Drugs summarizes the presentation and discussion of the workshop."--

"The Roundtable on Health Literacy brings together leaders from academia, industry, government, foundations, and associations and representatives of patient and consumer interests who work to improve health literacy. To achieve its mission, the roundtable discusses challenges facing health literacy practice and research and identifies approaches to promote health literacy through mechanisms and partnerships in both the public and private sectors. To explore the aspects of health literacy that impact the ability of patients to understand and follow discharge instructions and to learn from examples of how discharge instructions can be written to improve patient understanding of-and hence compliance with-discharge instructions, the Roundtable on Health Literacy held a public workshop. The workshop featured presentations and discussions that examined the implications of health literacy for discharge instructions for both ambulatory and inpatient facilities. Facilitating Patient Understanding of Discharge Instructions summarizes the presentations and discussions of the workshop. This report gives an overview of the impact of discharge instructions on outcomes, and discusses the specifics of inpatient discharge summaries and outpatient after-visit summaries. The report also contains case studies illustrating different approaches to improving discharge instructions."--

In today's world, the range of technologies with the potential to threaten the security of U.S. military forces is extremely broad. These include developments in explosive materials, sensors, control systems, robotics, satellite systems, and computing power, to name just a few. Such technologies have not only enhanced the capabilities of U.S. military forces, but also offer enhanced offensive capabilities to potential adversaries - either directly through the development of more sophisticated weapons, or more indirectly through opportunities for interrupting the function of defensive U.S. military systems. Passive and active electro-optical (EO) sensing technologies are prime examples. Laser Radar considers the potential of active EO technologies to create surprise; i.e., systems that use a source of visible or infrared light to interrogate a target in combination with sensitive detectors and processors to analyze the returned light. The addition of an interrogating light source to the system adds rich new phenomenologies that enable new capabilities to be explored. This report evaluates the fundamental, physical limits to active EO sensor technologies with potential military utility; identifies key technologies that may help overcome the impediments within a 5-10 year timeframe; considers the pros and cons of implementing each existing or emerging technology; and evaluates the potential uses of active EO sensing technologies, including 3D mapping and multi-discriminate laser radar technologies.

The Evidence for Violence Prevention Across the Lifespan and Around the World is the summary of a workshop convened in January 2013 by the Institute of Medicine's Forum on Global Violence Prevention to explore value and application of the evidence for violence prevention across the lifespan and around the world. As part of the Forum's mandate is to engage in multisectoral, multidirectional dialogue that explores crosscutting approaches to violence prevention, this workshop examined how existing evidence for violence prevention can continue to be expanded, disseminated, and implemented in ways that further the ultimate aims of improved individual well-being and safer communities. This report examines violence prevention interventions that have been proven to reduce different types of violence (e.g., child and elder abuse, intimate partner and sexual violence, youth and collective violence, and self-directed violence), identifies the common approaches most lacking in evidentiary support, and discusses ways that proven effective interventions can be integrated or otherwise linked with other prevention programs.

Over the past decade, preparedness and response capacities of government agencies, hospitals and clinics, public health agencies, and academic researchers in the United States and abroad have been challenged by a succession of public health emergencies, ranging from radiological threats to pandemics to earthquakes. Through After Action Reports, each of these emergencies has yielded important information and lessons learned that can inform future disaster response and recovery efforts. However, important information that needs to be collected during and immediately following these emergencies is often missed because of barriers and obstacles to gathering such data, such as varying institutional review board restrictions in different states, no sustainable funding network for this type of work, uncertainty on who should be involved in research response, and a lack of knowledge around how best to integrate research into response and recovery frameworks. Taking action to enable medical and public health research during disasters was the focus of a workshop held on June 12 and 13, 2014, coordinated and supported jointly by the Institute of Medicine Forum on Medical and Public Health Preparedness for Catastrophic Events, National Institute of Environmental Health Sciences, the National Library of Medicine, the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, and the Centers for Disease Control and Prevention. Invited speakers and participants from federal, state, and local government, academia, and community and worker organizations came together to discuss how to integrate research into existing response structures; identify critical research needs and priorities; identify obstacles and barriers to research; discuss structures and strategies needed for deployment of a research study; share ideas, innovations, and technologies to support research; and explore data collection tools and data-sharing mechanisms for both rapid and longitudinal research. Enabling Rapid and Sustainable Public Health Research During Disasters summarizes the presentations and discussion of the workshop.

A high percentage of defense systems fail to meet their reliability requirements. This is a serious problem for the U.S. Department of Defense (DOD), as well as the nation. Those systems are not only less likely to successfully carry out their intended missions, but they also could endanger the lives of the operators. Furthermore, reliability failures discovered after deployment can result in costly and strategic delays and the need for expensive redesign, which often limits the tactical situations in which the system can be used. Finally, systems that fail to meet their reliability requirements are much more likely to need additional scheduled and unscheduled maintenance and to need more spare parts and possibly replacement systems, all of which can substantially increase the life-cycle costs of a system. Beginning in 2008, DOD undertook a concerted effort to raise the priority of reliability through greater use of design for reliability techniques, reliability growth testing, and formal reliability growth modeling, by both the contractors and DOD units. To this end, handbooks, guidances, and formal memoranda were revised or newly issued to reduce the frequency of reliability deficiencies for defense systems in operational testing and the effects of those deficiencies. Reliability Growth evaluates these recent changes and, more generally, assesses how current DOD principles and practices could be modified to increase the likelihood that defense systems will satisfy their reliability requirements. This report examines changes to the reliability requirements for proposed systems; defines modern design and testing for reliability; discusses the contractor's role in reliability testing; and summarizes the current state of formal reliability growth modeling. The recommendations of Reliability Growth will improve the reliability of defense systems and protect the health of the valuable personnel who operate them.

"During the period 1990 to 2010, U.S. job growth occurred primarily in the high-skilled and low-skilled sectors. Yet, one-third of projected job growth for the period 2010 to 2020 will require middle-skilled workers -- who will earn strong middle-class wages and salaries -- important to both the production and consumption components of our economy. These jobs typically require significant training, often requiring more than a high school diploma but less than a baccalaureate degree. In the Gulf of Mexico, middle skilled workers play key roles in maintaining oil system safety, completing the numerous environmental restoration projects needed along the Gulf coast, and as workers in an integrated and resilient public health system. Educational pathways that lead to middle skilled jobs in these areas include: apprenticeship programs offered by schools, unions, and employers; high school career and technical education programs; community college courses, certificates, and associate degrees; and employer provided training. Opportunities for the Gulf Research Program: Middle-Skilled Workforce Needs is the summary of a workshop held on June 9-10, 2014 in Tampa, Florida. This workshop convened 40 thought leaders from the Gulf region's education, employer, and policymaking communities to facilitate a discussion of the current state of education and training pathways for preparing the region's middle-skilled workforce in both the short- and long-term and to identify perceived needs and potential opportunities that might be addressed by the GRP. Workshop participants discussed a variety of opportunities around building capacity in the region's middle-skilled workforce, including the need for competency-based education and training approaches and stronger partnerships among the region's employers and institutions of higher education."--Publisher's website.

"From the Institute of Medicine/National Research Council Report" printed on front cover.

"The Institute of Medicine launched an innovative outreach program in 1988. Through the generosity of the Rosenthal Family Foundation (formerly the Richard and Hinda Rosenthal Foundation), a discussion series was created to bring greater attention to some of the significant health policy issues facing our nation today. Each year a major health topic is addressed through remarks and conversation between experts in the field. The IOM later publishes the proceedings from this event for the benefit of a wider audience. This volume summarizes remarks by and an engaging discussion with Dr. Rima Khabbaz, Dr. Stuart Levy, Dr. Margaret (Peg) Riley, and Dr. Brad Spellberg on "Antimicrobial Resistance: A Problem Without Borders." The Centers for Disease Control and Prevention identified antimicrobial resistance as one of five urgent health threats facing the United States this year. Antimicrobial resistance is a global health security threat that will demand collaboration from many stakeholders around the world. This report highlights the crosscutting character of antimicrobial resistance and the needs for many disciplines to be brought together to be able to deal with it more effectively."--

Historically, regulations governing chemical use have often focused on widely used chemicals and acute human health effects of exposure to them, as well as their potential to cause cancer and other adverse health effects. As scientific knowledge has expanded there has been an increased awareness of the mechanisms through which chemicals may exert harmful effects on human health, as well as their effects on other species and ecosystems. Identification of high-priority chemicals and other chemicals of concern has prompted a growing number of state and local governments, as well as major companies, to take steps beyond existing hazardous chemical federal legislation. Interest in approaches and policies that ensure that any new substances substituted for chemicals of concern are assessed as carefully and thoroughly as possible has also burgeoned. The overarching goal of these approaches is to avoid regrettable substitutions, which occur when a toxic chemical is replaced by another chemical that later proved unsuitable because of persistence, bioaccumulation, toxicity, or other concerns. Chemical alternative assessments are tools designed to facilitate consideration of these factors to assist stakeholders in identifying chemicals that may have the greatest likelihood of harm to human and ecological health, and to provide guidance on how the industry may develop and adopt safer alternatives. A Framework to Guide Selection of Chemical Alternatives develops and demonstrates a decision framework for evaluating potentially safer substitute chemicals as primarily determined by human health and ecological risks. This new framework is informed by previous efforts by regulatory agencies, academic institutions, and others to develop alternative assessment frameworks that could be operationalized. In addition to hazard assessments, the framework incorporates steps for life-cycle thinking - which considers possible impacts of a chemical at all stages including production, use, and disposal - as well as steps for performance and economic assessments. The report also highlights how modern information sources such as computational modeling can supplement traditional toxicology data in the assessment process. This new framework allows the evaluation of the full range of benefits and shortcomings of substitutes, and examination of tradeoffs between these risks and factors such as product functionality, product efficacy, process safety, and resource use. Through case studies, this report demonstrates how different users in contrasting decision contexts with diverse priorities can apply the framework. This report will be an essential resource to the chemical industry, environmentalists, ecologists, and state and local governments.

The assessment of young children's development and learning has recently taken on new importance. Private and government organizations are developing programs to enhance the school readiness of all young children, especially children from economically disadvantaged homes and communities and children with special needs. Well-planned and effective assessment can inform teaching and program improvement, and contribute to better outcomes for children. This book affirms that assessments can make crucial contributions to the improvement of children's well-being, but only if they are well designed, implemented effectively, developed in the context of systematic planning, and are interpreted and used appropriately. Otherwise, assessment of children and programs can have negative consequences for both. The value of assessments therefore requires fundamental attention to their purpose and the design of the larger systems in which they are used. Early Childhood Assessment addresses these issues by identifying the important outcomes for children from birth to age 5 and the quality and purposes of different techniques and instruments for developmental assessments.

The United States Department of Agriculture's (USDA's) Economic Research Service's (ERS) Food Availability Data System includes three distinct but related data series on food and nutrient availability for consumption. The data serve as popular proxies for actual consumption at the national level for over 200 commodities (e.g., fresh spinach, beef, and eggs). The core Food Availability (FA) data series provides data on the amount of food available, per capita, for human consumption in the United States with data back to 1909 for many commodities. The Loss-Adjusted Food Availability (LAFA) data series is derived from the FA data series by adjusting for food spoilage, plate waste, and other losses to more closely approximate 4 actual intake. The LAFA data provide daily estimates of the per capita availability amounts adjusted for loss (e.g., in pounds, ounces, grams, and gallons as appropriate), calories, and food pattern equivalents (i.e., "servings") of the five major food groups (fruit, vegetables, grains, meat, and dairy) available for consumption plus the amounts of added sugars and sweeteners and added fats and oils available for consumption. This fiscal year, as part of its initiative to systematically review all of its major data series, ERS decided to review the FADS data system. One of the goals of this review is to advance the knowledge and understanding of the measurement and technical aspects of the data supporting FADS so the data can be maintained and improved. Data and Research to Improve the U.S. Food Availability System and Estimates of Food Loss is the summary of a workshop convened by the Committee on National Statistics of the National Research Council and the Food and Nutrition Board of the Institute of Medicine to advance knowledge and understanding of the measurement and technical aspects of the data supporting the LAFA data series so that these data series and subsequent food availability and food loss estimates can be maintained and improved. The workshop considered such issues as the effects of termination of selected Census Bureau and USDA data series on estimates for affected food groups and commodities; the potential for using other data sources, such as scanner data, to improve estimates of food availability; and possible ways to improve the data on food loss at the farm and retail levels and at restaurants. This report considers knowledge gaps, data sources that may be available or could be generated to fill gaps, what can be learned from other countries and international organizations, ways to ensure consistency of treatment of commodities across series, and the most promising opportunities for new data for the various food availability series.

"Development Planning provides recommendations to improve development planning for near-term acquisition projects, concepts not quite ready for acquisition, corporate strategic plans, and training of acquisition personnel. This report reviews past uses of development planning by the Air Force, and offers an organizational construct that will help the Air Force across its core functions. Developmental planning, used properly by experienced practitioners, can provide the Air Force leadership with a tool to answer the critical question, Over the next 20 years in 5-year increments, what capability gaps will the Air Force have that must be filled? Development planning will also provide for development of the workforce skills needed to think strategically and to defectively define and close the capability gap. This report describes what development planning could be and should be for the Air Force."--Publisher description.

"There is growing evidence from developed and developing countries that community-based approaches are effective in improving the health of individuals and populations. This is especially true when the social determinants of health are considered in the design of the community-based approach. With an aging population and an emphasis on health promotion, the United States is increasingly focusing on community-based health and health care. Preventing disease and promoting health calls for a holistic approach to health interventions that rely more heavily upon interprofessional collaborations. However, the financial and structural design of health professional education remains siloed and largely focused on academic health centers for training. Despite these challenges, there are good examples of interprofessional, community-based programs and curricula for educating health professionals. In May 2014, members of the Institute of Medicine's Global Forum on Innovation in Health Professional Education came together to substantively delve into issues affecting the scale-up and spread of health professional education in communities. Participants heard a wide variety of individual accounts from innovators about work they are undertaking and opportunities for education with communities. In presenting a variety of examples that range from student community service to computer modeling, the workshop aimed to stimulate discussions about how educators might better integrate education with practice in communities. Building Health Workforce Capacity Through Community-Based Health Professional Education summarizes the presentations and discussion of this event."--

Review of Army Research Laboratory Programs for Historically Black Colleges and Universities and Minority Institutions examines the ways in which historically black colleges and universities and minority institutions have used the Army Research Laboratory (ARL) funds to enhance the science, technology, engineering, and mathematics (STEM) programs at their institutions over the past decade. This report also considers which program elements reflect practices that are effective for assisting these institutions in enhancing the STEM programs and could be considered by other Department of Defense agencies for application to their programs.The Army Research Laboratory has contributed to building up the human and infrastructural capacities in the past, and this report looks for ways to enhance ARL program impact on institution-building in the future, confident that more capable black and minority-serving institutions will, in turn, help America as a whole develop a more diverse and intellectually capable STEM workforce.

This is the 18th Volume in the series Memorial Tributes compiled by the National Academy of Engineering as a personal remembrance of the lives and outstanding achievements of its members and foreign associates. These volumes are intended to stand as an enduring record of the many contributions of engineers and engineering to the benefit of humankind. In most cases, the authors of the tributes are contemporaries or colleagues who had personal knowledge of the interests and the engineering accomplishments of the deceased. Through its members and foreign associates, the Academy carries out the responsibilities for which it was established in 1964. Under the charter of the National Academy of Sciences, the National Academy of Engineering was formed as a parallel organization of outstanding engineers. Members are elected on the basis of significant contributions to engineering theory and practice and to the literature of engineering or on the basis of demonstrated unusual accomplishments in the pioneering of new and developing fields of technology. The National Academies share a responsibility to advise the federal government on matters of science and technology. The expertise and credibility that the National Academy of Engineering brings to that task stem directly from the abilities, interests, and achievements of our members and foreign associates, our colleagues and friends, whose special gifts we remember in this book.

"Natural gas in deep shale formations, which can be developed by hydraulic fracturing and associated technologies (often collectively referred to as "fracking") is dramatically increasing production of natural gas in the United States, where significant gas deposits exist in formations that underlie many states. Major deposits of shale gas exist in many other countries as well. Proponents of shale gas development point to several kinds of benefits, for instance, to local economies and to national "energy independence." Shale gas development has also brought increasing expression of concerns about risks, including to human health, environmental quality, non-energy economic activities in shale regions, and community cohesion. Some of these potential risks are beginning to receive careful evaluation; others are not. Although the risks have not yet been fully characterized or all of them carefully analyzed, governments at all levels are making policy decisions, some of them hard to reverse, about shale gas development and/or how to manage the risks. Risks and Risk Governance in Shale Gas Development is the summary of two workshops convened in May and August 2013 by the National Research Council's Board on Environmental Change and Society to consider and assess claims about the levels and types of risk posed by shale gas development and about the adequacy of existing governance procedures. Participants from engineering, natural, and social scientific communities examined the range of risks and of social and decision-making issues in risk characterization and governance related to gas shale development. Central themes included risk governance in the context of (a) risks that emerge as shale gas development expands, and (b) incomplete or declining regulatory capacity in an era of budgetary stringency. This report summarizes the presentations on risk issues raised in the first workshop, the risk management and governance concepts presented at the second workshop, and the discussions at both workshops."--Publisher's description.

"The Role and Potential of Communuties in Population Health Improvement is the summary of a workshop held by the Institute of Medicine Roundtable on Population Health Improvement in April 2014 that featured invited speakers from community groups that have taken steps to improve the health of their communities. Speakers from communities across the United States discussed the potential roles of communities for improving population health. The workshop focused on youth organizing, community organizing or other types of community participation, and partnerships between community and institutional actors. This report explores the roles and potential of the community as leaders, partners, and facilitators in transforming the social and environmental conditions that shape health and well-being at the local level."-- Publisher's description.

"Combined with the more traditional employer occupational safety and health protection activities are newer employment-based programs to promote better health through helping workers quit smoking, lose weight, reduce stress, or exercise more regularly. In support of these efforts, some employers have made changes in their policies and facilities to support physical activity and healthier eating, and some employers connect with community resources for health education, health fairs, and other services. This diverse array of activities most typically has been planned, managed, and assessed - to the extent they exist in the workplace at all - by different, often uncoordinated departments within the business entity. Some employers have reconceptualized their safety, prevention, and promotion initiatives and attempted to bring them together into a coherent whole. The National Institute for Occupational Safety and Health (NIOSH) has supported this integration, defining Total Worker Health as "a strategy integrating occupational safety and health protection with health promotion to prevent worker injury and illness and to advance health and well-being." In May 2014, with support from NIOSH, the Institute of Medicine organized a workshop on Total Worker Health. Rather than a review of published literature, this workshop sought input from a wide variety of on-the-ground stakeholders regarding their experiences with integrating occupational safety and health protection with health promotion in the workplace. Promising and Best Practices in Total Worker Health is the summary of the discussions and presentations of the event. This report identifies prevalent and best practices in programs that integrate occupational safety and health protection with health promotion in small, medium, and large workplaces; employer and employee associations; academia; government agencies; and other stakeholder groups."--

Many people in the United States are exposed to formaldehyde. Exposure can occur from environmental sources (for example, combustion processes, building materials, and tobacco smoke) or in occupational settings (for example, the furniture, textile, and construction industries). Formaldehyde exposure also has endogenous sources--it is produced intracellularly as a component of the one carbon pool intermediary metabolism pathway. Scientists have studied formaldehyde for decades to determine whether exogenous formaldehyde exposure may be associated with cancer in humans. In 1981, The National Toxicology Program (NTP) first listed formaldehyde in the 2nd Report on Carcinogens as "e;reasonably anticipated to be a human carcinogen"e;. In 2011, NTP upgraded the listing of formaldehyde to "e;known to be a human carcinogen"e;. Following the new listing, Congress directed the Department of Health and Human Services to arrange for the National Academy of Sciences to independently review formaldehyde's substance profile and listing. This report presents the findings and conclusions of the committee formed in response to the congressional request.Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens concurs with NTP that there is sufficient evidence in studies that had adequate characterization of relevant exposure metrics to enable a strong conclusion about the association between formaldehyde exposure and cancer in humans. Additionally, the authoring committee independently reviewed the scientific evidence from studies in humans, experimental animals, and other studies relevant to the mechanisms of carcinogenesis and made level-of-evidence conclusions. This report finds clear and convincing epidemiologic evidence of an association between formaldehyde exposure and nasopharyngeal and sinonasal cancers in humans.

Health care has been called one of the most complex sectors of the U.S. economy. Driven largely by robust innovation in treatments and interventions, this complexity has created an increased need for evidence about what works best for whom in order to inform decisions that lead to safe, efficient, effective, and affordable care. As health care becomes more digital, clinical datasets are becoming larger and more numerous. By realizing the potential of knowledge generation that is more closely integrated with the practice of care, it should be possible not only to produce more usable evidence to inform decisions, but also to increase the efficiency and decrease the costs of doing clinical research. Patient-Centered Clinical Research Network, or PCORnet, is a nation-wide patient-centered clinical research network intended to form a resource of clinical, administrative, and patient data that can be used to carry out observational and interventional research studies and enhance the use of clinical data to advance the learning health care system. The primary goal of the first phase of PCORnet will be to establish the data infrastructure necessary to do such research. In April and June 2014 the Institute of Medicine's Roundtable on Value and Science-Driven Health Care convened two workshops aimed at accelerating progress toward real-time knowledge generation through the seamless integration of clinical practice and research, one of the fundamental concepts of a continuously learning health system, centered on the development of the PCORnet. The first workshop brought together health care system leaders, both administrative and clinical, and researchers to consider issues and strategic priorities for building a successful and durable clinical research network and facilitate progress toward a continuously learning health care system more broadly, including issues related to science, technology, ethics, business, regulatory oversight, sustainability, and governance. The second workshop focused on implementation approaches. Health system CEOs convened to consider strategic priorities and explore approaches to implementation. These workshops will inform the decisions of field leaders moving forward, including PCORI, the PCORnet steering committee, and PCORnet grantees. Integrating Research and Practice is the summary of the presentations and discussions of the workshops.

"Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle"--

"Despite spending far more on medical care than any other nation and despite having seen a century of unparalleled improvement in population health and longevity, the United States has fallen behind many of its global counterparts and competitors in such health outcomes as overall life expectancy and rates of preventable diseases and injuries. A fundamental but often overlooked driver of the imbalance between spending and outcomes is the nation's inadequate investment in non-clinical strategies that promote health and prevent disease and injury population-wide, strategies that fall under the rubric of "population health." Given that it is unlikely that government funding for governmental public health agencies, whether at the local, state, or federal levels, will see significant and sustained increases, there is interest in finding creative sources of funding for initiatives to improve population health, both through the work of public health agencies and through the contributions of other sectors, including nonhealth entities. Financing Population Health Improvement is the summary of a workshop convened by the Institute of Medicine Roundtable on Population Health Improvement in February 2014 to explore the range of resources that might be available to provide a secure funding stream for non-clinical actions to enhance health. Presenters and participants discussed the range of potential resources (e.g., financial, human, and community) explored topics related to financial resources. This report discusses return on investment, the value of investing in population-based interventions, and possible sources of funding to improve population health"--

"Culture Matters is the summary of a workshop convened by the Government-University-Industry Research Roundtable (GUIRR) in July 2013 to address how culture and cultural perception influence and impact the process by which research agreements are made and negotiated across international boundaries. In this workshop, "Culture Matters: An Approach to International Research Agreements," representatives from around the world and from GUIRR's three constituent sectors - government, university, and industry - gathered to provide input into four specific meeting tracks or domains. The tracks focused on research and agreements affecting or involving people/human subjects; environmental and natural resources; science, engineering, and manufacturing; and agriculture and animal issues. This report examines each of these domains and the role that culture and cultural expectations may have in the forging and implementation of international research agreements."--

Papers originally presented at a National Academies workshop.

The National Children's Study (NCS) was authorized by the Children's Health Act of 2000 and is being implemented by a dedicated Program Office in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The NCS is planned to be a longitudinal observational birth cohort study to evaluate the effects of chronic and intermittent exposures on child health and development in the U.S.. The NCS would be the first study to collect a broad range of environmental exposure measures for a national probability sample of about 100,000 children, followed from birth or before birth to age 21. Detailed plans for the NCS were developed by 2007 and reviewed by a National Research Council / Institute of Medicine panel. At that time, sample recruitment for the NCS Main Study was scheduled to begin in 2009 and to be completed within about 5 years. However, results from the initial seven pilot locations, which recruited sample cases in 2009-2010, indicated that the proposed household-based recruitment approach would be more costly and time consuming than planned. In response, the Program Office implemented a number of pilot tests in 2011 to evaluate alternative recruitment methods and pilot testing continues to date. At the request of Congress, The National Children's Study 2014 reviews the revised study design and proposed methodologies for the NCS Main Study. This report assesses the study's plan to determine whether it is likely to produce scientifically sound results that are generalizable to the United States population and appropriate subpopulations. The report makes recommendations about the overall study framework, sample design, timing, content and need for scientific expertise and oversight. The National Children's Study has the potential to add immeasurably to scientific knowledge about the impact of environmental exposures, broadly defined, on children\'s health and development in the United States. The recommendations of this report will help the NCS will achieve its intended objective to examine the effects of environmental influences on the health and development of American children.

Population surveys traditionally collect information from respondents about their circumstances, behaviors, attitudes, and other characteristics. In recent years, many surveys have been collecting not only questionnaire answers, but also biologic specimens such as blood samples, saliva, and buccal swabs, from which a respondent's DNA can be ascertained along with other biomarkers (e.g., the level of a certain protein in the blood). The National Health and Nutrition Examination Survey (NHANES), sponsored by the National Center for Health Statistics (NCHS), has been collecting and storing genetic specimens since 1991, and other surveys, such as the Health and Retirement Study (HRS) funded by the National Institute on Aging, have followed suit. In order to give their informed consent to participate in a survey, respondents need to know the disposition and use of their data. Will their data be used for one research project and then destroyed, or will they be archived for secondary use? Sponsors of repeated cross-sectional surveys, such as NHANES, and of longitudinal surveys that follow panels of individuals over time, such as HRS, generally want to retain data for a wide range of secondary uses, many of which are not explicitly foreseen at the time of data collection. They typically inform respondents that their data will be stored in a secure manner and may be provided to researchers with suitable protections against individual identification. The addition of biologic specimens to a survey adds complications for storing, protecting, and providing access to such data and measurements made from them. There are also questions of whether, when, and for which biologic measurements the results should be reported back to individual respondents. Recently, the cost of full genomic sequencing has plummeted, and research findings are beginning to accumulate that bear up under replication and that potentially have clinical implications for a respondent. For example, knowing that one possesses a certain gene or gene sequence might suggest that one should seek a certain kind of treatment or genetic counseling or inform one's blood relatives. Biomedical research studies, in which participants are asked to donate tissues for genetic studies and are usually told that they will not be contacted with any results, are increasingly confronting the issue of when and which DNA results to return to participants. Issues in Returning Individual Results from Genome Research Using Population-Based Banked Specimens, with a Focus on the National Health and Nutrition Examination Survey is the summary of a workshop convened in February 2013 by the Committee on National Statistics in the Division of Behavioral and Social Sciences and Education of the National Research Council. This report considers how population surveys, in particular NHANES, should implement the reporting of results from genomic research using stored specimens and address informed consent for future data collection as well as for the use of banked specimens covered by prior informed consent agreements. The report will be of interest to survey organizations that include or contemplate including the collection of biologic specimens in population surveys for storing for genetic research. The issues involved are important for advancing social, behavioral, and biomedical knowledge while appropriately respecting and protecting individual survey respondents.