Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard (...) view of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Bradford Hill (1965) highlighted nine aspects of the complex evidential situation a medical researcher faces when determining whether a causal relation exists between a disease and various conditions associated with it. These aspects are widely cited in the literature on epidemiological inference as justifying an inference to a causal claim, but the epistemological basis of the Hill aspects is not understood. We offer an explanatory coherentist interpretation, explicated by Thagard's ECHO model of explanatory coherence. The ECHO model captures the (...) complexity of epidemiological inference and provides a tractable model for inferring disease causation. We apply this model to three cases: the inference of a causal connection between the Zika virus and birth defects, the classic inference that smoking causes cancer, and John Snow’s inference about the cause of cholera. (shrink)

An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it (...) requires us to know more about the potential outcomes of research than we ever could. Second, it is false, because it conflicts with the so-called “soft paternalist” principles of liberal democracy. In place of this flawed rule I propose a new way of making risk-benefit assessments, one that does comport with the principles of liberalism. I argue that a protocol is moral only if it would be entered into by competent subjects who are informed about the protocol. The new rule this eschews all pseudo-utilitarian calculation about the protocol’s likely harms and benefits. (shrink)

Hysteria, a mysterious disease known since antiquity, is said to have ceased to exist. Challenging this commonly held view, this is the first cross-disciplinary study to examine the current functional neuroimaging research into hysteria and compare it to the nineteenth-century image-based research into the same disorder. Paula Muhr's central argument is that, both in the nineteenth-century and the current neurobiological research on hysteria, images have enabled researchers to generate new medical insights. Through detailed case studies, Muhr (...) traces how different images, from photography to functional brain scans, have reshaped the historically situated medical understanding of this disorder that defies the mind-body dualism. (shrink)

As a result of the world-wide COVID-19 epidemic, an internal tension in the goals of medicine has come to the forefront of public debate. Medical professionals are continuously faced with a tug of...

Mainstream views of medical research tell us it should be a fact-based, value-free endeavor: what a scientist (or her funding source) wants or cares about should not influence her findings. At the same time, we also sometimes criticize medical research for failing to embody certain values, e.g. when we criticize pharmaceutical companies for largely ignoring the diseases that affect the global poor. This chapter seeks to reconcile these perspectives by distinguishing appropriate from inappropriate influences of values (...) on medical research. It divides this broad question into two narrower ones, the Role Question (at what points in the research process is value influence potentially acceptable?) and the Content Question (when value influence is potentially acceptable, what specific values should researchers use?), and then draws on the philosophical literature on values in science to explore answers to each of them. (shrink)

Smajdor argues that “recognition” is the solution to the “reifying attitude” that results from “the urge to protect ‘vulnerable’ people through exclusion from research”. Drawing on theories of reification, we argue that it is the concepts of autonomy and vulnerability themselves that have been reified, resulting in the impoverishment of approaches to autonomy at law and in research ethics. Overcoming such reification demands a deeper consideration of the grounds on which vulnerable individuals are owed recognition and thereby the (...) forms such recognition should take. Smajdor argues for a recognition that appeals to autonomy and that manifests in providing vulnerable individuals with the opportunity to assent. The problem is that this kind of recognition is dependent on a more fundamental kind. It is this second form of recognition that would need to do the heavy lifting for assent-based frameworks to avoid the same problems we find with consent. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical studies in (...) the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

The case study presented by Winch and Sinnott (2011) shows not only how difficult it is for clinicians and researchers to identify conflicts of interest (COI), but also how damaging it can be when there are unin- formed and uncoordinated policy responses by senior administrators.

There have recently been novel applications of medical systematic review guidelines to economic policy interventions which contain controversial methodological assumptions that require further scrutiny. A landmark 2017 Cochrane review of unconditional cash transfer (UCT) studies, based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE), exemplifies both the possibilities and limitations of applying medical systematic review guidelines to UCT and universal basic income (UBI) studies. Recognizing the need to upgrade GRADE to incorporate the differences between medical (...) and policy interventions, the GRADE Public Health Project Group (PHPG) was convened to enumerate and address these methodological challenges. However, in light of our analysis of additional methodological challenges that arise for UCT and UBI studies, we argue that the adaptation of medical systematic review guidelines to economic methodology is far from straightforward and is in fact more challenging than claimed by the PHPG. (shrink)

In contemporary healthcare, medical image categorization is essential for illness prediction, diagnosis, and therapy planning. The emergence of digital imaging technology has led to a significant increase in research into the use of machine learning (ML) techniques for the categorization of images in medical data. We provide a thorough summary of recent developments in this area in this review, using knowledge from the most recent research and cutting-edge methods.We begin by discussing the unique challenges and opportunities (...) associated with medical image classification, including the complexity of anatomical structures, variability in imaging modalities, and the need for interpretability and reliability in clinical settings. Subsequently, we survey a wide range of ML algorithms and techniques employed for medical image classification, including traditional methods such as support vector machines and k-nearest neighbors, as well as deep learning approaches like convolutional neural networks (CNNs) and recurrent neural networks (RNNs). Furthermore, we examine key considerations in dataset preparation, feature extraction, and model evaluation specific to medical image classification tasks. We highlight the importance of large, annotated datasets, transfer learning, and data augmentation techniques in enhancing model performance and generalization. (shrink)

Assumptions about obesity—e.g., its connection to ill health, its causes, etc.—are still prevalent today, and they make up what I call the medical model of fatness. In this paper, I argue that the medical model was established on the basis of insufficient evidence and has nevertheless continued to be relied upon to justify methodological choices that further entrench the assumptions of the medical model. These choices are illegitimate in so far as they conflict with both the epistemic (...) and social aims of obesity research. I conclude the paper with a partial solution to these epistemic and social shortcomings. (shrink)

Pain medication is one of the responses to the mercy argument that utilitarian ethicists use for justifying active euthanasia on the grounds of prevention of cruelty and appeal to beneficence. The researcher reinforces the significance of pain medication in meeting this challenge and considers it the most preferred response among various other responses. It is because of its realism and effectiveness. In exploring the mechanism and considerations related to pain medication, the researcher briefly touches the Catholic ethical position on the (...) issue, a position that cannot be ignored in the development of contemporary bioethics. The researcher particularly deliberates on the contemporary Islamic discourse on the issue; by furthering the debate in line with the Islamic legal maxims and general guidance from the primary sources of Islamic law and ethics. The resolution on the issue is sought by synthesizing the views and legal maxims (al-Qawaid al-Fiqhiyyah) on the issue, which in conclusion provide justification for pain medication by considerably regarding pain as necessity and pressing need. However, such resolution allows pain medication to the limit and proportion that removes the pain and prohibits overdosing the patient with medication that may directly cause the death. (shrink)

Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the institutional Reviw boardsocial and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical (...) model", the point of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of human subjects, primarily through the use of informed consent. In fields as different as biomedical self-experimentation and ethnography there is the danger of losing sight of subjects' autonomy. Critiques of the so-called medical model are sometimes libertarian and sometimes utilitarian in spirit. Either way, such critiques have not yet demonstrated that these philosophical schools of thought have the resources to guard against the potential risk of harm that lexically prioritizing the autonomy of human subjects does. Precisely because IRB review recognizes that human subjects research occurs in different fields using different research methods, IRB review requires researchers to explain their particular methods, the particular risks of harm created by these methods, and the implementation of procedures by which subjects may autonomously consent to precisely those risks. (shrink)

This book examines the moral luck paradox, relating it to Kantian, consequentialist and virtue-based approaches to ethics. It also applies the paradox to areas in medical ethics, including allocation of scarce medical resources, informed consent to treatment, withholding life-sustaining treatment, psychiatry, reproductive ethics, genetic testing and medical research. If risk and luck are taken seriously, it might seem to follow that we cannot develop any definite moral standards, that we are doomed to moral relativism. However, Dickenson (...) offers strong counter-arguments to this view that enable us to think in terms of universal standards. (shrink)

Consensus statement by UK teachers of medical ethics and law.

There is a lot of conceptual engineering going on in medical research. I substantiate this claim with two examples, the medical debate about cancer classification and about obesity as a disease I also argue that the proper target of conceptual engineering in medical research are experts’ conceptions. These are explicitly written down in documents and guidelines, and they bear on research and policies. In the second part of the chapter, I propose an externalist framework (...) in which conceptions have both the explanatory power of psychological concepts and that of semantic concepts. It is likely, however, that human activities and practices distinct from medical research, and regulated by different practices and epistemic rules, call for different targets for conceptual engineering. I conclude with indicating an open agenda of problems for philosophers of medicine interested in conceptual engineering. (shrink)

This article argues that personal medical data should be made available for scientific research, by enabling and encouraging individuals to donate their medical records once deceased, similar to the way in which they can already donate organs or bodies. This research is part of a project on posthumous medical data donation developed by the Digital Ethics Lab at the Oxford Internet Institute at the University of Oxford. Ten arguments are provided to support the need to (...) foster posthumous medical data donation. Two major risks are also identified—harm to others, and lack of control over the use of data—which could follow from unregulated donation of medical data. The argument that record-based medical research should proceed without the need to secure informed consent is rejected, and instead a voluntary and participatory approach to using personal medical data should be followed. The analysis concludes by stressing the need to develop an ethical code for data donation to minimise the risks, and offers five foundational principles for ethical medical data donation suggested as a draft code. (shrink)

In medical settings, machines are in close proximity with human beings: with patients who are in vulnerable states of health, who have disabilities of various kinds, with the very young or very old, and with medical professionals. Machines in these contexts are undertaking important medical tasks that require emotional sensitivity, knowledge of medical codes, human dignity, and privacy. -/- As machine technology advances, ethical concerns become more urgent: should medical machines be programmed to follow a (...) code of medical ethics? What theory or theories should constrain medical machine conduct? What design features are required? Should machines share responsibility with humans for the ethical consequences of medical actions? How ought clinical relationships involving machines to be modeled? Is a capacity for empathy and emotion detection necessary? What about consciousness? -/- The essays in this collection by researchers from both humanities and science describe various theoretical and experimental approaches to adding medical ethics to a machine, what design features are necessary in order to achieve this, philosophical and practical questions concerning justice, rights, decision-making and responsibility, and accurately modeling essential physician-machine-patient relationships. -/- This collection is the first book to address these 21st-century concerns. (shrink)

Medical tourism can be defined as the process of travelling outside of an individual’s country to another to seek medical care. The current research studies medical tourism in Ghana historically, focusing on Korle Bu Teaching Hospital in Accra and Komfo Anokye Teaching Hospital in Kumase. Using a qualitative research approach, the study provides a historical argument on the continuities and discontinuities of medical tourism in Ghana. Indeed, medical tourism has undergone several transitions over (...) time. To emphasize, the current contribution has thoroughly discussed the evolution of medical tourism in Ghana, the pull and push factors of medical tourism, its impact on the local health systems and the need to further promote it. The study concludes among other things that the improvement of medical facilities, personnel and equipment, will enhance the medical tourism prospects of the country. (shrink)

: The Islamic jurists utilized the discipline of maqāṣid al-sharīʿah,in its capacity as the philosophy of Islamic law, in their legal and ethicalinterpretations, with added interest in addressing the issues of modern times.Aphoristically subsuming the major themes of the Sharīʿah, maqāṣid play apivotal role in the domain of decision-making and deduction of rulings onunprecedented ethical discourses. Ethics represent the infrastructure of Islamiclaw and the whole science of Islamic jurisprudence operates in the lightof maqāṣid to realize the ethics in people’s lives. (...) Scrutinizing the key themesof maqāṣid-based ijtihād and scope of ethics in maqāṣid, this article delvesinto the discourse on the application of maqāṣid to medical ethics. As a casestudy, this research analyses the extent of medical confidentiality in the light ofmaqāṣid and arrives at the conclusion that limited confidentiality goes more inline with the maxims of maqāṣid. (shrink)

Most people are completely oblivious to the danger that their medical data undergoes as soon as it goes out into the burgeoning world of big data. Medical data is financially valuable, and your sensitive data may be shared or sold by doctors, hospitals, clinical laboratories, and pharmacies—without your knowledge or consent. Medical data can also be found in your browsing history, the smartphone applications you use, data from wearables, your shopping list, and more. At best, data about (...) your health might end up in the hands of researchers on whose good will we depend to avoid abuses of power.2 Most likely, it will end up with data brokers who might sell it to a future employer, or an insurance company, or the government. At worst, your medical data may end up in the hands of criminals eager to commit extortion or identity theft. In addition to data harms related to exposure and discrimination, the collection of sensitive data by powerful corporations risks the creation of data monopolies that can dominate and condition access to health care. -/- This chapter aims to explore the challenge that big data brings to medical privacy. Section I offers a brief overview of the role of privacy in medical settings. I define privacy as having one’s personal information and one’s personal sensorial space (what I call autotopos) unaccessed. Section II discusses how the challenge of big data differs from other risks to medical privacy. Section III is about what can be done to minimise those risks. I argue that the most effective way of protecting people from suffering unfair medical consequences is by having a public universal healthcare system in which coverage is not influenced by personal data (e.g., genetic predisposition, exercise habits, eating habits, etc.). (shrink)

This article argues that personal medical data should be made available for scientific research, by enabling and encouraging individuals to donate their medical records once deceased, in a way similar to how they can already donate organs or bodies. This research is part of a project on posthumous medical data donation developed by the Digital Ethics Lab at the Oxford Internet Institute. Ten arguments are provided to support the need to foster posthumous medical data (...) donation. Two major risks are also identified—harm to others, and lack of control over the use of data—which could follow from unregulated donation of medical data. The argument that record-based medical research should proceed without the need to ask for informed consent is rejected, and it instead a voluntary and participatory approach to using personal medical data should be followed. The analysis concludes by stressing the need to develop an ethical code for data donation to minimise the risks providing five foundational principles for ethical medical data donation; and suggesting a draft for such a code. (shrink)

The new field of meta-research investigates industry bias, publication bias, contradictions between studies, and other trends in medical research. I argue that its findings should be used as meta-evidence for evaluating therapies. ‘Meta-evidence’ is evidence about the support that direct ‘first-order evidence’ provides the hypothesis. I consider three objections to my proposal: the irrelevance objection, the screening-off objection, and the underdetermination objection. I argue that meta-research evidence works by rationally revising our confidence in first-order evidence and, (...) consequently, in the hypothesis—typically, downward. (shrink)

Background: Besides regulatory learning skills, learning also requires students to relate to their social context and negotiate it as they transition and adjust to medical training. As such, there is a need to consider and explore the role of social and cultural aspects in student learning, particularly in problem-based learning, where the learning paradigm differs from what most students have previously experienced. In this article, we report on the findings of a study exploring first-year medical students’ experiences during (...) the first semester of an undergraduate problem-based learning medical program at an African medical school. Method: We employed a qualitative case study approach using in-depth interviews with 23 first-year medical students. Participants ranged in age from 18 to 25 years. All students were bi/multilingual (some spoke three to five languages), with English as the learning language. We conducted an inductive thematic analysis to systematically identify and analyze patterns in the data using the Braun and Clarke framework. Results: Before medical school, students worked hard to compete for admission to medical school, were primarily taught using a teacher-centered approach, and preferred working alone. At the beginning of medical school, students found it challenging to understand the problem-based learning process, the role of the case, speaking and working effectively in a group, managing a heavy workload, and taking increased responsibility for their learning. By the end of the first semester, most students were handling the workload better, were more comfortable with their peers and facilitators, and appreciated the value of the problem-based learning approach. Conclusions: Our study highlights the importance of interrogating contextual sociocultural factors that could cause tension when implementing problem-based learning in non-western medical schools. Adjustment to problem-based learning requires a conceptual and pedagogic shift towards learner-centered practice, particularly concerning self direction, the role of the case, and collaborative learning. As such, there is a need to develop and implement research informed learning development programs that enable students to reflect on their sociocultural beliefs and practices, and enhance their regulatory learning competence to optimize meaningful and early engagement with the problem based learning process. (shrink)

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation (...) are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (shrink)

Current challenges in medical practice, research, and administration demand physicians who are familiar with bioethics, health law, and health economics. Curriculum directors at American Association of Medical Colleges-affiliated medical schools were sent confidential surveys requesting the number of required hours of the above subjects and the years in which they were taught, as well as instructor names. The number of relevant publications since 1990 for each named instructor was assessed by a PubMed search.In sum, teaching in (...) all three subjects combined comprises less than two percent of the total hours in the American medical curriculum, and most instructors have not recently published articles in the fields they teach. This suggests that medical schools should reevaluate their curricula and instructors in bioethics, health law, and health economics. (shrink)

Biomedical science has been remarkably successful in explaining illness by categorizing diseases and then by identifying localizable lesions such as a virus and neoplasm in the body that cause those diseases. Not surprisingly, researchers have aspired to apply this powerful paradigm to addiction. So, for example, in a review of the neuroscience of addiction literature, Hyman and Malenka (2001, p. 695) acknowledge a general consensus among addiction researchers that “[a]ddiction can appropriately be considered as a chronic medical illness.” Like (...) other diseases, “Once addiction has taken hold, it tends to follow a chronic course.” (Koob and La Moal 2006, p. ?). Working from this perspective, much effort has gone into characterizing the symptomology of addiction and the brain changes that underlie them. Evidence for involvement of dopamine transmission changes in the ventral tegmental area (VTA) and nucleus accumbens (NAc) have received the greatest attention. Kauer and Malenka (2007, p. 844) put it well: “drugs of abuse can co-opt synaptic plasticity mechanisms in brain circuits involved in reinforcement and reward processing”. Our goal in this chapter to provide an explicit description of the assumptions of medical models, the different forms they may take, and the challenges they face in providing explanations with solid evidence of addiction. <br>. (shrink)

Forms of Artificial Intelligence (AI) are already being deployed into clinical settings and research into its future healthcare uses is accelerating. Despite this trajectory, more research is needed regarding the impacts on patients of increasing AI decision making. In particular, the impersonal nature of AI means that its deployment in highly sensitive contexts-of-use, such as in healthcare, raises issues associated with patients’ perceptions of (un) dignified treatment. We explore this issue through an experimental vignette study comparing individuals’ perceptions (...) of being treated in a dignified and respectful way in various healthcare decision contexts. Participants were subject to a 2 (human or AI decision maker) x 2 (positive or negative decision outcome) x 2 (diagnostic or resource allocation healthcare scenario) factorial design. We found evidence of a “human bias” (i.e., a preference for human over AI decision makers) and an “outcome bias” (i.e., a preference for positive over negative outcomes). However, we found that for perceptions of respectful and dignified interpersonal treatment, it matters more who makes the decisions in diagnostic cases and it matters more what the outcomes are for resource allocation cases. We also found that humans were consistently viewed as appropriate decision makers and AI was viewed as dehumanizing, and that participants perceived they were treated better when subject to diagnostic as opposed to resource allocation decisions. Thematic coding of open-ended text responses supported these results. We also outline the theoretical and practical implications of these findings. (shrink)

The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the (...) disclosure requirement for advance research directives. We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level. (shrink)

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent (...) to which the role of the REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (shrink)

Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review (...) of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. (shrink)

Although ethics is an essential component of undergraduate medical education, research suggests current medical ethics curricula face considerable challenges in improving students’ ethical reasoning. This paper discusses these challenges and introduces a promising new mode of graduate and professional ethics instruction for overcoming them. We begin by describing common ethics curricula, focusing in particular on established problems with current approaches. Next, we describe a novel method of ethics education and assessment for medical students that we have (...) devised, the Medical Ethics Bowl. Finally, we suggest pedagogical advantages to MEBs when compared to other ethics curricula. (shrink)

Modern health care relies extensively on the use of technologies for assessing and treating patients, so it is important to be certain that health care technologies perform their professed functions in an effective and safe manner. Philosophers of technology have developed methods to assign and evaluate the functions of technological products, the major elements of which are described in the ICE theory. This paper questions whether the standard of evidence advocated by the ICE theory is adequate for ascribing and assessing (...) technologies employed in health care. The paper proposes that the general problem with the standard of evidence embodied in the ICE theory is too permissive for assessing medical technologies, in that it does not take into account the relative benefit and harm of medical technologies in ensuring safe functional performance in patients. The paper illustrates how evidence-based medicine has demonstrated the value of clinical research methods, including observational studies, randomized and non-randomized clinical trials, and formal techniques, such as meta-analysis, to measure therapeutic effectiveness. I argue, therefore, that evidence from clinical research studies should take precedence over the testimonial evidence and other types of non-clinical evidence, in providing justification for health technologies. (shrink)

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure (...) that scarce resources such as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

Neutrosophic set, neutrosophic logic, neutrosophic probability, neutrosophic statistics, neutrosophic measure, neutrosophic precalculus, neutrosophic calculus and so on are gaining significant attention in solving many real life problems that involve uncertainty, impreciseness, vagueness, incompleteness, inconsistent, and indeterminacy. In the past years the fields of neutrosophics have been extended and applied in various fields, such as: artificial intelligence, data mining, soft computing, decision making in incomplete / indeterminate / inconsistent information systems, image processing, computational modelling, robotics, medical diagnosis, biomedical engineering, investment (...) problems, economic forecasting, social science, humanistic and practical achievements. There are about 7,000 neutrosophic researchers, within 89 countries around the globe, that have produced about 4,000 publications and tenths of PhD and MSc theses, within more than two decades. This is the sixth volume of the Encyclopedia of Neutrosophic Researchers, edited from materials offered by the authors who responded to the editor’s invitation, with an introduction contains a short history of neutrosophics, together with links to the main papers and books. -/- ES: Este es el Sexto volumen de la Enciclopedia de Investigadores Neutróficos, editados a partir de materiales ofrecidos por los autores que respondieron a la invitación del editor. Los autores se enumeran alfabéticamente. La introducción contiene una breve historia de la neutrosófica, y en especial se sus impacto en latinoamérica junto con enlaces a los principales artículos y libros. Conjunto neutrosófico, lógica neutrosófica, probabilidad neutrosófica, estadística neutrosófica, medida neutrosófica, precálculo neutrosófico, cálculo neutrosófico, psicología neutrosófica, sociología neutrosófica etc., están ganando una atención significativa en resolver muchos problemas de la vida real que implican incertidumbre, imprecisión, vaguedad, incompletitud, inconsistencia e indeterminación. En los últimos años, los campos de la neutrosófica se han ampliado y aplicado en diversos campos, tales como: inteligencia artificial, minería de datos, software informática, toma de decisiones en forma incompleta / indeterminada / inconsistente sistemas de información, procesamiento de imágenes, modelado computacional, robótica, diagnóstico médico, ingeniería biomédica, problemas de inversión, previsión económica, ciencias sociales, humanística y la validación y consolidación del conocimiento científico. (shrink)

Neutrosophic set, neutrosophic logic, neutrosophic probability, neutrosophic statistics, neutrosophic measure, neutrosophic precalculus, neutrosophic calculus and so on are gaining significant attention in solving many real life problems that involve uncertainty, impreciseness, vagueness, incompleteness, inconsistent, and indeterminacy. In the past years the fields of neutrosophics have been extended and applied in various fields, such as: artificial intelligence, data mining, soft computing, decision making in incomplete / indeterminate / inconsistent information systems, image processing, computational modelling, robotics, medical diagnosis, biomedical engineering, investment (...) problems, economic forecasting, social science, humanistic and practical achievements. There are about 7,000 neutrosophic researchers, within 89 countries around the globe, that have produced about 4,000 publications and tenths of PhD and MSc theses, within more than two decades. This is the fifth volume of the Encyclopedia of Neutrosophic Researchers, edited from materials offered by the authors who responded to the editor’s invitation, with an introduction contains a short history of neutrosophics, together with links to the main papers and books. (shrink)

This paper aims to analyze the ethical challenges in experimental drug use during the early stage of the COVID-19 pandemic, using Germany as a case study. In Germany uniform ethical guidelines were available early on nationwide, which was considered as desirable by other states to reduce uncertainties and convey a message of unity. The purpose of this ethical analysis is to assist the preparation of future guidelines on the use of medicines during public health emergencies. The use of hydroxychloroquine, remdesivir (...) and COVID-19 convalescent plasma in clinical settings was analyzed from the perspective of the ethical principles of beneficence, non-maleficence, justice and autonomy. We observed that drug safety and drug distribution during the pandemic affects all four ethical principles. We therefore recommend to establish ethical guidelines (i) to discuss experimental treatment options with patients from all population groups who are in urgent need, (ii) to facilitate the recording of patient reactions to drugs in off-label use, (iii) to expand inclusion criteria for clinical studies to avoid missing potentially negative effects on excluded groups, and (iv) to maintain sufficient access to repurposed drugs for patients with prior conditions. (shrink)

This paper assesses the state of research ethics in low- and middle-income countries and the achievements of the Fogarty International Center's bioethics training program since 2000. The vision of FIC for the next decade of research ethics education is encapsulated in four proposed goals: (1) Ensure sufficient expertise in ethics review by having someone with long-term training on every high-workload REC; (2) Develop LMIC capacity to conduct original research on critical ethical issues by supporting doctoral and postdoctoral (...) training and career paths for research ethicists; (3) Make research training and review at LMIC institutions sustainable by identifying additional funding mechanisms and models; (4) Make institutional research systems more ethical and efficient through context-specific training integrated into all levels of scientific training. (shrink)

The European Medical Information Framework project, funded through the IMI programme, has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice to ensure the privacy protection of data subjects, (...) protect the interests of data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board, to provide feedback on its approach, platform, and the EcoP. The most important challenges the ECoP team faced were: how to define, control and monitor the purposes for which federated health data are used; the kinds of organisation that should be permitted to conduct permitted research; and how to monitor this. This manuscript explores those issues, offering the combined insights of the EAB and EMIF core ECoP team. For some issues, a consensus on how to approach them is proposed. For other issues, a singular approach may be premature but the challenges are summarised to help the community to debate the topic further. Arguably, the issues and their analyses have application beyond EMIF, to many research infrastructures connected to health data sources. (shrink)

This article evaluates an emerging element in popular debate and inquiry: DYOR. (Haven’t heard of the acronym? Then Do Your Own Research.) The slogan is flexible and versatile. It is used frequently on social media platforms about topics from medical science to financial investing to conspiracy theories. Using conceptual and empirical resources drawn from philosophy and psychology, we examine key questions about the slogan’s operation in human cognition and epistemic culture.

Human embryo models formed from stem cells—known as embryoids—allow scientists to study the elusive first stages of human development without having to experiment on actual human embryos. But clear ethical guidelines for research involving embryoids are still lacking. Previously, a handful of researchers put forward new recommendations for embryoids, which they hope will be included in the next set of International Society for Stem Cell Research guidelines. Although these recommendations are an improvement over the default approach, they are (...) nonetheless unworkable, because they rely on a poorly conceived notion of an embryoid’s ‘potential’ to trigger stringent research regulations. (shrink)

Abstract: In this research, the Artificial Neural Network (ANN) model was developed and tested to predict the rate of treatment expenditure on an individual or family in a country. A number of factors have been identified that may affect treatment expenses. Factors such as age, grade level such as primary, preparatory, secondary or college, sex, size of disability, social status, and annual medical expenses in fixed dollars excluding dental and outpatient clinics among others, as input variables for the (...) ANN model. A model based on the multi-layer Perceptron topology was developed and trained using data on 5574 cases. The evaluation of the test data shows that the ANN model is capable of predicting correctly Medical Expenses. (shrink)

Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering the (...) arrangements. There are ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here. (shrink)

Background Professional communities such as the medical community are acutely concerned with negligence: the category of misconduct where a professional does not live up to the standards expected of a professional of similar qualifications. Since science is currently strengthening its structures of self-regulation in parallel to the professions, this raises the question to what extent the scientific community is concerned with negligence, and if not, whether it should be. By means of comparative analysis of medical and scientific codes (...) of conduct, we aim to highlight the role of negligence provisions in codes of conduct for scientists, and to discuss the normative consequences for future codes of conduct. -/- Methods We collected scientific and medical codes of conduct in a selection of OECD countries, and submitted each code of conduct to comparative textual analysis. -/- Results Negligence is invariably listed as an infraction of the norms of integrity in medical codes of conduct, but only rarely so in the scientific codes. When the latter list negligence, they typically do not provide any detail on the meaning of ‘negligence’. -/- Discussion Unlike codes of conduct for professionals, current codes of conduct for scientists are largely silent on the issue of negligence, or explicitly exclude negligence as a type of misconduct. In the few cases where negligence is stipulated to constitute misconduct, no responsibilities are identified that would help prevent negligence. While we caution against unreasonable negligence provisions as well as disproportionate sanctioning systems, we do argue that negligence provisions are crucial for justified trust in the scientific community, and hence that there is a very strong rationale for including negligence provisions in codes of conduct. (shrink)

The Medical bot project is built using artificial algorithms that analyses user’s queries and understand user’s message. This System is a web application which provides answer to the query of the patients. Patients just have to query through the bot which is used for chatting. Patients can chat using any format there is no specific format the user has to follow. The System uses built in artificial intelligence to answer the query. The answers are appropriate what the user queries. (...) The User can query any Medical related activities through the system. The user does not have to personally go to the Medical for enquiry. The System analyses the question and then answers to the user. The system answers to the query as if it is answered by the person. With the help of artificial intelligence, the system answers the query asked by the patients. The system replies using an effective Graphical user interface which implies that as if a real person is talking to the user. The user just has to register himself to the system and has to login to the system. After login user can access to the various helping pages. Various helping pages has the bot through which the user can chat by asking queries related to Medical activities. The system replies to the user with the help of effective graphical user interface. The user can query about the Medical related activities through online with the help of this web application. The user can query Medical related activities such as date and timing of annual day, sports day, and other cultural activities. This system helps the patients to be updated about the Medical activities. (shrink)

The creation of guidelines has long been a popular means of conveying normative requirements in scientific and medical research. The recent case of He Jiankui, whose research flouted both widely accepted ethical standards and a set of field-specific guidelines he co-authored, raises the question of whether guidelines are an effective means of preventing misconduct. This paper advances the theory that guidelines can facilitate moral rationalization, a form of motivated reasoning. Moral rationalization in research occurs when individuals (...) justify their actions with plausible reasons that cohere with their moral standards. This allows them to act as they want while believing in their own goodness. If guidelines facilitate moral rationalization, this has implications for research ethics training and for the work of applied ethicists. Research ethics training ought to incorporate reflection on conative features of reasoning, including incentives to commit misconduct, and applied ethicists ought to be circumspect about their use of ethics guidelines. Otherwise, they are feeding the fire of rationalization with the cognitive material practitioners need to accomplish their desired ends. (shrink)

Since their discovery in the early 1990s, Stem Cell has brought the prospect of radically improving treatments for a host of diseases such as Alzheimer's, Parkinson's disease, cancers and many among other diseases that currently render patients and scientists helpless to combat. With the advent of medical and scientific research, comes the inevitable emergence of ethical controversy that often accompanied major scientific and medical development. The use of Stem Cell is no different. Those who seek to curtail (...) the use of certain stem cell lines, revert to the argument that has defied many medical debates over the previous decades. The destruction of human life to create life is one of the key philosophical points that all anti-stem cell advocates attempt to make. However, the purpose of this paper is to analysis the various aspects of ethical debate concerning the use of stem cells in medical research. (shrink)

Research projects sponsored by rich countries or companies and carried out in developing countries are often described as exploitative. One important debate about the prevention of exploitation in research centres on whether and how clinical research in developing countries should be responsive to local health problems. This paper analyses the responsiveness debate and draws out more general lessons for how policy makers can prevent exploitation in various research contexts. There are two independent ways to do this (...) in the face of entrenched power differences: to impose restrictions on the content of benefit-sharing arrangements, and to institute independent effective oversight. Which method should be chosen is highly dependent on context. (shrink)

In the last two decades we have witnessed considerable efforts directed towards making electronic healthcare records comparable and interoperable through advances in record architectures and (bio)medical terminologies and coding systems. Deep semantic issues in general, and ontology in particular, have received some interest from the research communities. However, with the exception of work on so-called ‘controlled vocabularies’, ontology has thus far played little role in work on standardization. The prime focus has been rather the rapid population of terminologies (...) at the level of fine detail. In this paper, we argue that more efforts are needed on the side of both research and standardization to ensure that the coding systems used in electronic healthcare records enjoy a semantics that is coherent with the semantics of the record. We propose realist ontology as a method to bring about this coherence by means of a robust system of top-level ontological categories. (shrink)