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In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
Autoimmune Neurology presents the latest information on autoimmune neurologic disease, the immune response to the body where organs run wild, causing the immune system to attack itself. Autoimmunity is a main element in numerous nervous system diseases and can target any structure within the central or peripheral nervous system. Over the past 20 years, significant advances in our understanding of the pathophysiology of autoimmune disorders, including the use of biomarkers has led to new diagnosis and treatment options. Neurologic conditions associated with autoimmune reactions include dementia, neuromuscular disease, epilepsy, sleep disorders, diabetes, and other common neurologic disorders and disease. This current tutorial-reference will be a must-have title for clinical neurologists, research neurologists, neuroscientists, and any medical professional working with autoimmune disease and disorders. - Includes comprehensive coverage of autoimmune neurology - Details the latest techniques for the study, diagnosis, and treatment of diseases and disorders, including dementia, neuromuscular disease, epilepsy, and sleep disorders - Presents a focused reference for clinical practitioners and the clinical neurology and neurology research communities
The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. Founded in the late 1870s, NIH has produced extraordinary advances in the treatment of common and rare diseases and leads the world in biomedical research. It is a critical national resource that plays an important role in supporting national security. The 310-acre Bethesda campus supports some 20,000 employees and contractors, and it contains more than 12 million square feet of facilities divided amongst nearly 100 buildings, including the largest dedicated research hospital in the world. The Bethesda campus supports some of the most sophisticated and groundbreaking biomedical research in the world. However, while some new state-of-the-art buildings have been constructed in recent years, essential maintenance for many facilities and the campus overall has been consistently deferred for many years. The deteriorating condition of NIH's built environment is now putting its ability to fulfill its mission at substantial risk. Managing the NIH Bethesda Campus's Capital Assets for Success in a Highly Competitive Global Biomedical Research Environment identifies the facilities in greatest need of repair on the Bethesda campus and evaluates cost estimates to determine what investment is needed for the NIH to successfully accomplish its mission going forward.
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
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.
Much has been written about the care of research animals. Yet little guidance has appeared on protecting the health and safety of the people who care for or use these animals. This book, an implementation handbook and companion to Guide For the Care and Use of Laboratory Animals, identifies principles for building a program and discusses the accountability of institutional leaders, managers, and employees for a program's success. It provides a detailed description of risks-- physical and chemical hazards, allergens and zoonoses, and hazards from experiments--which will serve as a continuing reference for the laboratory. The book offers specific recommendations for controlling risk through administrative procedures, facility design, engineering controls, and periodic evaluations. The volume focuses on the worker, with detailed discussions of work practices, the use of personal protective gear, and the development of an emergency response plan. This handbook will be invaluable to administrators, researchers, and employees in any animal research facility. It will also be of interest to personnel in zoos, animal shelters, and veterinary facilities.
Provides critical evidenced based assessements and tools with which to investigate the role of rights abrogation in the health of populations.
Today, as never before, healthcare has the ability to enhance the quality and duration of life. At the same time, healthcare has become so costly that it can easily bankrupt governments and impoverish individuals and families. Health services research is a highly multidisciplinary field, including such areas as health administration, health economics, medical sociology, medicine, , political science, public health, and public policy. The Encyclopedia of Health Services Research is the first single reference source to capture the diversity and complexity of the field. With more than 400 entries, these two volumes investigate the relationship between the factors of cost, quality, and access to healthcare and their impact upon medical outcomes such as death, disability, disease, discomfort, and dissatisfaction with care. Key Features Examines the growing healthcare crisis facing the United States Encompasses the structure, process, and outcomes of healthcare Aims to improve the equity, efficiency, effectiveness, and safety of healthcare by influencing and developing public policies Describes healthcare systems and issues from around the globe Key Themes Access to Care Accreditation, Associations, Foundations, and Research Organizations Biographies of Current and Past Leaders Cost of Care, Economics, Finance, and Payment Mechanisms Disease, Disability, Health, and Health Behavior Government and International Healthcare Organizations Health Insurance Health Professionals and Healthcare Organizations Health Services Research Laws, Regulations, and Ethics Measurement; Data Sources and Coding; and Research Methods Outcomes of Care Policy Issues, Healthcare Reform, and International Comparisons Public Health Quality and Safety of Care Special and Vulnerable Groups The Encyclopedia is designed to be an introduction to the various topics of health services research for an audience including undergraduate students, graduate students, andgeneral readers seeking non-technical descriptions of the field and its practices. It is also useful for healthcare practitioners wishing to stay abreast of the changes and updates in the field.