All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the (...) class='Hi'>clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)

This textbook develops the issue of ethics to a philosophical level complex enough to be applicable to students of philosophy and applied ethics courses. It is the first book to address clinical problems from a classical perspective. This title available in eBook format. Click here for more information . Visit our eBookstore at: www.ebookstore.tandf.co.uk.

BackgroundDuring a commercial surrogacy arrangement, the event of embryo transfer can be seen as the formal starting point of the arrangement. However, it is common for surrogates to undergo a failed attempt at pregnancy conception or missed conception after an embryo transfer. This paper attempts to argue that such failed attempts can be understood as a loss. It aims to reconstruct the experiences of loss and grief of the surrogates and the intended parents as a consequence of their collective failure (...) to conceive a surrogate pregnancy.MethodsDrawing on a qualitative study conducted over a period of eight months between 2014 and 2015 at two fertility clinics in Delhi and two in Kolkata, India, this paper examines the experiences of the surrogates and the intended parents when faced with missed conceptions or failed conceptions during a surrogacy arrangement.ResultsWe argue that while the surrogate grieves the non-arrival of a ‘good news’ as an uncertain loss, the intended parents experience yet another, failure in addition to the losses they might have incurred during their previous fertility treatments. The body of the surrogate becomes a site of ‘a lost opportunity’. The surrogate embodies a loss in her quest to achieve social mobility and the intended parents experience a disembodied pregnancy loss. This very emotional experience stands in stark contrast to the conceptualisation of such failed attempts as non-events within the discourse of the surrogacy industry. The experience of loss of the intended parents is recognised but their grief is given no space. We argue that such ambiguity around the nature of losses resulting out of a missed or failed conception during surrogacy is an outcome of lack of interpersonal relationship between the surrogate and the intended parents.ConclusionsSince commercial surrogacy is a relational process, the only way in which the experiences of losses and failures of the actors at the preconception stage can be better addressed is through developing close sharing and understanding between each other through an ethics of care. Therefore, to nurture caring relationships, surrogacy needs to be understood as a moral commitment by –the surrogates and intended parents. To enable such a commitment, there is a need to reconsider the pre-defined and legally regulated professional duty of the doctors, agents and agencies. It cannot be a one-sided commitment, but has to have elements of mutuality. (shrink)

While evidence-based medicine (EBM) is often accused on relying on a paradigm of 'absolute truth', it is in fact highly consistent with Karl Popper's criterion of demarcation through falsification. Even more relevant, the first three steps of the EBM process are closely patterned on Popper's evolutionary approach of objective knowledge: (1) recognition of a problem; (2) generation of solutions; and (3) selection of the best solution. This places the step 1 of the EBM process (building an answerable question) in (...) a pivotal position for the understanding of the whole process, and underscores a few aspects which are often overlooked in EBM courses. First in this step internal evidence (including personal expertise) must be appraised and integrated in the problem. Second, issues of applicability of the possible solution should be anticipated. Third, and possibly more important, the goal of the intervention should be set at this stage (typically by choosing the outcome in a PICO question). Depending whether or not goals depend on the goals of others, and whether they concern others' voluntary behaviour, goals may be classified as self-serving, moral, altruistic or moralistic. Thus, delicate ethical questions must be addressed at this stage, which means that patient preferences and values must be carefully sought, so that empathy, counselling and narrative medicine must be mastered to be able to formulate correctly an answerable question. The need to modify the current description of the EBM process to increase the recognition of implicit assumptions and increase the consistency of this model is discussed. (shrink)

This book considers coercion within the healing and ethical framework of therapeutic relationships and partnerships at all levels, and addresses the universal ...

This book explores the ethical implications of managing uncertainty in clinical decision-making during the COVID-19 pandemic. It develops an ethics of clinical uncertainty that brings together insights from the clinical and biomedical ethical literatures. The book sets out to recognize the central role uncertainty plays in clinical decision-making and to acknowledge the different levels, kinds, and dimensions of clinical uncertainty. It also aims to aid clinicians and patients in managing clinical uncertainty, and (...) to recognize the ethical duty they have to manage clinical uncertainty. The book addresses four ethical duties related to clinical uncertainty: (1) the duty to advance the welfare of those in clinical medicine, (2) to respect the rights of those in clinical medicine, (3) to promote just access to health care, and (4) to care for one another in clinical medicine. These duties took on select urgency during the COVID-19 pandemic because clinical risk assessments about COVID-19 were limited, we were asked to give informed consent in the context of limited and changing knowledge, the pandemic unearthed myriad problems about the distribution of health care, and the pandemic raised questions about how we care for each other in medicine. An Ethics of Clinical Uncertainty will appeal to scholars, advanced students, and medical professionals working in philosophy of medicine, biomedical ethics, clinical medicine, nursing, public health care, and gerontology. (shrink)

Ethics boards have become obligatory passage points in today's medical science, and we forget how novel they really are. The use of humans in experiments is an age-old practice that records show goes back to at least the third century BC and, since the early modern period, as a practice it has become increasingly popular. Yet, in most countries around the world, hardly any formal checks and balances existed to govern the communal oversight of experiments involving human subjects until at (...) least the 1960s. Ethics by Committee traces the rise of ethics boards for human experimentation in the second half of the twentieth century. Using the Netherlands as a case-study, Noortje Jacobs shows how the authority of physicians to make decisions about clinical research gave way in most developed nations to formal mechanisms of communal decision-making that served to regiment the behavior of individual researchers. This historically unprecedented change in scientific governance came out of a growing international wariness of medical research in the decades after World War II. Research ethics committees were originally intended not only to make human experimentation more ethical but also to raise its epistemic quality. By examining complex negotiations over the appropriate governance of human subjects research, Ethics by Committee advances our understanding not only of the history of research ethics and the randomized controlled trial but also, more broadly, of how liberal democracies in the late twentieth century have sought to resolve public concerns over charged issues in medicine and science. (shrink)

This important volume covers ethics and integrity in health and life sciences research. It addresses concerns in gene editing, dual use and misuse of biotechnologies, big data and nutritional science in health and medicine, and covers attempts at ensuring ethical practices in such fields are shared internationally.

In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of (...) web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations. (shrink)

Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...

In clinical practice, modern medicine, especially intensive medicine, has made outstanding technological progress that has changed diagnostic and therapeutic paradigms. Nowadays, some patients for whom there were no treatments in the past not only survive but return to active life thanks to intensive medicine. However, in some cases intensive care will not help patients in a critical condition and merely prolong death. In such situations, the treatment is terminated or not extended, and the patient is allowed (...) to die in dignity. In this specific situation all intensive procedures are terminated. Palliative care is the next stage. This is a sensitive issue that should be discussed with healthcare professionals and experts from other areas of life to ensure it is communicated appropriately to patients and their relatives. (shrink)

This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law and (...) medicine, truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

The moral authority for professional ethics in medicine customarily rests in some source external to medicine, i.e., a pre-existing philosophical system of ethics or some form of social construction, like consensus or dialogue. Rather, internal morality is grounded in the phenomena of medicine, i.e., in the nature of the clinical encounter between physician and patient. From this, a philosophy of medicine is derived which gives moral force to the duties, virtues and obligations of (...) physicians qua physicians. Similarly, an ethic specific to the other healing professions, law, teaching or ministry, can be derived from the specific ends to telos of each of these professions, which like medicine, are focused on a special type of human relationship. (shrink)

Medicine is a scientific discipline, but it is sometimes difficult to separate what is scientific and what is a clinical, practical activity. Man is the object, but he is always the subject of medical research and therefore these two elements become closely bound together by a thread of moral interdependencies. Every mentor of a young academic and all institutions dealing with the teaching of and research into medicine must understand multidimensional, multifaceted, and multilevel aspects of (...) their activity and give them due regard in the educational process. The educational mission of an academic institution and of the teacher working there may be summed up in one phrase: Teach thinking! At the same time, the task of a school and the individual mentor is to teach the student to distinguish personal freedom from a lack of the feeling of responsibility. The medieval principle “Universitas magistrorum et scholarium”, and thus the corporation, the community of teachers and students, has not lost any of its relevance and value today. The situation is, in its far-reaching consequences, tragic in which the “insufficiently tutored teach”. Both physician and teacher, and especially physician-teacher, are not only professions, but also callings. (shrink)

Conflicts of interest are rampant in the American medical community. Today it is not uncommon for doctors to refer patients to clinics or labs in which they have a financial interest (40% of physicians in Florida invest in medical centers); for hospitals to offer incentives to physicians who refer patients (a practice that can lead to unnecessary hospitalization); or for drug companies to provide lucrative give-aways to entice doctors to use their "brand name" drugs (which are much more expensive than (...) generic drugs). In Medicine, Money and Morals, Marc A. Rodwin draws on his own experience as a health lawyer--and his research in health ethics, law, and policy--to reveal how financial conflicts of interest can and do negatively affect the quality of patient care. He shows that the problem has become worse over the last century and provides many actual examples of how doctors' decisions are influenced by financial considerations. We learn how two California physicians, for example, resumed referrals to Pasadena General Hospital only after the hospital started paying $70 per patient (their referrals grew from 14 in one month to 82 in the next). As Rodwin writes, incentives such as this can inhibit a doctor from taking action when a hospital fails to provide proper service, and may also lead to the unnecessary hospitalization of patients. We also learn of a Wyeth-Ayerst Labs promotion in which physicians who started patients on INDERAL (a drug for high blood pressure, angina, and migraines) received 1000 mileage points on American Airlines for each patient (studies show that promotions such as this have a direct effect on a doctor's choice of drug). Rodwin reveals why the medical community has failed to regulate conflicts of interest: peer review has little authority, state licensing boards are usually ignorant of abuses, and the AMA code of ethics has historically been recommended rather than required. He examines what can be learned from the way society has coped with the conflicts of interest of other professionals --lawyers, government officials, and businessmen--all of which are held to higher standards of accountability than doctors. And he recommends that efforts be made to prohibit and regulate certain kinds of activity (such as kickbacks and self-referrals), to monitor and regulate conduct, and to provide penalties for improper conduct. Our failure to face physicians' conflicts of interest has distorted the way medicine is practiced, compromised the loyalty of doctors to patients, and harmed society, the integrity of the medical profession, and patients. For those concerned with the quality of health care or medical ethics, Medicine, Money and Morals is a provocative look into the current health care crisis and a powerful prescription for change. (shrink)

What is health policy for? In Health and the Good Society, Alan Cribb addresses this question in a way that cuts across disciplinary boundaries. His core argument is that biomedical ethics should draw upon public health values and ethics; specifically, he argues that everybody has some share of responsibility for health, including a responsibility for promoting greater health equality. In the process, Cribb argues for a major rethink of the whole project of health education.

A Decent Proposal: Ethical Review of Clinical Research Donald Evans and Martyn Evans Centre for Philosophy and Health Care University of Wales Swansea, UK The investigation and development of modern medicines and medical technology can create numerous ethical dilemmas both for clinical researchers and research ethics committees. A Decent Proposal: Ethical Review of Clinical Research seeks to facilitate and encourage good clinical research by exploring the concerns, responsibilities, general issues and particular pitfalls associated (...) with ethical aspects of research. It provides practical guidelines for researchers on how to improve the quality of research design, while for those appointed to scrutinise research proposals it offers advice on how to apply consistent, careful and critical reasoning to the process of assessing ethical standards. As such, it will provide invaluable assistance to clinical researchers and ethics committees alike in understanding the moral challenges posed by modern health care. (shrink)

The importance of the collective management of immaterial resources is a key variable in the valorisation of products in a post-industrial economy. The purpose of this paper is to analyse how, in post-industrial economies, it is possible to devise alternative forms of mediation between producers and consumers, such as organic farmers' markets, to curb the appropriation of rent by transnational and/or local business elites from the value created by immaterial resources. More specifically, we analyse those aspects of the collective (...) management of ethical values that, in the case of organic farmers' markets, can be a strategic source of competitive advantage for local producers. In this paper, the Ecomercado de Granada is studied as an example of mediation between production and consumption in a post-industrial economy. (shrink)

Machine generated contents note: CHAPTER 1 HEALTH CARE PROFESSIONALS AND HIV: The Duty To WarnI -- CHAPTER 2 EMERGENCY CARE AND HIV: Treatment Policy and -- Pracice17 -- CHAPTER 3 A REVOLUTIONARY POLICY? Mandatory Disclosure of HIV -- Serostaus29 -- CHAPTER 4 MINORS AND HEALTH CARE: The Limits of Consent and -- Confidentiality39 -- CHAPTER 5 THE RIGHTS TO REFUSE AND DEMAND MEDICAL -- TREATMENT: The Bounds ofAutonomy andFutli{y47 -- CHAPTER 6 RELIGIOUS FREEDOM AND THE RIGHT TO REFUSE CARE: -- (...) What Are The Limits?65 -- CHAPTER 7 ASSISTED REPRODUCTIVE TECHNOLOGY: The Business of -- Making Babies 89 -- CHAPTER 8 TWINS AND TRANSPLANTS: Choosing Who Lives 113 -- CHAPTER 9 FREE ABORTION SERVICES AND FETAL TISSUE RESEARCH: -- Freedom of Choice and Coercion123 -- CHAPTER 10 PROPERTY RIGHTS, BODY PARTS, AND REPRODUCTION: -- Who Owns the Human Body? - 139 -- CHAPTER 11 OUTBREAK IN AMERICA: The Policy of Public Verses Private -- Interests 153 -- APPENDIX A CONFIDENTIALITY OF HIV TEST RESULTS: California Health -- and Safety Code Sections 120975 Through 121020169 -- APPENDIX B HEALTH CARE PROFESSIONALS AND HIV: Texas Health and -- Safety Code Section 58.204 175 -- APPENDIX C TARASOFF v, THE REGENTS OF THE UNIVERSITY OF -- CALIFORNIA: Supreme Court of California177 -- APPENDIX D THE RIGHTS OF MINORS TO CONSENT TO HEALTH CARE: -- California Family Code Sections 6903 Through 6929183 -- APPENDIX E FEDERAL DRUG AND ALCOHOL ABUSE CONFIDENTIALITY -- REGULATIONS: Title 42 Code of Federal Regulations Part 2 187 -- APPENDIX F CHILD ABUSE REPORTING LAWS: Caitfornia Penal Code -- Sections 11164 Through 11166 193. (shrink)

Books have their origins in conversations and seek to extend and expand those conversations over time and with different audiences. The conversations that have culminated in this book were initially stimulated through a research project at The Hastings Center on the role of religious voices in the professional fields of bioethical inquiry. Those professional conversations have continued throughout my academic career as a member of various institutional ethics committees, organizational ethics task forces, and in local, state, and national public policy (...) settings. The professional context of bioethics conversations can sometimes miss the richness of conversations that occur in the classroom and with various communities, including family members, friends, and religious and civic communities. These conversations provide an experiential depth, a groundedness in the lives and stories of persons, which augments and corrects the professionalized perspectives. I have been particularly fortunate and appreciative of opportunities to bridge the academic and professional with the personalized and communal through conversations about the ethical commitments and moral culture cultivated by The Church of Jesus Christ of Latter-day Saints (LDS or Mormon). I was invited to develop an overview essay on "Bioethics in Mormonism" for the professional reference work, Encyclopedia of Bioethics (3rd ed., 2004), and some years later received my first invitation to make a presentation on "LDS Ethics" in an academic setting at the University of Virginia. This book is the outgrowth of these many conversations and seeks to advance my communal bridging. My aim in this book is to begin bridging these various intersections between the LDS religious community and its moral culture, the professional fields of bioethics, and practical decision-making. This work seeks to be a catalyst for expanding discourse within the interdisciplinary field of Mormon studies to include ethics and bioethics. Ethics has not been a well-developed area in Mormon studies, in contrast to studies in LDS history, theology, or literature. To remedy this oversight, I present a substantive interpretation of the sources, theological background, and moral principles of LDS ethics. The historical narratives and conceptual intertwining I offer of both bioethics and of LDS moral culture is intended to complement and expand the realm of Mormon studies. A further objective is to create opportunities for reciprocal dialogues between the bioethics community and LDS scholarship. This conversation has yet to occur within academic disciplines, professional communities, or in public policy deliberations. My exposition, analysis, and critiques will intertwine and contextualize LDS moral values and health care practices within the ethical inquiry undertaken in the broader professional scholarship of bioethics. My arguments will disclose some points of common ground as well as areas of divergence towards the end of establishing the LDS faith tradition as a community of moral discourse for the bioethics field and the healing professions (medicine, nursing, pharmacy, etc.) it informs. My claim is that given its emerging cultural prominence, LDS ethical scholarship should engage in bioethical literacy and bioethics should be LDS-literate. I am also engaged in an effort to initiate more reflective dialogues regarding LDS ethics and moral culture among LDS scholars, LDS health care professionals, and the interested general LDS reader. The focus of the book on the interrelationship of religion, ethics, medicine, and health care should present for these various audiences new opportunities for mindful reflection and creative scholarship on the ethical implications of faith commitments, the responsibilities of the healing professions, and religious dimensions of public policy and public bioethics. A religious community that is formed through narratives and practices of covenantal commitments of love of neighbor needs to have a robust discourse about its ethical character. I have understood my scholarship in biomedical ethics and in religious ethics through a linking metaphor of my moral culture, of medicine, and the law, of bearing witness. The witness offers moral realities, moral truths about the way things are, vocalizes and embodies moral experience, and prophetically critiques the hypocrisies of the powerful and their oppression of the vulnerable by offering a new story, a re-storying, of tradition and conventional practice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the research (...) involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant (...) bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)

As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The rules (...) of behavior that may be considered to apply to today's pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality, safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is indeed hardly possible to maintain standards through regulation. Professor N.M. Graham Dukes, a physician and lawyer with long term experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change. *Provides a balanced picture of the current role of the pharmaceutical industry in society *Includes indices of conventions, laws, and regulations; as well as judicial and disciplinary cases *This is the only book addressing the legal implications of big pharma activities and ethical standards. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, (...) and with inadequate experimental methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, (...) and with inadequate experimental methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

Shows how international biomedical researchers in Sri Lanka work across cultural, epistemic, economic, and power differences to accomplish clinical trials.

Coercive medico-legal interventions are often employed to prevent people deemed to be unable to make competent decisions about their health, such as minors, people with mental illness, disability or problematic alcohol or other drug use, from harming themselves or others. These interventions can entail major curtailments of individuals' liberty and bodily integrity, and may cause significant harm and distress. The use of coercive medico-legal interventions can also serve competing social interests that raise profound ethical, legal and clinical questions. (...) Examining the ethical, social and legal issues involved in coerced care, this book brings together the views and insights of leading researchers from a range of disciplines, including criminology, law, ethics, psychology and public health, as well as legal and medical practitioners, social-service 'consumers' and government officials. Topics addressed in this volume include: compulsory treatment and involuntary detention orders in civil mental health and disability law; mandatory alcohol and drug treatment programs and drug courts; community treatment orders; the use of welfare cards with Indigenous populations; mandated treatment of seriously ill minors; as well as adult guardianship and substituted decision-making regimes. These contributions attempt to shed light on why we use coercive interventions, whether we should, whether they are effective in achieving the benefits that are offered to justify their use, and the impact that they have on some of society's most vulnerable citizens in the names of 'justice' and 'treatment'. This book is essential reading for clinicians, researchers and legal practitioners involved in the study and application of coerced care, as well as students and scholars in the fields of law, medicine, ethics and criminology. The collection asks important questions about the increasing use of coercive care that demand to be answered, and offers critical insights, guidance and recommendations for those working in the field. (shrink)

Faced with the exponential development of Big Data and both its legal and economic repercussions, we are still slightly in the dark concerning the use of digital information. In the perpetual balance between confidentiality and transparency, this data will lead us to call into question how we understand certain paradigms, such as the Hippocratic Oath in medicine. As a consequence, a reflection on the study of the risks associated with the ethical issues surrounding the design and manipulation of (...) this "massive data" seems to be essential. This book provides a direction and ethical value to these significant volumes of data. It proposes an ethical analysis model and recommendations to better keep this data in check. This empirical and ethico-technical approach brings together the first aspects of a moral framework directed toward thought, conscience and the responsibility of citizens concerned by the use of data of a personal nature. Defines Big Data applications in health Presents the ethical value of the medical datasphere via the description of a model of an ethical analysis of Big Data Provides the recommendations and steps necessary for successful management and governance of personal health data Helps readers determine what conditions are essential for the development of the study of Big Data. (shrink)

: Written to help the practicing health professional and students in the health professions decide whether to act on the reports of research projects that affect their practice, the book is geared to the professional consumer of research, not the performer of research. Discusses how to sort out principal types of clinical investigations, describe their strengths and weaknesses, list the main difficulties likely to occur with each, and deal with informed consent, vulnerable subjects, patients' rights, professional responsibility, and other (...) ethical concerns. (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

While certain substantial moral dilemmas in health care have been given much attention, like abortion, euthanasia or gene testing, doctors rarely reflect on the moral implications of their daily clinical work. Yet, with its aim to help patients and relieve suffering, medicine is replete with moral decisions. In this qualitative study we analyse how doctors handle the moral aspects of everyday clinical practice. About one hundred consultations were observed, and interviews conducted with (...) fifteen clinical doctors from different practices. It turned out that the doctors’ approach to clinical cases followed a rather strict pattern across specialities, which implied transforming patients’ diverse concerns into specific medical questions through a process of ‘essentialising’: Doctors broke the patient’s story down, concretised the patient’s complaints and categorised the symptoms into a medical sense. Patients’ existential meanings were removed, and the focus placed on the patients’ functioning. By essentialising, doctors were able to handle a complex and ambiguous reality, and establish a medically relevant problem. However, the process involved a moral as well as a practical simplification. Overlooking existential meanings and focusing on purely functional aspects of patients was an integral part of clinical practice and not an individual flaw. The study thus questions the value of addressing doctors’ conscious moral evaluations. Yet doctors should be aware that their daily clinical work systematically emphasises beneficence at the expense of others—that might be more important to the patient. (shrink)

Examining stem cell biology from a philosophy of science perspective, this book clarifies the field's central concept, the stem cell, as well as its aims, methods, models, explanations and evidential challenges. The first chapters discuss what stem cells are, how experiments identify them, and why these two issues cannot be completely separated. The basic concepts, methods and structure of the field are set out, as well as key limitations and challenges. The second part of the book shows how rigorous explanations (...) emerge from stem cell experiments, and compares these to other kinds of scientific explanation. Model organisms, the role of genes, and the significance of collaboration are also discussed. The last part of the book considers relations to systems biology and clinical medicine, arguing that both the mathematical models of the former, and ethical principles of the latter, are necessary for stem cell biology to deliver on its promises. (shrink)

The National Women's Hospital research scandal saw women being involved in medical research without their knowledge and without the opportunity to make a choice about their participation. The 1988 Cartwright Inquiry into this decades-long study established a template for ethics review in New Zealand. Ethics committees were subsequently established to independently assess the potential benefits as well as risks of research. This book describes the gradual undermining of the independence of New Zealand ethics review and the politicisation of ethics committees (...) between 1988 and 2014. The authors, involved continuously in ethics review matters over the period, have seen substantial change brought about by government in response to another medical research crisis - in Gisborne in the late 1990s - and then between 2008 and 2010 an economic crisis involving foreign pharmaceutical companies. Some New Zealand medical researchers claimed that the ethics review process for clinical trials was too slow and was losing the country its economic advantage. This book traces the changes and the implications for a robust ethics review process in all research environments in New Zealand, especially those affecting Maori. The book includes a set of suggestions and recommendations aimed at enhancing independent ethics review, best practice, and the provision of adequate protection for all citizens. (shrink)

Diminishing resources seem to be forcing rationing of medical services. Rationing the public health care system means that there needs to be ethical discussion on justice. Several years before resource allocation could impact on the levels of morbidity and mortality, economic problems created numerous methods of regulating medical and nursing services. In clinical practice, regularisation means a reduction of the possibility to decide autonomously and therefore requires specific ethical discussion. The different methods of regularisation from standards and (...) quality control to managed care are discussed with respect to their influence on medical thinking and decision making. Formalised decisions in severe disease can also be a field for regularisation, for example guidelines on the termination of life sustaining treatment (vs. Do-Not-Attempt-Resuscitation Orders). The debate on futility is discussed as a part of the economic discussion, with special regard to the impact of the macroeconomic situation on ”peripheral” medical decisions, which very often are made unconsciously, as shown by a new German study. It is impossible to discuss the influence of macroeconomy, different attempts at regularisation and the individual decision of the doctor without reflecting on their principle interdependency. Ethical reflection in this field cannot be sectioned into an economic, medical decision-making and futility sections. (shrink)

Dans la médecine occidentale, le patient fut longtemps conçu comme un enfant à sauver, incapable ne serait-ce que de recevoir, de manière raisonnable, le savoir du médecin. Après la seconde Guerre Mondiale, la découverte des expérimentations scientifiques intolérables menées sur l’homme, mais aussi le vent libéral et individualiste des années 60, le progrès des biotechnologies, la démocratisation des savoirs ont favorisé l’émergence d’un nouveau paradigme et d’une nouvelle discipline : la bioéthique. Aujourd’hui, le médecin ne peut plus imposer son traitement (...) au malade, il doit, par respect de son autonomie, chercher à obtenir son consentement libre et éclairé. Les normes médicales et sociales, autrefois coercitives, voire transcendantes, sont aujourd’hui discutées et interrogées au regard des préférences et des valeurs individuelles. Des comités d’éthique pluridisciplinaires sont chargés de prendre en compte les demandes des patients qui ne cessent de bousculer les normes établies. (shrink)

The sixth edition of the Manual for Research Ethics Committees is a unique compilation of legal and ethical guidance which will prove invaluable for members of research ethics committees, 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)

BackgroundThe issue of stigma is very important in the battle against HIV/aids in Africa since it may affect patient attendance at healthcare centres for obtaining antiretroviral medications and regular medical check-ups. Stigmatization creates an unnecessary culture of secrecy and silence based on ignorance and fear of victimization. This study was designed to determine if there is external stigmatization of people living with HIV and AIDS by health care workers at a tertiary hospital in KwaZulu-Natal province, South Africa. The study investigated (...) the impact of knowledge of HIV/aids by HCWs on treatment of patients, as well as the comfort level and attitude of HCWs when rendering care to PLWHA.MethodsA descriptive cross sectional study was designed to collect data using an anonymous self-administered structured questionnaire from 334 HCWs. The study was conducted in clinical departments of a large multidisciplinary 922-bed tertiary care teaching hospital in Durban, KZN.ResultsOverall HCWs had an above average knowledge about HIV/aids although some gaps in knowledge were identified. Tests of statistical significance showed that there was association between level of education and knowledge of HIV/aids ; occupation and knowledge of HIV/aids ; and gender and knowledge of HIV/aids. Test for comfort level was only significant for gender, with males showing more comfort and empathy when dealing with PLWHA. The study also revealed that patients were sometimes tested for HIV without informed consent before surgery, due to fear of being infected, and there was some gossiping about patients' HIV status by HCWs, thereby compromising patient confidentiality. The majority of HCWs showed a willingness to report incidents of stigmatization and discrimination to higher authorities, for better monitoring and control.ConclusionsAlthough knowledge, attitude and comfort level of HCWs taking care of PLWHA was above average, enforcement of existing antidiscrimination laws and continuing education in medical ethics and healthcare law, would greatly improve the performance of HCWs taking care of PLWHAs. More psychological support and counselling should be provided to HCWs, to further reduce the impact of stigmatization and discrimination against PLWHA. (shrink)

This book contains the results of two European/American preparatory workshops for the First World Conference on Ethics Codes in Medicine and Biotechnology (October 1997, Freiburg, Germany) supported by the leading national institutions in the field. It aims to stimulate research about codes, the effects of codification and other forms of implementing ethics. It breaks new ground with interdisciplinary and international discourse on the subject, emphasising the need for a complete collection of codes for systematic research and evaluation and filling (...) the gap in literature on the subject to date. (shrink)

Commercial genetic testing offered over the internet, known as direct-to-consumer genetic testing (DTC GT), currently is under ethical attack. A common critique aims at the limited validation of the tests as well as the risk of psycho-social stress or adaption of incorrect behavior by users triggered by misleading health information. Here, we examine in detail the specific role of advertising communication of DTC GT companies from a medical ethical perspective. Our argumentative analysis departs from the starting point that (...) DTC GT operates at the intersection of two different contexts: medicine on the one hand and the market on the other. Both fields differ strongly with regard to their standards of communication practices and the underlying normative assumptions regarding autonomy and responsibility. Following a short review of the ethical contexts of medical and commercial communication, we provide case examples for persuasive messages of DTC GT websites and briefly analyze their design with a multi-modal approach to illustrate some of their problematic implications. We observe three main aspects in DTC GT advertising communication: (1) the use of material suggesting medical professional legitimacy as a trust-establishing tool, (2) the suggestion of empowerment as a benefit of using DTC GT services and (3) the narrative of responsibility as a persuasive appeal to a moral self-conception. While strengthening and respecting the autonomy of a patient is the focus in medical communication, specifically genetic counselling, persuasive communication is the normal mode in marketing of consumer goods, presuming an autonomous, rational, independent consumer. This creates tension in the context of DTC GT regarding the expectation and normative assessment of communication strategies. Our analysis can even the ground for a better understanding of ethical problems associated with intersections of medical and commercial communication and point to perspectives of analysis of DTC GT advertising. (shrink)

Designer babies: choosing our children -- Haven't I seen you before? -- Exchange parts for everybody -- How to improve yourself -- Who wants to live forever? -- Big brother is watching your genome -- Something on your mind? -- Playing God -- Trust me, I'm a scientist!

In Science and Ethics, Bernard Rollin examines the ideology that denies the relevance of ethics to science. Providing an introduction to basic ethical concepts, he discusses a variety of ethical issues that are relevant to science and how they are ignored, to the detriment of both science and society. These include research on human subjects, animal research, genetic engineering, biotechnology, cloning, xenotransplantation, and stem cell research. Rollin also explores the ideological agnosticism that scientists have displayed regarding subjective experience (...) in humans and animals, and its pernicious effect on pain management. Finally, he articulates the implications of the ideological denial of ethics for the practice of science itself in terms of fraud, plagiarism, and data falsification. In engaging prose and with philosophical sophistication, Rollin cogently argues in favor of making education in ethics part and parcel of scientific training. (shrink)

There has been significant debate about whether the moral norms of medical practice arise from some feature or set of features internal to the discipline of medicine. In this article, I analyze Edmund Pellegrino’s conception of the internal morality of medicine, and situate it in the context of Alasdair MacIntyre’s influential account of “practice.” Building upon MacIntyre, Pellegrino argued that medicine is a social practice with its own unique goals—namely, the medical, human, and spiritual good of (...) the patient—and that the moral norms that govern medical practice are derived from these goals. After providing an overview of Pellegrino’s work, I discuss some forceful objections to his theory—specifically, that it is too rigid and incapable of entering into dialogue with contemporary values systems; that it is dependent on an external conception of human flourishing; and that it is incompatible with the rapidly changing nature of modern medicine. In the final section of this article, I consider how theorists working in the Hippocratic tradition might respond to these objections against ethical essentialism by drawing upon MacIntyre’s historico-cultural method as well as what he calls Aristotle’s “metaphysical biology.”. (shrink)