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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.
1341.54

The Belmont Report

United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Published: 1978

Total Pages: 614


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A one-stop reference for all medical professionals who encounter ethicolegal problems during their management of patients.
Medicine is a complex social institution which includes biomedical research, clinical practice, and the administration and organization of health care delivery. As such, it is amenable to analysis from a number of disciplines and directions. The present volume is composed of revised papers on the theme of "Responsibility in Health Care" presented at the Eleventh Trans Disciplinary Symposium on Philosophy and Medicine, which was held in Springfield, illinois on March 16-18, 1981. The collective focus of these essays is the clinical practice of medicine and the themes and issues related to questions of responsibility in that setting. Responsibility has three related dimensions which make it a suitable theme for an inquiry into clinical medicine: (a) an external dimension in legal and political analysis in which the State imposes penalties on individuals and groups and in which officials and governments are held accountable for policies; (b) an internal dimension in moral and ethical analysis in which individuals take into account the consequences of their actions and the criteria which bear upon their choices; and (c) a comprehensive dimension in social and cultural analysis in which values are ordered in the structure of a civilization ([8], p. 5). The title "Responsibility in Health Care" thus signifies a broad inquiry not only into the ethics of individual character and actions, but the moral foundations of the cultural, legal, political, and social context of health care generally.
Informed consent - as an ethical ideal and legal doctrine - has been the source of much concern to clinicians. Drawing on a diverse set of backgrounds and two decades of research in clinical settings, the authors - a lawyer, a physician, a social scientist, and a philosopher - help clinicians understand and cope with their legal obligations and show how the proper handling of informed consent can improve , rather than impede, patient care. Following a concise review of the ethical and legal foundations of informed consent, they provide detailed, practical suggestions for incorporating informed consent into clinical practice. This completely revised and updated edition discusses how to handle informed consent in all phases of the doctor-patient relationship, use of consent forms, patients' refusals of treatment, and consent to research. It comments on recent laws and national policy, and addresses cutting edge issues, such as fulfilling physician obligations under managed care. This clear and succinct book contains a wealth of information that will not only help clinicians meet the legal requirements of informed consent and understand its ethical underpinnings, but also enhance their ability to deal with their patients more effectively. It will be of value to all those working in areas where issues of informed consent are likely to arise, including medicine, biomedical research, mental health care, nursing, dentistry, biomedical ethics, and law.
Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.
The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a comprehensive resource intended to provide a state-of-the-art overview of complex ethical, regulatory, and legal issues of importance to clinical healthcare professionals in the area of acute care medicine; including, for example, physicians, advanced practice providers, nurses, pharmacists, social workers, and care managers. In addition, this book also covers key legal and regulatory issues relevant to non-clinicians, such as hospital and practice administrators; department heads, educators, and risk managers. This text reviews traditional and emerging areas of ethical and legal controversies in healthcare such as resuscitation; mass-casualty event response and triage; patient autonomy and shared decision-making; medical research and teaching; ethical and legal issues in the care of the mental health patient; and, medical record documentation and confidentiality. Furthermore, this volume includes chapters dedicated to critically important topics, such as team leadership, the team model of clinical care, drug and device regulation, professional negligence, clinical education, the law of corporations, tele-medicine and e-health, medical errors and the culture of safety, regulatory compliance, the regulation of clinical laboratories, the law of insurance, and a practical overview of claims management and billing. Authored by experts in the field, The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a valuable resource for all clinical and non-clinical healthcare professionals.
Physician-Assisted Death is the eleventh volume of Biomedical Ethics Reviews. We, the editors, are pleased with the response to the series over the years and, as a result, are happy to continue into a second decade with the same general purpose and zeal. As in the past, contributors to projected volumes have been asked to summarize the nature of the literature, the prevailing attitudes and arguments, and then to advance the discussion in some way by staking out and arguing forcefully for some basic position on the topic targeted for discussion. For the present volume on Physician-Assisted Death, we felt it wise to enlist the services of a guest editor, Dr. Gregg A. Kasting, a practicing physician with extensive clinical knowledge of the various problems and issues encountered in discussing physician assisted death. Dr. Kasting is also our student and just completing a graduate degree in philosophy with a specialty in biomedical ethics here at Georgia State University. Apart from a keen interest in the topic, Dr. Kasting has published good work in the area and has, in our opinion, done an excellent job in taking on the lion's share of editing this well-balanced and probing set of essays. We hope you will agree that this volume significantly advances the level of discussion on physician-assisted euthanasia. Incidentally, we wish to note that the essays in this volume were all finished and committed to press by January 1993.