The various statements and declarations of the World Medical Association that address conflicts of interest on the part of physicians as (1) researchers, and (2) practitioners, are examined, with particular reference to the October 2000 revision of the Declaration of Helsinki. Recent contributions to the literature, notably on conflicts of interest in medical research, are noted. Finally, key provisions of the American Medical Association’s Code of Medical Ethics (2000–2001 Edition) that address the various forms of conflict of interest that can (...) arise in the practice of medicine are outlined. (shrink)
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)
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)
Mit Beitragen von: Wolfgang U. Eckart, Christian Bonah, Wolfgang U. Eckart / Andreas Reuland, Alexander Neumann, Peter Steinkamp, Volker Roelcke, Anne ...
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)
Preliminary results of an empirical study of humanexperimentation practices are presented and contrasted with those of a survey conducted a hundred years ago when clinical research, although tolerated, was culturally deviant. Now that biomedical research is both authorized and controlled, its actors (sponsors, committees, investigators, subjects) come out with heterogeneous rationalities, and they appear to be engaged in a transactional process of negotiating their rationales with one another. In the European context protective of subjects, surprisingly the subjects (...) we interviewed (and especially patient-subjects) were creative and revealed an aptitude for integrating experimental medicine into common culture. (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 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)
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)
The first IVF baby was born in the 1970s. Less than 20 years later, we had cloning and GM food, and information and communication technologies had transformed everyday life. In 2000, the human genome was sequenced. More recently, there has been much discussion of the economic and social benefits of nanotechnology, and synthetic biology has also been generating controversy. This important volume is a timely contribution to increasing calls for regulation - or better regulation - of these and other (...) new technologies. Drawing on an international team of legal scholars, it reviews and develops the role of human rights in the regulation of new technologies. Three controversies at the intersection between human rights and new technology are given particular attention. First, how the expansive application of human rights could contribute to the creation of a brave new world of choice, where human dignity is fundamentally compromised; second, how new technologies, and our regulatory responses to them, could be a threat to human rights; and, third, how human rights could be used to create better regulation of these technologies. (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)
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.
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)
v. 1. Exterminative medicine in Nazi Germany and contemporary America -- v. 2. The language of exterminative medicine in Nazi Germany and contemporary America.
Introduction The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. Objective The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Methods Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a (...) retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Results Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1 – ethics in research (26); 2 – ethical procedures and advanced technology (46); 3 – ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. Conclusion The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical education, these findings are significant for curriculum change and modification plans in the future of Brazilian medical education. (shrink)
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 ...
"This is an extremely interesting and innovative collection with unusual empirical richness, with ethical and epistemological discussions cutting across ...
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.
For ten years, 1971–1981, the Institute onHuman Values in Medicine (IHVM) played a keyrole in the development of Bioethics as afield. We have written this history andanalysis to bring to new generations ofBioethicists information about the developmentof their field within both the humanitiesdisciplines and the health professions. Thepioneers in medical humanities and ethics cametogether with medical professionals in thedecade of the 1960s. By the 1980s Bioethics wasa fully recognized discipline. We show the rolethat IHVM programs played in defining thefield, (...) training faculty and helping schools todevelop programs. We review the beginnings ofthe IHVM in the crucible of social andtechnological change that led to theestablishment of the IHVM's parentorganization, the Society for Health and HumanValues. We then turn to the IHVM programsthrough which Faculty members receivedfellowships to explore new crossovers betweenthe humanities and the health professions. Wehave not only described the Fellows Program asit existed in 1973–1980, but have completed asurvey of the fellows a quarter of a centuryafter they held their fellowships. We describeother IHVM programs designed to facilitate theinitiation and development of new humanitiesprograms, to explore conceptual issues betweenmedicine and five humanities fields, to conductissue driven or educational method conferencesand to advance humanities programs intograduate education through the Directors ofMedical Education. (shrink)
Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading (...) cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)
This volume will collect Tom Beauchamp's 15 most important published articles in bioethics, most of which were published over the last 25 years, and most of ...
Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.
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.
The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to ...
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.
La obra recoge, desde una perspectiva interdisciplinar, las aportaciones de un grupo de investigadores españoles e italianos que han trabajado conjuntamente durante varios años en distintas cuestiones en torno a las posibilidades y riesgos de los avances biotecnológicos y su incidencia en el campo de los derechos humanos. Los estudios y debates se han realizado en el marco del programa de doctorado internacional sobre "Derechos humanos: Problemas actuales" encabezado por las Universidades de Valencia y Palermo. El Profesor Jesús Ballesteros, Catedrático (...) de Filosofía del Derecho en la Universidad de Valencia, ha sido el encargado de dirigir y coordinar este proyecto. (shrink)
Die Textsammlung bietet eine Zusammenstellung aller wichtigen Rechtstexte völkerrechtlicher, gemeinschaftsrechtlicher und nationaler Natur aus dem Bereich der humanen Biomedizin.
Relatively subtle forms of exploitation of human subjects may arise from the inefficiency or incompetence of a researcher, from the existence of a power imbalance between principal and subject, or from the uneven distribution of research risks among various segments of the population. A powerful and knowledgeable person (or institution) may perpetrate the exploitation of an unempowered and ignorant individual even without intending to. There is an ethical burden on the former to protect the interests of the vulnerable. Excessive (...) or insufficient compensation may be exploitative. However, genuine economic imperatives motivating needy volunteers have to be considered. These forms of exploitation should be appreciated in the context of social and cultural factors suggesting that the relationship between researcher and subject cannot properly be appraised as a contractual undertaking. While compliance with pertinent codes and regulations minimises the exploitative potential, they cannot be enforced in a way that does not recognise a society's peculiar characteristics. The experience with some Filipino cultural traits illustrates this point. (shrink)
The puzzling case of the broken arm -- Hernias, diets, and drugs -- Why physicians cannot know what will benefit patients -- Sacrificing patient benefit to protect patient rights -- Societal interests and duties to others -- The new, limited, twenty-first-century role for physicians as patient assistants -- Abandoning modern medical concepts: doctor's "orders" and hospital "discharge" -- Medicine can't "indicate": so why do we talk that way? --"Treatments of choice" and "medical necessity": who is fooling whom? -- Abandoning (...) informed consent -- Why physicians get it wrong and the alternatives to consent: patient choice and deep value pairing -- The end of prescribing: why prescription writing is irrational -- The alternatives to prescribing -- Are fat people overweight? -- Beyond prettiness: death, disease, and being fat -- Universal but varied health insurance: only separate is equal -- Health insurance: the case for multiple lists -- Why hospice care should not be a part of ideal health care I: the history of the hospice -- Why hospice care should not be a part of ideal health care II: hospice in a postmodern era -- Randomized humanexperimentation: the modern dilemma -- Randomized humanexperimentation: a proposal for the new medicine -- Clinical practice guidelines and why they are wrong -- Outcomes research and how values sneak into finding of fact -- The consensus of medical experts and why it is wrong so often. (shrink)
In his story entitled "Toenails," the surgeon Richard Selzer (1982) warns readers that total immersion in medicine is wrongheaded. Rather, to ensure their own health, doctors should discover other passions that permit them periodically to disconnect from medical practice. Selzer's surgeon character devotes his Wednesday afternoons to the public library, where he joins "a subculture of elderly men and women who gather … to read or sleep beneath the world's newspapers" (p. 69). Among these often eccentric personages is Neckerchief, (...) an arthritic man in his 80s who suffers from severe foot pain. His toenails, never trimmed because of his inability to reach them, have grown so long that they curve beneath his toes and .. (shrink)
Individualized care and equality of care remain two imperatives for formulating any scientifically and morally informed public health policy. Yet both continue to be elusive goals, even in the age of genomics, proteomics, and evidence-based medicine. Nonetheless, with the rapid growth and improvement of human biotechnologies, the need to individualize therapies while allocating medical care equally may result partly from our biological constitution. Human beings are all unique, and their biological differences significantly influence variability in disease causation (...) and therapeutic response to treatments. However, because humans have equal moral worth, there is no ethically justifiable reason to establish an a .. (shrink)
In this thesis, I give a metascientific account of causality in medicine. I begin with two historical cases of causal discovery. These are the discovery of the causation of Burkitt’s lymphoma by the Epstein-Barr virus, and of the various viral causes suggested for cervical cancer. These historical cases then support a philosophical discussion of causality in medicine. This begins with an introduction to the Russo- Williamson thesis (RWT), and discussion of a range of counter-arguments against it. Despite these, (...) I argue that the RWT is historically workable, given a small number of modifications. I then expand Russo and Williamson’s account. I first develop their suggestion that causal relationships in medicine require some kind of evidence of mechanism. I begin with a number of accounts of mechanisms and produce a range of consensus features of them. I then develop this consensus position by reference to the two historical case studies with an eye to their operational competence. In particular, I suggest that it is mechanistic models and their representations which we are concerned with in medicine, rather than the mechanism as it exists in the world. -/- I then employ these mechanistic models to give an account of the sorts of evidence used in formulating and evaluating causal claims. Again, I use the two human viral oncogenesis cases to give this account. I characterise and distinguish evidence of mechanism from evidence of difference-making, and relate this to mechanistic models. I then suggest the relationship between types of evidence presents us with a means of tackling the reference-class problem. This sets the scene for the final chapter. Here, I suggest the manner in which these two different classes of evidence become integrated is also reflected in the way that developing research programmes change as their associated causal claims develop. (shrink)
All the powerful influences exertedby the subjective-interpersonal dimension onthe organic or technical-functional dimensionof sickness and health do not make anintersubjective test concerning medicaltherapeutic results impossible. Theseinfluences are not arbitrary; on the contrary,they obey laws that are de facto sufficientlystable to allow predictions and explanationssimilar to those of experimental sciences.While, in this respect, the rules concerninghuman action are analogous to the scientificlaws of nature, they can at any time be revokedby becoming aware of them. Law-like andreproducible regularities in the sciences ofman (...) are by no means separated from a patient'spersonal-hermeneutic mediation. This makes itpossible for human beings to modify, improve orsometimes even entirely (or better almostentirely) suspend these psychological,sociological, ethnological, medical,regularities. For this reason the sciences ofman including medicine are under the obligationof constantly inspecting the continuingvalidity of the rules on which theirpredictions and explanations are based, namelyby indirect, statistical methods. Thisrequires a synergistic collaboration ofextra-clinical and clinical tests through whichmedicine can obtain a good level ofintersubjective testability. (shrink)
When Did I Begin? investigates the theoretical, moral, and biological issues surrounding the debate over the beginning of human life. With the continuing controversy over the use of in vitro fertilization techniques and experimentation with human embryos, these issues have been forced into the arena of public debate. Following a detailed analysis of the history of the question, Reverend Ford argues that a human individual could not begin before definitive individuation occurs with the appearance of the (...) primitive streak about two weeks after fertilization. This, he argues, is when it becomes finally known whether one or more human individuals are to form from a single egg. Thus, he questions the idea that the fertilized egg itself could be regarded as the beginning of the development of the human individual. The author also differs sharply, however, from those who would delay the beginning of the human person until the brain is formed, or until birth or the onset of conscious states. (shrink)
Addresses the issues at the heart of international medicine and social responsibility. A number of international declarations have proclaimed that health care is a fundamental human right. But if we accept this broad commitment, how should we concretely define the state’s responsibility for the health of its citizens? Although there is growing debate over this issue, there are few books for general readers that provide engaging accounts of critical incidents, practices, and ideas in the field of human (...) rights, health care, and medicine. Included in the book are case studies of such issues as AIDS among orphans in Romania, organ trafficking, prison conditions, health care rationing, medical research in the third world, and South Africa’s constitutionally guaranteed right of access to health care. It uses these topics to address themes of protection of vulnerable populations, equity and fairness in delivering competent medical care, informed consent and the free flow of information, and state responsibility for ensuring physical, mental, and social well-being. (shrink)
Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety (...) trial, subacute incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial. (shrink)
This article discusses the ethical and methodological issues associated with boredom experienced by human participants during psychological experiments. Ways are suggested in which informed consent, briefing, and debriefing can be used to prevent or remedy boredom induced during experiments. We address methodological and ethical concerns, and we discuss the advantages of the proposed approach for experimenters' practice and training of undergraduate students. Future directions for much needed research on these topics are also emphasized.
The case of women radium dial painters â women who tipped their brushes while painting the dials of watches and instruments with radioactive paint â has been extensively discussed in the medical and historical literature. Their painful and abhorrent deaths have occupied the interest of physicians, lawyers, politicians, military agencies, and the public. Hardly any discussion has concerned, however, the use of those women as experimental subjects in a number of epidemiological studies that took place from 1920 to 1990. This (...) article addresses the neglected issue of humanexperimentation in relation to the radium dial painters. Although womenâs medical examinations have been classified as simple, routine measurements of radiation burden on the body and presented as a great offer to humanity, for more than fifty years those women had been repeatedly used as experimental subjects without proper consent. I argue that through this case it becomes obvious that the issue of defining what counts as humanexperimentation shifts from an epistemological to a serious ethical and political question, concerning the making of scientific knowledge while issues of gender related to this process are also discussed. (shrink)
The often-emphasized tension between the singularity of the patient and technicalâscientific reproducibility in medicine cannot be resolved without a discussion of the epistemological and methodological status of the human sciences. On the one hand, the rules concerning human action are analogous to the scientific laws of nature. They are de facto sufficiently stable to allow predictions and explanations similar to those of experimental sciences. From this point of view, it is only a trivial truth, but still a (...) methodological irrelevancy, that the patient and the doctorâpatient relationship represent an ontologically irreproducible reality. On the other hand, however, one can never exclude that one can fail in the application of "laws" of the human sciences to the individual patient, for such laws are by no means wholly separated from a patient's personal-hermeneutic mediation, and can at any time be revoked by becoming aware of them. This requires a synergistic collaboration of clinical and statistical methods, and shows a methodologically relevant sense in which one cannot disregard the singularity of the patient. The reason for the crucial role of the patient's singularity in medicine is every individual patient's capacity to revoke, in principle, routines and quasi-automatisms, even though the personal mediation by the patient's consciousness de facto changes them in such a small degree that predictions and explanations modeled in experimental science remain possible. (shrink)
Although access to medicines is a vital feature of the right to the highest attainable standard of health (“right to health”), almost two billion people lack access to essential medicines, leading to immense avoidable suffering. While the human rights responsibility to provide access to medicines lies mainly with States, pharmaceutical companies also have human rights responsibilities in relation to access to medicines. This article provides an introduction to these responsibilities. It briefly outlines the new UN Guiding Principles on (...) Business and Human Rights and places the human rights responsibilities of pharmaceutical companies in this context. The authors draw from the work of the first UN Special Rapporteur on the right to the highest attainable standard of health, in particular the Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines that he presented to the UN General Assembly in 2008, and his UN report on GlaxoSmithKline (GSK). While the Guiding Principles on Business and Human Rights are general human rights standards applicable to all business entities, the Human Rights Guidelines for Pharmaceutical Companies consider the specific human rights responsibilities of one sector (pharmaceutical companies) in relation to one area of activity (access to medicines). The article signals the human rights responsibilities of all pharmaceutical companies, with particular attention to patent-holding pharmaceutical companies. Adopting a right-to-health “lens,” the article discusses GSK and accountability. The authors argue that human rights should shape pharmaceutical companies' policies, and provide standards in relation to which pharmaceutical companies could, and should, be held accountable. They conclude that it is now crucial to devise independent, accessible, transparent, and effective mechanisms to monitor pharmaceutical companies and hold them publicly accountable for their human rights responsibilities. (shrink)
This is the first re-publication and first English translation of regulations concerning HumanExperimentation which were binding law prior to and during the Third Reich, 1931 to 1945. The introduction briefly describes the duties of the Reichsgesundheitsamt, which formulated these regulations. It then outlines the basic concept of the Richtlinien for protecting subjects and patients on the one hand and for encouraging New Therapy and HumanExperimentation on the other hand. Major issues, like personal responsibility of (...) the physician or researcher, teaching of ethics of research and therapy, and research and therapy on vulnerable populations, are compared with the regulations in the Nuremberg Code and subsequent regulations influenced by the Nuremberg Code. CiteULike Connotea Del.icio.us What's this? (shrink)
This essay argues that making a diagnosis in medicine is essentially a hermeneutic enterprise, one in which interpretation skills play a major part in understanding a disease. The clinical encounter is an event comprised of two voices; one is the voice of science which is grounded in empiricism, the other is that of human experience, which is grounded in story-telling and the interpretation of those stories.Using two voices, one from the Diagnostic and Statistical Manual of Mental Disorders-III-Revised, which (...) describes alcohol abuse and alcohol dependence, and the other, that of Claire, a character in Edward Albee's play, A Delicate Balance, who is conversing with her brother-in-law, Tobias, I apply principles from Hans-Georg Gadamer's hermeneutics to the clinical diagnostic process. The essay will demonstrate that we overlook an enormous amount of information about alcoholism by an overreliance on objective data and that our hope for understanding alcoholics is in listening to their voices, and sharing the interpretation of their experiences with them. (shrink)
In the past, hypothesis testing in medicine has employed the paradigm of the repeatable experiment. In statistical hypothesis testing, an unbiased sample is drawn from a larger source population, and a calculated statistic is compared to a preassigned critical region, on the assumption that the comparison could be repeated an indefinite number of times. However, repeated experiments often cannot be performed on human beings, due to ethical or economic constraints. We describe a new paradigm for hypothesis testing which (...) uses only rearrangements of data present within the observed data set. The token swap test, based on this new paradigm, is applied to three data sets from cardiovascular pathology, and computational experiments suggest that the token swap test satisfies the Neyman Pearson condition. (shrink)
In this article, I argue that distinguishing ‘evolutionary’ from ‘Darwinian’ medicine will help us assess the variety of roles that evolutionary explanations can play in a number of medical contexts. Because the boundaries of evolutionary and Darwinian medicine overlap to some extent, however, they are best described as distinct ‘research traditions’ rather than as competing paradigms. But while evolu- tionary medicine does not stand out as a new scientific field of its own, Darwinian medicine is united (...) by a number of distinctive theoretical and methodological claims. For example, evolutionary medicine and Darwinian medicine can be distinguished with respect to the styles of evolutionary explanations they employ. While the former primarily involves ‘forward looking’ explanations, the latter depends mostly on ‘backward looking’ explanations. A forward looking explanation tries to predict the effects of ongoing evolutionary processes on human health and disease in contem- porary environments (e.g., hospitals). In contrast, a backward looking explanation typically applies evolutionary principles from the vantage point of humans’ distant biological past in order to assess present states of health and disease. Both approaches, however, are concerned with the prevention and control of human diseases. In con- clusion, I raise some concerns about the claim that ‘nothing in medicine makes sense except in the light of evolution’. (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 (...) class='Hi'>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)
In Medicine, Society, and Faith in the Ancient and Medieval Worlds Darrel Amundsen explores the disputed boundaries of medicine and Christianity by focusing on the principle of the sanctity of human life, including the duty to treat or attempt to sustain the life of the ill. As he examines his themes and moves from text to context, Amundsen clarifies a number of Christian principles in relation to bioethical issues that are hotly debated today. In his examination of (...) the moral stance of the earliest syphilographers, for example, he finds insights into the ethical issues surrounding the treatment of AIDS, which he believes has its closest historical antecedent not in plague but in syphilis. He also shows that the belief that all healing comes from God, whether directly, through prayer, or through the use of medicine -- a sentiment commonly held by contemporary Christians -- cannot be accurately attributed to any extant source from the patristic period. Indeed, all the Church Fathers were convinced that healing sometimes came from evil sources: Satan and his demons were able to heal, for example, and Asclepius was a demon "to be taken very seriously indeed.". (shrink)
This work brings together Philip van der Eijk's previously-published essays on the close connections that existed between medicine and philosophy throughout antiquity. Medical authors such as the Hippocratic writers, Diocles, Galen, Soranus and Caelius Aurelianus elaborated on philosophical methods such as causal explanation, definition and division and applied key concepts such as the notion of nature to their understanding of the human body. Similarly, philosophers such as Plato and Aristotle were highly valued for their contributions to medicine. (...) This interaction was particularly striking in the study of the human soul in its relation to the body, as illustrated by approaches to specific topics such as intellect, sleep and dreams, and diet and drugs. With a detailed introduction surveying the subject as a whole and a new essay on Aristotle's treatment of sleep, this wide-ranging and accessible collection is essential reading for the student of ancient philosophy and science. (shrink)
Kenneth F. Schaffner compares the practice of biological and medical research and shows how traditional topics in philosophy of science--such as the nature of theories and of explanation--can illuminate the life sciences. While Schaffner pays some attention to the conceptual questions of evolutionary biology, his chief focus is on the examples that immunology, human genetics, neuroscience, and internal medicine provide for examinations of the way scientists develop, examine, test, and apply theories. Although traditional philosophy of science has regarded (...) scientific discovery--the questions of creativity in science--as a subject for psychological rather than philosophical study, Schaffner argues that recent work in cognitive science and artificial intelligence enables researchers to rationally analyze the nature of discovery. As a philosopher of science who holds an M.D., he has examined biomedical work from the inside and uses detailed examples from the entire range of the life sciences to support the semantic approach to scientific theories, addressing whether there are "laws" in the life sciences as there are in the physical sciences. Schaffner's novel use of philosophical tools to deal with scientific research in all of its complexity provides a distinctive angle on basic questions of scientific evaluation and explanation. (shrink)
Medicine and families, two venerable institutions crucial to human well-being, are in crisis. The medical profession, struggling to control and equitably distribute care, finds itself compromised by its own success; families are shattered by divorce, violence and confusion about their own nature. What has gone unnoticed is the way these two powerful and pervasive spheres contribute to each other's loss of direction. The Patient in the Family diagnoses the ways in which the worlds of home and hospital misunderstand (...) each other. The authors explore how medicine, through its new reproductive technologies, is altering the structure of families, how families can participate more fully in medical decision-making, and how to understand the impact on families when medical advances extend life but not vitality . This book takes an unprecedented perspective on both institutions. Innovative and vivid, their stories tell the tales of families interacting with the medical establishment. (shrink)
United States military medical ethics 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 medical ethics 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 medical ethics are not established. Looking to the future, medicine and medical ethics have not articulated a vision for an ongoing military-civilian dialogue to ensure that standards of medical ethics do not evolve simply in accord with military exigency. (shrink)
Background The justification for Nazi programs involving involuntary euthanasia, forced sterilisation, eugenics and humanexperimentation were strongly influenced by views about human dignity. The historical development of these views should be examined today because discussions of human worth and value are integral to medical ethics and bioethics. We should learn lessons from how human dignity came to be so distorted to avoid repetition of similar distortions. Discussion Social Darwinism was foremost amongst the philosophies impacting views (...) of human dignity in the decades leading up to Nazi power in Germany. Charles Darwin's evolutionary theory was quickly applied to human beings and social structure. The term 'survival of the fittest' was coined and seen to be applicable to humans. Belief in the inherent dignity of all humans was rejected by social Darwinists. Influential authors of the day proclaimed that an individual's worth and value were to be determined functionally and materialistically. The popularity of such views ideologically prepared German doctors and nurses to accept Nazi social policies promoting survival of only the fittest humans. A historical survey reveals five general presuppositions that strongly impacted medical ethics in the Nazi era. These same five beliefs are being promoted in different ways in contemporary bioethical discourse. Ethical controversies surrounding human embryos revolve around determinations of their moral status. Economic pressures force individuals and societies to examine whether some people's lives are no longer worth living. Human dignity is again being seen as a relative trait found in certain humans, not something inherent. These views strongly impact what is taken to be acceptable within medical ethics. Summary Five beliefs central to social Darwinism will be examined in light of their influence on current discussions in medical ethics and bioethics. Acceptance of these during the Nazi era proved destructive to many humans. Their widespread acceptance today would similarly lead to much human death and suffering. A different ethic in needed which views human dignity as inherent to all human individuals. (shrink)
Medicine is unique in being a combination of natural science and human science in which both are essential. Therefore, in order to make sense of medical practice, we need to begin by drawing a clear distinction between the natural and the human sciences. In this paper, I try to bring the old distinction between the Geistes and Naturwissenschaften up to date by defending the essential difference between a realist explanatory theoretical study of nature including the body in (...) which the scientist discovers the causal properties of natural kinds and the interpretive understanding of human beings as embodied agents which, as Charles Taylor has convincingly argued, requires a hermeneutic account of self-interpreting human practices. (shrink)
Genomics has brought biology, medicine, agriculture, psychology, anthropology, and even philosophy to a new threshold. In this new context, the question about "what is human in humans" may end up being answered by geneticists, specialists of technoscience, and owners of biotech companies. The author defends, in this article, the idea that humanity is at risk in our age of genetic engineering, biotechnologies, and market-geared genetic research; he also argues that the values at the very core of our postgenomic (...) era bring to its peak the science-based ideology that has developed since the time of Galileo, Newton, Descartes, and Harvey; finally, it shows that the bioindustry has invented a new genomythology that goes against the scientific evidence produced by the research in human sciences in which life is interpreted as a language. (shrink)
This article provides an introduction to the articles in this theme issue. This collection examines epistemological, ontological, moral and political questions in medicine in light of the philosophical ideas of Charles Taylor. A synthesis of Taylor's relevant work is presented. Taylor has argued for a conception of the human sciences that regards human life as meaningful–deriving meaning from surrounding horizons of significance. An overview of the interdisciplinary articles in this issue is presented. This collection advances our thinking (...) in the philosophy of medicine as well as the philosophy of Charles Taylor. (shrink)
The tradition of anthropological medicine in philosophy of medicine is analyzed in relation to the earlier interest in epistemological issues in medicine around the turn of the century as well as to the current interest in medical ethics. It is argued that there is a continuity between epistemological, anthropological and ethical approaches in philosophy of medicine. Three basic ideas of anthropologically-oriented medicine are discussed: the rejection of Cartesian dualism, the notion of medicine as science (...) of the human person, and the necessity of a comprehensive understanding of disease. Next, it is discussed why the anthropological movement has been superseded by the increasing interest in medical ethics. It is concluded that the present-day moral issues cannot be interpreted and resolved without clarification of the underlying anthropological images. (shrink)
Medicine does not usually consider the human body from an aesthetic point of view. This article explores the notion of the lived body as aesthetic object in anthropological medicine, concentrating on the views of Buytendijk and Straus on human uprightness and gracefulness. It is argued that their insights constitute a counter-balance to the way the human body is predominantly approached in medicine and medical ethics. In particular, (1) the relationship between anthropological, aesthetic and ethical (...) norms, (2) the possible danger of a naturalistic fallacy, (3) the implications for the care of disabled people and (4) the intrinsic aesthetic quality of the human body are dealt with. (shrink)
The principal argument of the present paper is that the human body is as much a reflective formation of multiple discourses as it is an effect of natural and environmental processes. This paper examines the implications of this argument, and suggests that recognizing the body in this light can be illuminating, not only for our conception of the body, but also for our understanding of medicine. Since medicine is itself a discursive formation, a science with both a (...) history, and a future, it is argued that much can be learned by reflecting on the progression of models, or "paradigm-shifts,", in terms of which modern medicine has articulated the human body that figures at the heart of its discourse. Four historical periods of medicine will be considered, each one governed by its own distinctive paradigm. It is argued, finally, that, with the emergence of behavioural medicine, and, more particularly, psychoneuroimmunology, a new discursive formation in medicine, one can see a new conceptualization of the human body beginning to take shape; and that this new figure of the body makes it possible for the very first time to conceive the construction of testable hypotheses regarding correlations between the objective body of science and the phenomenological body of experienced meaning. Keywords: body of experienced meaning, discursive formation, immunocompetence, objective body, psychoneuro-immunology CiteULike Connotea Del.icio.us What's this? (shrink)
The development of the philosophy of medicine in the Federal Republic of Germany since 1945 is presented in a thematic form. The first two decades were characterized by the evolution of an anthropological school of thought that aimed at relating physician and patient in a more personal and existential form than had hitherto been the case. In the last years, this tendency to demand deeper psychic and broader social involvement with medical problems had increased. Somatic disorders were considered to (...) be fundamentally caused by socially induced mental stress. After a brief period during which the theme of organisms in general and phenomenologically grasped living-body of human beings in particular were discussed, there followed since the mid-seventies an essential preoccupation with the methodology and epistemology of medicine. According to this trend, medicine is to be analyzed in terms of the theory of action, with its conceptual and strategic orientation towards practice and not, as generally believed, towards the standards of scientific truth. The concepts of disease, diagnosis and therapy are therefore relative and their validity is dependent on time, persons and circumstances involved. Thus, the highest criteria of utility for medical actions cannot but be the affected patient and society. (shrink)