Background Ethicscommittees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethicscommittees. The purpose of this study was to describe the characteristics and developments of ethicscommittees established at medical schools and general hospitals in Japan. Methods This study consisted of four national surveys sent twice over (...) a period of eight years to two separate samples. The first target was the ethicscommittees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses. Results Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethicscommittees over the eight years. The primary activities for medical school and hospital ethicscommittees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethicscommittees. Conclusion Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethicscommittees. (shrink)
The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research EthicsCommittees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since (...) most research proposal are reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals. (shrink)
The Polish equivalents of Research EthicsCommittees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (...) (range: 0–71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary. (shrink)
The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the (...) complex ethical issues that arise in clinical and organizational settings. Handbook for Health Care EthicsCommittees is the first resource designed to address the range of work performed by ethicscommittees as part of their multiple responsibilities, including education, case consultation, and policy development. It features an eight-chapter curriculum reviewing the content of contemporary health care bioethics and discussing the ethical foundations of clinical practice, with each subsequent section focusing on a set of ethical issues that commonly arise in the clinical setting. Through case studies, the authors explore issues such as informed consent and refusal, decision making and decisional capacity, truth telling, decision-making concerns of minors, end-of-life issues, palliation, justice in and access to health care services, and organizational ethics. They offer sample policies and procedures, draft guidelines and protocols, and key legal cases. Providing both a strong theoretical foundation and practical applications, this handbook will be essential reading for every member of a health care ethics committee. (shrink)
A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethicscommittees in Germany can perform their task of providing expert opinions for clinical research. The so-called “revaluation” of the Medical Device Law Deutsches Medizinproduktegesetz—MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethicscommittees are now seen as being sub-organs of the state medical associations or the (...)medical faculties and are therefore official authorities. It follows that the votes of ethicscommittees are then “sovereign acts” or authoritative measures! However, equality and justice speak against this misleading conclusion and its resulting consequence that an ethics committee’s vote is a sovereign act. This has, in turn, resulted in the public ethicscommittees obtaining their long-sought goal of having a state-sanctioned monopoly. The private ethicscommittees are not recognized as being authoritative bodies, nor are they to be seen as such in the future (i.e. such a status has been denied the Freiburg Ethics Commission International (FEKI) in Baden-Württemberg). This political mistake must be corrected, otherwise, conducting clinical research will become increasingly difficult. (shrink)
Machine generated contents note: Introduction Chapter 1: The basics of ethical decision-making Chapter 2: Hospital ethicscommittees and clinical ethicists Chapter 3: The settings of health care ethical dilemmas Chapter 4: Advance directives Chapter 5: Do Not Resuscitate orders and "Code Blue" Chapter 6: Non-beneficial medical interventions Chapter 7: Quality of life and treatment burdens Chapter 8: Patient privacy and confidentiality Chapter 9: Refusing medical treatment Chapter 10: Health care at the end of life Chapter 11: (...) Transplant ethics Chapter 12: Neuroethics Chapter 13: Ethics and reproductive technology Chapter 14: Genetics and ethics Chapter 15: Pediatric ethics Chapter 16: Participating in a research study Appendix A: Resource List Appendix B: Glossary Index. (shrink)
Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better (...) understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. (shrink)
This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethicscommittees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, (...) and suggests procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethicscommittees. (shrink)
Western society today is less unified by a set of core values than ever before. Undoubtedly, the concept of moral consensus is a difficult one in a liberal, democratic and pluralistic society. But it is imperative to avoid a rigid majoritarianism where sensitive personal values are at stake, as in bioethics. Bioethics has become an influential part of public and professional discussions of health care. It has helped frame issues of moral values and medicine as part of a more general (...) effort to find consensus about some of the most perplexing questions of our time. But why is it thought that a moral consensus is important or that it deserves respect? How does moral consensus acquire legitimacy in a society that includes diverse value systems? How is moral consensus possible and how do small groups help create or distort consensus processes? Written by a medical school professor trained in philosophy, this timely work tackles these questions from philosophical, historical, and social scientific standpoints. It begins by describing the traditional ambivalence about consensus in Western culture as well as the uncertain relationship in modernity between consensus and expertise. After outlining the current bioethical consensus, the book gives philosophical and political analyses of the idea of consensus, then assesses the role of consensus in national ethics commissions and in the ethics committee movement. Moreno constructs an original, naturalistic philosophy of moral consensus, referred to as "bioethical naturalism", and then applies sociology and social psychology to actual consensus processes. The book concludes with an account of bioethics as a consensus-oriented social reform movement. This insightful volume will be essential reading for bioethicists, philosophers, physicians, members of ethicscommittees, and all those concerned with ethical and social issues in health care. (shrink)
The American Medical Association enacted its Code of Ethics in 1847, the first such national codification. In this volume, a distinguished group of experts from the fields of medicine, bioethics, and history of medicine reflect on the development of medicalethics in the United States, using historical analyses as a springboard for discussions of the problems of the present, including what the editors call "a sense of moral crisis precipitated by the shift from a system of (...) fee-for-service medicine to a system of fee-for-system medicine, better known as 'managed care.'" The authors begin with a look at how the medical profession began to consider ethical issues in the 1800s and subsequent developments in the 1900s. They then address the sociological, historical, ethical, and legal aspects of the practice of medicine. Later chapters discuss current and future challenges to medicalethics and professional values. Appendixes display various versions of the AMA's Code of Ethics as it has evolved over time. Contributors: George J. Annas, J.D., M.P.H., Arthur Isak Applbaum, Ph.D., Robert B. Baker, Ph.D., Chester R. Burns, M.D., Ph.D., Arthur L. Caplan, Ph.D., Alexander Morgan Capron, J.D., Christine K. Cassel, M.D., Linda L. Emanuel, M.D., Ph.D., Eliot L. Freidson, Ph.D., Albert R. Jonsen, Ph.D., Stephen R. Latham, J.D., Ph.D., Susan E. Lederer, Ph.D., Florencia Luna, Ph.D., Edmund D. Pellegrino, M.D., Charles E. Rosenberg, Ph.D., Mark Siegler, M.D., Rosemary A. Stevens, Ph.D., Robert M. Tenery, Jr., M.D., Robert M. Veatch, Ph.D., John Harley Warner, Ph.D., Paul Root Wolpe, Ph.D. (shrink)
A physician says, "I have an ethical obligation never to cause the death of a patient," another responds, "My ethical obligation is to relieve pain even if the patient dies." The current argument over the role of physicians in assisting patients to die constantly refers to the ethical duties of the profession. References to the Hippocratic Oath are often heard. Many modern problems, from assisted suicide to accessible health care, raise questions about the traditional ethics of medicine and the (...)medical profession. However, few know what the traditional ethics are and how they came into being. This book provides a brief tour of the complex story of medicalethics evolved over centuries in both Western and Eastern culture. It sets this story in the social and cultural contexts in which the work of healing was practiced and suggests that, behind the many different perceptions about the ethical duties of physicians, certain themes appear constantly, and may be relevant to modern debates. The book begins with the Hippocratic medicine of ancient Greece, moves through the Middle Ages, Renaissance and Enlightenment in Europe, and the long history of Indian and Chinese medicine, ending as the problems raised modern medical science and technology challenge the settled ethics of the long tradition. (shrink)
The doctor patient relationship starts with a story. Doctors' notes, a patient's chart, the recommendations of ethicscommittees and insurance justifications all hinge on written and verbal narrative interaction. The "practice" of narrative profoundly affects decision making, patient health and treatment and the everyday practice of medicine. In this edited collection, the contributors provide conceptual foundations, practical guidelines and theoretical considerations central to the practice of narrative ethics.
The sixth edition of the Manual for Research EthicsCommittees is a unique compilation of legal and ethical guidance which will prove invaluable for members of research ethicscommittees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic authors (...) and practitioners, pharmaceutical industry associations and professional bodies. In the sixth edition there are fifteen new chapters covering key issues from participation in clinical trials to cloning, and for the first time the manual has been produced in one easy-to-search hardback volume. (shrink)
This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research EthicsCommittees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the (...) research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. (shrink)
Should a brain-dead woman be artificially maintained for the sake of her fetus? Does a physician have the right to administer a life-saving transfusion despite the patient's religious beliefs? Can a family request a hysterectomy for their retarded daughter? Physicians are facing moral dilemmas with increasing frequency. But how should these delicate questions be resolved and by whom? A Casebook of MedicalEthics offers a real-life view of the central issue involved in clinical medicalethics. Since (...) the analysis of cases plays a critical role in this study, the authors have assembled a broad collection of histories encountered in their work as medicalethics educators and consultants. The cases are developed in substantial detail to reflect the rich medical and psychosocial complexity involved, and each is brought to a decision point at which a course of action must be chosen. Among the issues examined are conflicts between patients' wishes and respect for their well-being, tensions concerning duties to patients unable to care for themselves and obligations to family members, and clashes between patient care obligations and the interests of other persons, including physicians, third parties, and the general public. The book also includes commentaries that combine general discussion of ethical principles with specific analysis of the cases examined in the text, as well as various options for resolving conflicts. Readers are invited to assess the comparative merits and liabilities of these approaches. An ideal text for undergraduate and medical school courses, A Casebook of MedicalEthics brings readers to the forefront of medicine, where they share in the determination of crucial ethical decisions. (shrink)
This collection brings together original essays demonstrating the cutting edge of philosophical research in medicalethics. With contributions from a range of established and up-and-coming authors, it examines topics at the forefront of medical technology, such as ethical issues raised by developments in how we research stem cells and genetic engineering, as well as new questions raised by methodological changes in how we approach medicalethics.
The Cambridge World History of MedicalEthics is the first comprehensive scholarly account of the global history of medicalethics. Offering original interpretations of the field by leading bioethicists and historians of medicine, it will serve as the essential point of departure for future scholarship in the field. The volumes reconceptualize the history of medicalethics through the creation of new categories, including the life cycle; discourses of religion, philosophy, and bioethics; and the relationship (...) between medicalethics and the state, which includes a historical reexamination of the ethics of apartheid, colonialism, communism, health policy, imperialism, militarism, Nazi medicine, Nazi "medicalethics," and research ethics. Also included are the first global chronology of persons and texts; the first concise biographies of major figures in medicalethics; and the first comprehensive bibliography of the history of medicalethics. An extensive index guides readers to topics, texts, and proper names. (shrink)
This book is intended as a practical introduction to the ethical problems which doctors and other health professionals can expect to encounter in their practice. It is divided into three parts: ethical foundations, clinical ethics, and medicine and society. The authors incorporate new chapters on topics such as theories of medicalethics, cultural aspects of medicine, genetic dilemmas, aging, dementia and mortality, research ethics, justice and health care (including an examination of resource allocation), and medicine, (...) class='Hi'>ethics and medical law. MedicalEthics also covers issues having to do with the beginning and end of life, as well as ethical questions surrounding the human body and the use of human tissue, confidentiality and AIDS, care of the mentally ill, and the implications of genetic technology. Each chapter presents a range of ethical views, drawing both from traditional philosophy and the most recent contemporary trends. The theoretical discussion is extended and illustrated by case studies and examples. This book is a non-technical guide to ethics written with the needs of medical students and medical practitioners in mind. It will also appeal to students and practitioners of allied health professions, and for all users of health care services. (shrink)
The practice of clinical medicine is inextricably linked with the need for moral values and ethical principles. The study of medicalethics is, therefore, rightly assuming an increasingly significant place in undergraduate and postgraduate medical courses and in allied health curricula. Making Sense of MedicalEthics offers a no-nonsense introduction to the principles of medicalethics, as applied to the everyday care of patients, the development of novel therapies and the undertaking of pioneering (...) basic medical research. Written from a practical rather than a philosophical perspective, the authors call upon their extensive experience of clinical practice, research and teaching to illustrate how ethical principles can be applied in different "real-life" situations. Making Sense of MedicalEthics encourages readers to understand the principles of medicalethics as they apply to clinical practice; explore and evaluate common misconceptions; consider the ethics underlying any medical decision; and as a result, to realize that a good appreciation of medicalethics will help them to practice more effectively in the future. (shrink)
How is the concept of patient care adapting in response to rapid changes in healthcare delivery and advances in medical technology? How are questions of ethical responsibility and social diversity shaping the definitions of healthcare? In this topical study, scholars in anthropology, nursing theory, law and ethics explore questions involving the changing relationship between patient care and medicalethics. Contributors address issues that challenge the boundaries of patient care, such as: · HIV-related care and research · (...) the impact of new reproductive technologies · preventative healthcare · technological breakthroughs that are changing personal-caring relationships. Chapters range from a consideration of the practicalities of nursing and family healthcare to a debate about ‘universal human needs’ and patients’ rights. This book is a provocative exploration of the ways in which healthcare models are socially constructed. It will be of interest to policy-makers, medical practitioners and administrators, as well as students of sociology, anthropology and social policy. (shrink)
This interactive independent teaching and learning tutorial can be used by individuals or small groups and takes a problem-based-learning approach to the complex legal and ethical issues raised by six scenarios. Based on real cases clearly demonstrating the problems arising from recent medical advancements, the cases cover reproductive technology, consent, genetic screening, participation in research trials, paternity and confidentiality. Additional features of the CD-ROM are a comprehensive glossary, cross-references to The Cambridge MedicalEthics Workbook and definitions from (...) the Dictionary of MedicalEthics. (shrink)
Disciplining doctors : medical courts of honour and professional conduct -- Medical confidentiality : the debate on private versus public interests -- Patient information and consent : self-determination versus paternalism -- Duties and habitus of a doctor : the literature on medicalethics.
This new edition of Law and MedicalEthics continues to chart the ever-widening field that the topics cover. The interplay between the health caring professions and the public during the period intervening since the last edition has, perhaps, been mainly dominated by wide-ranging changes in the administration of the National Health Service and of the professions themselves but these have been paralleled by important developments in medical jurisprudence.
Introduction -- Historical perspectives of medicalethics -- The medicalethics Renaissance: a brief assessment -- Risk disclosure/'informed consent' -- Consent, control and minors: Gillick and beyond -- Sterilisation/best interests: legislation intervenes -- The end of life: total abrogation -- Medicalethics in government-commissioned reports -- Conclusion.
Thus far in the development of the discipline of medicalethics, the overriding concern has been with solutions to specific problems. But discussion is hampered by lack of understanding of the scope and methodology of medicalethics, and its scientific and philosophical basis. In Underpinnings of MedicalEthics Edmond A. Murphy, James J. Butzow, and Edward L. Suarez-Murias offer much-needed clarification of the purview, ontological basis, and methodology of a medicalethics that (...) is to be comprehensive and yet readily accepted by all. The authors begin by describing the scope of the analysis and discussing possible ethical systems and paradigms. They then deal with the structures and concepts necessary in the formulation of a coherent philosophy: normality and disease, scientific and juridical law, certainty and certitude, decisions. Finally, they introduce particular human dimensions, such as quality of life, pain, and responsibility. Throughout, case examples illustrate the authors' theoretical framework. (shrink)
This rich collection, popular among teachers and students alike, provides an in-depth look at major cases that have shaped the field of medicalethics. The book presents each famous (or infamous) case using extensive historical and contextual background, and then proceeds to illuminate it by careful discussion of pertinent philosophical theories and legal and ethical issues.
The Blackwell Guide to MedicalEthics is a guide to the complex literature written on the increasingly dense topic of ethics in relation to the new technologies of medicine. Examines the key ethical issues and debates which have resulted from the rapid advances in biomedical technology Brings together the leading scholars from a wide range of disciplines, including philosophy, medicine, theology and law, to discuss these issues Tackles such topics as ending life, patient choice, selling body parts, (...) resourcing and confidentiality Organized with a coherent structure that differentiates between the decisions of individuals and those of social policy. (shrink)
Medicalethics changed dramatically in the past 30 years because physicians and humanists actively engaged each other in discussions that sometimes led to confrontation and controversy, but usually have improved the quality of medical decision-making. Before then medicalethics had been isolated for almost two centuries from the larger philosophical, social, and religious controversies of the time. There was, however, an earlier period where leaders in medicine and in the humanities worked closely together and both (...) fields were richer for it. This volume begins with the 18th century Scottish Enlightenment when professors of medicine such as John Gregory, Edward Percival, and the American, Benjamin Rush, were close friends of philosophers like David Hume, Adam Smith, and Thomas Reid. They continually exchanged views on matters of ethics with each other in print, at meetings of elite intellectual groups, and at the dinner table. Then something happened, physicians and humanists quit talking with each other. In searching for the causes of the collapse, this book identifies shifts in the social class of physicians, developments in medical science, and changes in the patterns of medical education. Only in the past three decades has the dialogue resumed as physicians turned to humanists for help just when humanists wanted their work to be relevant to real-life social problems. Again, the book asks why, finding answers in the shift from acute to chronic disease as the dominant pattern of illness, the social rights revolution of the 1960's, and the increasing dissonance between physician ethics and ethics outside medicine. The book tells the critical story of how the breakdown in communication between physicians and humanists occurred and how it was repaired when new developments in medicine together with a social revolution forced the leaders of these two fields to resume their dialogue. (shrink)
This is a practical introduction to the range of ethical questions which doctors and other health-care professionals may be expected to encounter in practice. The books covers both the traditional "end of life" issues and also deals with medical research and consent issues, confidentiality and AIDS, resource allocation, care of the mentally ill, and the doctor/patient relationship. Each chapter canvasses a range of ethical views, drawing both from traditional philosophical responses and the most recent contemporary responses. Theoretical discussion is (...) extended and enlivened by the use of hypothetical and actual examples, suitable both for private study or group discussion. While the needs of medical students for a non-technical guide to ethics have been kept firmly in mind, the clarity of writing and avoidance of specialist medical and philosophical terminology ensure that it will be of value to students of nursing and related disciplines, and accessible to the lay reader. (shrink)
Mason and McCall Smith's classic textbook discusses the relationship of medical practice and ethics with the operation of the law. The subjects covered include natural and assisted reproduction, the impact of modern genetics on medicine, medical confidentiality, consent to medical treatment, the use of resources and problems surrounding death in the new medical era. It is of significance to anyone with an interest in the ethical and legal practice of medicine.
United States military medicalethics evolved during its involvement in two recent wars, Gulf War I (1990–1991) and the War on Terror (2001–). Norms of conduct for military clinicians with regard to the treatment of prisoners of war and the administration of non-therapeutic bioactive agents to soldiers were set aside because of the sense of being in a ‘new kind of war’. Concurrently, the use of radioactive metal in weaponry and the ability to measure the health consequences of (...) trade embargos on vulnerable civilians occasioned new concerns about the health effects of war on soldiers, their offspring, and civilians living on battlefields. Civilian medical societies and medical ethicists fitfully engaged the evolving nature of the medicalethics issues and policy changes during these wars. Medical codes of professionalism have not been substantively updated and procedures for accountability for new kinds of abuses of medicalethics are not established. Looking to the future, medicine and medicalethics have not articulated a vision for an ongoing military-civilian dialogue to ensure that standards of medicalethics do not evolve simply in accord with military exigency. (shrink)
Foundations of medicalethics and law -- Professionalism and medicalethics -- The doctor, the patient, and society -- Ethics and law at the beginning and end of life -- Healthcare commissioning and resource allocation -- Introduction to sociology and disease -- Experience of health and illness -- Organization of health care provision in the UK -- Inequalities in health and health care provision -- Epidemiology and public health -- Clinical governance.
Abstract Context: Established in 1997, Summa Health System’s MedicalEthics Committee (EC) serves as an educational, supportive, and consultative resource to patients/families and providers, and serves to analyze, clarify, and ameliorate dilemmas in clinical care. In 2009 the EC conducted its 100th consult. In 2002 a Palliative Care Consult Service (PCCS) was established to provide supportive services for patients/families facing advanced illness; enhance clinical decision-making during crisis; and improve pain/symptom management. How these services affect one another has thus (...) far been unclear. Objectives: This study describes EC consults: types, reasons, recommendations and utilization, and investigates the impact the PCCS may have on EC consult requests or recommendations. Methods: Retrospective reviews of 100 EC records explored trends and changes in types of consults, reasons for consults, and EC recommendations and utilization. Results: There were 50 EC consults each in the 6 years pre- and post-PCCS. Differences found include: (1) a decrease in number of reasons for consult requests (133–62); (2) changes in top two reasons for EC consult requests from ‘Family opposed to withdrawing life-sustaining treatment (LST)’ and ‘Patient capacity in question’ to ‘Futility’ and ‘Physician opposed to providing LST’; (3) changes in top two recommendations given by the EC from ‘Emotional Support for Patient/Family’ and ‘Initiate DNR Order’ to ‘Comfort Care’ and ‘Withdraw Treatment.’ Overall, 88% of recommendations were followed. Conclusion: PCCS availability and growth throughout the hospital may have influenced EC consult requests. EC consults regarding family opposition to withdrawing LST and EC recommendations for patient/family support declined. Content Type Journal Article Pages 1-16 DOI 10.1007/s10730-011-9170-9 Authors Jessica Richmond Moeller, Department of Psychiatry and Behavioral Sciences, Akron General Medical Center, 400 Wabash Ave, Akron, OH 44307, USA Teresa H. Albanese, Health Services Research and Education Institute, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Kimberly Garchar, Kent State University, 6000 Frank Ave., N.W, North Canton, OH 44720, USA Julie M. Aultman, Department of Family and Community Medicine, Northeast Ohio Medical University, P.O. Box 95, Rootstown, OH 44272, USA Steven Radwany, Palliative Care and Hospice Services, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Dean Frate, Internal Medicine, Palliative Care and Hospice Services, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737. (shrink)
Tough Decisions presents many of the complex medical-ethical issues likely to confront practitioners in critical situations. Through fictional but true-to-life cases, vividly described in clinical terms, the authors force the reader to choose among different courses of action and to confront a range of possible consequences. A two-year-old has been diagnosed with a malignant brain tumor. Who should be allowed to make decisions about the child's surgery and subsequent therapy, and on what basis? A family history of Huntington's disease (...) emerges when a fiancee seeks genetic counseling. Who should be informed? An elderly patient suffers a cardiac arrest. Should "do-not-resuscitate" orders always be followed? How should legal liability affect medical decisions? Other ethical issues considered include surgical complications, patient autonomy, rights of the retarded, informed consent, euthanasia, and the fair allocation of finite resources. Each case presented conveys the drama and pressure of weighing alternatives, and the realistic consequences of the choices made. The authors show that ethical decision-making is not limited to "matters of life and death", and that it is not the decision but the ethical process by which it is made that gives the decision moral integrity. With realistic detail, Tough Decisions brings to life and makes the student share in the many complexities of ethical decision-making when the health and lives of patients are at stake. (shrink)
This book examines the extremely important issue of the consistency of medical involvement in ending lives in medicine, law and war. It uses philosophical theory to show why medical doctors may be involved at different stages of the capital punishment process. The author uses the theories of Emmanuel Kant and John S. Mill, combined with Gerwith's principle of generic consistency, to concretize ethics in capital punishment practice. This book does not discuss the moral justification of capital punishment, (...) but rather looks at the possible forms of involvement and shows why consistency would demand medical involvement. The author takes a general approach, using arguments that may apply universally. The book broaches different academic fields, such as medicine, ethics, business, politics and defense. The Ethics of Medical Involvement in Capital Punishment is of interest to students, teachers, lecturers and researchers working in the areas of capital punishment, medical, legal and business ethics, and political philosophy. (shrink)
Medical error is a leading problem of health care in the United States. Each year, more patients die as a result of medical mistakes than are killed by motor vehicle accidents, breast cancer, or AIDS. While most government and regulatory efforts are directed toward reducing and preventing errors, the actions that should follow the injury or death of a patient are still hotly debated. According to Nancy Berlinger, conversations on patient safety are missing several important components: religious voices, (...) traditions, and models. In After Harm, Berlinger draws on sources in theology, ethics, religion, and culture to create a practical and comprehensive approach to addressing the needs of patients, families, and clinicians affected by medical error. She emphasizes the importance of acknowledging fallibility, telling the truth, confronting feelings of guilt and shame, and providing just compensation. After Harm adds important human dimensions to an issue that has profound consequences for patients and health care providers. (shrink)
Doing Right: A Practical Guide to Ethics for Medical Trainees and Physicians is a concise and practical guide to ethical decision-making in medicine. The text is aimed at second- and third-year one-semester ethics courses offered in medical schools, health sciences departments, and nursing programs. By taking an applied approach rather than a theoretical approach, this text serves the needs of medical and nursing students, residents, and practicing physicians by sorting through questions of moral principles relevant (...) to the diverse and growing number of healthcare professionals. The many topics covered include truth telling, refusal of treatment, assisted suicide, managing error, and reproductive choice. (shrink)
: Calls for ethics education for members of hospital ethicscommittees presume that the effects and benefits of such education are well-established. This is not the case. A review of the literature reveals that studies consistently have failed to uncover any significant effect of ethics education on the moral reasoning, moral competency, and/or moral development of medical professionals. The present paper discusses this negative result and describes the author's national study of the value priorities of (...) members of hospital ethicscommittees. This study discovered correlations between moral decision making and factors like age and type of institution where the committee operates. The results of this study also resemble those of previous studies in finding no correlation between ethics education and moral decision making. The author concludes that there is a need for more research on the effects of nonmoral personal, societal, and institutional factors on the moral reasoning of members of hospital ethicscommittees. Further, in the absence of any firm empirical basis, calls for ethics education for medical professionals and ethics committee members should be rethought. (shrink)
Mainstream philosophical discussions of ethics usually involve either a search for a problem-solving theory (such as utilitarianism), or an exploration of ontological status (of things like obligations or reasons). This book will argue that such efforts are often misplaced. Instead, the proper starting point should always be the actual words and deeds of ordinary people in ordinary disagreements; for the ethical concepts in play can only derive their full meaning within the context of ordinary human lives. This will require (...) a better understanding of the 'ordinary', and of what it means to lead a life. (shrink)
Providing health care in the most cost-effective way has become a priority in recent years. This book tackles the important issue of the potential conflict between economic expediency and the welfare of individual patients. Contributors examine different attitudes to this complex problem, along with a variety of legal and historical perspectives. The book addresses particular aspects of health care, such as medical expert systems, general practice, medical education, and clinical decision-making where the direct involvement of doctors in allocating (...) scarce and expensive resources is perhaps most obvious. (shrink)
We argue that a turn toward virtue ethics as a way of understanding medical professionalism represents both a valuable corrective and a missed opportunity. We look at three ways in which a closer appeal to virtue ethics could help address current problems or issues in professionalism education—first, balancing professionalism training with demands for professional virtues as a prerequisite; second, preventing demands for the demonstrable achievement of competencies from working against ideal professionalism education as lifelong learning; and third, (...) avoiding temptations to dismiss moral distress as a mere “hidden curriculum” problem. As a further demonstration of how best to approach a lifelong practice of medical virtue, we will examine altruism as a mean between the extremes of self-sacrifice and selfishness. (shrink)
Background: The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of EthicsCommittees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross-sectional study aims to give an overview of the different types of activities of Italian ECs and favour (...) discussion at a European level.Methods: A questionnaire was emailed to all Italian EthicsCommittees contained in the national Registry of the Ministry of Health, enquiring whether the EC was conducting, or planning to conduct, 4 specific activities. A telephone interview was conducted to determine reasons for failure to respond.Results: Response rate was 53% (101 respondents out of 191). 20% of ECs restrict their responsibilities to research protocol review, 25% also offer ethical consultation to institutions, support on individual health care decisions and promotes educational initiatives, while the remaining 50% conduct a few of the examined activities to varying degrees. Large variation was observed across different types of hosting institutions and geographical locations.Conclusions: A common European model should be developed, defining EC functions, member selection modalities, necessary member competences, decision-making criteria and measures for work verification. In the absence of sound empirical evidence, it would be interesting to study the effectiveness and efficiency of the different existing models. (shrink)
Guidelines for Institutional Review Boards (IRBs) or research ethicscommittees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs (...) attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)
This paper describes the medicalethics scene in Britain. After giving a brief account of the structure of British medicalethics and of the roles of the different groups involved it mentions some of the important medico-moral events and issues of the fairly recent past, and describes in greater detail four important examples of professional, legal, governmental and media concerns with medicalethics, themselves illustrating the wide variety of interests wishing to influence the British (...)medical profession's ethics. The examples offered are the development of research ethicscommittees, the Sidaway case concerning informed consent, the Warnock Committee's Report on in vitro fertilisation and associated issues, and the 1980 Reith Lectures on Unmasking Medicine. In the final section a fairly new methodological development in British medicalethics is described in which the medical profession is increasingly recognising the need to add to traditional medicalethics education, with its longstanding history of the inculation and enforcement of ethical norms, an element of philosophical or critical medicalethics, at the heart of which is justification of substantive medico-moral claims in the light of counterarguments. (shrink)
In this article a brief overview is given of the field of medicalethics in Sweden in recent years. The presentation concentrates on the occurrence of official ethical norms for physicians, current ethical committees, the educational situation, legislation in force, and some essential features of the ethical debate on a few central issues.
Although ethicscommittees in Japan have been developing in major medical schools and in some hospitals, their members are usually medical professionals from the same institution. The lack of national legislation for setting up ethicscommittees permits only a voluntary code of standards for doing clinical research work in high tech medical applications. The author argues for the necessity of more open debate on bioethical issues and proposes the participation of the lay public (...) and bioethicists in EthicsCommittees in Japan. Keywords: ethicscommittees, bioethics, Japan, patients' rights, high-tech medicine CiteULike Connotea Del.icio.us What's this? (shrink)
Despite recommendations from the Cartwright Report ethical review by health ethicscommittees has continued in New Zealand without health practitioners ever having to acknowledge their dual roles as health practitioners researching their own patients. On the other hand, universities explicitly identify doctor/research-patient relations as potentially raising conflict of role issues. This stems from the acknowledgement within the university sector itself that lecturer/research-student relations are fraught with such conflicts. Although similar unequal relationships are seen to exist between health researchers (...) and their patients, the patient/subjects are not afforded the levels of protection that are afforded student/subjects. In this paper we argue that the difference between universities and health research is a result of the failure of the Operational Standard Code for EthicsCommittees to explicitly acknowledge the vulnerability of the patient and conflict of interests in the dual roles of health practitioner/researcher. We end the paper recommending the Ministry of Health consider the rewriting of the Operational Standard Code for EthicsCommittees, in particular in the rewriting of section 26 of the Operational Standard Code for EthicsCommittees. We also identify the value of comparative ethical review and suggest the New Zealand's Health Research Council's trilateral relationship with Australia's NHMRC (National Health and Medical Research Council) and Canada's CIHR (Canadian Institute of Health Research) as a useful starting point for such a process. (shrink)
Background: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research EthicsCommittees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of (...) the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results: We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion: Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs. (shrink)
Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research EthicsCommittees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. (...) Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)
Background Clinical trials throughout the world must be evaluated by research ethicscommittees. No one has yet attempted to clearly quantify at the national level the activity of ethicscommittees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research EthicsCommittees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Methods Retrospective cohort of 976 protocols (...) approved by a representative sample of 25/48 of French Research EthicsCommittees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Results Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14–17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25–53) and 37 (95% CI: 27–46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. Conclusion The estimated workload justifies specific and independent administrative and financial support for Research EthicsCommittees. (shrink)