This book explores the tradition of the 'science of man' in French medicine of the era 1750-1850, focusing on controversies about the nature of the 'physical-moral' relation and their effects on the role of medicine in French society. Its chief purpose is to recover the history of a holistic tradition in French medicine that has been neglected because it lay outside the mainstream themes of modern medicine, which include experimental, reductionist, and localistic conceptions of health and disease. Professor Williams (...) also challenges existing historiography, which argues that the 'anthropological' approach to medicine was a short-term by-product of the leftist politics of the French Revolution. This work argues instead that the medical science of man long outlived the Revolution, that it spanned traditional ideological divisions, and that it reflected the shared aim of French physicians, whatever their politics, to claim broad cultural authority in French society. (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)
In a randomized clinical trial (RCT), a group of patients, initially assembled through a mixture of deliberation (involving explicit inclusion and exclusion criteria) and serendipity (which patients happen to walk into which doctor’s clinic while the trial is in progress), are divided by some random process into an experimental group (members of which will receive the therapy under test) and a control group (members of which will receive some other treatment – perhaps placebo, perhaps the currently standard treatment for (...) the condition at issue). In a ‘double blind’ trial neither the patient nor the clinician knows to which of the groups a particular patient belongs. The results of double blind randomized controlled trials are almost universally regarded as providing the ‘gold standard’ for evidence in medicine. Fairly extreme claims to this effect can be found in the literature. For example the statistician Tukey wrote (1977, p. 679) “almost the only source of reliable evidence [in medicine] … is that obtained from … carefully conducted randomised trials”. And the clinician Victor Herbert claimed (1977, p. 690) “..the only source of reliable evidence rising to the level of proof about the usefulness of any new therapy is that obtained from wellplanned and carefully conducted randomized, and, where possible, coded (double blind) clinical trials. [Other] studies may point in a direction, but cannot be evidence as lawyers use the term evidence to mean something probative … [that is] tending to prove or actually proving”. Finally, the still very influential movement in favour of ‘Evidence Based Medicine’ (EBM) that began at McMaster University in the 1980s was initially often regarded as endorsing the claim that only RCTs provide real scientifically telling evidence. (shrink)
Proponents of Evidence-based medicine (EBM) do not provide a clear role for basic science in therapeutic decision making. Of what they do say about basic science, most of it is negative. Basic science resides on the lower tiers of EBM’s hierarchy of evidence. Therapeutic decisions, according to proponents of EBM, should be informed by evidence from randomised studies (and systematic reviews of randomised studies) rather than basic science. A framework of models explicates the links between the mechanisms of basic science, (...)experimental inquiry, and observed data. Relying on the framework of models I show that basic science often plays a role not only in specifying experiments, but also analysing and interpreting the data that is provided. Further, and contradicting what is implied in EBM’s hierarchy of evidence, appeals to basic science are often required to apply clinical research to therapeutic questions. (shrink)
The nineteenth century science of teratology concerned itself with the study of malformations or “monstrosities”, as they were then called. The first major contribution to the field was the work of Isidore Geoffroy Saint-Hilaire, Histoire Generale et Particulière des Anomalies de l’Organisation chez l’Homme et les Animaux, published in 1832, whose classifications formed the basis for the later experimental science of teratogeny, the art of reproducing monstrosities in animal embryos. In this article, I will argue that recent developments in (...) the field of regenerative medicine can be situated in the tradition of teratological and teratogenic studies dating back to the nineteenth century. In particular, I will be interested in the historical link between studies in teratogenesis (the artificial production of teratomas) and stem cell research. Recent advances in stem cell research, I will suggest, return us to the questions that animated nineteenth century investigations into the nature of the monstrous or the anomalous. In the process, our most intuitive conceptions of “life itself” are undergoing a profound transformation. (shrink)
In the early eighteenth century, chemistry became the main academic locus where, in Francis Bacon's words, Experimenta lucifera were performed alongside Experimenta fructifera and where natural philosophy was coupled with natural history and 'experimental history' in the Baconian and Boyleian sense of an inventory and exploration of the extant operations of the arts and crafts. The Dutch social and political system and the institutional setting of the university of Leiden endorsed this empiricist, utilitarian orientation toward the sciences, which was (...) forcefully propagated by one of the university's most famous representatives in the first half of the eighteenth century, the professor of medicine, botany and chemistry Herman Boerhaave. Recent historical investigations on Boerhaave's chemistry have provided important insights into Boerhaave's religious background, his theoretical and philosophical goals, and his pedagogical agenda. But comparatively little attention has been paid to the chemical experiments presented in Boerhaave's famous chemical textbook, the Elementa chemiae, and to the question of how these experiments relate not only to experimental philosophy but also to experimental history and natural history, and to contemporary utilitarianism. I argue in this essay that Boerhaave shared a strong commitment to Baconian utilitarianism and empiricism with many other European chemists around the middle of the eighteenth century, in particular to what Bacon designated 'experimental history' and I will provide evidence for this claim through a careful analysis of Boerhaave's plant-chemical experiments presented in the Elementa chemiae. (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)
A broad range of evidence regarding the functional organization of the vertebrate brain – spanning from comparative neurology to experimental psychology and neurophysiology to clinical data – is reviewed for its bearing on conceptions of the neural organization of consciousness. A novel principle relating target selection, action selection, and motivation to one another, as a means to optimize integration for action in real time, is introduced. With its help, the principal macrosystems of the vertebrate brain can be seen to (...) form a centralized functional design in which an upper brain stem system organized for conscious function performs a penultimate step in action control. This upper brain stem system retained a key role throughout the evolutionary process by which an expanding forebrain – culminating in the cerebral cortex of mammals – came to serve as a medium for the elaboration of conscious contents. This highly conserved upper brainstem system, which extends from the roof of the midbrain to the basal diencephalon, integrates the massively parallel and distributed information capacity of the cerebral hemispheres into the limited-capacity, sequential mode of operation required for coherent behavior. It maintains special connective relations with cortical territories implicated in attentional and conscious functions, but is not rendered nonfunctional in the absence of cortical input. This helps explain the purposive, goal-directed behavior exhibited by mammals after experimental decortication, as well as the evidence that children born without a cortex are conscious. Taken together these circumstances suggest that brainstem mechanisms are integral to the constitution of the conscious state, and that an adequate account of neural mechanisms of conscious function cannot be confined to the thalamocortical complex alone. (Published Online May 1 2007) Key Words: action selection; anencephaly; central decision making; consciousness; control architectures; hydranencephaly; macrosystems; motivation; target selection; zona incerta. (shrink)
This article explores Galen's analysis of and response to the Rationalist and Empiricist medical sects. It argues that his interest in their debate concerning the epistemology of medicine and anatomy was key to his advancement of an experimental methodology.
Preliminary results of an empirical study of human experimentation 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)
Background: The experimental method to acquire knowledge about efficacy and efficiency of medical procedures is well established in evidence-based medicine. A method to attain evidence about the significance of diseases and interventions from the patients' perspectives taking into account their right to self-determination about their lives and bodies has however not been sufficiently characterized.Design: Identification of a method to acquire evidence about the clinical significance of disease and therapeutic options from the patients' perspectives.Arguments: Communication between patient and physician is (...) analyzed as the method to attain evidence about what is at stake for individual patients in disease and therapy. It is the method that enables physicians to directly take into account patients' disease experiences and their aims regarding treatments. These patients' perspectives in turn determine the clinical significance of diagnoses and therapeutic options, if patient-autonomy is taken seriously.Conclusions: A full account of evidence-based medicine needs to include experimentation and communication between physician and patient as equally important methods to attain evidence necessary to practice patient-oriented medicine. The communicative method is especially important for primary physicians as they direct patients within the medical system to have their medical problems most effectively and efficiently addressed. (shrink)
This article outlines in details specific experiments that Galen performed. It explores how his methodology for experimentation was a sophisticated response to the rationalist-empirist debate as it occurred in ancient medicine. -/- .
In his concept of an anthropological physiology, F.J.J. Buytendijk has tried to lay down the theoretical and scientific foundations for an anthropologically-oriented medicine. The aim of anthropological physiology is to demonstrate, empirically, what being specifically human is in the most elementary physiological functions. This article contains a sketch of Buytendijk''s life and work, an overview of his philosophical-anthropological presuppositions, an outline of his idea of an anthropological physiology and medicine, and a discussion of some episternological and methodological problems. It is (...) demonstrated that Buytendijk''s design of an anthropological physiology is fragmentary and programmatic and that his methodology offers few points of contact for specific anthropological experimental research.Notwithstanding, it is argued that Buytendijk''s description of the subjective, animated body forms a pre-eminent point of reference for all research in physiology and psychology in which the specific human aspect is not ignored beforehand. (shrink)
Obesity is the focus of multiple lines of inquiry that have -- together and separately -- produced many deep insights into the physiology of weight gain and maintenance. We examine three such streams of research and show how they are oriented to obesity intervention through multilevel integrated approaches. The first research programme is concerned with the genetics and biochemistry of fat production, and it links metabolism, physiology, endocrinology and neurochemistry. The second account of obesity is developmental and draws together epigenetic (...) and environmental explanations that can be embedded in an evolutionary framework. The third line of research focuses on the role of gut microbes in the production of obesity, and how microbial activities interact with host genetics, development and metabolism. These interwoven explanatory strategies are driven by an orientation to intervention, both for experimental and therapeutic outcomes. We connect the integrative and intervention-oriented aspects of obesity research through a discussion of translation, broadening the concept to capture the dynamic, iterative processes of scientific practice and therapy development. This system-oriented analysis of obesity research expands the philosophical scrutiny of contemporary developments in the biosciences and biomedicine, and has the potential to enrich philosophy of science and medicine. (shrink)
Luigi Sacco (1769–1863) was the main protagonist of early vaccination campaign in Italy. He found a native source of vaccine lymph: with that, he personally vaccinated more than 500,000 people and furnished all Italy and some Middle East countries too. Starting from the pictures of his books, Sacco proposed to create wax models of real and spurious smallpox pustules in human, cow, sheep and horse; just to permit, not only to doctors, but also to all other health operators, the identification (...) of the right pustules from where to extract active lymph for vaccination. In the Museum of Pathological Anatomy of the Padua University Medical School, we have four anatomical waxes which corresponded exactly to the explicative pictures in 1809 Sacco’s treatise on Vaccine. We have found the same models also at the University of Milan, Pavia and Bologna—the main cities of Cisalpine Republic , the state of North Italy formed at the epoch of Sacco following the Napoleon conquest. The history of the diffusion of these models presented in this text will be a starting point to develop wider questions. In particular, this history could be useful to improve our understanding of the birth of scientific and experimental medicine through XIX and XX Century. (shrink)
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 human experimentation 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 human experimentation 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)
This paper explores the scientific production of experimental wounds, suggesting that these scientific research programs illuminate the consequences of the historical relationship between technical knowledge production and the state's monopoly on violence.
Obesity is the focus of multiple lines of inquiry that have -- together and separately -- produced many deep insights into the physiology of weight gain and maintenance. We examine three such streams of research and show how they are oriented to obesity intervention through multilevel integrated approaches. The first research programme is concerned with the genetics and biochemistry of fat production, and it links metabolism, physiology, endocrinology and neurochemistry. The second account of obesity is developmental and draws together epigenetic (...) and environmental explanations that can be embedded in an evolutionary framework. The third line of research focuses on the role of gut microbes in the production of obesity, and how microbial activities interact with host genetics, development and metabolism. These interwoven explanatory strategies are driven by an orientation to intervention, both for experimental and therapeutic outcomes. We connect the integrative and intervention-oriented aspects of obesity research through a discussion of translation, broadening the concept to capture the dynamic, iterative processes of scientific practice and therapy development. This system-oriented analysis of obesity research expands the philosophical scrutiny of contemporary developments in the biosciences and biomedicine, and has the potential to enrich philosophy of science and medicine. (shrink)
Claude Bernard's concept of the internal environment ( milieu intérieur ) played a crucial role in the development of experimental physiology and the specific medical therapeutics derived from it. This concept allowed the experimentalist to approach the organism as fully determined yet relatively autonomous with respect to its external environment. However, Bernard's theory of knowledge required that he find organismic functioning as the result of an external necessity. He is therefore unable to explain adequately the origin or operation of (...) organismic autonomy. A more complete conception of biological autonomy must include a theory of knowledge that can accommodate the organism as a source of discrimination and determination. Only in this way will it be possible to see organisms as active as well as reactive, as ordering as well as ordered. This shift in perspective is crucial if medicine is to be able to characterize, for example, susceptibility to disease. A cognitive sense of the organic interior is proposed as an alternative to Bernard's internal environment. Keywords: biological autonomy, Claude Bernard, epistemology, internal environment ( milieu intérieur ) CiteULike Connotea Del.icio.us What's this? (shrink)
Taking the Royal College of Barcelona (1760–1843) as a case study, this paper shows the development of modern surgery in Spain initiated by the Bourbon Monarchy when they founded new kinds of institutions as academic activities to spread scientific knowledge. Antoni Gimbernat was the most famous internationally recognised Spanish surgeon. He was trained as a surgeon at the Royal College of Surgery in Cadiz and was later appointed Professor of Anatomy at the College of Barcelona. He then became Royal Surgeon (...) of King Carlos IV, and with that esteemed position in Madrid, he worked relentlessly to improve the quality of the Royal Colleges in Spain. Learning human body structure by performing hands-on dissections in the anatomical theatre has become a fundamental element of modern medical education. Gimbernat favoured the study of natural sciences, the new chemistry of Lavoisier and experimental physics in the academic programmes of surgery. According to the study of a very relevant set of documents preserved in the library, the so-called “juntas literarias”, among the main subjects debated in the clinical sessions was the concept of human beings and diseases in relation to the development of the new experimental sciences. These documents showed that chemistry and experimental physics were considered crucial tools to understand the unexplained processes that occurred in the diseased and healthy human body and in a medico-surgical context. It is important to stress that through these manuscripts, we can examine the role and the reception of the new sciences as they were applied to the healing arts. (shrink)
A search for consensus about the methodology of discovery among physicians and physiologists led the author to identify a crucial anomaly of medical historiography: in general, physicians stress the significance of clinicopathologic method, while physiologists emphasize the experimental. Hence, physicians and bench scientists might be perceived as members of epistemically distinct research traditions. However, analysis of the historical development of discoveries in medicine, exemplified by case studies in physiology, bacteriology, immunology, and therapeutics, reveals that the epistemic dichotomy is (...) illusory. Both physicians and bench scientists discover in the same way: by identifying and explaining clinical anomalies. It is argued that the sociological role of experimentation is to dramatize clinical hypotheses and not test them in a Popperian sense. Keywords: accident, anomaly, continuity, experiment, logic of discovery, psycholinguistic realm CiteULike Connotea Del.icio.us What's this? (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 human experimentation, 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)
The invocation of moral rights in moral/social debate today is a recipe for deadlock in our consideration of substantive issues. How we treat animals and humans in part should derive from the value of their lives, which is a function of the quality of their lives, which in turn is a function of the richness of their lives. Consistency in argument requires that humans with a low quality of life should be chosen as experimental subjects over animals with a (...) higher quality of life. (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)
Reshaping the neo-Aristotelian doctrines about the human soul was Descartes’s most spectacular enterprise, which gave birth to some of the sharpest debates in the Republic of Letters. Neverthe- less, it was certainly Descartes’s intention, as already expressed in the Discours de la méthode, to show that his new metaphysics could be supplemented with experimental research in the field of medicine and the conservation of life. It is no surprise then that several natural philosophers and doctors, such as Henricus Regius (...) from Utrecht, who had studied in Padua with William Harvey, rallied in support, in order to gain a more substantial theoretical basis for their research. Taking as his ground some general metaphysical assumptions, such as the existence of God, the immortality of the soul, and perhaps the separability of the pure understanding, Regius intended to secure a new philosophy of man, which was able to reflect his medical interests and complement his account of human nature. This is the story that is now gaining currency, and it is surely accurate, at least in part. Desmond Clarke has recently defended the same view1, based on the remarkable studies of the Utrecht scholars Theo Verbeek and Erik-Jan Bos. Here I would like to challenge some aspects of this view and ask how Regius, who was perceived as the philosopher most closely associated with Descartes, became a betrayer of his mentor. (shrink)
In this article ethical issues are discussed which play a role in pharmacogenetics. Developments in pharmacogenetics have a large impact on many different practices such as clinical trials, the practice of medicine and society at large. In clinical trials, questions rise regarding the exclusion of genetic subgroups that may be non- or poor-responders to the experimental drug. Also, the question is asked how pharmaceutical companies should deal with their growing knowledge about the relations between genetic variation and adverse effects. (...) Moreover, pharmacogenetics may provide disease-specific predictive information which may have a significant impact on the relations between physicians, patients and their relatives in the practice of medicine. Here, issues also arise regarding responsibility of patients and physicians for health and disease. In the society at large, the high costs of new pharmacogenetic possibilities lead to questions concerning solidarity and fair distribution on a national as well as an international level. It is concluded that in the near future, ethical research should be focused on the themes responsibility, inclusion and exclusion and global justice. (shrink)
Aircraft with increasingly high performance were important to the war effort in World War II. Changes in technology allowed aircraft to reach faster speeds and to complete missions at higher altitudes. With these changes came new obstacles for pilots who had to tolerate these stresses. Of primary concern to the U.S. War Department was the loss of consciousness that often occurred with high-speed maneuvers and especially during pull-up after dive-bombing missions. In some cases, pilots would experience up to 9G of (...) force during rapid ascent, much more than the 6G threshold that typically leads to loss of consciousness. In 1941, a research team in Red Wing, MN, proposed experiments to elucidate the mechanism .. (shrink)
In few other areas of bioethical inquiry exists as close a connection between bioethical professional advice and policy development as is the case with HIV and AIDS. Historically, the reasons for this have much to do with one of the groups initially affected most severely by HIV and AIDS, namely well-educated middle-class gay men in developed countries. This particular group of people, highly sophisticated and used to political activism in its pursuit of civil rights-related objectives, engaged the medical profession as (...) well as regulatory agencies such as the US Food and Drug Administration, and legislators (more so in the USA than in other countries) in a number of bioethically interesting policy areas. Many of the controversies of the times were framed as civil rights and/or ethical disputes. The initial areas of concern and inquiry focused on: informed consent to HIV testing and trial participation, the confidentiality of HIV test results, access to trials as a means of access to experimental drugs, the length of time it took to get an experimental drug to the market approval stage, and end-of-life decision-making. This line-up of issues explains why AIDS has become such an interesting topic for bioethicists. Bioethicists concerned about the traditional breadand- butter themes of medical ethics themes of the doctor - patient relationship (e.g., Daniels, 1991; Boyd, 1992), as well as bioethicists more concerned about policy and regulatory issues in the drug research and approval process (e.g., Edgar & Rothman, 1990; Salisbury & Schechter, 1990), found research topics worthy of vigorous pursuit. No surprise, then, that HIV/AIDS led to a probably unprecedented number of books and articles in professional journals (Manuel et al., 1990). HIV/AIDS has become a permanent fixture in all major mainstream bioethics textbooks (e.g., Kuhse & Singer, 1998; Arras & Steinbock, 1999). Reference series in medicine, ethics and law provide for dedicated volumes on AIDS.1 Even specialist bioethics textbooks, for instance those directed at dentistry students, carry chapters on HIV/AIDS (Ozar & Sokol, 2002). 128 Udo Schuklenk AIDS, designated by the medical profession a pandemic lives up to its classification. It did not stop at the borders of developed countries. As one would expect of a primarily sexually transmitted illness in the age of globalisation, it spread rapidly across the globe. Indeed, in many countries it has become one of the main causes of death, as in sub- Saharan Africa (Shisana & Simbayi, 2002). Dramatic increases in the number of AIDS cases are predicted for many Eastern European countries as well as for the two most populous nations on earth, India and China. Some of the HIV/AIDS-related bioethical and policy issues of concern to developed countries remain the same for developing countries. However, in ethically important ways they are dwarfed by concerns over drug prices, intellectual property rights, and affordable access to essential AIDS drugs for the impoverished masses of infected people in such countries. Of increasing importance have become ethical issues pertaining to the ever-growing research industry associated with clinical trials undertaken in developing countries. Indeed, major funding initiatives both in the USA and UK have brought clinical research in developing countries into focus. Some have questioned whether this attention is appropriate, considering other bioethical problems of arguably greater importance to developing countries (Chadwick & Schuklenk, 2003). Standards of clinical care in a study, and after a trial has concluded, as well as community benefits and access to the trial regime after the trial's conclusion remain contentious issues. It is worth noting that more often than not it was an AIDS-related trial or policy decision that led to a great deal of bioethical analysis, yet the issues discussed almost always have ramifications far beyond AIDS. For instance, decisions about the question of what (if any) standards of care failures in preventive trials (of HIV vaccines or microbicides) ought to receive have important implications for non-AIDS prevention trials. (shrink)
The homeopathic principle of similitude is not based on the principle of vaccination but on the more general principle of inversion of effects, a widespread medical phenomenon. Based on the systemic networks which play an important role in response to stress, this principle concerns the reorganization of regulation systems, through a coherent response to the medicine. This model is backed by a large number of published studies from our laboratory and others, by toxicological evidence such as the emerging fields of (...) ‘hormesis’, of neuropharmacology, and of systems biology. The immune system is just one example of the possible application of this law of similitude, which constitutes the true ‘heart’ of the homeopathic idea, and again ethically justifies the attempt to apply it to experimental pharmacology. (shrink)
The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important (...) changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)
Given the possibilities of synthetic biology, weapons of mass destruction and global climate change, humans may achieve the capacity globally to alter life. This crisis calls for an ethics that furnishes effective motives to take global action necessary for survival. We propose a research program for understanding why ethical principles change across time and culture. We also propose provisional motives and methods for reaching global consensus on engineering field ethics. Current interdisciplinary research in ethics, psychology, neuroscience and evolutionary theory grounds (...) these proposals. Experimental ethics, the application of scientific principles to ethical studies, provides a model for developing policies to advance solutions. A growing literature proposes evolutionary explanations for moral development. Connecting these approaches necessitates an experimental or scientific ethics that deliberately examines theories of morality for reliability. To illustrate how such an approach works, we cover three areas. The first section analyzes cross-cultural ethical systems in light of evolutionary theory. While such research is in its early stages, its assumptions entail consequences for engineering education. The second section discusses Howard University and University of Puerto Rico/Mayagüez (UPRM) courses that bring ethicists together with scientists and engineers to unite ethical theory and practice. We include a syllabus for engineering and STEM (Science, Technology, Engineering and Mathematics) ethics courses and a checklist model for translating educational theory and practice into community action. The model is based on aviation, medicine and engineering practice. The third and concluding section illustrates Howard University and UPRM efforts to translate engineering educational theory into community action. Multidisciplinary teams of engineering students and instructors take their expertise from the classroom to global communities to examine further the ethicality of prospective technologies and the decision-making processes that lead to them. (shrink)
You recognize when you know something for certain, right? You "know" the sky is blue, or that the traffic light had turned green, or where you were on the morning of September 11, 2001--you know these things, well, because you just do. In On Being Certain , neurologist Robert Burton challenges the notions of how we think about what we know. He shows that the feeling of certainty we have when we "know" something comes from sources beyond our control and (...) knowledge. In fact, certainty is a mental sensation, rather than evidence of fact. Because this "feeling of knowing" seems like confirmation of knowledge, we tend to think of it as a product of reason. But an increasing body of evidence suggests that feelings such as certainty stem from primitive areas of the brain, and are independent of active, conscious reflection and reasoning. The feeling of knowing happens to us; we cannot make it happen. Bringing together cutting edge neuroscience, experimental data, and fascinating anecdotes, Robert Burton explores the inconsistent and sometimes paradoxical relationship between our thoughts and what we actually know. Provocative and groundbreaking, On Being Certain , will challenge what you know (or think you know) about the mind, knowledge, and reason. ROBERT BURTON, M.D. graduated from Yale University and University of California at San Francisco medical school, where he also completed his neurology residency. At age 33, he was appointed chief of the Division of Neurology at Mt. Zion-UCSF Hospital, where he subsequently became Associate Chief of the Department of Neurosciences. His non-neurology writing career includes three critically acclaimed novels. He lives in Sausalito, California. Visit his website at http://www.rburton.com/ “What do we do when we recognize that a false certainty feels the same as certainty about the sky being blue? A lesser guide might get bogged down in nail-biting doubts about the limits of knowledge. Yet Burton not only makes clear the fascinating beauty of this tangled terrain, he also brings us out the other side with a clearer sense of how to navigate. It's a lovely piece of work; I'm all but certain you'll like it. “ --David Dobbs, author of Reef Madness; Charles Darwin, Alexander Agassiz, and the Meaning of Coral “Burton has a great talent for combining wit and insight in a way both palatable and profound.” --Johanna Shapiro PhD, professor of Family Medicine at UC Irvine School of Medicine “A new way of looking at knowledge that merits close reading by scientists and general readers alike.” -- Kirkus “This could be one of the most important books of the year. With so much riding on ‘certainty,’ and so little known about how people actually reach a state of certainty about anything, some plain speaking from a knowledgeable neuroscientist is called for. If Gladwell's Blink was fascinating but largely anecdotal, Burton's book drills down to the real science behind snap judgments and other decision-making.” -- Howard Rheingold, futurist and author of Smart Mobs “A fascinating read. Burton’s engaging prose takes us into the deepest corners of our subconscious, making us question our most solid contentions. Nobody who reads this book will walk away from it and say ‘I know this for sure’ ever again.” --Sylvia Pagán Westphal, science reporter, The Wall Street Journal “Burton provides a compelling and though-provoking case that we should be more skeptical about our beliefs. Along the way, he also provides a novel perspective on many lines of research that should be of interest to readers who are looking for a broad introduction to the cognitive sciences.” -- Seed Magazine. (shrink)
Non-invasive brain stimulation promises innovative experimental possibilities for psychology and neurosci- ence as well as new therapeutic and palliative measures in medicine. Because of its good risk–benefit ratio, non-invasiveness and reversibility as well as its low effort and cost it has good chances of becoming a wide- spread tool in science, medicine and even in lay use. While most issues in medical and research ethics such as informed consent, safety, and potential for misuse can be handled with manageable effort, (...) the real promise of brain stimulation does raise one prominent moral worry: it may lay the foundation of reliable, precise and stable manipulations of the mind. This article addresses this worry and concludes that it is not the possibility of manipulation, but the shift in our understanding of our mind which stands in need of careful consideration. (shrink)
Machine generated contents note: -- Introduction -- Setting the Scene -- Plato and Aristotle -- From the Roman Empire to the Empire of Islam -- The Western Middle Ages -- The Renaissance -- New Methods of Science -- Bringing Mathematics and Natural Philosophy Together -- Practice and Theory in Renaissance Medicine: William Harvey and the Circulation of the Blood -- The Spirit of System: Rene; Descartes and the Mechanical Philosophy -- The Royal Society and Experimental Philosophy -- Experiment, Mathematics, (...) and Magic: Isaac Newton -- Newton's Legacy: Forces and Fluids (electricity and heat) -- The Chemical Revolution: From Newton to John Dalton, via Priestley and Lavoisier -- Natural Theology and Natural Order: Newtonian Optimism and the History of Science -- The Making of Geology: From James Hutton to Charles Lyell via Catastrophism -- The History of Plants and Animals: Successive Emergence or Evolution? -- Religion and Progress in Victorian Britain: Robert Chambers versus Hugh Miller -- Bringing it All Together?: Charles Darwin's Evolution -- Darwinian Aftermaths: Religion; Social Science; Biology -- Beyond Newton: Energy and Thermodynamics -- Newton deposed: Einstein and Relativity Theory -- Mathematics instead of a World Picture: From Atomism to Quantum Theory -- Afterword. (shrink)
Agenda 21 of United Nations demands better situation of ecology, economy, health, etc. in all countries. An evaluation of scientific contributions in international congresses of fundamental anthropological sciences (philosophy, psychology, psychosomatics, physiology, genito-urology, radio-oncology, etc.) demonstratesevidence of large discrepancies in the participation not only of developing and industrial countries, but also between the last ones themselves. Low degree of research and education leads to low degree of economy, health, ecology, etc. [Lit.: Neu, Michailov et al.: Physiology in Agenda 21. Proc. (...) Int. Un. Physiol. Sci. San Francisco, Faseb J. 19/5, A1355, 2005; Agenda 21 in Psychol. 28th Int. Congr. Psychol. Beijing, 1028.62/3028.96, 2004]. CONCEPTION: The science is leading in the social and economic development of humanity, but the misuse of science causes disastrous repercussions (ecological and self-destruction). New models for scientific education, beginning with philosophy, followed by philosophical, pedagogical, medical, theological anthropology, and research are necessary tosupport Agenda 21 and prevent misuse of science. According to proposals on foundation of experimental schools (Immanuel Kant) and international universities (Bertrand Russell) the International Academy of Science/ICSD supports these ideas and initiated the creation of first (interdisciplinary) International Faculties forAnthropology as paradigm for humanization, higher effectiveness and pluralistic internationalization of science, leading to better education ("Erziehung und Ausbildung") and research in all countries, i.e. decrease of the gap between industrial and developing countries. CONCLUSION: Foundation of international institutes for general (philosophy, pedagogy, medicine) as well as for special anthropology (theology, informatics-logic-mathematics, culture, biology, (bio-) physics/chemistry) in context of an integralanthropology via networks of national ones from selected countries of Africa, America, Asia, Australia, Europe can permit the necessary implication of philosophy in education of anthropological sciences as well as research and education (post graduate) by common international research and educational programmes, lecturers, students, etc. in one country. This project needs political and financial support by UNO, European Union, governments, banks, industries to support the education of a homo sanus, humanus et spiritualis for the future humanity. (shrink)
The Phenomenology of Everyday Life presents results from a rigorous qualitative approach to the psychological study of everyday human activities and experiences. This book does not replace scientific observation with humanistic analysis, but provides an additional perspective on significant human questions. The qualitative approach this book employs is grounded in the philosophical traditions of existentialism and phenomenology, which use dialogue as their major method of inquiry. These traditions are especially well adapted to encompass and describe human events and activities. In (...) addition, such events can be properly investigated only on the basis of a method sensitive enough to articulate the nuances of human experience and reflection. In this latter regard, it is important to note that insights deriving from literature and the humanities are equally as revealing of the human world as those from experimental psychology, biology or medicine. (shrink)
From the Upanishads to Homer -- Philosophy, did the Greeks invent it -- Pythagoras and the divinity of number -- What is there? -- The Greek tragedians on man's fate -- Herodotus and the lamp of history -- Socrates on the examined life -- Plato's search for truth -- Can virtue be taught? -- Plato's Republic, man writ large -- Hippocrates and the science of life -- Aristotle on the knowable -- Aristotle on friendship -- Aristotle on the perfect life (...) -- Rome, the Stoics, and the rule of law -- The Stoic bridge to Christianity -- Roman law, making a city of the once-wide world -- The light within, Augustine on human nature -- Islam -- Secular knowledge, the idea of university -- The reappearance of experimental science -- Scholasticism and the theory of natural law -- The Renaissance, was there one? -- Let us burn the witches to save them -- Francis Bacon and the authority of experience -- Descartes and the authority of reason -- Newton, the saint of science -- Hobbes and the social machine -- Locke's Newtonian science of the mind -- No matter? The challenge of materialism -- Hume and the pursuit of happiness -- Thomas Reid and the Scottish school -- France and the philosophes -- The federalist papers and the great experiment -- What is enlightenment? Kant on freedom -- Moral science and the natural world -- Phrenology, a science of the mind -- The idea of freedom -- The Hegelians and history -- The aesthetic movement, genius -- Nietzsche at the twilight -- The liberal tradition, J.S. Mill -- Darwin and nature's "purposes" -- Marxism, dead but not forgotten -- The Freudian world -- The radical William James -- William James' pragmatism -- Wittgenstein and the discursive turn -- Alan Turing in the forest of wisdom -- Four theories of the good life -- Ontology, what there "really" is -- Philosophy of science, the last word? -- Philosophy of psychology and related confusions -- Philosophy of mind, if there is one -- What makes a problem "moral" -- Medicine and the value of life -- On the nature of law -- Justice and just wars -- Aesthetics, beauty without observers -- God, really? (shrink)
While for the majority of physicists the problem of the deciphering of the brain code, the intelligence code, is a matter for future generations, the author boldly and forcefully disagrees. Breaking with the dogma of classical logic he develops in the form of the conversion postulate a concrete working hypothesis for the actual thought mechanism. The reader is invited on a fascinating mathematical journey to the very edges of modern scientific knowledge. From lepton and quark to mind, from cognition to (...) a logic analogue of the Schrodinger equation, from Fibonacci numbers to logic quantum numbers, from imaginary logic to a quantum computer, from coding theory to atomic physics - the breadth and scope of this work is overwhelming. Combining quantum physics, fundamental logic and coding theory this unique work sets the stage for future physics and is bound to titillate and challenge the imagination of physicists, biophysicists and computer designers. Growing from the author's matrix operator formalization of logic, this work pursues a synthesis of physics and logic methods, leading to the development of the concept of infophysics. The experimental verification of the proposed quantum hypothesis of the brain is presently in preparation in cooperation with the Cavendish Laboratory, Cambridge, UK, and, if proved positive, would have major theoretical implications. Even more significant should be the practical applications in such fields as molecular electronics and computer science, biophysics and neuroscience, medicine and education. The new possiblities that could be opened up by quantum level computing could be truly revolutionary. The book aims at researchers and engineers in technical sciences as well as in biophysics and biosciences in general. It should have great appeal for physicists, mathematicians, logicians and for philosophers with a mathematical bent. (shrink)
Mortal and immortal DNA : Craig Venter and the lure of "lamia" -- Homeopathy : Holmes, hogwarts, and the Prince of Wales -- Citizen Pinel and the madman at Bellevue -- The experimental pathology of stress : Hans Selye to Paris Hilton -- Gore's fever and Dante's Inferno : Chikungunya reaches Ravenna -- Giving things their proper names : Carl Linnaeus and W.H. Auden -- Spinal irritation and fibromyalgia : Lincoln's surgeon general and the three graces -- Tithonus and (...) the fruit fly : new science and old myths -- Swiftboating "America the beautiful" : Katharine Lee Bates and a Boston marriage -- Nothing makes sense in medicine except in the light of biology -- Apply directly to the forehead : Holmes, Zola, and Hennapecia -- Elizabeth Blackwell breaks the bonds -- Chronic lyme disease and medically unexplained syndromes -- Eugenics and the immigrant : Rosalyn Yalow and Rita Levi-Montalcini -- Science in the Middle East : Robert Koch and the cholera war -- How to win a Nobel prize : thinking inside and outside the box -- Homer Smith and the lungfish : the last gasp of intelligent design -- DDT is back : let us spray! -- Academic boycotts and the Royal Society -- Teach evolution, learn science : John William Draper and the "bone bill" -- Diderot and the yeti crab : the encyclopedias of life -- Dengue fever in Rio : Macumba versus Voltaire. (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 ...
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)
The paper looks in detail at patients that were treated at one of the most discussed companies operating in the field of untried stem cell treatments, Beike Biotech of Shenzhen, China. Our data show that patients who had been treated at Beike Biotech view themselves as proactively pursuing treatment choices that are not available in their home countries. These patients typically come from a broad variety of countries: China, the United Kingdom, the United States, South Africa and Australia. Among the (...) patients we interviewed there seemed to be both an awareness of the general risks involved in such experimental treatments and a readiness to accept those risks weighed against the possible benefits. We interpret this evidence as possibly reflecting the emergence of risk-taking patients as ‘consumers’ of medical options as well as the drive of patients to seek treatment options in the global arena, rather than being hindered by the ethical and regulatory constraints of their home countries. Further, we found that these patients tend to operate in more or less stable networks and groups in which they interact and cooperate closely and develop opinions and assessments of available treatment options for their ailments. These patients also perform a multiple role as patients, research subjects, and research funders because they are required to pay their way into treatment and research activities. This new social dynamics of patienthood has important implications for the ethical governance of stem cell treatments. (shrink)
Over the last decade, stem cell research has generated an enormous amount of public, political and bioethical debate. These debates have overwhelmingly tended to focus on two moral issues: the moral status of human embryos and the duty to care for the sick and vulnerable. This preoccupation, especially on the question of moral status, has not only dichotomized the debate around two fundamentally incommensurable positions, it has come at the cost of other important issues largely being ignored. In highlighting some (...) of the bioethical and regulatory deficiencies of this fixation, we draw on recent developments in the experimental use of autologous adult stem cells to argue for a more inclusive approach to the ethical issues surrounding stem cell research. (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)
To analyze science as practice and culture has become, since the early 1970s, the object of the new history and sociology of science. Hence, historians and sociologists pay now more attention to the role of experiment in science. In order to study experiments we need to think more carefully about instruments, apparatus and their use. In this article I put forward a method which allows to do both, to study the materiality of experiment as well as the activities involved in (...) the production of experimental results: The replication of an experiment, ie. the reworking of historical experiments with a replica as close to the original as possible. A study of the experiments jointly done by James Joule, and William Thomson in 1852 will demonstrate what might be learned by this method about an experiment. The origins of instruments and the apparatus used in these experiments, their historical context and use will be discussed in detail. With the help of this case study I will try to show that the replication of experiments has much to contribute to an enhanced understanding of experimental practices. (shrink)
v. 1. Exterminative medicine in Nazi Germany and contemporary America -- v. 2. The language of exterminative medicine in Nazi Germany and contemporary America.
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 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 human experimentation: the modern dilemma -- Randomized human experimentation: 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)
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)
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)
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.
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 ...
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 ...
The liberal approach to ethics quite naturally tends toward the classic individualistic theory of society, to reductionism or psychologism so-called, that is, to a reduction of all social action to individual action.2 For example, liberalism allows one to experiment with new medications on one's own body. By extension, liberalism allows one to experiment, it seems, on another person's body with new medication if one acts as the other person's agent, that is, if one has the other person's proper consent. We (...) all know that new medicines are introduced into the market experimentally; indeed, government agencies, such as food and drug administrations, are supposed to supervise such experimentations and eliminate from the market as quickly as possible new (or old) medications that prove harmful. Hence, the very introduction of a new medicine into the market requires the consent of the public - in the form of proper permits to manufacture and market new (and old) drugs and other medications. (shrink)
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)
"This is an extremely interesting and innovative collection with unusual empirical richness, with ethical and epistemological discussions cutting across ...
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)
Die Textsammlung bietet eine Zusammenstellung aller wichtigen Rechtstexte völkerrechtlicher, gemeinschaftsrechtlicher und nationaler Natur aus dem Bereich der humanen Biomedizin.
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)
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.
