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The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject. Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.
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.
Health Care Law and Ethics, Ninth Edition offers a relationship-oriented approach to health law—covering the essentials, as well as topical and controversial subjects. The book provides thoughtful and teachable coverage of every aspect of health care law. Current and classic cases build logically from the fundamentals of the patient/provider relationship to the role of government and institutions in health care. The book is adaptable to both survey courses and courses covering portions of the field. Key Features: New authors Nick Bagley and Glenn Cohen Incorporated anticipated changes to the Affordable Care Act More current cases and more streamlined notes, including ones on medical malpractice, bioethics, and on finance and regulation More coverage of “conscientious objection” and “big data” - Discussion of new “value based” methods of physician payment - Expanded coverage of “fraud and abuse” Current issues in public health (e.g., Ebola, Zika) and controversies in reproductive choice (e.g., Hobby Lobby) Coverage of cutting-edge genetic technologies (e.g., gene editing and mitochondrial replacement)
Pamphlet is a succinct statement of the ethical obligations and duties of individuals who enter the nursing profession, the profession's nonnegotiable ethical standard, and an expression of nursing's own understanding of its commitment to society. Provides a framework for nurses to use in ethical analysis and decision-making.
Medical Law and Ethics is a feature-rich introduction to medical law and ethics, discussing key principles, cases, and statutes. It provides examination of a range of perspectives on the topic, such as feminist, religious, and sociological, enabling readers to not only understand the law but also the tensions between different ethical notions.
Instructor Resources: Test bank, PowerPoint slides for each chapter and a model answer to each of the activities in the text. Contemporary Issues in Healthcare Law and Ethics, Fourth Edition, examines the most important legal and ethical issues in healthcare, and presents essential information that will help students learn to identify and tackle potential legal problems. This thoroughly revised edition includes new information and extensive updates on topics such as: The Patient Protection and Affordable Care Act (ACA), including legal requirements about health insurance and health reform The 2012 Supreme Court decision regarding the individual mandate to buy health insurance, the penalty for not having insurance, and the expansion of Medicaid Ongoing legal challenges to mandated contraceptive coverage and whether federal subsidies may be provided for coverage that is purchased through a federally operated exchange New legal obligations for tax-exempt hospitals under the ACA and federal regulations Important changes to Medicare and Medicaid Other changes to laws about abortion, physician-assisted suicide, privacy of medical information, and reform of medical malpractice laws. New to this edition are more activities that apply legal principles in the text to specific facts. Also, an in-text glossary has been added.
Professionals in need of such training and bioethicists will be interested.
When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.
This is a short textbook of ethics and law aimed primarily at medical students. The book is in two sections. The first considers general aspects of ethics (in the context of medicine); the second section covers the topics identified in the 'consensus agreement'. The content of medical law is not intended to be comprehensive and relates very much to the ethical issues. The law will be updated throughout including: consent in light of Mental Capacity Act; mental health law in light of Mental Health Act; end of life (depending on outcome of Burke case and the passage of the Joffe Bill); assisted reproduction in light of expected changes in HFEA. New guidelines to be added: the guidelines and processes around medical research are under review and likely to develop and change; GMC guidelines are under continual revision (the Burke case in particular may have direct impact, but it is also likely that the confidentiality guidelines will undergo revision particularly in view of the increasing importance of genetic data). The new legal aspects outlined above will require some changes to the ethical analysis: the ethical issues of new technology will be included (cloning; transgenesis and chimera, i.e. forming organisms from more than one species) and stem-cells; resource allocation ethics is moving on to examining a wider range of issues than covered in the first edition and this will be discussed; the whole area of mental disorder and capacity to consent is an active area of ethical research and the second edition would cover some of this new work.
This Open Access book highlights the ethical issues and dilemmas that arise in the practice of public health. It is also a tool to support instruction, debate, and dialogue regarding public health ethics. Although the practice of public health has always included consideration of ethical issues, the field of public health ethics as a discipline is a relatively new and emerging area. There are few practical training resources for public health practitioners, especially resources which include discussion of realistic cases which are likely to arise in the practice of public health. This work discusses these issues on a case to case basis and helps create awareness and understanding of the ethics of public health care. The main audience for the casebook is public health practitioners, including front-line workers, field epidemiology trainers and trainees, managers, planners, and decision makers who have an interest in learning about how to integrate ethical analysis into their day to day public health practice. The casebook is also useful to schools of public health and public health students as well as to academic ethicists who can use the book to teach public health ethics and distinguish it from clinical and research ethics.