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)
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 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 book focuses on experimentation that is carried out on human beings, including medical research, drug research and research undertaken in the social sciences. It discusses the ethics of such experimentation and asks the question: who defends the interests of these human subjects and ensures that they are not harmed? The author finds that ethical research depends on the adequacy of review by committee. Indeed most countries now rely on research ethics committees for the protection (...) of the interests of the human participants in research. Dr McNeill analyses how successful these committees are in balancing the interests of science with the interests of human subjects. (shrink)
There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on (...) class='Hi'>human subjects is in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)
Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns (...) that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that arise when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging issues in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (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)
Bernard Rollin historically and conceptually 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 relevant to science and how they are ignored, to the detriment of both science and society. These issues 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. (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 ethics committees. 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 ethics committees. (shrink)
Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell research -- International research.
IRBs in action -- Everyone's an expert? Warrants for expertise -- Local precedents -- Documents and deliberations: an anticipatory perspective -- Setting IRBs in motion in Cold War America -- An ethics of place -- The many forms of consent -- Deflecting responsibility -- Conclusion: the making of ethical research.
Justice at Nuremberg traces the history of the Nuremberg Doctors' Trial held in 1946-47, as seen through the eyes of the Austrian bliogemigrbliogé psychiatrist Leo Alexander. His investigations helped the United States to prosecute twenty German doctors and three administrators for war crimes and crimes against humanity. The legacy of Nuremberg was profound. In the Nuremberg code--a landmark in the history of modern medical ethics--the judges laid down, for the first time, international guidelines for permissible experiments on humans. One of (...) those who helped to formulate the code was Alexander. Justice at Nuremberg provides a detailed insight into the origins of human rights in medical science and into the changing role of international law, ethics and politics. (shrink)
Machine generated contents note: Preface; Acknowledgements; 1. Why medicine needs moral leaders; 2. Creating an organizational narrative; 3. Understanding normative expectations in medical moral leadership; Prologue to chapters four and five; 4. Expressing fiduciary, bureaucratic and collegial propriety; 5. Expressing inquisitorial and restorative propriety; Epilogue to chapters four and five; 6. Understanding organizational moral narrative; 7. Moral leadership for ethical organizations; Appendix 1. How the research was done; Appendix 2. Accountability for clinical performance: individuals (...) and organisations; Appendix 3. A brief guide to commonly used ethical frameworks; Index. (shrink)
Up to the present, there have not been any specific norms regarding medically assisted human reproduction in Romanian legislation. Due to this situation the general legislation regarding medical assistance (law no. 95/2006, regarding the Reform in Health Care System), the Penal and Civil law and the provisions of the Code of Deontology of the Romanian College of Physicians are applied to the field of medically assisted human reproduction. By analysing the ethical and legal conflicts regarding medically assisted (...)human reproduction in Romania, some characteristics cannot be set apart because they derive from religious, cultural and socio-economic aspects. In this article the authors identify the development stages of medically assisted human reproduction in Romania, beginning from these characteristics and insisting upon the failure of the legal system in this specific field. The authors consider that the law regarding medically assisted human reproduction cannot be effective because it did not take into account the ethical and cultural aspects that might appear. Furthermore, in this framework of the legal process, no public debate involving the representatives of civil society was undertaken although the Council of Europe Oviedo Convention approved by our country according to law no. 17/2001 stipulated exactly this working method. Content Type Journal Article Pages 4-13 Authors Beatrice Ioan, PHD, MD, MA IN BIOETHICS, University of Medicine and Pharmacy, Iasi, Romania Vasile Astarastoae, PHD, MD, JD, University of Medicine and Pharmacy, Iasi, Romania Journal Human Reproduction & Genetic Ethics Online ISSN 2043-0469 Print ISSN 1028-7825 Journal Volume Volume 14 Journal Issue Volume 14, Number 2 / 2008. (shrink)
This essay explores some moral problems raised by experimentation involving the human fetus. In the first part of the essay three examples of fetal experimentation from the medical literature are described in some detail. Next, the ethical and legal arguments employed in the two major existing public policy-documents on fetal experimentation are analyzed. Finally, the author seeks to identify four fundamental presuppositions which underlie divergent normative positions on the problem of fetal experimentation.
Spectacular treatment disasters in recent years have made it clear that informal "let's-try-it-and-see" methods of testing new proposals are more risky now than ever before, and have led many to call for a halt to experimentation in clinical medicine. In this easy-tp-read, philosophical guide to humanexperimentation, William Silverman pleads for wider use of randomized clinical trials, citing many examples that show how careful trials can overturn preconceived or ill-conceived notions of a therapy's effectiveness and lead (...) to a clearer understanding of clinical anomalies. Because it gives careful guidance on setting up trials and avoiding conceptual pitfalls, this book will be of great interest to all epidemiologists and clinical statisticians, and to a wide varitey of clinicians, pharmacologists, and nurses. Since it requires no medical or statistical knowledge, it will also appeal to ethicists, lawyers, and the general public. (shrink)
Summary The author of the paper studies the ethical views of Matthias Bel expressed in his Preface to Johann Arndt's treatise and in Davidian-Solomonian Ethics, which contain a critique of false Christianity and ancient (especially Aristotle's) ethics. Bel refuses any philosophical ethics based on human nature, since man, in his very essence, is sinful and vicious. This leads to the general moral downfall of the young and mankind. He only recognises ethics whose source and the highest good (...) is God. He accepts ancient ethics as long as it is useful for achieving Christian moral values. Bel was a vociferous critic of the morality of the time; he adopted a highly negative stance towards the Jews and Gypsies living in the then Historical Hungary. The author considers Matthias Bel a confident, or enthusiastic, Pietist in the early period of his life and work; later, he rates him as a moderate Pietist. (shrink)
In the article, we analyse ethical and moral issues of public administration in region of Eastern Slovakia through some cases of the last years. We focused on self-governing regions, namely the Košice and Prešov self-governing regions. We identified two fundamental situations where failures on the side of public administrators occur: selection processes for vacant positions, be it directly in public administration or institutions that fall under its domain, and public procurement with regard to the acquisition of goods and (...) services. The year 2009 was the year of elections to self-governing regions which is why a great number of negative cases dealt with the election campaign. Further, we stated that negative cases dealt with failures of bodies of self-governing regions from both the legal (breaking the law) and moral viewpoint. By claiming that public administrators failed morally, we meant breaking moral norms and rules. Contradictions, which were identified (from the ethical viewpoint), predominantly result from the conflict between public and private interests. In many cases, private interests of public administrators are preferred at the expense of public interests. And it is exactly this preference (a conflict of interests) that is sensitively perceived by the public. (shrink)
This book provides an analysis of the debate surrounding cultural diversity, and attempts to reconcile the seemingly opposing views of "ethical imperialism," the belief that each individual is entitled to fundamental human rights, and cultural relativism, the belief that ethics must be relative to particular cultures and societies. The author examines the role of cultural tradition, often used as a defense against critical ethical judgments. Key issues in health and medicine are explored in the context of (...) cultural diversity: the physician-patient relationship, disclosing a diagnosis of a fatal illness, informed consent, brain death and organ transplantation, rituals surrounding birth and death, female genital mutilation, sex selection of offspring, fertility regulation, and biomedical research involving human subjects. Among the conclusions the author reaches are that ethical universals exist, but must not be confused with ethical absolutes. The existence of ethical universals is compatible with a variety of culturally relative interpretations, and some rights related to medicine and health care should be considered human rights. Illustrative examples are drawn from the author's experiences serving on international ethical review committees and her travels to countries in Africa, Asia, and Latin America, where she conducted educational workshops and carried out out her own research. (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.
Advances in genetic technology in general and medical genetics in particular will enable us to intervene in the process of human biological development which extends from zygotes and embryos to people. This will allow us to control to a great extent the identities and the length and quality of the lives of people who already exist, as well as those we bring into existence in the near and distant future. Genes and Future People explores two general philosophical questions, one (...) metaphysical, the other moral: (1) How do genes, and different forms of genetic intervention (gene therapy, genetic enhancement, presymptomatic genetic testing of adults, genetic testing of preimplantation embryos), affect the identities of the people who already exist and those we bring into existence? and (2) How do these interventions benefit or harm the people we cause to exist in the near future and those who will exist in the distant future by satisfying or defeating their interest in having reasonably long and disease-free lives? Genes and Future People begins by explaining the connection between genes and disease, placing genetic within a framework of evolutionary biology. It then discusses such topics as how genes and genetic intervention influence personal identity, what genetic testing of individuals and the knowledge resulting from it entails about responsibility to others who may be at risk, as well as how gene therapy and genetic enhancement can affect the identities of people and benefit or harm them. Furthermore, it discusses various moralaspects of cloning human beings and body parts. Finally, it explores the metaphysical and moral implications of genetic manipulation of the mechanisms of aging to extend the human life span.The aim Genes and Future People is to move philosophers, bioethicists, and readers in general to reflect on the extent to which genes determine whether we are healthy or diseased, our identities as persons, the quality of our lives, and our moral obligations to future generations of people. (shrink)
From an ethical standpoint, the goal of clinical research is to benefit patients. While individual investigations may not yield results that directly improve patients’ evaluation or treatment, the corpus of the research should lead in that direction. Without the goal of ultimate benefit to patients, such research fails as a moral enterprise. While this may seem obvious, the need to protect and benefit patients can get lost in the milieu of clinical research. Many advances in emergency medicine (...) have been based upon the results of research studies conducted both within the specialty and by others outside of the field. But has this research benefited patients? Has it followed the Hippocratic commitment “to do good or at least do no harm”? The answer is: yes, and no. This paper attempts to demonstrate this: first by citing advances from applied research that have benefited emergency department patients over the past three decades, and follows with some aspects of emergency medicine research that makes one question both its safety and its efficacy. While enormous gains have been made in patient care as a result of emergency medical research, ethical considerations complicate this rosy picture, and point to future areas of concern for researchers. (shrink)
Due to the rapid advances in medical technology, medical students are now being faced with increasingly complex and unparalleled ethical and practical dilemmas during their training. The new and future challenges of high-tech medicine demand improvements in current medical education, not only by meeting the needs of students through humanized training programs, but also by involving them in finding solutions to the ethical and legal quandaries they encounter. Today’s students of medical universities must acquire knowledge and understanding (...) of the ethical and legal issues relevant to the practice of medicine, and we have to do everything possible to introduce these students to the current discussions on more or less controversial ethical and legal topics. Although final answers may not be found, the very discussion, argumentation, and awakening of students’ interest should become an essential part of the core curriculum of every doctor. (shrink)
Rosalind Hursthouse carefully introduces one of three standard approaches in current ethical theory: utilitarianism, rights, and virtue ethics. She then proceeds to clearly explain how each approach encourages us to think about our treatment of animals. Every chapter is linked to a reading from a key exponent of each approach. With readings from Singer, Regan and Midgley.
This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and (...) dilemmas of our staff participants. We explore the views of our study participants in relation to two themes: (1) rights to information and anticipating how donors might be informed about future research findings and (2) occupational work goals and trust. (shrink)
What is the relationship between the self and society? Where do moral judgments come from? As Blakey Vermeule demonstrates in The Party of Humanity, such questions about sociability and moral philosophy were central to eighteenth-century writers and artists. Vermeule focuses on a group of aesthetically complicated moral texts: Alexander Pope's character sketches and Dunciad , Samuel Johnson's Life of Savage, and David Hume's self-consciously theatrical writings on pride and his autobiographical writings on religious melancholia. These writers and (...) their characters confronted familiar social dilemmas--sexual desire, gender identity, family relations, cheating, ambition, status, rivalry, and shame--and responded by developing a practical ethics about their own behavior at the same time that they refined their moral judgments of others. The Party of Humanity frames its discussion about emotions, social conflict, and aesthetics within two broad theories: the emerging field of evolutionary psychology and Kantian moral philosophy. By studying how eighteenth-century Britons experienced the demands of their social identities, Vermeule argues, we can better understand the most salient problems facing moral philosophy today--the issue of self-interest and the question of how moral norms are shaped by social agendas. (shrink)
Research that involves the creation of animals with human-derived parts opens the door to potentially valuable scientific and therapeutic advances, yet invokes unsettling moral questions. Critics and champions alike stand to gain from clear identification and careful consideration of the strongest ethical objections to this research. A prevailing objection argues that crossing the human/nonhuman species boundary introduces inexorable moral confusion (IMC) that warrants a restriction to this research on precautionary grounds. Though this objection may capture (...) the intuitions of many who find this research unsettling, it relies on mistaken views of both biology and moral standing, ultimately distorting the morally relevant facts. We critically examine IMC, identify mistaken essentialist assumptions, and reframe ethical concerns. The upshot is a stronger line of objection that encourages a more inclusive and productive ethical discourse. (shrink)
In The Ethical Primate, renowned philosopher Mary Midgley tackles important questions about human freedom and morality. Scientists and philosophers have found it difficult to understand how each human being can be both a living part of the natural world and, at the same time, a genuinely free agent. Midgley explores their responses to this seeming paradox and argues that our evolutionary origin, properly understood, explains why human freedom and morality have come about.
Current frameworks on ethical decision-making process have some limitations. This paper argues that the consideration of moral competencies, understood as moral virtues in the workplace, can enhance our understanding of why moral character contributes to ethical decision-making. After discussing the universal nature of four moral competencies (prudence, justice, fortitude and temperance), we analyse their influence on the various stages of the ethical decision-making process. We conclude by considering the managerial implications of our findings (...) and proposing further research. (shrink)
The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. (...) First-in-human trials, in particular, raise a number of ethical concerns including informed consent, subject recruitment and harm minimisation as well as the inherent uncertainty and risks which are involved in testing medical procedures on humans for the first time. These issues, while a feature of any human research, become more complex in the case of iPS cell therapy, given the seriousness of the potential risks, the unreliability of available animal models, the vulnerability of the target patient group, and the high stakes of such an intensely public area of science. Our paper will present a detailed case study of iPS cell replacement therapy for Parkinson's disease to highlight these broader ethical and epistemological concerns. If we accept that iPS cell technology is fraught with challenges which go far beyond merely refuting the potentiality of the stem cell line, we conclude that iPS cell research should not replace, but proceed alongside embryonic and adult somatic stem cell research to promote cross-fertilisation of knowledge and better clinical outcomes. (shrink)
Plutarch is virtually unique in surviving classical authors in arguing that animals are rational and sentient, and in concluding that human beings must take notice of their interests. Stephen Newmyer explores Plutarch's three animal-related treatises, as well as passages from his other ethical treatises, which argue that non-human animals are rational and therefore deserve to fall within the sphere of humanmoral concern. Newmyer shows that some of the arguments Plutarch raises strikingly foreshadow those found (...) in the works of such prominent animal rights philosophers as Peter Singer and Tom Regan in maintaining that non-human animals are the sorts of creatures that have intellectual qualities that cause them to be proper objects of man's concern, and have interests and desires that entitle them to respect from their human counterparts. This volume is groundbreaking in viewing Plutarch's views not only in the context of ancient philosophical and ethical thought, but in its place, generally overlooked, in the history of speculation on human-animal relations, and in pointing out how remarkably Plutarch differs from such predominantly anti-animal thinkers as the Stoics. (shrink)