The lively and revealing letters of a woman who, with thousands of others, volunteered for service in World War I Europe, taking on jobs that freed men for the trenches.
Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
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.
Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Discusses "the safety concepts which form the basis of modern bridge design and assessment codes" and "the background work carried out in the development of the new UK bridge and route-specific traffic loading requirements, and the proposed whole life performance-based assessment rules" -- Preface.
Who should police corporate misconduct and how should it be policed? In recent years, the Department of Justice has resolved investigations of dozens of Fortune 500 companies via deferred prosecution agreements and non-prosecution agreements, where, instead of facing criminal charges, these companies become regulated by outside agencies. Increasingly, the threat of prosecution and such prosecution agreements is being used to regulate corporate behavior. This practice has been sharply criticized on numerous fronts: agreements are too lenient, there is too little oversight of these agreements, and, perhaps most important, the criminal prosecutors doing the regulating aren’t subject to the same checks and balances that civil regulatory agencies are. Prosecutors in the Boardroom explores the questions raised by this practice by compiling the insights of the leading lights in the field, including criminal law professors who specialize in the field of corporate criminal liability and criminal law, a top economist at the SEC who studies corporate wrongdoing, and a leading expert on the use of monitors in criminal law. The essays in this volume move beyond criticisms of the practice to closely examine exactly how regulation by prosecutors works. Broadly, the contributors consider who should police corporate misconduct and how it should be policed, and in conclusion offer a policy blueprint of best practices for federal and state prosecution. Contributors: Cindy R. Alexander, Jennifer Arlen, Anthony S. Barkow, Rachel E. Barkow, Sara Sun Beale, Samuel W. Buell, Mark A. Cohen, Mariano-Florentino Cuellar, Richard A. Epstein, Brandon L. Garrett, Lisa Kern Griffin, and Vikramaditya Khanna
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Congress has continued to debate the efficacy and constitutionality of federal regulation of firearms and ammunition, with strong advocates arguing for and against greater gun control. While several dozen gun control-related proposals have been introduced in recent Congresses, only a handful of those bills received significant legislative action. The 109th Congress, for example, passed two bills with firearmsrelated provisions that were enacted into law. P.L. 109-72 prohibits certain types of lawsuits against firearm manufacturers and dealers to recover damages related to the criminal or unlawful use of their products by other persons, and P.L. 109-295 includes a provision that prohibits federal officials from seizing any firearm from private persons during a major disaster or emergency, if possession of that firearm was not already prohibited under federal or state law. Nevertheless, the 110th Congress could possibly reconsider several gun control proposals that were considered as part of appropriations and crime legislation in the previous Congress. During the 109th Congress, the House amended the Children's Safety Act of 2005 (H.R. 3132) to prohibit the transfer or possession of a firearm to or by any person convicted of a sex offense against a minor. The House also amended Secure Access to Justice and Court Protection Act of 2005 (H.R. 1751) to authorize certain federal court judges and officials to carry firearms for personal protection. The Senate passed a different version of H.R. 1751 that included similar provisions, as well as provisions designed to clarify and expand the Law Enforcement Officers Safety Act (P.L. 108-277) -- a law that gives concealed carry privileges to qualified on-duty and retired law enforcement officers. None of those provisions were enacted into law, however. In addition, the House Judiciary considered four gun-related bills: the ATFE Modernization and Reform Act of 2006 (H.R. 5092), the Firearms Corrections and Improvement Act (H.R. 5005), the Firearm Commerce Modernization Act (H.R. 1384), and the NICS Improvement Act of 2005 (H.R. 1415). H.R. 5092 was passed by the House. The 109th Congress, moreover, maintained a fee prohibition for Brady background checks and other funding limitations and conditions related to gun enforcement in the FY2006 DOJ appropriations (P.L. 109-108). Those limitations and conditions have been continued into FY2007 under continuing resolutions. They are often referred to as the "Tiahrt amendment," for their sponsor in the FY2004 appropriations cycle, Representative Todd Tiahrt. Issues addressed in those bills, as well as the Tiahrt funding limitations and conditions, could be reconsidered in the 110th Congress. Senator Charles Schumer, for example, has introduced a bill (S. 77) that would repeal portions of the Tiahrt amendment that limit the sharing of firearm trace data. Other gun control-related issues that may reemerge in the 110th Congress include (1) retaining Brady background check records for approved transactions to enhance terrorist screening, (2) more strictly regulating certain long-range fifty caliber rifles, (3) further regulating certain firearms previously defined in statute as "assault weapons," and (4) requiring background checks for firearm transfers at gun shows. This report will updated to reflect legislative action.
For patients and their loved ones, no care decisions are more profound than those made near the end of life. Unfortunately, the experience of dying in the United States is often characterized by fragmented care, inadequate treatment of distressing symptoms, frequent transitions among care settings, and enormous care responsibilities for families. According to this report, the current health care system of rendering more intensive services than are necessary and desired by patients, and the lack of coordination among programs increases risks to patients and creates avoidable burdens on them and their families. Dying in America is a study of the current state of health care for persons of all ages who are nearing the end of life. Death is not a strictly medical event. Ideally, health care for those nearing the end of life harmonizes with social, psychological, and spiritual support. All people with advanced illnesses who may be approaching the end of life are entitled to access to high-quality, compassionate, evidence-based care, consistent with their wishes. Dying in America evaluates strategies to integrate care into a person- and family-centered, team-based framework, and makes recommendations to create a system that coordinates care and supports and respects the choices of patients and their families. The findings and recommendations of this report will address the needs of patients and their families and assist policy makers, clinicians and their educational and credentialing bodies, leaders of health care delivery and financing organizations, researchers, public and private funders, religious and community leaders, advocates of better care, journalists, and the public to provide the best care possible for people nearing the end of life.