Human experimentation can have different meanings: indeed, with the development of medical research, therapeutic acts have to be distinguished from acts of cognitive values. For each kind of acts, specific conditions of acceptability and specific protections of human beings have to be defined.Human experimentation must be envisaged at different levels to evaluate ethical aspects: its scientific value, the risks, benefits envisaged, the populations implicated, etc…The individual consent must be present too in the relationship between the (...) subject and the doctors. In fact, is a real consent possible?Instead to insist on problems in terms of medical research, one would have to insist perhaps more on the fact that the medical practice in general would have to answer more to ethical grounds and to scientific rules. It is the non scientific medicine which is immoral and dangerous, as well the medicine with financial interests, or also the medecine without experimentation.The main arguments must remain at the level of the dignity of the persons, autonomy and freedom of choice must remain the fundamental values. (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)

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

Tremendous development in recent medical science and the consequent discoveries resulting in successful prevention and also cure of different diseases are shared by clinical research involving the human volunteers. Preceding the trials in the human subjects, and to ensure safety, the proposed drug and other interventions are either tested in animals (vivo) or in laboratory (vitro) to evaluate initial safe starting dose for the human beings and to key out the benchmarks for the clinical monitoring for the (...) potential unfavorable effects. These pre human trials might not necessarily protect against the untoward effects in the human beings as happened in the case of thalidomide tragedy, which caused disability and killed thousands of babies born to the mothers, those who took this medicine. Use of healthy human volunteers in the preliminary experiments or phase I clinical trials either reduces or excludes risks of subsequent undesirable effects in the future trails (1). Phase-1 trials are conducted in order to test the safety, reactions and immunogenicity of vaccines in volunteers. Novel treatments for the cancer are first tested in phase 1 trials enrolling the patients with advanced disease, who have exhausted the standard treatment options. Phase-1 oncology trials are the pivot point in the translation of new cancer therapies from bench to bedside. Nevertheless, these trials remain ethically controversial. The controversy stems from the fact that, classically, phase-1 oncology clinical trials involve first-in-human testing of experimental treatment candidates in patients with a terminal diagnosis, who typically have exhausted standard treatment options. Commentators on the ethics of phase-1 clinical trials make diametrically opposed claims about the prospect of direct medical benefit from participation in these trials-benefits that can be attributed to receiving the experimental treatment intervention. One camp of benefit skeptics, inhabited mainly by bioethicists, characterizes this form of research as lacking any reasonable prospect of direct medical benefit. They see an ethical cloud hovering over phase-1 trials, because the vast majority of patients volunteer for phase-1 trials out of a motivation to receive medical benefit. In the view of these skeptics, such patients therefore harbor a ‘therapeutic misconception’ about research participation. This misconception calls into question the validity of informed consent and thereby undercuts the ethical basis of these trials (2). In this paper, I will discuss the ethical justification of the participation of human volunteers in phase-1 trials. (shrink)

How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. An (...) ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society. (shrink)

How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. An (...) ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society. (shrink)

People do not choose to suffer from catastrophic illnesses, but considerable human choice is involved in the ways in which the participants in the process treat and conduct research on these diseases. Catastrophic Diseases draws a powerful and humane portrait of the patients who suffer from these illnesses as well as of the physician-investigators who treat them, and describes the major pressures, conflicts, and decisions which confront all of them. By integrating a discussion of "facts" and "values," the authors (...) highlight the forces which affect new developments in medicine—such as kidney and heart transplants—and the controversial issues they generate. Katz and Capron explore these issues through the use of dual conceptual perspectives. Their study first examines and evaluates the authority which should be vested in each of the chief participants in the catastrophic disease process—the physician-investigator, the patient-subject and his relatives, the professionals, and the state. Challenging questions are raised concerning medical education, informed consent, and professional responsibility. The authors next explore how the roles and capacities of the participants vary not only according to the basic issues they face but also according to the point in decision-making at which these issues arise. The process of investigating and treating catastrophic diseases, the authors believe, can thus usefully be divided into three decision-making stages—the formulation of policy, the administration of research and therapy, and the review of the decisions and their consequences. In conclusion, Katz and Capron demonstrate the need for a variety of individuals and groups with diverse values to be involved in decision-making in a manner which will not unnecessarily impede the scientific investigation of these diseases. (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)

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)

This important new work surveys the source and ramifications of the famed Nuremburg Code -- recognized around the world as one of the cornerstones of modern bioethics.

This chapter contains sections titled: Introduction History of Experimentation on Human Beings Regulation of Human Experimentation Guidelines, Regulations and Directives to Regulate Human Experimentation Regulation of Experimentation in Surgery and Clinical Medicine Discussion References.

Inclusion of the humanities in undergraduate medicine curricula remains controversial. Skeptics have placed the burden of proof of effectiveness upon the shoulders of advocates, but this may lead to pursuing measurement of the immeasurable, deflecting attention away from the more pressing task of defining what we mean by the humanities in medicine. While humanities input can offer a fundamental critical counterweight to a potentially reductive biomedical science education, a new wave of thinking suggests that the kinds of arts (...) and humanities currently used in medical education are neither radical nor critical enough to have a deep effect on students’ learning and may need to be reformulated. The humanities can certainly educate for tolerance of ambiguity as a basis to learning democratic habits for contemporary team-based clinical work. William Empson’s ‘seven types of ambiguity’ model for analyzing poetry is transposed to medical education to: (a) formulate seven values proffered by the humanities for improving medical education; (b) offer seven ways of measuring impact of medical humanities provision, thereby reducing ambiguity; and (c) --as a counterweight to (b) – celebrate seven types of ambiguity in contemporary medical humanities that critically reconsider issues of proof of impact. (shrink)

This essay examines the risks of racialized science as revealed in the American mustard gas experiments of World War II. In a climate of contested beliefs over the existence and meanings of racial differences, medical researchers examined the bodies of Japanese American, African American, and Puerto Rican soldiers for evidence of how they differed from whites.

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

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)

In the last decades it has become clear that medicine must find some way to combine its scientific and humanistic sides. In other words, an adequate notion of medicine requires an integrative position that mediates between the analytic-reductionist and the normative-holistic tendencies we find therein. This is especially important as these different styles of reasoning separate “illness” (something perceived and managed by the whole individual in concert with their environment) and “disease” (a “mechanical failure” of a biological element (...) within the body). While the demand for an integrative view has typically been motivated by ethical concerns, we claim that it is also motivated, perhaps even more fundamentally, by epistemological and methodological reasons. Evidence-based bio-medicine employs experimental and statistical techniques which eliminate important differences in the ways that conscious humans evaluate, live with, and react to disease and illness. However, it is precisely these experiences that underpin the concepts and norms of bio-medicine. Humanistic disciplines, on the other hand, have the resources to investigate these experiences in an intersubjectively testable way. Medicine, therefore, cannot afford to ignore its nature as a human science; it must be concerned not only with disease and illness, but also with the ways in which patients as persons respond to malady. Insofar as attitudes and expectations influence the criteria of illness and disease, they must be studied as part of the genuine subject matter of medicine as a human science. In general, we urge that this is a necessary step to overcome today's trend to split evidence-based and clinical medicine. (shrink)

Mit Beitragen von: Wolfgang U. Eckart, Christian Bonah, Wolfgang U. Eckart / Andreas Reuland, Alexander Neumann, Peter Steinkamp, Volker Roelcke, Anne ...

From an ethical standpoint, the goal of clinical research is to benefit patients. While individual investigations may not yield results that directly improve patients’ evaluation or treatment, the corpus of the research should lead in that direction. Without the goal of ultimate benefit to patients, such research fails as a moral enterprise. While this may seem obvious, the need to protect and benefit patients can get lost in the milieu of clinical research. Many advances in emergency medicine have been (...) based upon the results of research studies conducted both within the specialty and by others outside of the field. But has this research benefited patients? Has it followed the Hippocratic commitment “to do good or at least do no harm”? The answer is: yes, and no. This paper attempts to demonstrate this: first by citing advances from applied research that have benefited emergency department patients over the past three decades, and follows with some aspects of emergency medicine research that makes one question both its safety and its efficacy. While enormous gains have been made in patient care as a result of emergency medical research, ethical considerations complicate this rosy picture, and point to future areas of concern for researchers. (shrink)

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)

This chapter contains sections titled: Scandalous Research in the Twentieth Century Basic Principles of Research Ethics Respect for Persons Beneficence Justice Conclusion.

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)

This is the first book in healthcare ethics addressing the moral issues regarding ownership of the human body. Modern medicine increasingly transforms the body and makes use of body parts for diagnostic, therapeutic and preventive purposes. The book analyzes the concept of body ownership. It also reviews the ownership issues arising in clinical care (for example, donation policies, autopsy) and biomedical research. Societies and legal systems also have to deal with issues of body ownership. A comparison is made (...) between specific legal arrangements in The Netherlands and France, as examples of legal approaches. In the final section of the book, different theoretical perspectives on the human body are analyzed: libertarian, personalist, deontological and utilitarian theories of body ownership. (shrink)

Rationale: In this article, I argue that we need a new perspective in the debate on autonomy in medicine, to understand many of the problems we face today – dilemmas that are situated at the intersection of autonomy and heteronomy, such as why well informed and autonomous people make unhealthy lifestyle choices. If people do not choose what they want, this is not simply caused by their lack of character or capability, but also by the fact that absolute autonomy (...) is impossible; autonomous individuals are ‘contaminated’ by heteronymous aspects, by influences from ‘outside’. Consequently, there are many good reasons to question the widely accepted hierarchical opposition of autonomy (progress) versus heteronomy (paternalism) in medicine. In an earlier article an analysis is made of the neologism ‘oughtonomy’ to support the thesis that when it comes down to human existence, autonomy and heteronomy are intertwined, rather than being merely opposites. Methods: In this article, I reflect upon how social conditions might improve our ‘choice architecture’, what Thaler & Sunstein have called ‘nudging’: how to change individual health choices without being paternalistic? I explore the extent to which both oughtonomy and nudging are able to challenge the question of autonomy in today’s medicine. Results and Conclusions: Autonomy may and should be a shared target in today’s medicine, but we should never forget that it is always intertwined with heteronomy. Starting from this perspective, progress in medicine demands far more than the increase of autonomy. (shrink)

Targeted modifications of the human epigenome, epigenome editing (EE), are around the corner. For EE, techniques similar to genome editing (GE) techniques are used. While in GE the genetic information is changed by directly modifying DNA, intervening in the epigenome requires modifying the configuration of DNA, for example, how it is folded. This does not come with alterations in the base sequence (‘genetic code’). To date, there is almost no ethical debate about EE, whereas the discussions about GE are (...) voluminous. Our article introduces EE into bioethics by translating knowledge from science to ethics and by comparing the risks of EE with those of GE. We, first (I), make the case that a broader ethical debate on EE is due, provide scientific background on EE, compile potential use-cases and recap previous debates. We then (II) compare EE and GE and suggest that the severity of risks of novel gene technologies depends on three factors: (i) the choice of an ex vivo versus an in vivo editing approach, (ii) the time of intervention and intervention windows and (iii) the targeted diseases. Moreover, we show why germline EE is not effective and reject the position of strong epigenetic determinism. We conclude that EE is not always ethically preferable to GE in terms of risks, and end with suggestions for next steps in the current ethical debate on EE by briefly introducing ethical challenges of new areas of preventive applications of EE (III). (shrink)

Ethical questions in medicine have become common topics of discussion during the past twenty years. Bitter disputes have arisen regarding abortion, suicide, human experimentation, as well as the management of the dying patient and the severely disabled newborn. These issues are loaded with such emotion that it is sometimes difficult to look at them in a rational manner. Noted neurosurgeon and author Milton D. Heifetz has made the tough decisions in tragic, often anguishing situations. As a member (...) of hospital ethics committees for many years, Dr. Heifetz found that discussions of complex issuesmany involving urgent matters of life and deathwere all too often clouded by tradition, dogma, and gut reactions. A comprehensive moral foundation with the flexibility to respond to often rapidly changing circumstances is desperately needed if health-care professionals are to confront head-on the daily questions of medical ethics. Dr. Heifetz offers this moral grounding to help all who must make difficult medical choices: physicians, nurses, patients, families, and policy makers struggling to develop substantive rules for medical conduct. (shrink)

The seminal 1993 article by LaFollette and Shanks “Animal Models in Biomedical Research: Some Epistemological Worries” introduced an influential taxonomy into the debate about the value of animal experimentation. The distinction they made between hypothetical and causal analog models served to highlight a concern regarding extrapolating results obtained in animal models to human subjects, which endures today. Although their taxonomy has made a significant contribution to the field, we maintain that it is flawed, and instead, we offer a (...) new practice-oriented taxonomy of animal models as a means to allow philosophers, modelers, and other interested parties to discuss the epistemic merits and shortcomings, purpose, and predictive capacities of specific modeling practices. (shrink)

How should one think about innovation in medicine and surgery? Increasingly, the answer to this question has involved reference to what might be called the regulatory ethics paradigm (REP). The regulatory ethics paradigm holds that deviations from standard care involve a degree or kind of experimentation that requires the application of a set of procedures designed to assure the protection of the rights and welfare of the subjects of research. In REP, innovative treatments are regarded as questionable until (...) they are framed in a research protocol with formal mechanisms of informed consent. The protocol must be reviewed and approved by an Institutional Review Board (IRB) or equivalent. The regulatory ethics paradigm in effect imposes the condition that clinical innovations be conducted according to scientific research methodologies. It creates the presumption that without review by an IRB, innovation cannot be conducted in an ethically defensible fashion. The regulatory ethics paradigm also requires the preparation of investigational protocols according to sound evidentiary and methodological standards. In so doing, it creates a presumption that innovations that are not rigorously validated are ethically dubious. These assumptions have deep roots. The Belmont Report, for example, articulated the orienting intuition that “radically new procedures... should... be made the object of formal research at an early stage [emphasis added] in order to determine whether they are safe and effective”.1 The Belmont Report takes the view that formal research to establish safety and efficacy of new interventions is usually feasible at an early stage in the development of a novel intervention. It thus establishes a bias that innovative treatments be conducted and evaluated under a research protocol that has passed muster at an IRB review. Given the …. (shrink)

Targeted modifications of the human epigenome, epigenome editing (EE), are around the corner. For EE, techniques similar to genome editing (GE) techniques are used. While in GE the genetic information is changed by directly modifying DNA, intervening in the epigenome requires modifying the configuration of DNA, for example, how it is folded. This does not come with alterations in the base sequence (‘genetic code’). To date, there is almost no ethical debate about EE, whereas the discussions about GE are (...) voluminous. Our article introduces EE into bioethics by translating knowledge from science to ethics and by comparing the risks of EE with those of GE. We, first (I), make the case that a broader ethical debate on EE is due, provide scientific background on EE, compile potential use-cases and recap previous debates. We then (II) compare EE and GE and suggest that the severity of risks of novel gene technologies depends on three factors: (i) the choice of an ex vivo versus an in vivo editing approach, (ii) the time of intervention and intervention windows and (iii) the targeted diseases. Moreover, we show why germline EE is not effective and reject the position of strong epigenetic determinism. We conclude that EE is not always ethically preferable to GE in terms of risks, and end with suggestions for next steps in the current ethical debate on EE by briefly introducing ethical challenges of new areas of preventive applications of EE (III). (shrink)

Side effects are a concern in medical decision making and a robust area of biomedical research. However, there is relatively little philosophical investigation into side effects as such, especially given that side effects are appealed to for various applications in philosophy of medicine. In addition, health authorities like the FDA, CDC, and WHO have contrary definitions of ‘side effect.’ Moreover, these definitions have clear counterexamples. This dissertation aims to provide a complete account of what side effects are. I posit (...) that an account of side effects ought to draw clean conceptual lines between side effects and related treatment outcomes. I contend that an account of side effects must address two components: the reasons behind an intervention that produced the side effect, and the causal powers of the intervention that brought about that effect. With this account in mind, I address contemporary philosophical models that distinguish placebo effects from side effects. These arguments, respectively in chapters 2 and 3, yield a more complete, less problematic account of side effects than previous accounts. The dissertation then turns to the process of discovering side effects, specifically in the post-market context. Given the paucity of external validity in pre-market drug trials, chapter 4 argues that post-market ‘phase IV’ trials blur the received distinction of ‘confirmatory’ versus ‘exploratory’ experimentation in philosophy of science. The other component of post-market drug research is spontaneous reporting, or the voluntary reporting of a suspected side effect to a regulatory body. Chapter 5 uses the framework of risks and values in science to examine why clinicians underreport, which hinders our ability to prevent drug-related harms. Chapter 6 looks at how patients could mitigate underreporting and develops a social-epistemic, pragmatic, and ethical framework which can evaluate proposals to engage patients to spontaneously report their suspected side effects. In short, this dissertation aims to firstly address the conceptual problems in how we define ‘side effect’ and relate it to other treatment outcomes, and secondly it addresses issues that hinder the scientific investigation of side effects. (shrink)

Bioethics; medical ethics; human experimentation in medicine; law and legislation.

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices :168–175, 2001). Institutions such as Institutional Review Boards and Ethics (...) Committees oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki. Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants. The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees’ reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures. (shrink)

Following decades of silence about the involvement of doctors, medical researchers and other health professionals in the Holocaust and other National Socialist (Nazi) crimes, scholars in recent years have produced a growing body of research that reveals the pervasive extent of that complicity. This interdisciplinary collection of studies presents documentation of the critical role medicine played in realizing the policies of Hitler's regime. It traces the history of Nazi medicine from its roots in the racial theories of the (...) 1920s, through its manifestations during the Nazi period, on to legacies and continuities from the postwar years to the present. (shrink)

Artificial Intelligence (AI) is transforming our world: today machines not only can mimic human actions but out-perform human agents in many activities, including learning and thinking. AI offers revolutionary solutions and new possibilities in transportation, business, communication, medicine, law, and other domains. While some welcome this brave new world, others fear the threats AI pose to people’s livelihoods, social relations, individuality, freedom, and perhaps even the very survival of the human species. No doubt some of this (...) existential angst is exaggerated, but AI does raise questions for our understanding of the world and ourselves that require serious reflection, including questions about adequacy of education in various aspects. This chapter offers, from the perspectives of John Dewey’s Pragmatism as well as Confucianism, some reflections on the role of the humanities in education in response to the opportunities and challenges of the development and widespread use of AI. It shows that Dewey and Confucius share similar views regarding the humanistic purpose of education and their philosophies of education offer arguments for why humanities education will be relevant, if not more important, when many jobs we are familiar with become obsolete. Their attitudes toward the economic motive in education will help us rethink the meaning of work in a “world without work.” At the same time, they offer a critical evaluation of contemporary humanities education, which have failed to realize their visions of personal cultivation and growth. Among its failings is the continued dichotomy between the humanities and the sciences. In the age of AI, it has become even more vital to integrate them to avoid science and technology from becoming materialistic and anti-human while the humanities become merely literary and without any means to transform the world. (shrink)

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

In lieu of an abstract, here is a brief excerpt of the content:Isaac Barrow on the Mathematization of Nature: Theological Voluntarism and the Rise of Geometrical OpticsAntoni MaletIntroductionIsaac Newton’s Mathematical Principles of Natural Philosophy embodies a strong program of mathematization that departs both from the mechanical philosophy of Cartesian inspiration and from Boyle’s experimental philosophy. The roots of Newton’s mathematization of nature, this paper aims to demonstrate, are to be found in Isaac Barrow’s (1630–77) philosophy of the mathematical sciences.Barrow’s attitude (...) towards natural philosophy evolved from his earnest interest in medicine of around 1650, when a young Cambridge graduate, to natural philosophy (apparently under Henry More’s influence); from his thesis on the insufficiency of the Cartesian hypothesis to geometrical optics and the strong program of mathematization of natural philosophy of the middle 1660s; from Lucasian professor of Mathematics to Chaplain of his Majesty and eminent Restoration divine. Contemporary accounts of Barrow’s life suggest that he grew ever more skeptical about the worth of natural philosophy and mathematics. 1 In his last years he became a prolific [End Page 265] author of sermons and theological works. Published shortly after his death by John Tillotson (1630–94), later archbishop of Canterbury, they occupy over two thousand folio pages. Overloaded with involved philosophical arguments, Barrow’s sermons were apparently not very popular, but they were highly regarded by scholars and the Anglican hierarchy. 2 It is on certain of his sermons, as well as on the philosophical discussions contained in the Mathematical Lectures that our account of Barrow’s philosophy of the mathematical sciences will rest. 3 Barrow’s understanding of the mathematical sciences will allow us to discuss together three issues often analyzed independently: the theological background to English natural philosophy, the changing notion of mixed mathematical sciences during the seventeenth century, and finally the philosophical foundations of modern geometrical optics.It has long been recognized that significant relationships exist between theological voluntarism or intellectualism and views on natural philosophy. In particular Robert Boyle’s theological voluntarism is seen as grounding his experimentalist approach to natural philosophy. It is not quite so clear, however, how well theological voluntarism may relate to a strong program of mathematization such as the one embodied in Newton’s Principia Mathematica. In fact it has been suggested that the relationship is a negative one. This is derived from the necessary character of mathematical laws, which would put unwanted restrictions on God’s absolute dominion over nature, and also from the notion that theological intellectualism is conducive to a deductive, a priori science—the paradigm of which is of course geometry. However, Barrow’s theological voluntarism lead him to heighten the role of mathematics within natural philosophy.During the seventeenth century the so-called mixed or subalternate mathematical sciences changed profoundly. In the Enlightenment mixed mathematics—meaning above all rational mechanics—became one of the most prestigious and influential disciplines. The mixed mathematics of the Enlightenment, however, was markedly different from the Aristotelian [End Page 266] mixed mathematical sciences. The differences are noticeable both in the subject matter and in the substitution of mathematical infinitesimal analysis for geometrical synthesis, but also in the way of grounding mathematical theory on empirical evidence. Barrow’s Mathematical Lectures (delivered at Cambridge from 1664 to 1666) offer a fresh insight into the metamorphosis of these sciences just when Newton’s “mathematical principles” were in the making. Not the least interesting feature of Barrow’s discussion is that God’s omnipotence allows an evaluation of the truth of mathematical theories that do not apply to this world. Therefore, Barrow is led to introduce the distinction between the internal consistency, or mathematical truth, of a mathematical theory and its physical truth. This, in turn, leads him to the notion that theories need testing.Barrow on Matter and GodRecent literature has established significant correlations between theological voluntarism and empiricism, as well as between theological intellectualism and rationalism. As E. B. Davis writes, “the Christian doctrine of creation is a dialogue between God’s unconstrained will, which utterly transcends the bounds of human comprehension, and God’s orderly intellect, which serves as the model for the human mind.” Intellectualist theology considers God’s omniscience His... (shrink)

We are living in an unprecedented era of biomedical revolution. Medicine is remaking humans, and controversy surrounds such topics as abortion, artificial organs, brain circuitry, eugenics, euthanasia, and gene therapy. At the same time, medical advances are posing complex ethical problems for both patients and professionals. The most comprehensive and up-to-date collection of its kind, Case Studies in Biomedical Ethics: Decision-Making, Principles, and Cases explores fundamental ethical questions arising from real situations faced by health professionals, patients, and others. Featuring (...) a wide range of more than 100 case studies drawn from current events, court cases, and physicians' experiences, the book is divided into three parts. Part I presents a basic framework for ethical decision-making in healthcare, covering such issues as separating evaluative questions from questions of fact; distinguishing between ethical and nonethical evaluations; and identifying the source of ethical judgments. Expanding upon this framework, Part II explains the ethical principles: beneficence and nonmaleficence, justice, respect for autonomy, veracity, fidelity, and avoidance of killing. Parts I and II provide students with the background to analyze the ethical dilemmas presented in Part III, which features cases on a broad spectrum of issues including abortion, genetics, mental health, confidentiality, health insurance, experimentation on humans, the right to refuse treatment, and death and dying. Each case is accompanied by the authors' commentary, which guides students in considering the issues. Ideal for undergraduate and graduate courses in biomedical ethics, bioethics, and medical ethics, Case Studies in Biomedical Ethics incorporates opening text boxes in each chapter that cross-reference relevant cases in other chapters. It also includes an appendix of important ethical codes and a glossary of key terms. (shrink)

The case of women radium dial painters — women who tipped their brushes while painting the dials of watches and instruments with radioactive paint — 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 women’s 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)

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

Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more (...) particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments. (shrink)

This paper explores ethical considerations for active studies of circumcision, i.e., the amputation of the foreskin, in the form of a case study of three major trials performed in African countries in the early 2000s. The paper outlines the function of the foreskin and method and history of its amputation as well as its current use in attempting to combat the global AIDS crisis. These trials are then interrogated in accordance with the Declaration of Helsinki. In particular, the irreversible nature (...) of amputation is given great consideration. The case studies are found to have serious failures in terms of the modern iteration of the Declaration of Helsinki. This paper calls for extreme scrutiny in accordance with international norms relating to the ethical treatment of human subjects in a research context of studies of circumcision if and when they are proposed again. (shrink)