Since the end of the Second World War, the United States has developed the world's preeminent system for biomedical research, one that has given rise to revolutionary medical advances as well as a dynamic and innovative business sector generating high-quality jobs and powering economic output and exports for the U.S. economy. However, there is a growing concern that the biomedical research enterprise is beset by several core challenges that undercut its vitality, promise, and productivity and that could diminish its critical role in the nation's health and innovation in the biomedical industry. Among the most salient of these challenges is the gulf between the burgeoning number of scientists qualified to participate in this system as academic researchers and the elusive opportunities to establish long-term research careers in academia. The patchwork of measures to address the challenges facing young scientists that has emerged over the years has allowed the U.S. biomedical enterprise to continue to make significant scientific and medical advances. These measures, however, have not resolved the structural vulnerabilities in the system, and in some cases come at a great opportunity cost for young scientists. These unresolved issues could diminish the nation's ability to recruit the best minds from all sectors of the U.S. population to careers in biomedical research and raise concerns about a system that may favor increasingly conservative research proposals over high-risk, innovative ideas. The Next Generation of Biomedical and Behavioral Sciences Researchers: Breaking Through evaluates the factors that influence transitions into independent research careers in the biomedical and behavioral sciences and offers recommendations to improve those transitions. These recommendations chart a path to a biomedical research enterprise that is competitive, rigorous, fair, dynamic, and can attract the best minds from across the country.
For many years, experiments using chimpanzees have been instrumental in advancing scientific knowledge and have led to new medicines to prevent life-threatening and debilitating diseases. However, recent advances in alternate research tools have rendered chimpanzees largely unnecessary as research subjects. The Institute of Medicine, in collaboration with the National Research Council, conducted an in-depth analysis of the scientific necessity for chimpanzees in NIH-funded biomedical and behavioral research. The committee concludes that while the chimpanzee has been a valuable animal model in the past, most current biomedical research use of chimpanzees is not necessary, though noted that it is impossible to predict whether research on emerging or new diseases may necessitate chimpanzees in the future.
For many years, experiments using chimpanzees have been instrumental in advancing scientific knowledge and have led to new medicines to prevent life-threatening and debilitating diseases. However, recent advances in alternate research tools have rendered chimpanzees largely unnecessary as research subjects. The Institute of Medicine, in collaboration with the National Research Council, conducted an in-depth analysis of the scientific necessity for chimpanzees in NIH-funded biomedical and behavioral research. The committee concludes that while the chimpanzee has been a valuable animal model in the past, most current biomedical research use of chimpanzees is not necessary, though noted that it is impossible to predict whether research on emerging or new diseases may necessitate chimpanzees in the future.
The report identified various factors which contributed to creating an unfulfilled need for veterinarians in the biomedical research workforce, including an increase in the number of NIH grants utilizing animals and the burgeoning use of transgenic rodents, without a comparable change in the supply of appropriately-trained veterinarians. The committee developed strategies for recruiting more veterinarians into careers in biomedical research.
On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary focuses on six broad topic areas: 1. Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions. 2. The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk. 3. The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data). 4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data. 5. Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB. 6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight.
US-Japan meetings on laboratory animal science have been held virtually every year since 1980 under the US-Japan Cooperative Program on Science and Technology. Over the years these meetings have resulted in a number of important documents including the Manual of Microbiologic of Monitoring of Laboratory Animals published in 1994 and the article Establishment and Preservation of Reference Inbred Strains of Rats for General Purposes published in 1991. In addition to these publications, these meetings have been instrumental in increasing awareness of the need for microbiologic monitoring of laboratory rodents and the need for genetic definition and monitoring of mice and rats.
For many years, experiments using chimpanzees have been instrumental in advancing scientific knowledge and have led to new medicines to prevent life-threatening and debilitating diseases. However, recent advances in alternate research tools have rendered chimpanzees largely unnecessary as research subjects. The Institute of Medicine, in collaboration with the National Research Council, conducted an in-depth analysis of the scientific necessity for chimpanzees in NIH-funded biomedical and behavioral research. The committee concludes that while the chimpanzee has been a valuable animal model in the past, most current biomedical research use of chimpanzees is not necessary, though noted that it is impossible to predict whether research on emerging or new diseases may necessitate chimpanzees in the future.
A rising median age at which PhD's receive their first research grant from the National Institutes of Health (NIH) is among the factors forcing academic biomedical researchers to spend longer periods of time before they can set their own research directions and establish there independence. The fear that promising prospective scientists will choose other career paths has raised concerns about the future of biomedical research in the United States. At the request of NIH, the National Academies conducted a study on ways to address these issues. The report recommends that NIH make fostering independence of biomedical researchers an agencywide goal, and that it take steps to provide postdocs and early-career investigators with more financial support for their own research, improve postdoc mentoring and establish programs for new investigators and staff scientists among other mechanisms.
At the dawn of the twenty-first century, Americans enjoyed better overall health than at any other time in the nation's history. Rapid advancements in medical technologies, breakthroughs in understanding the genetic underpinnings of health and ill health, improvements in the effectiveness and variety of pharmaceuticals, and other developments in biomedical research have helped develop cures for many illnesses and improve the lives of those with chronic diseases. By itself, however, biomedical research cannot address the most significant challenges to improving public health. Approximately half of all causes of mortality in the United States are linked to social and behavioral factors such as smoking, diet, alcohol use, sedentary lifestyle, and accidents. Yet less than five percent of the money spent annually on U.S. health care is devoted to reducing the risks of these preventable conditions. Behavioral and social interventions offer great promise, but as yet their potential has been relatively poorly tapped. Promoting Health identifies those promising areas of social science and behavioral research that may address public health needs. It includes 12 papersâ€"commissioned from some of the nation's leading expertsâ€"that review these issues in detail, and serves to assess whether the knowledge base of social and behavioral interventions has been useful, or could be useful, in the development of broader public health interventions.
Motivated by the explosion of molecular data on humans-particularly data associated with individual patients-and the sense that there are large, as-yet-untapped opportunities to use this data to improve health outcomes, Toward Precision Medicine explores the feasibility and need for "a new taxonomy of human disease based on molecular biology" and develops a potential framework for creating one. The book says that a new data network that integrates emerging research on the molecular makeup of diseases with clinical data on individual patients could drive the development of a more accurate classification of diseases and ultimately enhance diagnosis and treatment. The "new taxonomy" that emerges would define diseases by their underlying molecular causes and other factors in addition to their traditional physical signs and symptoms. The book adds that the new data network could also improve biomedical research by enabling scientists to access patients' information during treatment while still protecting their rights. This would allow the marriage of molecular research and clinical data at the point of care, as opposed to research information continuing to reside primarily in academia. Toward Precision Medicine notes that moving toward individualized medicine requires that researchers and health care providers have access to very large sets of health- and disease-related data linked to individual patients. These data are also critical for developing the information commons, the knowledge network of disease, and ultimately the new taxonomy.
Scientific experiments using animals have contributed significantly to the improvement of human health. Animal experiments were crucial to the conquest of polio, for example, and they will undoubtedly be one of the keystones in AIDS research. However, some persons believe that the cost to the animals is often high. Authored by a committee of experts from various fields, this book discusses the benefits that have resulted from animal research, the scope of animal research today, the concerns of advocates of animal welfare, and the prospects for finding alternatives to animal use. The authors conclude with specific recommendations for more consistent government action.
The nature of biomedical research has been evolving in recent years. Technological advances that make it easier to study the vast complexity of biological systems have led to the initiation of projects with a larger scale and scope. In many cases, these large-scale analyses may be the most efficient and effective way to extract functional information from complex biological systems. Large-Scale Biomedical Science: Exploring Strategies for Research looks at the role of these new large-scale projects in the biomedical sciences. Though written by the National Academies' Cancer Policy Board, this book addresses implications of large-scale science extending far beyond cancer research. It also identifies obstacles to the implementation of these projects, and makes recommendations to improve the process. The ultimate goal of biomedical research is to advance knowledge and provide useful innovations to society. Determining the best and most efficient method for accomplishing that goal, however, is a continuing and evolving challenge. The recommendations presented in Large-Scale Biomedical Science are intended to facilitate a more open, inclusive, and accountable approach to large-scale biomedical research, which in turn will maximize progress in understanding and controlling human disease.
Emerging Cognitive Neuroscience and Related Technologies, from the National Research Council, identifies and explores several specific research areas that have implications for U.S. national security, and should therefore be monitored consistently by the intelligence community. These areas include: neurophysiological advances in detecting and measuring indicators of psychological states and intentions of individuals the development of drugs or technologies that can alter human physical or cognitive abilities advances in real-time brain imaging breakthroughs in high-performance computing and neuronal modeling that could allow researchers to develop systems which mimic functions of the human brain, particularly the ability to organize disparate forms of data. As these fields continue to grow, it will be imperative that the intelligence community be able to identify scientific advances relevant to national security when they occur. To do so will require adequate funding, intelligence analysts with advanced training in science and technology, and increased collaboration with the scientific community, particularly academia. A key tool for the intelligence community, this book will also be a useful resource for the health industry, the military, and others with a vested interest in technologies such as brain imaging and cognitive or physical enhancers.
Comprehensive research and a highly-trained workforce are essential for the improvement of health and health care both nationally and internationally. During the past 40 years the National Research Services Award (NRSA) Program has played a large role in training the workforce responsible for dramatic advances in the understanding of various diseases and new insights that have led to more effective and targeted therapies. In spite of this program, the difficulty obtaining jobs after the postdoc period has discouraged many domestic students from pursuing graduate postdoc training. In the United States, more than 50 percent of the postdoc workforce is made up of individuals who obtained their Ph.D.s from other countries. Indeed, one can make a strong argument that the influx of highly trained and creative foreigners has contributed greatly to U.S. science over the past 70 years. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences discusses a number of important issues, including: the job prospects for postdocs completing their training; questions about the continued supply of international postdocs in an increasingly competitive world; the need for equal, excellent training for all graduate students who receive NIH funding; and the need to increase the diversity of trainees. The book recommends improvements in minority recruiting, more rigorous and extensive training in the responsible conduct of research and ethics, increased emphasis on career development, more attention to outcomes, and the requirement for incorporating more quantitative thinking in the biomedical curriculum.
The population of Asia is growing both larger and older. Demographically the most important continent on the world, Asia's population, currently estimated to be 4.2 billion, is expected to increase to about 5.9 billion by 2050. Rapid declines in fertility, together with rising life expectancy, are altering the age structure of the population so that in 2050, for the first time in history, there will be roughly as many people in Asia over the age of 65 as under the age of 15. It is against this backdrop that the Division of Behavioral and Social Research at the U.S. National Institute on Aging (NIA) asked the National Research Council (NRC), through the Committee on Population, to undertake a project on advancing behavioral and social research on aging in Asia. Aging in Asia: Findings from New and Emerging Data Initiatives is a peer-reviewed collection of papers from China, India, Indonesia, Japan, and Thailand that were presented at two conferences organized in conjunction with the Chinese Academy of Sciences, Indian National Science Academy, Indonesian Academy of Sciences, and Science Council of Japan; the first conference was hosted by the Chinese Academy of Social Sciences in Beijing, and the second conference was hosted by the Indian National Science Academy in New Delhi. The papers in the volume highlight the contributions from new and emerging data initiatives in the region and cover subject areas such as economic growth, labor markets, and consumption; family roles and responsibilities; and labor markets and consumption.
This report is the twelfth assessment of the National Institutes of Health National Research Service Awards program. The research training needs of the country in basic biomedical, clinical, and behavioral and social sciences are considered. Also included are the training needs of oral health, nursing, and health services research. The report has been broadly constructed to take into account the rapidly evolving national and international health care needs. The past and present are analyzed, and predictions with regard to future needs are presented.
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