Background The increase in empirical methods of research in bioethics over the last two decades is typically perceived as a welcomed broadening of the discipline, with increased integration of social and life scientists into the field and ethics consultants into the clinical setting, however it also represents a loss of confidence in the typical normative and analytic methods of bioethics. Discussion The recent incipiency of "Evidence-Based Ethics" attests to this phenomenon and should be rejected as a (...) solution to the current ambivalence toward the normative resolution of moral problems in a pluralistic society. While "evidence-based" is typically read in medicine and other life and social sciences as the empirically-adequate standard of reasonable practice and a means for increasing certainty, I propose that the evidence-based movement in fact gains consensus by displacing normative discourse with aggregate or statistically-derived empirical evidence as the "bottom line". Therefore, along with wavering on the fact/value distinction, evidence-based ethics threatens bioethics' normative mandate. The appeal of the evidence-based approach is that it offers a means of negotiating the demands of moral pluralism. Rather than appealing to explicit values that are likely not shared by all, "the evidence" is proposed to adjudicate between competing claims. Quantified measures are notably more "neutral" and democratic than liberal markers like "species normal functioning". Yet the positivist notion that claims stand or fall in light of the evidence is untenable; furthermore, the legacy of positivism entails the quieting of empirically non-verifiable considerations like moral claims and judgments. As a result, evidence-based ethics proposes to operate with the implicit normativity that accompanies the production and presentation of all biomedical and scientific facts unchecked. Summary The "empirical turn" in bioethics signals a need for reconsideration of the methods used for moral evaluation and resolution, however the options should not include obscuring normative content by seemingly neutral technical measure. (shrink)

BackgroundThe increase in empirical methods of research in bioethics over the last two decades is typically perceived as a welcomed broadening of the discipline, with increased integration of social and life scientists into the field and ethics consultants into the clinical setting, however it also represents a loss of confidence in the typical normative and analytic methods of bioethics.DiscussionThe recent incipiency of "Evidence-Based Ethics" attests to this phenomenon and should be rejected as a solution to the (...) current ambivalence toward the normative resolution of moral problems in a pluralistic society. While "evidence-based" is typically read in medicine and other life and social sciences as the empirically-adequate standard of reasonable practice and a means for increasing certainty, I propose that the evidence-based movement in fact gains consensus by displacing normative discourse with aggregate or statistically-derived empirical evidence as the "bottom line". Therefore, along with wavering on the fact/value distinction, evidence-based ethics threatens bioethics' normative mandate. The appeal of the evidence-based approach is that it offers a means of negotiating the demands of moral pluralism. Rather than appealing to explicit values that are likely not shared by all, "the evidence" is proposed to adjudicate between competing claims. Quantified measures are notably more "neutral" and democratic than liberal markers like "species normal functioning". Yet the positivist notion that claims stand or fall in light of the evidence is untenable; furthermore, the legacy of positivism entails the quieting of empirically non-verifiable (or at least non-falsifiable) considerations like moral claims and judgments. As a result, evidence-based ethics proposes to operate with the implicit normativity that accompanies the production and presentation of all biomedical and scientific facts unchecked.SummaryThe "empirical turn" in bioethics signals a need for reconsideration of the methods used for moral evaluation and resolution, however the options should not include obscuring normative content by seemingly neutral technical measure. (shrink)

BackgroundThe concept of evidence-based medicine has strongly influenced the appraisal and application of empirical information in health care decision-making. One principal characteristic of this concept is the distinction between "evidence" in the sense of high-quality empirical information on the one hand and rather low-quality empirical information on the other hand. In the last 5 to 10 years an increasing number of articles published in international journals have made use of the term "evidence-based ethics", making (...) a systematic analysis and explication of the term and its applicability in ethics important.DiscussionIn this article four descriptive and two normative characteristics of the general concept "evidence-based" are presented and explained systematically. These characteristics are to then serve as a framework for assessing the methodological and practical challenges of evidence-based ethics as a developing methodology. The superiority of evidence in contrast to other empirical information has several normative implications such as the legitimization of decisions in medicine and ethics. This implicit normativity poses ethical concerns if there is no formal consent on which sort of empirical information deserves the label "evidence" and which does not. In empirical ethics, which relies primarily on interview research and other methods from the social sciences, we still lack gold standards for assessing the quality of study designs and appraising their findings.ConclusionThe use of the term "evidence-based ethics" should be discouraged, unless there is enough consensus on how to differentiate between high- and low-quality information produced by empirical ethics. In the meantime, whenever empirical information plays a role, the process of ethical decision-making should make use of systematic reviews of empirical studies that involve a critical appraisal and comparative discussion of data. (shrink)

ZusammenfassungIm Zuge des „empirical turn“ der Medizin- und Bioethik ist von verschiedenen Autoren in den vergangenen Jahren die Idee einer „evidenzbasierten Ethik“ diskutiert worden. Die Analogie zwischen evidenzbasierter Medizin und „evidenzbasierter Ethik“ soll in diesem Beitrag kritisch diskutiert und dabei gezeigt werden, dass der Ausdruck „evidenzbasierte Ethik“ irreführend ist. Zentraler Ausgangspunkt der Kritik ist die unterschiedliche Bedeutung, die empirische Informationen für das medizinisch-klinische Urteil zum einen und das ethische Urteil in der Medizin zum anderen haben. Im medizinisch-klinischen Urteil können mit (...) Hilfe empirischer Informationen hypothetische Handlungsnormen generiert werden, welche auf den der Medizin inhärenten Zwecksetzungen basieren. Bei Fragen der Ethik in der Medizin hingegen sind die Handlungsziele selbst Gegenstand des Urteils; diese aber können allein aus empirischem Wissen heraus nicht zureichend bestimmt werden. Die Diskussion um die Möglichkeit einer „evidenzbasierten Ethik“ eröffnet weiterhin aufschlussreiche Perspektiven in Bezug auf empirische Forschung und den Umgang mit empirischen Informationen in der Angewandten Ethik und das Aufgabenfeld der Medizinethik. (shrink)

This is an account of the evolution of ideas and the confluence of support and vision that has eventuated in the founding of the Journal of Empirical Research on Human Research Ethics (JERHRE). Many factors have contributed to the creation of this rather atypical academic journal, including a scientific and administrative culture that finally saw the need for it, modern electronic technology, individuals across the world who were committed to somehow finding common ground between researchers and those charged with (...) ethical oversight of research, a network of helpful colleagues, and a university whose administration gave moral support to the endeavor in a time of fiscal austerity. Perhaps equally important were the decisions to make JERHRE a nonprofit undertaking, to emphasize the implications of empirical research for specific best practices, to serve the educational needs of those concerned with human research, and to seek to stimulate the interest of students in gaining an evidence-based understanding of the research contexts in which they decide to work. This article explores the ‘chemistry’ that has made it possible to develop a somewhat unorthodox journal and set of related activities. (shrink)

The assumption in current U.S. mainstream medicine is that birthing requires hospitalization. In fact, while the American College of Obstetricians and Gynecologists supports the right of every birthing person to make a medically informed decision about their delivery, they do not recommend home birth owing to data indicating greater neonatal morbidity and mortality. In this article, we examine the evidence surrounding home birth in the United States and its current limitations, as well as the ethical considerations around birth setting.

Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members (...) during review processes. We collected every instance (N = 4,195) of feedback made on N = 197 ‘low-risk’ protocols by all HREC staff (N = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including ‘Risk to Researchers’, ‘Commercial benefit, scope and scale’, ‘Diversity’ (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research. (shrink)

The use of platelet rich plasma as a novel treatment is discussed in the context of a qualitative research study comprising 38 interviews with sports medicine practitioners and other stakeholders working within the English Premier League during the 2013–16 seasons. Analysis of the data produced several overarching themes: conservatism versus experimentalism in medical attitudes; therapy perspectives divergence; conflicting versions of appropriate evidence; subcultures; community beliefs/practices; and negotiation of medical decision-making. The contested evidence base for the efficacy of PRP (...) is presented in the context of a broader professional shift towards evidence based medicine within sports medicine. Many of the participants while accepting this shift are still committed to casuistic practices where clinical judgment is flexible and does not recognize a context-free hierarchy of evidentiary standards to ethically justifiable practice. We also discuss a tendency in the data collected to consider the use of deceptive, placebo-like, practices among the clinician participants that challenge dominant understandings of informed consent in medical ethics. We conclude that the complex relation between evidence and ethics requires greater critical scrutiny for this emerging specialism within the medical community. (shrink)

In this groundbreaking book, psychiatrist and ethicist Mona Gupta analyzes the basic assumptions of Evidence-based medicine (EBM), and critically examines their applicability to psychiatry. Highlighting ethical tensions between psychiatry and EBM, she asks the controversial question - should psychiatrists practice evidence-based medicine at all?

Everything we do in life involves a connection with information, experience and know-how: together these represent the most valuable of intangible human assets encompassing our history, cultures and wisdom. However, the more easily new technologies gather information, the more we are confronted with our limited capacity to distinguish between what is essential, important or merely ‘nice-to-have’. This article presents the case study of a multilingual Knowledge Management System, the Business enabling e-Platform that gathers and protects tacit knowledge, as the key (...) to developing structured intellectual capital, while acknowledging the urgent need here to integrate Ethics-by-design alongside AI-by-design, in view of the far-reaching consequences involved, for good or ill. It also explains how a beneficial Circular Economy of Knowledge depends on evidence-based answers, and how harmonising taxonomies, terminology and standards promotes global trust as the basis for the unhindered transfer of tacit knowledge between generations in a way that benefits everyone. (shrink)

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

The clinical decision is supposed to be based on evidence. In fact, what counts as evidence is far from being established. Some definition of "proof" is needed to distinguish between scientific medicine and charlatanism. My thesis is that unfortunately a clear-cut boundary between evidence and lack of evidence cannot be found, for several reasons that I summarise in the paper. Evidence in medicine very often has fuzzy boundaries, and dichotomising fuzziness and uncertainty can have (...) serious consequences. Physicians and patients should accept the irreducible fuzziness of many of the concepts they use when dealing with health and disease. (shrink)

Evidence-based practice is often acknowledged as the future state of psychology, yet those graduate students who will soon be applying such practices tend to hold several misconceptions about the major components within this framework. This review highlights implications for graduate education, clinical training, and professional competence in light of the movement toward evidence-based practice in psychology. These implications are discussed in relation to the close parallel between the major components of the evidence-based framework and (...) the current Ethical Principles of Psychologists and Code of Conduct. The evidence-based framework is discussed as an ideology that promotes lifelong learning and best prepares graduate students for ethical clinical practice throughout their careers as psychologists. (shrink)

The primacy in modern medical ethics of the principle of respect for autonomy has led to the widespread assumption that it is unethical to change someone’s beliefs, because doing so would constitute coercion or paternalism., In this Viewpoint we suggest that persuasion is not necessarily paternalistic and is an essential component of modern medical practice.

The literature has recognised the fundamental role of teaching business ethics to students earning business administration degrees, but it is hard to find a methodology for teaching this topic successfully. We propose a new management tool—evidence-based administration—for the study of business ethics. The method developed on the basis of this management tool provides a practical vision to the students, motivates them, and favours the development of multiple facets of their education.

The literature has recognised the fundamental role of teaching business ethics to students earning business administration degrees, but it is hard to find a methodology for teaching this topic successfully. We propose a new management tool—evidence-based administration—for the study of business ethics. The method developed on the basis of this management tool provides a practical vision to the students, motivates them, and favours the development of multiple facets of their education.

The literature has recognised the fundamental role of teaching business ethics to students earning business administration degrees, but it is hard to find a methodology for teaching this topic successfully. We propose a new management tool—evidence-based administration—for the study of business ethics. The method developed on the basis of this management tool provides a practical vision to the students, motivates them, and favours the development of multiple facets of their education.

This paper challenges the traditional assumption that descriptive and prescriptive sciences are essentially distinct by presenting a study on the implicit normativity of the production and presentation of biomedical scientific facts within evidence-based medicine. This interdisciplinary study serves as an illustration of the potential worth of the concept of implicit normativity for bioethics in general and for integrated empirical ethics research in particular. It demonstrates how both the production and presentation of scientific information in an evidence- (...) class='Hi'>based decision-support contain implicit presuppositions and values, which pre-structure the moral environment of the clinical process of decision-making. As a consequence, the evidence-based decision support did not only support the clinical decision-making process; it also transformed it in a morally significant way. This phenomenon undermines the assumption within much of the literature on patient autonomy that information disclosure is a conditional requirement before patient autonomy even starts; patient autonomy is already influenced during the production and presentation of information. These results imply an increased responsibility of those who produce and present evidence-based facts(i.e. scientists in general and physicians in particular). The insights of this study not only involve a different focus on both theory and practice of patient autonomy and informed consent, but they also call for a broader scope of morality than does traditional empirical research in bioethics. The concept of implicit normativity within integrated empirical ethics research calls for a strong cooperation between bioethicists and descriptive scientists, i.e., a cooperation that goes beyond the discipline-specific epistemic values and that takes place during all phases of the research process. (shrink)

The institutional review board at the University of Nebraska Medical Center has a policy on contraceptive use in research that aims to balance the protection of potential fetuses from potential harm resulting from drug exposure in research against respect for the autonomy of women research participants. The policy draws on the U.S. Food and Drug Administration’s Use-in-Pregnancy categories in an innovative way. These categories are meant to help prevent the exposure of fetuses to harmful drugs when used for therapy by (...) pregnant women. The UNMC IRB policy applies the FDA categories as a guideline for mandating contraceptive use among research participants. Clinical trials of drugs in the different FDA categories require different levels of contraceptive protection under the UNMC IRB policy. Though we agree with the insight that contraceptive requirements in research could helpfully be guided by the current and future FDA Use-in-Pregnancy guidelines, we argue that in several places, the UNMC IRB policy unjustifiably prioritizes the protection of potential fetuses from potential harm at the expense of respecting the autonomy and well-being of women research participants. In response to the deficiencies we identify in the UNMC IRB policy, we formulate an alternative, ideal policy on contraceptive use in research. (shrink)

ABSTRACTEvidence-based practice in psychology is ordinarily understood to demarcate between legitimate and illegitimate psychotherapy practice, based upon the epistemic demarcation distingui...

A contemporary serious lack of scientific knowledge by the general public and many decision-makers is now quite perceptible, both globally and in Portugal. Living in a science-driven technological world filled with scientific illiteracy is dangerous and a path toward disaster. Recent years brought a fairly strong global movement promoting the so-called “alternative therapy” that also affected Portugal. I propose an evidence-based ethics reflection and argumentation, both encompassing the global and the specific Portuguese reality. I debate the specific (...) arguments used in favour of alternative therapies, demonstrating the inherent fallacies of thought, deliberate manipulation of words and concepts, and the dire consequences for global and local health politics by following this line of biased reasoning. (shrink)

The editors of the symposium hope it will provide a balanced appraisal of evidence based medicine.This symposium is devoted to evidence based medicine and the ethical issues it raises. Since Sir Archie Cochrane’s seminal Nuffield Provincial Hospitals Trust lectures in 1972 and their publication as the Rock Carling monograph for that year, Effectiveness and Efficiency: Random Reflections on Health Services, the idea that medical interventions and health services should be evaluated and selected on the basis of (...) the most reliable evidence available for their effectiveness and cost effectiveness has become very widely accepted.1,2 This widespread acceptance has not been complete, and it sometimes seems that there are as many critics of EBM as advocates. Whereas the importance of randomised trial evidence, critical appraisal, meta-analysis, and systematic review …. (shrink)

Traditionally, surgical practice has been experiential and based on the contemporary understanding of basic mechanisms of disease. It was both a science and an art and depended to far too great an extent on the individualism and self belief of its main exponents. “Evidence based medicine” emerged in the 1980s and a new gospel of “Rules of Evidence” was introduced. There is no doubt that the net effect of EBM has been beneficial, but over reliance on (...) randomised controlled trials and the lack of generalisability of scientific evidence to individual patients has perhaps led to less enthusiasm for its tenets among surgeons. There are valid and spurious reasons for this that are discussed. The situation is improving but inevitable tensions remain between the surgeon committed to the individual patient here and now, and the clinical researcher whose focus is the benefit of future patients in the larger community. (shrink)

Evidence based medicine has had an increasing impact on primary care over the last few years. In the UK it has influenced the development of guidelines and quality standards for clinical practice and the allocation of resources for drug treatments and other interventions. It has informed the thinking around patient involvement in decision making with the concept of evidence based patient choice. There are, however, concerns among primary care clinicians that evidence based medicine is (...) not always relevant to primary care and that undue emphasis placed on it can lead to conflict with a clinician’s duty of care and respect for patient autonomy. In this paper we consider the impact of evidence based medicine on primary care, and the ethical implications of its increasing prominence for clinicians and managers in primary care. (shrink)

Uncertainty is the name of the game in philosopher Kenneth W Goodman’s attempt to apply ethics to evidence based medicine . Indeed, the book is as much about epistemology, or the study of how we learn and know about the world, as it is about ethics. Goodman’s desire is to understand what constitutes proof, or evidence, that a particular treatment is better than others. One of the ethical connections is that a failure to use such (...) treatments is blameworthy.EBM is a concept that is getting a great deal of attention these days. At least two factors drive this …. (shrink)

Evidence-based medicine has been rapidly and widely adopted because it claims to provide a method for determining the safety and efficacy of medical therapies and public health interventions more generally. However, as others have noted, EBM may be riven through with cultural bias, both in the generation of evidence and in its translation. We suggest that technological and scientific advances in medicine accentuate and entrench these cultural biases, to the extent that they may invalidate the evidence (...) we have about disease and its treatment. This creates a significant ethical, epistemological and ontological challenge for medicine. (shrink)

Gupta effectively probes the methodological and ethical presuppostions of Evidence Based Medicine, and its more contestable application to psychiatry. She concludes with an endorsement of a very modest reformulation of it as one guide to practice among many.

Complementary and alternative medicine has become an important section of healthcare. Its high level of acceptance among the general population represents a challenge to healthcare professionals of all disciplines and raises a host of ethical issues. This article is an attempt to explore some of the more obvious or practical ethical aspects of complementary and alternative medicine.

Evidence-Based Medicine (EBM) is defined as the conscious, and judicious use of current best evidence in making decisions about the care of individual patients. The greater the level of evidence the greater the grade of recommendation. This pioneering explicit concept of EBM is embedded in a particular view of medical practice namely the singular nature of the patient-physician relation and the commitment of the latter towards a specific goal: the treatment and the well being of his (...) or her client. Nevertheless, in many European countries as well as the United States, this integration of the best evidence from systematic research with clinical expertise and patient values appears to be re-interpreted in light of the scarcity of healthcare resources. The purpose of this paper is double. First, to claim that from an ethical perspective EBM should be a guideline to clinical practice; and second, that in specific circumstances EBM might be a useful tool in macro-allocation of healthcare resources. Methodologically the author follows Norman Daniels' theory of democratic accountability to justify this assumption. That is, choices in healthcare must be accountable by democratic procedures. This perspective of distributive justice is responsible for the scope and limits of healthcare services. It follows that particular entitlements to healthcare — namely expensive innovative treatments and medicines —may be fairly restricted as long as this decision is socially and democratically accountable and imposed by financial restrictions of the system. In conclusion, the implementation of EBM, as long as it limits the access to drugs and treatments of unproven scientific results is in accordance with this perspective. The use of EBM is regarded as an instrument to facilitate the access of all citizens to a reasonable level of healthcare and to promote the efficiency of the system. (shrink)

Drawing on previous empirical research, we provide an exemplary narrative to illustrate how patients have experienced hospital care organized according to evidence‐based fast‐track programmes. The aim of this paper was to analyse and discuss if and how it is possible to include patients’ individual perspectives in an evidence‐based practice as seen from the point of view of nursing theory. The paper highlights two conflicting courses of development. One is a course of standardization founded on evidence‐ (...) class='Hi'>based recommendations, which specify a set of rules that the patient must follow rigorously. The other is a course of democratization based on patients’ involvement in care. Referring to the analysis of the narrative, we argue that, in the current implementation of evidence‐based practice, the proposed involvement of patients resembles empty rhetoric. We argue that the principles and values from evidence‐based medicine are being lost in the transformation into the current evidence‐based hospital culture which potentially leads to a McDonaldization of nursing practice reflected as ‘one best way’. We argue for reviving ethics of care perspectives in today's evidence practice as the fundamental values of nursing may potentially bridge conflicts between evidence‐based practice and the ideals of patient participation thus preventing a practice of ‘McNursing’. (shrink)

In this paper, the author argues that the requirement to conduct randomised clinical trials to inform policy in cases where one wants to identify a cheaper alternative to known effective but expensive interventions raises an important ethical issue. This situation will eventually arise whenever there are resource constraints, and a policy decision has been made not to fund an intervention on cost effectiveness grounds. It has been thought that this is an issue only in extremely resource poor settings. This paper (...) gives an example from the United Kingdom illustrating that this is also a problem faced by richer countries. (shrink)

Fox, Danis, Tarzian, and Duke have made a substantial contribution to the field of bioethics through the project described in this issue’s target articles (Fox, Tarzian, et al. 2022; Fox, Danis, et...