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"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.

"Dual-use applications for chemical manufacturing equipment have been recognized as a concern for many years, and export-control regulations worldwide are in place as a result. These regulations, in conjunction with the verification and inspection requirements of Article VI of the Chemical Weapons Convention, are designed to support non-proliferation of manufacturing equipment suitable for production of chemical warfare agents. In recent years, globalization has changed the distribution of chemical manufacturing facilities around the world. This has increased the burden on current inspection regimes, and increased the amount of manufacturing equipment available around the world. Movement of that equipment, both domestically and as part of international trade, has increased to accommodate these market shifts. To better understand the movement and tracking of chemical manufacturing equipment of dual-use concern, the Project on Advanced Systems and Concepts for Countering Weapons of Mass Destruction at the Naval Postgraduate School contracted with the Board on Chemical Sciences and Technology of the National Research Council to hold a workshop on the global movement and tracking of chemical manufacturing equipment. The workshop, held in May 2014, looked at key concerns regarding the availability and movement of equipment for chemical manufacturing, particularly used and decommissioned equipment that is of potential dual-use concern. The workshop examined today's industrial, security, and political contexts in which these materials are being produced, regulated, and transferred. The workshop also facilitated discussions about current practices, including consideration of their congruence with current technologies and security threats in the global chemical industrial system. The Global Movement and Tracking of Chemical Manufacturing Equipment summarizes the presentations and discussion of the event."--Publisher's description.

Created in 1982 through the Small Business Innovation Development Act, the Small Business Innovation Research (SBIR) program remains the nation's single largest innovation program for small business. The SBIR program offers competitive awards to support the development and commercialization of innovative technologies by small private-sector businesses. At the same time, the program provides government agencies with technical and scientific solutions that address their different missions.SBIR at the Department of Defense considers ways that the Department of Defense SBIR program could work better in addressing the congressional objectives for the SBIR program to stimulate technological innovation, use small businesses to meet federal research and development (R & D) needs, foster and encourage the participation of socially and economically disadvantaged small businesses, and increase the private sector commercialization of innovations derived from federal R&D. An earlier report, An Assessment of the Small Business Innovation Research Program at the Department of Defense, studied how the SBIR program has stimulated technological innovation and used small businesses to meet federal research and development needs. This report builds on the previous one, with a revised survey of SBIR companies. SBIR at the Department of Defense revisits some case studies from the 2009 study and develops new ones, and interviews agency managers and other stakeholders to provide a second snapshot of the program's progress toward achieving its legislative goals.

Science, technology, engineering, and mathematics (STEM) permeate the modern world. The jobs people do, the foods they eat, the vehicles in which they travel, the information they receive, the medicines they take, and many other facets of modern life are constantly changing as STEM knowledge steadily accumulates. Yet STEM education in the United States, despite the importance of these subjects, is consistently falling short. Many students are not graduating from high school with the knowledge and capacities they will need to pursue STEM careers or understand STEM-related issues in the workforce or in their roles as citizens. For decades, efforts to improve STEM education have focused largely on the formal education system. Learning standards for STEM subjects have been developed, teachers have participated in STEM-related professional development, and assessments of various kinds have sought to measure STEM learning. But students do not learn about STEM subjects just in school. Much STEM learning occurs out of school--in organized activities such as afterschool and summer programs, in institutions such as museums and zoos, from the things students watch or read on television and online, and during interactions with peers, parents, mentors, and role models. To explore how connections among the formal education system, afterschool programs, and the informal education sector could improve STEM learning, a committee of experts from these communities and under the auspices of the Teacher Advisory Council of the National Research Council, in association with the California Teacher Advisory Council organized a convocation that was held in February 2014. Entitled "STEM Learning Is Everywhere: Engaging Schools and Empowering Teachers to Integrate Formal, Informal, and Afterschool Education to Enhance Teaching and Learning in Grades K-8," the convocation brought together more than 100 representatives of all three sectors, along with researchers, policy makers, advocates, and others, to explore a topic that could have far-reaching implications for how students learn about STEM subjects and how educational activities are organized and interact. This report is the summary of that meeting. STEM Learning is Everywhere explores how engaging representatives from the formal, afterschool, and informal education sectors in California and from across the United States could foster more seamless learning of STEM subjects for students in the elementary and middle grades. The report also discusses opportunities for STEM that may result from the new expectations of the Next Generation Science Standards and the Common Core Standards for Mathematics and Language Arts.

Despite decades of government, university, and employer efforts to close the gender gap in engineering, women make up only 11 percent of practicing engineers in the United States. What factors influence women graduates' decisions to enter the engineering workforce and either to stay in or leave the field as their careers progress? Researchers are both tapping existing data and fielding new surveys to help answer these questions. On April 24, 2013, the National Research Council Committee on Women in Science, Engineering, and Medicine held a workshop to explore emerging research and to discuss career pathways and outcomes for women who have received bachelor's degrees in engineering. Participants included academic researchers and representatives from the Department of Labor, National Science Foundation, and Census Bureau, as well as several engineering professional societies. Career Choices of Female Engineers summarizes the presentations and discussions of the workshop.

This report develops a set of integrated and comprehensive technical goals and objectives of importance to the civil aeronautics community and the nation.

"The forested land in the United States is an asset that is owned and managed not only by federal, state, and local governments, but also by families and other private groups, including timber investment management organizations and real estate investment trusts. The more than 10 million family forestland owners manage the largest percentage of forestland acreage (35 percent) and the majority of the privately owned forestland (62 percent). The Forest Service of the United States Department of Agriculture, which is responsible for the stewardship of all of the nation's forests, has long worked with private owners of forestland on forest management and preservation. At a time when all forestland is facing intensified threats because of the long-term effects of global climate change, the Forest Service recognizes that family forestland owners play a key role in protecting forestland. It is working to identify optimal ways to engage this diverse group and support them in mitigating threats to the biologically diverse land they own or manage. Climate Change Education: Engaging Family Private Forest Owners on Issues Related to Climate Change is the summary of a workshop, convened by the National Research Council's Board on Science Education and Board on Environmental Change and Society as part of its Climate Change Education Roundtable series, to explore approaches to the challenges that face state foresters, extension agents, private forestry consultants, and others involved with private family forestland owners on how to take climate change into consideration when making decisions about their forests. The workshop focused on how findings from the behavioral, social, and educational sciences can be used to help prepare for the impacts of climate change. The workshop participants discussed the threats to forests posed by climate change and human actions; private forestland owners' values, knowledge, and dispositions about forest management, climate change, and related threats; and strategies for improving communication between forestland owners and service providers about forest management in the face of climate change."--Publisher's description.

Over the last three decades, researchers have made remarkable progress in creating and testing family-focused programs aimed at fostering the cognitive, affective, and behavioral health of children. These programs include universal interventions, such as those for expecting or new parents, and workshops for families whose children are entering adolescence, as well as programs targeted to especially challenged parents, such as low-income single teens about to have their first babies, or the parents of children with autism. Some family-focused programs have been shown to foster significantly better outcomes in children, including enhanced educational performance, and reduced rates of teen pregnancy, substance abuse, and child conduct and delinquency, as well as reduced child abuse. The favorable cost-benefit ratios of some of these programs are due, in part, to the multiple and far-ranging effects that family-focused prevention programs targeting children can have. Other family-focused programs have shown success in smaller academic studies but have not been widely applied, or have not worked as effectively or failed when applied to more diverse real-world settings. Strategies for Scaling Effective Family-Focused Preventive Interventions to Promote Children's Cognitive, Affective, and Behavioral Health is the summary of a workshop convened by the Institute of Medicine Forum on Promoting Children's Cognitive, Affective, and Behavioral Health to explore effective preventive interventions for youth that can modify risk and promote protective factors that are linked to mental, emotional, and behavioral health, and how to apply this existing knowledge. Based on the 2009 report Preventing Mental, Emotional, and Behavioral Disorders Among Young People, this report considers how to build a stronger research and practice base around the development and implementation of programs, practices, and policies that foster children's health and well-being across the country, while engaging multi-sectorial stakeholders. While research has advanced understanding of risk, promotive, and protective factors in families that influence the health and well-being of youth, a challenge remains to provide family-focused interventions across child and adolescent development at sufficient scale and reach to significantly reduce the incidence and prevalence of negative cognitive, affective, and behavioral outcomes in children and adolescents nationwide, as well as to develop widespread demand for effective programs by end users. This report explores new and innovative ways to broaden the reach and demand for effective programs and to generate alternative paradigms for strengthening families.

Extremely hazardous substances can be released accidentally as a result of chemical spills, industrial explosions, fires, or accidents involving railroad cars and trucks transporting EHSs. Workers and residents in communities surrounding industrial facilities where these substances are manufactured, used, or stored and in communities along the nation's railways and highways are potentially at risk of being exposed to airborne EHSs during accidental releases or intentional releases by terrorists. Pursuant to the Superfund Amendments and Reauthorization Act of 1986, the U.S. Environmental Protection Agency (EPA) has identified approximately 400 EHSs on the basis of acute lethality data in rodents. Acute Exposure Guideline Levels for Selected Airborne Chemicals, Volume 17 identifies, reviews, and interprets relevant toxicologic and other scientific data for selected AEGL documents for acrylonitrile, carbon tetrachloride, cyanogen, epichlorohydrin, ethylene chlorohydrin, toluene, trimethylacetyl chloride, hydrogen bromide, and boron tribromide in order to develop acute exposure guideline levels (AEGLs) for these high-priority, acutely toxic chemicals. AEGLs represent threshold exposure limits (exposure levels below which adverse health effects are not likely to occur) for the general public and are applicable to emergency exposures ranging from 10 minutes (min) to 8 h. Three levels - AEGL-1, AEGL-2, and AEGL-3 - are developed for each of five exposure periods (10 min, 30 min, 1 h, 4 h, and 8 h) and are distinguished by varying degrees of severity of toxic effects. This report will inform planning, response, and prevention in the community, the workplace, transportation, the military, and the remediation of Superfund sites.

"The content of this guide was derived from the original report as an abridged version for providers of victim and support services"--Title page verso.

"Bullying - long tolerated as just a part of growing up - finally has been recognized as a substantial and preventable health problem. Bullying is associated with anxiety, depression, poor school performance, and future delinquent behavior among its targets, and reports regularly surface of youth who have committed suicide at least in part because of intolerable bullying. Bullying also can have harmful effects on children who bully, on bystanders, on school climates, and on society at large. Bullying can occur at all ages, from before elementary school to after high school. It can take the form of physical violence, verbal attacks, social isolation, spreading rumors, or cyberbullying. Increased concern about bullying has led 49 states and the District of Columbia to enact anti-bullying legislation since 1999. In addition, research on the causes, consequences, and prevention of bullying has expanded greatly in recent decades. However, major gaps still exist in the understanding of bullying and of interventions that can prevent or mitigate the effects of bullying. Building Capacity to Reduce Bullying is the summary of a workshop convened by the Board on Children, Youth, and Families of the Institute of Medicine and National Research Council in April 2014 to identify the conceptual models and interventions that have proven effective in decreasing bullying, examine models that could increase protective factors and mitigate the negative effects of bullying, and explore the appropriate roles of different groups in preventing bullying. This report reviews research on bullying prevention and intervention efforts as well as efforts in related areas of research and practice, implemented in a range of contexts and settings, including schools, peers, families, communities, laws and public policies, and technology. Building Capacity to Reduce Bullying considers how involvement or lack of involvement by these sectors influences opportunities for bullying, and appropriate roles for these sectors in preventing bullying. This report highlights current research on bullying prevention, considers what works and what does not work, and derives lessons learned."--Publisher's description.

The Integrated Risk Information System (IRIS) is a program within the US Environmental Protection Agency (EPA) that is responsible for developing toxicologic assessments of environmental contaminants. An IRIS assessment contains hazard identifications and dose-response assessments of various chemicals related to cancer and noncancer outcomes. Although the program was created to increase consistency among toxicologic assessments within the agency, federal, state, and international agencies and other organizations have come to rely on IRIS assessments for setting regulatory standards, establishing exposure guidelines, and estimating risks to exposed populations. Over the last decade, the National Research Council (NRC) has been asked to review some of the more complex and challenging IRIS assessments, including those of formaldehyde, dioxin, and tetrachloroethylene. In 2011, an NRC committee released its review of the IRIS formaldehyde assessment. Like other NRC committees that had reviewed IRIS assessments, the formaldehyde committee identified deficiencies in the specific assessment and more broadly in some of EPA's general approaches and specific methods. Although the committee focused on evaluating the IRIS formaldehyde assessment, it provided suggestions for improving the IRIS process and a roadmap for its revision in case EPA decided to move forward with changes to the process. Congress directed EPA to implement the report's recommendations and then asked the National Research Council to review the changes that EPA was making (or proposing to make) in response to the recommendations.Review of EPA's Integrated Risk Information System (IRIS) Process provides an overview of some general issues associated with IRIS assessments. This report then addresses evidence identification and evaluation for IRIS assessments and discusses evidence integration for hazard evaluation and methods for calculating reference values and unit risks. The report makes recommendations and considerations for future directions. Overall, Review of EPA's Integrated Risk Information System Process finds that substantial improvements in the IRIS process have been made, and it is clear that EPA has embraced and is acting on the recommendations in the NRC formaldehyde report. The recommendations of this report should be seen as building on the progress that EPA has already made.

Supporting a Movement for Health and Health Equity is the summary of a workshop convened in December 2013 by the Institute of Medicine Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities and the Roundtable on Population Health Improvement to explore the lessons that may be gleaned from social movements, both those that are health-related and those that are not primarily focused on health. Participants and presenters focused on elements identified from the history and sociology of social change movements and how such elements can be applied to present-day efforts nationally and across communities to improve the chances for long, healthy lives for all. The idea of movements and movement building is inextricably linked with the history of public health. Historically, most movements - including, for example, those for safer working conditions, for clean water, and for safe food - have emerged from the sustained efforts of many different groups of individuals, which were often organized in order to protest and advocate for changes in the name of such values as fairness and human rights. The purpose of the workshop was to have a conversation about how to support the fragments of health movements that roundtable members believed they could see occurring in society and in the health field. Recent reports from the National Academies have highlighted evidence that the United States gets poor value on its extraordinary investments in health - in particular, on its investments in health care - as American life expectancy lags behind that of other wealthy nations. As a result, many individuals and organizations, including the Healthy People 2020 initiative, have called for better health and longer lives.

Many of the elements of the Affordable Care Act (ACA) went into effect in 2014, and with the establishment of many new rules and regulations, there will continue to be significant changes to the United States health care system. It is not clear what impact these changes will have on medical and public health preparedness programs around the country. Although there has been tremendous progress since 2005 and Hurricane Katrina, there is still a long way to go to ensure the health security of the Country. There is a commonly held notion that preparedness is separate and distinct from everyday operations, and that it only affects emergency departments. But time and time again, catastrophic events challenge the entire health care system, from acute care and emergency medical services down to the public health and community clinic level, and the lack of preparedness of one part of the system places preventable stress on other components. The implementation of the ACA provides the opportunity to consider how to incorporate preparedness into all aspects of the health care system. The Impacts of the Affordable Care Act on Preparedness Resources and Programs is the summary of a workshop convened by the Institute of Medicine's Forum on Medical and Public Health Preparedness for Catastrophic Events in November 2013 to discuss how changes to the health system as a result of the ACA might impact medical and public health preparedness programs across the nation. This report discusses challenges and benefits of the Affordable Care Act to disaster preparedness and response efforts around the country and considers how changes to payment and reimbursement models will present opportunities and challenges to strengthen disaster preparedness and response capacities.

Big Data in Materials Research and Development is the summary of a workshop convened by the National Research Council Standing Committee on Defense Materials Manufacturing and Infrastructure in February 2014 to discuss the impact of big data on materials and manufacturing. The materials science community would benefit from appropriate access to data and metadata for materials development, processing, application development, and application life cycles. Currently, that access does not appear to be sufficiently widespread, and many workshop participants captured the constraints and identified potential improvements to enable broader access to materials and manufacturing data and metadata. This report discusses issues in defense materials, manufacturing and infrastructure, including data ownership and access; collaboration and exploitation of big data's capabilities; and maintenance of data.

"Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes, and spinal cord injury. Clinical trials of stem cell treatments are under way in countries around the world, but the evidence base to support the medical use of stem cells remains limited. Despite this paucity of clinical evidence, consumer demand for treatments using stem cells has risen, driven in part by a lack of available treatment options for debilitating diseases as well as direct-to-consumer advertising and public portrayals of stem cell-based treatments. Clinics that offer stem cell therapies for a wide range of diseases and conditions have been established throughout the world, both in newly industrialized countries such as China, India, and Mexico and in developed countries such as the United States and various European nations. Though these therapies are often promoted as being established and effective, they generally have not received stringent regulatory oversight and have not been tested with rigorous trials designed to determine their safety and likely benefits. In the absence of substantiated claims, the potential for harm to patients - as well as to the field of stem cell research in general - may outweigh the potential benefits. To explore these issues, the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research held a workshop in November 2013. Stem Cell Therapies summarizes the workshop. Researchers, clinicians, patients, policy makers, and others from North America, Europe, and Asia met to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from treatments that are dangerous or ineffective or by steering them toward treatments that are effective. This report discusses the current environment in which patients are receiving unregulated stem cell offerings, focusing on the treatments being offered and their risks and benefits. The report considers the evidence base for clinical application of stem cell technologies and ways to assure the quality of stem cell offerings."--

The Department of Energy's Office of Environmental Management's (EM) mission is the safe cleanup of sites associated with the government-led development of nuclear weapons and nuclear energy. While many of these legacy sites have completed cleanup, the largest and most complex sites have not been fully remediated. The cleanup of these sites is proceeding under legally enforceable agreements with timelines for hundreds of milestones. EM is reviewing alternative approaches to increase effectiveness and improve cost efficiencies of its cleanup activities, especially for sites that will have residual contamination when active cleanup is complete. This report is the summary of two workshops convened in October 2013 and January 2014 on best practices for risk-informed remedy selection, closure, and post-closure control of radioactive and chemically contaminated sites that present significant difficulty for remediation to unrestricted release. The workshop series aimed to explore best practices that promote effective, risk-informed decision making and future opportunities to improve remediation approaches and practices.In the Workshop #1 section of Best Practices for Risk-Informed Decision Making Regarding Contaminated Sites, the report examines holistic approaches for remediating sites with multiple contaminant sources and post-closure uses, and approaches for incorporating a sustainability framework into decision making regarding site remediation, closure, and post-closure control. In Workshop #2, the report focuses on post-closure controls, assessment of long-term performance of site remedies, and best practices for risk-based remediation decisions.

"Microbial forensics is a scientific discipline dedicated to analyzing evidence from a bioterrorism act, biocrime, or inadvertent microorganism or toxin release for attribution purposes. This emerging discipline seeks to offer investigators the tools and techniques to support efforts to identify the source of a biological threat agent and attribute a biothreat act to a particular person or group. Microbial forensics is still in the early stages of development and faces substantial scientific challenges to continue to build capacity. The unlawful use of biological agents poses substantial dangers to individuals, public health, the environment, the economies of nations, and global peace. It also is likely that scientific, political, and media-based controversy will surround any investigation of the alleged use of a biological agent, and can be expected to affect significantly the role that scientific information or evidence can play. For these reasons, building awareness of and capacity in microbial forensics can assist in our understanding of what may have occurred during a biothreat event, and international collaborations that engage the broader scientific and policy-making communities are likely to strengthen our microbial forensics capabilities. One goal would be to create a shared technical understanding of the possibilities--and limitations--of the scientific bases for microbial forensics analysis. Science Needs for Microbial Forensics: Developing Initial International Research Priorities, based partly on a workshop held in Zabgreb, Croatia in 2013, identifies scientific needs that must be addressed to improve the capabilities of microbial forensics to investigate infectious disease outbreaks and provide evidence of sufficient quality to support legal proceedings and the development of government policies. This report discusses issues of sampling, validation, data sharing, reference collection, research priorities, global disease monitoring, and training and education to promote international collaboration and further advance the field"--Publisher's description.

For the first time in decades, promising news has emerged regarding efforts to curb the obesity crisis in the United States. Obesity rates have fallen among low-income children in 18 states, the prevalence of obesity has plateaued among girls, regardless of ethnicity, and targeted efforts in states such as Massachusetts have demonstrably reduced the prevalence of obesity among children. Although the reasons for this turnaround are as complex and multifaceted as the reasons for the dramatic rise in obesity rates in recent decades, interventions to improve nutrition and increase physical activity are almost certainly major contributors. Yet major problems remain. Diseases associated with obesity continue to incur substantial costs and cause widespread human suffering. Moreover, substantial disparities in obesity rates exist among population groups, and in some cases these disparities are widening. Some groups and regions are continuing to experience increases in obesity rates, and the prevalence of severe obesity is continuing to rise. The Current State of Obesity Solutions in the United States is the summary of a workshop convened in January 2014 by the Institute of Medicine Roundtable on Obesity Solutions to foster an ongoing dialogue on critical and emerging implementation, policy, and research issues to accelerate progress in obesity prevention and care. Representatives of public health, health care, government, the food industry, education, philanthropy, the nonprofit sector, and academia met to discuss interventions designed to prevent and treat obesity. The workshop focused on early care and education, schools, worksites, health care institutions, communities and states, the federal government, and business and industry. For each of these groups, this report provides an overview of current efforts to improve nutrition, increase physical activity, and reduce disparities among populations.

Workshop held October 9-10, 2013; Washington, DC (page 85).

"Support for this project was provided by the National Academy of Sciences and the Uniformed Sciences University of the Health Sciences under Grant No. HT9404-12-1-0028."--Title page verso.

"Drug development can be time-consuming and expensive. Recent estimates suggest that, on average, it takes 10 years and at least $1 billion to bring a drug to market. Given the time and expense of developing drugs de novo, pharmaceutical companies have become increasingly interested in finding new uses for existing drugs--a process referred to as drug repurposing or repositioning. Historically, drug repurposing has been largely an unintentional, serendipitous process that took place when a drug was found to have an offtarget effect or a previously unrecognized on-target effect that could be used for identifying a new indication. Perhaps the most recognizable example of such a successful repositioning effort is sildenafil. Originally developed as an anti-hypertensive, sildenafil, marketed as Viagra and under other trade names, has been repurposed for the treatment of erectile dysfunction and pulmonary arterial hypertension. Viagra generated more than $2 billion worldwide in 2012 and has recently been studied for the treatment of heart failure. Given the widespread interest in drug repurposing, the Roundtable on Translating Genomic-Based Research for Health of the Institute of Medicine hosted a workshop on June 24, 2013, in Washington, DC, to assess the current landscape of drug repurposing activities in industry, academia, and government. Stakeholders, including government officials, pharmaceutical company representatives, academic researchers, regulators, funders, and patients, were invited to present their perspectives and to participate in workshop discussions. Drug Repurposing and Repositioning is the summary of that workshop. This report examines enabling tools and technology for drug repurposing; evaluates the business models and economic incentives for pursuing a repurposing approach; and discusses how genomic and genetic research could be positioned to better enable a drug repurposing paradigm"--Publisher's description. --

Being able to communicate is a cornerstone of healthy aging. People need to make themselves understood and to understand others to remain cognitively and socially engaged with families, friends, and other individuals. When they are unable to communicate, people with hearing impairments can become socially isolated, and social isolation can be an important driver of morbidity and mortality in older adults. Despite the critical importance of communication, many older adults have hearing loss that interferes with their social interactions and enjoyment of life. People may turn up the volume on their televisions or stereos, miss words in a conversation, go to fewer public places where it is difficult to hear, or worry about missing an alarm or notification. In other cases, hearing loss is much more severe, and people may retreat into a hard-to-reach shell. Yet fewer than one in seven older Americans with hearing loss use hearing aids, despite rapidly advancing technologies and innovative approaches to hearing health care. In addition, there may not be an adequate number of professionals trained to address the growing need for hearing health care for older adults. Further, Medicare does not cover routine hearing exams, hearing aids, or exams for fitting hearing aids, which can be prohibitively expensive for many older adults. Hearing Loss and Healthy Aging is the summary of a workshop convened by the Forum on Aging, Disability, and Independence in January 2014 on age-related hearing loss. Researchers, advocates, policy makers, entrepreneurs, regulators, and others discussed this pressing social and public health issue. This report examines the ways in which age-related hearing loss affects healthy aging, and how the spectrum of public and private stakeholders can work together to address hearing loss in older adults as a public health issue.

Once ice-bound, difficult to access, and largely ignored by the rest of the world, the Arctic is now front and center in the midst of many important questions facing the world today. Our daily weather, what we eat, and coastal flooding are all interconnected with the future of the Arctic. The year 2012 was an astounding year for Arctic change. The summer sea ice volume smashed previous records, losing approximately 75 percent of its value since 1980 and half of its areal coverage. Multiple records were also broken when 97 percent of Greenland's surface experienced melt conditions in 2012, the largest melt extent in the satellite era. Receding ice caps in Arctic Canada are now exposing land surfaces that have been continuously ice covered for more than 40,000 years. What happens in the Arctic has far-reaching implications around the world. Loss of snow and ice exacerbates climate change and is the largest contributor to expected global sea level rise during the next century. Ten percent of the world's fish catches comes from Arctic and sub-Arctic waters. The U.S. Geological Survey estimated that up to 13 percent of the world's remaining oil reserves are in the Arctic. The geologic history of the Arctic may hold vital clues about massive volcanic eruptions and the consequent release of massive amount of coal fly ash that is thought to have caused mass extinctions in the distant past. How will these changes affect the rest of Earth? What research should we invest in to best understand this previously hidden land, manage impacts of change on Arctic communities, and cooperate with researchers from other nations? The Arctic in the Anthropocene reviews research questions previously identified by Arctic researchers, and then highlights the new questions that have emerged in the wake of and expectation of further rapid Arctic change, as well as new capabilities to address them. This report is meant to guide future directions in U.S. Arctic research so that research is targeted on critical scientific and societal questions and conducted as effectively as possible. The Arctic in the Anthropocene identifies both a disciplinary and a cross-cutting research strategy for the next 10 to 20 years, and evaluates infrastructure needs and collaboration opportunities. The climate, biology, and society in the Arctic are changing in rapid, complex, and interactive ways. Understanding the Arctic system has never been more critical; thus, Arctic research has never been more important. This report will be a resource for institutions, funders, policy makers, and students. Written in an engaging style, The Arctic in the Anthropocene paints a picture of one of the last unknown places on this planet, and communicates the excitement and importance of the discoveries and challenges that lie ahead.

Many people in the United States are exposed to styrene. Sources of environmental exposure included food (from migration of styrene from polymer packaging materials), cigarette smoke, vehicle exhaust and other forms of combustion and incineration of styrene polymers. Occupational exposure to humans can occur during the industrial processing of styrene. It is used to create a broad spectrum of products, including latex paints and coatings; synthetic rubbers; construction materials, such as pipes, fittings, and lighting fixtures; packaging; household goods, such as synthetic marble, flooring, and molded furnishings; and automotive parts. In 2011, the National Toxicology Program (NTP) listed styrene as "e;reasonably anticipated to be a human carcinogen"e; in its 12th Report on Carcinogens, marking the first time that the substance was listed. Congress directed the Department of Health and Human Services to arrange for the National Academy of Sciences to independently review the substance profile of styrene and it listing in the NTP report.Review of the Styrene Assessment in the National Toxicology Program 12th Report on Carcinogens concurs with the NTP determination that there is limited but credible evidence that exposure to styrene in some occupational settings is associated with an increase in the frequency of lymphohematopoietic cancers. Additionally, the NRC report 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. Based on credible but limited evidence of carcinogenicity in traditional epidemiologic studies, on sufficient evidence of carcinogenicity in animals, and on convincing evidence that styrene is genotoxic in exposed humans, this report finds that compelling evidence exists to support a listing of styrene as, at a minimum, "e;reasonably anticipated to be a human carcinogen."e;