A SCHOLARLY BOOK REPOSITORY
Research with human subjects has long been controversial because of the conflicts that often arise between promoting scientific knowledge and protecting the rights and welfare of subjects. Twenty-five years ago the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addressed these conflicts. The result was the Belmont Report: Ethical Principles and Guidance for Research Involving Human Subjects, a report that identified foundational principles for ethical research with human subjects: respect for persons, beneficence, and justice.
Since the publication of Belmont, these three principles have greatly influenced discussions of research with human subjects. While they are often regarded as the single-most influential set of guidelines for biomedical research and practice in the United States (and other parts of the world), not everyone agrees that they provide adequate guidance. Belmont Revisited brings together a stellar group of scholars in bioethics to revisit the findings of that original report. Their responses constitute a broad overview of the development of the Belmont Report and the extent of its influence, especially on governmental commissions, as well as an assessment of its virtues and shortcomings.
Belmont Revisited looks back to reexamine the creation and influence of the Belmont Report, and also looks forward to the future of research—with a strong call to rethink how institutions and investigators can conduct research more ethically.
Today's scientists follow federal guidelines for research on human subjects developed during the 1960s and 1970s. But long before these government regulations, medical investigators observed informal rules when conducting human research. They insisted that the dangers of natural disease should outweigh the risks of a medical intervention, and they struggled to accurately assess the relative hazards. Halpern explores this logic of risk in immunization controversies extending as far back as the eighteenth century. Then, focusing on the period between 1930 and 1960, she shows how research physicians and their sponsors debated the moral quandaries involved in moving vaccine use from the laboratory to the clinic.
This probing work vividly describes the efforts of clinical investigators to balance the benefits and dangers of untested vaccines, to respond to popular sentiment about medical hazards, and to strategically present risk laden research to sponsors and the public.
In Spirituality and Health Research: Methods, Measurement, Statistics, and Resources, Dr. Harold G. Koenig leads a comprehensive overview of this complex subject. Dr. Koenig is one of the world’s leading authorities on the relationship between spirituality and health, and a leading researcher on the topic. As such, he is distinctively qualified to author such a book.
With Inclusion, Steven Epstein argues that strategies to achieve diversity in medical research mask deeper problems, ones that might require a different approach and different solutions.
Formal concern with this issue, Epstein shows, is a fairly recent phenomenon. Until the mid-1980s, scientists often studied groups of white, middle-aged men—and assumed that conclusions drawn from studying them would apply to the rest of the population. But struggles involving advocacy groups, experts, and Congress led to reforms that forced researchers to diversify the population from which they drew for clinical research. While the prominence of these inclusive practices has offered hope to traditionally underserved groups, Epstein argues that it has drawn attention away from the tremendous inequalities in health that are rooted not in biology but in society.
“Epstein’s use of theory to demonstrate how public policies in the health profession are shaped makes this book relevant for many academic disciplines. . . . Highly recommended.”—Choice
“A masterful comprehensive overview of a wide terrain.”—Troy Duster, Biosocieties
Contributors: John A. Garcia, Arline T. Geronimus, Laura E. Gómez, Joseph L. Graves Jr., Janet E. Helms, Derek Kenji Iwamoto, Jonathan Kahn, Jay S. Kaufman, Mai M. Kindaichi, Simon J. Craddock Lee, Nancy López, Ethan H. Mereish, Matthew Miller, Gabriel R. Sanchez, Aliya Saperstein, R. Burciaga Valdez, Vicki D. Ybarra
In 1927 the first bill to secure government support in the search for a cure for cancer was introduced to Congress. In 1971 Congress passed the Conquest of Cancer Act, which initiated a new and enlarged effort in the fight against cancer, including possible annual expenditures of up to one billion dollars. The forty-four years between these two dates have witnessed the evolution of medical research from a limited, private endeavor to a major national enterprise commanding substantial support from the federal government.
In this first historical analysis of national policy in biomedical research, Stephen Strickland examines the rise of the National Institutes for Health, tells of the recurrent struggle between elected public officials and science administrators over the pace and direction of cancer and heart disease research; analyzes the roles that key members of Congress have played in the development of medical research; and discusses the medical research lobby and its founder, Mrs. Albert D. Lasker. What emerges is a clear picture of how government officials actually formulate national policy, not only in medical research but in other areas as well.
---The World Future Society, Best Books and Reports
"This excellent book provides a broad overview of the development, impact, and evaluation of health technology in the United States. . . .The authors take a well-organized and thorough approach to address these topics, combining reviews of each with case examples of particular technologies. . . .Given the broad scope of the book, it could serve as a text for students, an introduction to the field for healthcare professionals, or a tool for academics and policymakers wishing to fill knowledge gaps outside their disciplines. . . .The book makes a compelling case for the logic and potential benefits of medical technology evaluation as a tool for improving health care."
---Journal of the American Medical Association
"By being comprehensive in their review, the authors chart a clear path to understanding the future of health care technology in America. They clarify the technical methods for evaluation and provide insight into the sociopolitical aspects of development and diffusion. Case studies are informative. Excellent reading for students and health professionals either as a textbook or as an off-the-shelf guide to methods for deciding among alternative technologies."
---Norman W. Weissman, University of Alabama
"Technology today dominates every aspect of health care. This useful book offers a diverse range of perspectives for students, professors, and medical practitioners who wish to understand how to evaluate medical technology."
---Joel Howell, University of Michigan Medical School
Technology in American Health Care is a comprehensive, multidisciplinary guide to understanding how medical advances-new drugs, biological devices, and surgical procedures-are developed, brought to market, evaluated, and adopted into health care.
Cost-effective delivery of evidence-based health care is the sine qua non of American medicine in the twenty-first century. Health care decision makers, providers, payers, policymakers, and consumers all need vital information about the risks, benefits, and costs of new technologies in order to make informed decisions about which ones to adopt and how to use them. Alan B. Cohen and Ruth S. Hanft explore the evolving field of medical technology evaluation (MTE), as well as the current controversies surrounding the evaluation and diffusion of medical technologies, including the methods employed in their assessment and the policies that govern their adoption and use.
The book opens with an introduction that provides basic definitions and the history of technological change in American medicine, and a second chapter that explores critical questions regarding medical technology in health care. Part I discusses biomedical innovation, the development and diffusion of medical technology, and the adoption and use of technology by hospitals, physicians, and other health care organizations and professions under changing health care market conditions. Part II examines the methods of MTE-including randomized controlled trials, meta-analyses, economic evaluation methods (such as cost-benefit, cost-effectiveness, and cost-utility analyses), and clinical decision analysis. Part III focuses on key public policy issues and concerns that affect the organization, financing, and delivery of health care and that relate importantly to medical technology, including safety, efficacy, quality, cost, access, equity, social, ethical, legal, and evaluation concerns. All three parts of the book provide a historical perspective on the relevant issues, methods, and policy concerns and contain examples of technologies whose development, adoption, evaluation, and use have contributed to our understanding of the field.
This book will be invaluable in making MTE more accessible to individuals who are directly involved in the evaluation process and those who are touched by it in their professional lives-policymakers, clinicians, managers, and researchers.
Robotic exoskeletons that allow stroke survivors to regain use of their limbs, 3D-printed replacement body parts, and dozens of other innovations still in schematic design are revolutionizing the treatment of debilitating injuries and nervous system disorders. What all these technologies have in common is that they are modeled after engineering strategies found in nature—strategies developed by a vast array of organisms over eons of evolutionary trial and error.
Eugene Goldfield lays out many principles of engineering found in the natural world, with a focus on how evolutionary and developmental adaptations, such as sensory organs and spinal cords, function within complex organisms. He shows how the component parts of highly coordinated structures organize themselves into autonomous functional systems. For example, when people walk, spinal cord neurons generate coordinated signals that continuously reorganize patterns of muscle activations during the gait cycle. This self-organizing capacity is just one of many qualities that allow biological systems to be robust, adaptive, anticipatory, and self-repairing. To exploit the full potential of technologies designed to interact seamlessly with human bodies, properties like these must be better understood and harnessed at every level, from molecules to cells to organ systems.
Bioinspired Devices brings together insights from a wide range of fields. A member of the Wyss Institute for Biologically Inspired Engineering, Goldfield offers an insider’s view of cutting-edge research, and envisions a future in which synthetic and biological devices share energy sources and control, blurring the boundary between nature and medicine.
In his most mind-bending book yet, Ball makes that disconcerting question the focus of a tour through what scientists can now do in cell biology and tissue culture. He shows how these technologies could lead to tailor-made replacement organs for when ours fail, to new medical advances for repairing damage and assisting conception, and to new ways of “growing a human.” For example, it might prove possible to turn skin cells not into neurons but into eggs and sperm, or even to turn oneself into the constituent cells of embryos. Such methods would also create new options for gene editing, with all the attendant moral dilemmas. Ball argues that such advances can therefore never be about “just the science,” because they come already surrounded by a host of social narratives, preconceptions, and prejudices. But beyond even that, these developments raise questions about identity and self, birth and death, and force us to ask how mutable the human body really is—and what forms it might take in years to come.
Big data, genomics, and quantitative approaches to network-based analysis are combining to advance the frontiers of medicine as never before. Network Medicine introduces this rapidly evolving field of medical research, which promises to revolutionize the diagnosis and treatment of human diseases. With contributions from leading experts that highlight the necessity of a team-based approach in network medicine, this definitive volume provides readers with a state-of-the-art synthesis of the progress being made and the challenges that remain.
Medical researchers have long sought to identify single molecular defects that cause diseases, with the goal of developing silver-bullet therapies to treat them. But this paradigm overlooks the inherent complexity of human diseases and has often led to treatments that are inadequate or fraught with adverse side effects. Rather than trying to force disease pathogenesis into a reductionist model, network medicine embraces the complexity of multiple influences on disease and relies on many different types of networks: from the cellular-molecular level of protein-protein interactions to correlational studies of gene expression in biological samples. The authors offer a systematic approach to understanding complex diseases while explaining network medicine’s unique features, including the application of modern genomics technologies, biostatistics and bioinformatics, and dynamic systems analysis of complex molecular networks in an integrative context.
By developing techniques and technologies that comprehensively assess genetic variation, cellular metabolism, and protein function, network medicine is opening up new vistas for uncovering causes and identifying cures of disease.
Awarded first place in the 2016 American Journal of Nursing Book of the Year Award in the History and Public Policy category
The most dramatic growth of Christianity in the late twentieth century has occurred in Africa, where Catholic missions have played major roles. But these missions did more than simply convert Africans. Catholic sisters became heavily involved in the Church’s health services and eventually in relief and social justice efforts. In Into Africa, Barbra Mann Wall offers a transnational history that reveals how Catholic medical and nursing sisters established relationships between local and international groups, sparking an exchange of ideas that crossed national, religious, gender, and political boundaries.
Both a nurse and a historian, Wall explores this intersection of religion, medicine, gender, race, and politics in sub-Saharan Africa, focusing on the years following World War II, a period when European colonial rule was ending and Africans were building new governments, health care institutions, and education systems. She focuses specifically on hospitals, clinics, and schools of nursing in Ghana and Uganda run by the Medical Mission Sisters of Philadelphia; in Nigeria and Uganda by the Irish Medical Missionaries of Mary; in Tanzania by the Maryknoll Sisters of New York; and in Nigeria by a local Nigerian congregation. Wall shows how, although initially somewhat ethnocentric, the sisters gradually developed a deeper understanding of the diverse populations they served. In the process, their medical and nursing work intersected with critical social, political, and cultural debates that continue in Africa today: debates about the role of women in their local societies, the relationship of women to the nursing and medical professions and to the Catholic Church, the obligations countries have to provide care for their citizens, and the role of women in human rights.
A groundbreaking contribution to the study of globalization and medicine, Into Africa highlights the importance of transnational partnerships, using the stories of these nuns to enhance the understanding of medical mission work and global change.
A nuanced critique of the ambivalent relationships among religion, capitalism, and humanitarian aid, Conversionary Sites draws important connections between religion and science, capitalism and charity, and the US and the Global South.
In Britain, the Thatcher government's plan to inject a market into the state-administered national health service resulted in a circumscribed experiment orchestrated from above. In Germany, the Kohl government sought to repair defects in the corporatist arrangement with doctors and insurers, thus limiting the market experiment and designing it to enhance the solidarity of the national health insurance system. In the United States, private market actors foiled Clinton's bid to expand the federal government's role in the private health care system through managed competition and national insurance. But market reform continued, albeit led by private employers and with government officials playing a reactive role. Actors and institutions surrounding the existing health care settlement in each country created particular reform politics that either militated against or fostered the deployment of competition.
The finding that major transformations are occurring in private as well as public systems of social protection suggests that studies of social policy change expand their focus beyond statutory welfare state programs. The book will interest political scientists and policymakers concerned with welfare state reform in advanced industrial societies; social scientists interested in the changing balance among state, market, and societal interests in governance; and health policy researchers, health policymakers, and health care professionals.
Susan Giaimo is an independent scholar. She completed her Ph.D. in Political Science at the University of Wisconsin-Madison. She also earned an MSc in Politics from the London School of Economics and Political Science, with the Politics and Government of Western Europe as the branch of study. After completing her doctorate, she was a postdoctoral fellow in the Robert Wood Johnson Foundation Scholars in Health Policy Research Program, University of California at Berkeley, and the Robert Bosch Foundation Scholars Program in Comparative Public Policy and Comparative Institutions, American Institute for Contemporary German Studies, Johns Hopkins University. She taught in the Political Science Department at Massachusetts Institute of Technology for five years. During that period she won the Society for the Advancement of Socio-Economics Founder's Prize for "Adapting the Welfare State: The Case of Health Care Reform in Britain, Germany, and the United States," a paper she coauthored with Philip Manow. She has also worked for health maintenance organizations (HMOs) and medical practices in the United States.
In this concise, straightforward analysis, Jost challenges the historical and theoretical assumptions on which the consumer-driven health care movement is based and reexamines the empirical evidence that it claims as support. He traces the histories of both private health insurance in the United States and the CDHC movement. The idea animating the drive for consumer-driven health care is that the fundamental problem with the American health care system is what economists call “moral hazard,” the risk that consumers overuse services for which they do not bear the cost. Jost reveals moral hazard as an inadequate explanation of the complex problems plaguing the American health care system, and he points to troubling legal and ethical issues raised by CDHC. He describes how other countries have achieved universal access to high-quality health care at lower cost, without relying extensively on cost sharing, and he concludes with a proposal for how the United States might do the same, incorporating aspects of CDHC while recognizing its limitations.
To promote and ensure consumer protection in an increasingly adversarial and complicated health-care culture, Kinney first analyzes the procedures by which consumer concerns are presently discerned and resolved and then explains why these systems are unsatisfactory. She also discusses problematic procedures for making coverage policy and quality standards and proposes reforms in a variety of processes that would enable all consumers, including the uninsured, to influence key policies and standards and also to raise concerns and obtain appropriate remedies.
As the first comprehensive treatment of administrative procedures in American health plans and other such institutions, Protecting American Health Care Consumers will be welcomed by state and federal policymakers, managed care executives, and lawyers charged with designing and implementing protections for consumers in public and private health plans.
Along the way she makes these principal points: She criticizes as politically conservative the idea that diseases result from a multifactorial web of causes. Placing responsibility for disease prevention on "society" is ideological, she argues. In connection with the air traffic controllers she questions whether it is in a union's best interests to claim that workers' jobs are stressful. She shows why there are no entirely neutral answers to questions about the toxicity of environmental pollutants. In a final chapter, Tesh urges scientists to incorporate egalitarian values into their search for the truth, rather than pretending science can be divorced from that political ideology.
In Dying Green, award-winning educator Christine Vatovec offers an engaging study that asks us to consider the broader environmental sustainability of health care. Through a comparative analysis of the care provided to terminally ill patients in a conventional cancer ward, a palliative care unit, and an acute-care hospice facility, she shows how decisions made at a patient’s bedside govern the environmental footprint of the healthcare industry. Likewise, Dying Green offers insights on the many opportunities that exist for reducing the ecological impacts of medical practices in general, while also enhancing care for the dying in particular. By envisioning a more sustainable approach to care, this book offers a way forward that is better for both patients and the planet.
Unfortunately, most hospitals that have formed alliances with a previous competitor or nearby teaching facility have found that they are not yet achieving the savings originally forecast. Weil finds that these shortcomings often have been caused by the difficulties in achieving a strategic fit between two partners, in finding a middle ground when differences in culture and values surface, and in implementing operational efficiencies. The book concludes with a discussion of a number of ways in which networks might cut costs in the future.
Health Networks will be of interest to medical practitioners and administrators, as well as to students in health services management programs.
Thomas P. Weil is President, Bedford Health Associates, Inc., management consultants for health and hospital services.
Looking specifically at the labor market, Mulligan reveals how the costs of health care under the ACA actually create implicit taxes on individuals, and how increased costs to employers will be passed on to their employees. Mulligan shows how, as a result, millions of workers will find themselves in a situation in which full-time work, adjusted for the expense of health care, will actually pay less than part-time work or even not working at all. Analyzing the incentives—or lack thereof—for people to earn more by working more, Mulligan offers projections on how many hours people will work and how productively they will work, as well as how much they will spend in general. Using the powerful tools of economics, he then illustrates the detrimental consequences on overall employment in the near future.
Drawing on extensive knowledge of the labor market and the economic theories at its foundation, Side Effects and Complications offers a crucial wake-up call about the risks the ACA poses for the economy. Plainly laying out the true costs of the ACA, Mulligan’s grounded and thorough predictions are something that workers and policy makers cannot afford to ignore.
A provocative call to rethink America's values in health care.
To Live and Die in America details how the United States has among the worst indicators of health in the industrialised world and at the same time spends significantly more on its health care system than any other industrial nation.
Robert Chernomas and Ian Hudson explain this contradictory phenomenon as the product of the unique brand of capitalism that has developed in the US. It is this particular form of capitalism that created both the social and economic conditions that largely influence health outcomes and the inefficient, unpopular and inaccessible health care system that is incapable of dealing with them.
The authors argue that improving health in America requires a change in the conditions in which people live and work as well as a restructured health care system.
“I’m covered—why should I foot the bill for somebody who isn’t?”
This question, unspoken but simmering at the center of the debate over universal health care coverage, comes in for a thoughtful hearing—and, perhaps, gentle corrective—in Larry Churchill’s timely book. Churchill, whose Rationing Health Care in America put the nation’s health care crisis into perspective, here does the same for our crisis of conscience over health care coverage. As Clinton and Congress spar over the financing and organization of a national health system, the true debate, this book reveals, is about moral and political values, about the meaning and ethics of health care reform.
Churchill begins by cutting through the confused discussion about rationing health care. Concerns about rationing, with all the moral and political questions they raise, deflect our attention from a more important issue, which this book brings into focus. Arguing that care is already rationed by ability to pay, Churchill suggests that the proper question is not whether to ration but how to do so fairly, and that answering requires a clear sense of the aims of a health care system. In pursuit of this necessary understanding, Churchill explores values and concepts such as security and solidarity, self-interest and social affinity, rights and responsibilities. Drawing on philosophical ideas of justice and individual responsibility, rendered here with remarkable clarity, he shows that universal care is morally as well as economically comprehensible and that a truly inclusive health care system should be seen as a common civic purpose rather than as a supply of services to be consumed. Accessible, deeply felt, and cogently argued, this book should revise the terms of the national debate over health care reform.
Flatlined lifts the veil of secrecy on twenty-first century health care and delves into the realities of good people caught in a bad medical system. Dr. Guy L. Clifton, a practitioner as well as a policy advocate, reveals first-hand accounts of needless tragedy, such as the young man who died after a car wreck for lack of a bed in a qualified hospital and the surgeon who was dejected by the scarcity of resources needed to enable him to perform heart surgery on an uninsured man.
Arguing that a lack of coordinated care and quality medical practice benchmarks result in high levels of redundancy and ineffectiveness, Clifton proposes that the key to reducing health care costs, improving quality, and financially protecting the uninsured, is to reduce wastefulness, and offers a solution for achieving success.
Flatlined sounds the warning call: By 2018 Medicare and Medicaid will consume about one-third of the federal budget. American businesses now pay three times as much of their payroll for health care as global competitors, expected to worsen as health care grows at twice the rate of the U.S. economy. Based on his years of experience in policy and medicine, Clifton offers an attainable solution through the development of an American Medical Quality System.
Unaffordable covers, in a conversational style punctuated by apt examples, topics ranging from health insurance, pharmaceutical pricing, and physician training to health maintenance organizations and hospital networks. Along the way, Engel introduces approaches that other nations have taken in organizing and paying for healthcare and offers insights on ethical quandaries around end-of-life decisions, neonatal care, life-sustaining treatments, and the limits of our ability to define death. While describing the political origins of many of the federal and state laws that govern our healthcare system today, he never loses sight of the impact that healthcare delivery has on our wallets and on the balance sheets of hospitals, doctors' offices, government agencies, and private companies.
Chronic Condition provides a compelling analysis of the causes of the current health care crisis and of the shortcomings of reform proposals. It also offers an ingenious new framework for reform that, while minimizing government interference, would provide a means for financing care for the less affluent.
Sherry Glied shows that rising health care spending is consistent with a rising standard of living. Since we can, as a nation, afford more health care, reform must address not the overall level of health care costs but the distribution of health care spending.
Prior reform proposals, Glied argues, have failed to account for the tension between the clearly manifested desire for improving the quality of health care and the equally widespread interest in assuring that the less fortunate share in these improvements. After careful analysis of the ill-fated Clinton plan, Glied proposes a new solution that would make the willingness to pay for innovation the means of financing health care improvements for the less affluent. While rejecting the idea that the distribution of health care should be perfectly equal, Glied's proposal would enable all Americans to benefit from the dynamics of the free market.
Universal health care was on the national political agenda for nearly a hundred years until a comprehensive (but not universal) health care reform bill supported by President Obama passed in 2010. The most common explanation for the failure of past reform efforts is that special interests were continually able to block reform by lobbying lawmakers. Yet, beginning in the 1970s, accelerating with the failure of the Clinton health care plan, and continuing through the passage of the Affordable Care Act in 2010, health policy reform was alive and well at the state level.
Interest Groups and Health Care Reform across the United States assesses the impact of interest groups to determine if collectively they are capable of shaping policy in their own interests or whether they influence policy only at the margins. What can this tell us about the true power of interest groups in this policy arena? The fact that state governments took action in health policy in spite of opposing interests, where the national government could not, offers a compelling puzzle that will be of special interest to scholars and students of public policy, health policy, and state politics.
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