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  1. Animal Models in Neuropsychiatry: Do the Benefits Outweigh the Moral Costs?Carrie Figdor - forthcoming - Cambridge Quarterly of Healthcare Ethics.
    Animal models have long been used to investigate human mental disorders, including depression, anxiety, and schizophrenia. This practice is usually justified in terms of the benefits (to humans) outweighing the costs (to the animals). I argue on utility maximization grounds that we should phase out animal models in neuropsychiatric research. Our leading theories of how human minds and behavior evolved invoke sociocultural factors whose relation to nonhuman minds, societies, and behavior has not been homologized. Thus it is not at all (...)
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  2. Bioética y Derechos Humanos: Sobre la Representación Intelectual Del Origen de la Bioética.Mastroleo Ignacio - forthcoming - Véritas (Arequipa).
    En este trabajo se comparan dos representaciones en competencia sobre el origen de la bioética para llamar la atención sobre un posible cambio de marco teórico dentro de la disciplina. Por un lado, una representación parroquiana del origen de la bioética, centrada en problemas tecnológicos locales, y fundamentada en tradiciones culturales particulares. Por otro lado, una representación universal y pluralista, que enfrenta problemas de justicia y salud globales y que intenta buscar el fundamento normativo del discurso de la bioética en (...)
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  3. Can We Learn From Hidden Mistakes? Self-Fulfilling Prophecy and Responsible Neuroprognostic Innovation.Mayli Mertens, Owen C. King, Michel J. A. M. van Putten & Marianne Boenink - forthcoming - Journal of Medical Ethics.
    A self-fulfilling prophecy (SFP) in neuroprognostication occurs when a patient in coma is predicted to have a poor outcome, and life-sustaining treatment is withdrawn on the basis of that prediction, thus directly bringing about a poor outcome (viz. death) for that patient. In contrast to the predominant emphasis in the bioethics literature, we look beyond the moral issues raised by the possibility that an erroneous prediction might lead to the death of a patient who otherwise would have lived. Instead, we (...)
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  4. Ancillary Care Obligations in Light of an African Bioethic: From Entrustment to Communion (Repr.).Thaddeus Metz - forthcoming - In Ike Iyioke (ed.), African Research Ethics (tentative title). Brill.
    Reprint of an article that first appeared in Theoretical Medicine and Bioethics (2017).
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  5. Avoiding the Potentiality Trap: Thinking About the Moral Status of Synthetic Embryos.Monika Piotrowska - forthcoming - Monash Bioethics Review.
    Research ethics committees must sometimes deliberate about objects that do not fit nicely into any existing category. This is currently the case with the “gastruloid,” which is a self-assembling blob of cells that resembles a human embryo. The resemblance makes it tempting to group it with other members of that kind, and thus to ask whether gastruloids really are embryos. But fitting an ambiguous object into an existing category with well-worn pathways in research ethics, like the embryo, is only a (...)
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  6. The Moral Obligation to Prioritize Research Into Deep Brain Stimulation Over Brain Lesioning Procedures for Severe Enduring Anorexia Nervosa.Jonathan Pugh, Jacinta Tan, Tipu Aziz & Rebecca J. Park - forthcoming - Frontiers in Psychiatry 9:523.
    Deep Brain Stimulation is currently being investigated as an experimental treatment for patients suffering from treatment-refractory AN, with an increasing number of case reports and small-scale trials published. Although still at an exploratory and experimental stage, initial results have been promising. Despite the risks associated with an invasive neurosurgical procedure and the long-term implantation of a foreign body, DBS has a number of advantageous features for patients with SE-AN. Stimulation can be fine-tuned to the specific needs of the particular patient, (...)
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  7. Navigating Conflicts of Justice in the Use of Race and Ethnicity in Precision Medicine.G. Owen Schaefer, Tai E. Shyong & Shirley Hsiao-Li Sun - forthcoming - Bioethics (Early View).
    Given the sordid history of injustices linking genetics to race and ethnicity, considerations of justice are central to ensuring the responsible development of precision medicine programmes around the world. While considerations of justice may be in tension with other areas of concern, such as scientific value or privacy, there are also be tensions between different aspects of justice. This paper focuses on three particular aspects of justice relevant to this context: social justice, distributive justice and human rights. The implications of (...)
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  8. Quantitative Framework for Retrospective Assessment of Interim Decisions in Clinical Trials.Roger Stanev - forthcoming - Medical Decision Making.
    This article presents a quantitative way of modeling the interim decisions of clinical trials. While statistical approaches tend to focus on the epistemic aspects of statistical monitoring rules, often overlooking ethical considerations, ethical approaches tend to neglect key epistemic dimension. The proposal is a second-order decision theoretic framework. The framework provides means for retrospective assessment of interim decisions based on a clear and consistent set of criteria that combines both ethical and epistemic considerations. The framework is broadly Bayesian and addresses (...)
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  9. Medical Ontology.Kazem Sadegh-Zadeh - 2nd ed. 2015 - In Handbook of Analytic Philosophy of Medicine. Springer Verlag.
    Due to the intricate nature of its subject matter, medicine is always threatened by speculations and disagreements about which among its entities exist, e.g., any specific biological structures, substructures or substances, pathogenic agents, pathophysiological processes, diseases, psychosomatic relationships, therapeutic effects, and other possible and impossible things. To avoid confusion, and to determine what entities an item of medical knowledge presupposes to exist if it is to be true, we need medical ontology. The term “medical ontology” we understand to mean the (...)
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  10. Reconciling Regulation with Scientific Autonomy in Dual-Use Research.Nicholas G. Evans, Michael J. Selgelid & Robert Mark Simpson - 2022 - Journal of Medicine and Philosophy 47 (1):72-94.
    In debates over the regulation of communication related to dual-use research, the risks that such communication creates must be weighed against against the value of scientific autonomy. The censorship of such communication seems justifiable in certain cases, given the potentially catastrophic applications of some dual-use research. This conclusion however, gives rise to another kind of danger: that regulators will use overly simplistic cost-benefit analysis to rationalize excessive regulation of scientific research. In response to this, we show how institutional design principles (...)
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  11. Equipoise, Standard of Care, and Consent: Responding to the Authorisation of New COVID-19 Treatments in Randomised Controlled Trials.Søren Holm, Jonathan Lewis & Rafael Dal-Ré - 2022 - Journal of Medical Ethics:1-6.
    In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...)
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  12. Justifying the Risks of COVID-19 Challenge Trials: The Analogy with Organ Donation.Athmeya Jayaram, Jacob Sparks & Daniel Callies - 2022 - Bioethics 36 (1):100-106.
    In the beginning of the COVID pandemic, researchers and bioethicists called for human challenge trials to hasten the development of a vaccine for COVID. However, the fact that we lacked a specific, highly effective treatment for COVID led many to argue that a COVID challenge trial would be unethical and we ought to pursue traditional phase III testing instead. These ethical objections to challenge trials may have slowed the progress of a COVID vaccine, so it is important to evaluate their (...)
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  13. Governing AI-Driven Health Research: Are IRBs Up to the Task?Phoebe Friesen, Rachel Douglas-Jones, Mason Marks, Robin Pierce, Katherine Fletcher, Abhishek Mishra, Jessica Lorimer, Carissa Véliz, Nina Hallowell, Mackenzie Graham, Mei Sum Chan, Huw Davies & Taj Sallamuddin - 2021 - Ethics and Human Research 2 (43):35-42.
    Many are calling for concrete mechanisms of oversight for health research involving artificial intelligence (AI). In response, institutional review boards (IRBs) are being turned to as a familiar model of governance. Here, we examine the IRB model as a form of ethics oversight for health research that uses AI. We consider the model's origins, analyze the challenges IRBs are facing in the contexts of both industry and academia, and offer concrete recommendations for how these committees might be adapted in order (...)
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  14. Risk, Double Effect and the Social Benefit Requirement.Robert C. Hughes - 2021 - Journal of Medical Ethics 47 (12):29-29.
    Many ethicists maintain that medical research on human subjects that presents no prospect of direct medical benefit must have a prospect of social benefit to be ethical. Payment is not the sort of benefit that justifies exposing subjects to risk. Alan Wertheimer has raised a serious challenge to this view, pointing out that in industry, social value is not considered necessary to make dangerous jobs ethical. This article argues that Wertheimer was correct to think that the ethics of hazard pay (...)
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  15. Avoiding Exploitation in Multinational Covid-19 Vaccine Trials.Alexander A. Iyer, Joseph Millum, Christine Grady & David Wendler - 2021 - The BMJ 372:n541.
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  16. Motives and Risk Perceptions of Participants in a Phase 1 Trial for Hepatitis C Virus Investigational Therapy in Pregnancy.Yasaswi Kislovskiy, Catherine Chappell, Emily Flaherty, Megan E. Hamm, Flor de Abril Cameron, Elizabeth Krans & Judy C. Chang - 2021 - Sage Publications Ltd: Research Ethics 18 (2):132-150.
    Research Ethics, Volume 18, Issue 2, Page 132-150, April 2022. Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to (...)
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  17. Aporia of the Gift: Precision Medicine’s Obligations Without Expectations.Elizabeth Lanphier - 2021 - American Journal of Bioethics 21 (4):83-85.
    In “Obligations of the Gift” Sandra Lee (2021) suggests that social norms of reciprocity and the expectations and obligations associated with gift-giving afford a framework for addressing social justice considerations in precision medicine. Lee is particularly concerned with obligations to marginalized or oppressed racial and ethnic groups, which are also historically under-represented populations in precision medicine. Obligations arise, Lee argues, through the “gift” that research participants make when they contribute their data or biospecimens to precision medicine research. This conceptualization of (...)
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  18. Ethical Issues in Genomics Research on Neurodevelopmental Disorders: A Critical Interpretive Review.Signe Mezinska, L. Gallagher, M. Verbrugge & E. M. Bunnik - 2021 - Human Genomics 16 (15).
    Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of research results. Ethical (...)
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  19. Why iBlastoids (Embryo-Like Structures) Do Not Raise Significant Ethical Issues.Alberto Molina-Pérez & Aníbal Monasterio Astobiza - 2021 - American Journal of Bioethics 22 (1):59-61.
    Most technology is used properly for their intended purpose, but certain technological breakthroughs have a dual-use nature, pose risks or lead to unintended consequences when applied in some areas...
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  20. Normative Framework of Informed Consent in Clinical Research in Germany, Poland, and Russia.Marcin Orzechowski, Katarzyna Woniak, Cristian Timmermann & Florian Steger - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...)
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  21. Improving the Ethical Review of Health Policy and Systems Research: Some Suggestions.Govind Persad - 2021 - Journal of Law, Medicine and Ethics 49 (1):123-125.
    Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.
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  22. Psychiatric Research Ethics.Dominic Sisti & William R. Smith - 2021 - In Ana S. Iltis & Douglas MacKay (eds.), Oxford Handbook of Research Ethics. Oxford University Press.
    Psychiatric research often poses special ethical concerns. This chapter first provides historical context, including scandals that stoked public concern about psychiatric research and led to the promulgation of canonical documents and bioethics scholarship, and then explores issues related to the decision-making capacity and safety of participants—including the use of placebos and washout periods, the design of suicide prevention studies, and research in emergency psychiatry. The chapter then describes how shifting models of psychiatric nosology have precipitated conflicts in the determination of (...)
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  23. Centrifugal and Centripetal Thinking About the Biopsychosocial Model in Psychiatry.Kathryn Tabb - 2021 - European Journal of Analytic Philosophy 17 (2):(M3)5-28.
    The biopsychosocial model, which was deeply influential on psychiatry following its introduction by George L. Engel in 1977, has recently made a comeback. Derek Bolton and Grant Gillett have argued that Engel’s original formulation offered a promising general framework for thinking about health and disease, but that this promise requires new empirical and philosophical tools in order to be realized. In particular, Bolton and Gillett offer an original analysis of the ontological relations between Engel’s biological, social, and psychological levels of (...)
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  24. An Argument For Reinterpreting the Benign Behavioral Intervention Exemption.Ian Tully - 2021 - Ethics and Human Research 43 (4):20-26.
    Recent changes to the Common Rule have helped reduce regulatory burden on researchers conducting minimal risk research. However, in this paper, I propose a way of minimizing burden further within the existing confines of the current regulations. I focus my discussion on the newly created “benign behavioral interventions” category of exempt research, arguing that this exemption from the federal regulations governing research with human subjects should be more expansively interpreted by the Secretary's Advisory Committee on Human Research Protections (SACHRP) than (...)
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  25. Public Interest in Health Data Research: Laying Out the Conceptual Groundwork.Angela Ballantyne & G. Owen Schaefer - 2020 - Journal of Medical Ethics 46 (9):610-616.
    The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...)
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  26. COVID-19 and Mental Health: Government Response and Appropriate Measures.Genevieve Bandares-Paulino & Randy A. Tudy - 2020 - Eubios Journal of Asian and International Bioethics 30 (7):378-382.
    As governments around the world imposed lockdowns or stay-at-home measures, people began to feel the stress as time dragged on. There were already reports on some individuals committing suicide. How do governments respond to such a phenomenon? Our main focus is the Philippine government and how it responded to the COVID-19 pandemic. In this paper, we argue that the problem with COVID-19 went forth just dealing with physical health. First, people suffer not just from being infected but the psychological stress (...)
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  27. Pandemic Ethics: The Case for Risky Research.Richard Yetter Chappell & Peter Singer - 2020 - Research Ethics 16 (3-4):1-8.
    There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of risk parity: if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of ex ante risk in order to minimize overall harm from the virus, then it is permissible to expose fully informed volunteers to a (...)
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  28. Clinical Reasoning: Knowledge, Uncertainty, and Values in Health Care.Daniele Chiffi - 2020 - Cham: Springer.
    This book offers a philosophically-based, yet clinically-oriented perspective on current medical reasoning aiming at 1) identifying important forms of uncertainty permeating current clinical reasoning and practice 2) promoting the application of an abductive methodology in the health context in order to deal with those clinical uncertainties 3) bridging the gap between biomedical knowledge, clinical practice, and research and values in both clinical and philosophical literature. With a clear philosophical emphasis, the book investigates themes lying at the border between several disciplines, (...)
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  29. Severe Acute Respiratory Syndrome Coronavirus 2 Human Challenge Trials: Too Risky, Too Soon.Liza Dawson, Jake Earl & Jeffrey Livezey - 2020 - Journal of Infectious Diseases 222 (3):514-516.
    Eyal et al have recently argued that researchers should consider conducting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) human challenge studies to hasten vaccine development. We have conducted (J. L.) and overseen (L. D.) human challenge studies and agree that they can be useful in developing anti-infective agents. We also agree that adults can autonomously choose to undergo risks with no prospect of direct benefit to themselves. However, we disagree that SARS-CoV-2 challenge studies are ethically appropriate at this time, for (...)
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  30. The Belmont Report and Innovative Practice.Jake Earl - 2020 - Perspectives in Biology and Medicine 63 (2):313-326.
    One of the Belmont Report’s most important contributions was the clear and serviceable distinction it drew between standard medical practice and biomedical research. A less well-known achievement of the Report was its conceptualization of innovative practice, a type of medical practice that is often mistaken for research because it is new, untested, or experimental. Although the discussion of innovative practice in Belmont is brief and somewhat cryptic, this does not reflect the significant progress its authors made in understanding innovative practice (...)
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  31. The Ethics of Information-Gathering in Innovative Practice.Jake Earl & David Wendler - 2020 - Internal Medicine Journal 50 (12):1583-1587.
    Innovative practice involves medical interventions that deviate from standard practice in significant ways. For many patients, innovative practice offers the best chance of successful treatment. Because little is known about most innovative treatments, clinicians who engage in innovative practice might consider including extra procedures, such as scans or blood draws, to gather information about the innovation. Such information-gathering interventions can yield valuable information for modifying the innovation to benefit future patients and for designing scientific studies of the innovation. However, existing (...)
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  32. Unethical Informed Consent Caused by Overlooking Poorly Measured Nocebo Effects.Jeremy Howick - 2020 - Journal of Medical Ethics 16:00-03.
    Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about (...)
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  33. A Moral Obligation to Proper Experimentation: Research Ethics as Epistemic Filter in the Aftermath of World War II.Noortje Jacobs - 2020 - Isis 111 (4):759-780.
  34. Ethical Arguments Concerning Human-Animal Chimera Research: A Systematic Review.Koko Kwisda, Lucie White & Dietmar Hübner - 2020 - BMC Medical Ethics 21:1-14.
    The burgeoning field of biomedical research involving the mixture of human and animal materials has attracted significant ethical controversy. Due to the many dimensions of potential ethical conflict involved in this type of research, and the wide variety of research projects under discussion, it is difficult to obtain an overview of the ethical debate. This paper attempts to remedy this by providing a systematic review of ethical reasons in academic publications on human-animal chimera research. We conducted a systematic review of (...)
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  35. Experimental Design: Ethics, Integrity and the Scientific Method.Jonathan Lewis - 2020 - In Ron Iphofen (ed.), Handbook of Research Ethics and Scientific Integrity. Cham, Switzerland: pp. 459-474.
    Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...)
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  36. Relational Autonomy as a Way to Recognise and Enhance Children’s Capacity and Agency to Be Participatory Research Actors.Janice McLaughlin - 2020 - Ethics and Social Welfare 14 (2):204-219.
  37. Clarifying How to Deploy the Public Interest Criterion in Consent Waivers for Health Data and Tissue Research.G. Owen Schaefer, Graeme Laurie, Sumytra Menon, Alastair V. Campbell & Teck Chuan Voo - 2020 - BMC Medical Ethics 21 (1):1-10.
    Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the (...)
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  38. Ethical Approval and Being a Virtuous Social Work Researcher. The Experience of Multi-Site Research in UK Health and Social Care: An Approved Mental Health Professional Case Study.Kevin Stone, Sarah Vicary, Charlotte Scott & Rosie Buckland - 2020 - Ethics and Social Welfare 14 (2):156-171.
  39. Researching Social Work Practice Ethically and Developing Ethical Researchers.Brian Stout, Ann Dadich, Susan Evans, Debbie Plath & Kenny Lawson - 2020 - Ethics and Social Welfare 14 (2):172-186.
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  40. The History of Methylprednisolone, Ascorbic Acid, Thiamine, and Heparin Protocol and I-MASK+ Ivermectin Protocol for COVID-19.Mika Turkia - 2020 - Cureus 12 (12):e12403.
    An alliance of established experts on critical care, Front Line COVID-19 Critical Care Alliance (FLCCC), has published two protocols for treatment of COVID-19. The first one, methylprednisolone, ascorbic acid, thiamine, and heparin (MATH+), is intended for hospital and intensive care unit treatment of pulmonary phases of the disease. It is based on affordable, commonly available components: anti-inflammatory corticosteroids (methylprednisolone, "M"), high-dose vitamin C infusion (ascorbic acid, "A"), vitamin B1 (thiamine, "T"), anticoagulant heparin ("H"), antiparasitic agent ivermectin, and supplemental components ("+") (...)
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  41. The Fifth Face of Fair Subject Selection: Population Grouping.Tomasz Żuradzki - 2020 - American Journal of Bioethics 20 (2):41-43.
    The article by MacKay and Saylor (2020) claims that the principle of fair subject selection yields conflicting imperatives (e.g. in the case of pregnant women) and should be understood as “a bundle of four distinct sub-principles” (i.e. fair inclusion, burden sharing, opportunity, distribution of third-party risks), each having conflicting normative recommendations (MacKay and Saylor 2020). The authors also offer guidance as to how we should navigate between subprinciples that may conflict with each other. The problem is a crucial one since (...)
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  42. Vulnérabilité des Femmes Enceintes En Éthique de la Recherche: Un Problème Sémantique.Sihem Neïla Abtroun - 2019 - Canadian Journal of Bioethics/Revue canadienne de bioéthique 2 (2):11-14.
    This commentary explores the notion of vulnerability applied to pregnant women in clinical research. The use of this notion, related to a semantic problem, raises an ethical issue and participates in the quasi-systematic exclusion of this sub-population from the research process.
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  43. Criminalization of Scientific Misconduct.William Bülow & Gert Helgesson - 2019 - Medicine, Health Care and Philosophy 22 (2):245-252.
    This paper discusses the criminalization of scientific misconduct, as discussed and defended in the bioethics literature. In doing so it argues against the claim that fabrication, falsification and plagiarism (FFP) together identify the most serious forms of misconduct, which hence ought to be criminalized, whereas other forms of misconduct should not. Drawing the line strictly at FFP is problematic both in terms of what is included and what is excluded. It is also argued that the criminalization of scientific misconduct, despite (...)
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  44. Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine.Jake Earl - 2019 - American Journal of Bioethics 19 (6):7-18.
    Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of patients (...)
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  45. Clinical Equipoise and Adaptive Clinical Trials.Nicolas Fillion - 2019 - Topoi 38 (2):457-467.
    Ethically permissible clinical trials must not expose subjects to risks that are unreasonable in relation to anticipated benefits. In the research ethics literature, this moral requirement is typically understood in one of two different ways: as requiring the existence of a state of clinical equipoise, meaning a state of honest, professional disagreement among the community of experts about the preferred treatment; or as requiring an equilibrium between individual and collective ethics. It has been maintained that this second interpretation makes it (...)
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  46. Introduction: The Limits of Respect for Autonomy.David Kirchhoffer - 2019 - In David G. Kirchhoffer & Bernadette J. Richards (eds.), Beyond Autonomy: Limits and Alternatives to Informed Consent in Research Ethics and Law. Cambridge: pp. 1-14.
    This book makes an important contribution to ongoing efforts in the fields of medical law and bioethics to answer the challenges posed by the limitations of the principle of respect for autonomy, especially as these pertain to human research ethics. The principle of respect for autonomy seems to have become firmly embedded in human research ethics since its inclusion in the 1947 Nuremberg Code, which was a response to atrocities committed by Nazi doctors. Nonetheless, there is an increasing awareness of (...)
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  47. Introduction: The Limits of Respect for Autonomy.David G. Kirchhoffer - 2019 - In D. Kirchhoffer & B. Richards (eds.), Beyond Autonomy: Limits and Alternatives to Informed Consent in Research Ethics and Law. Cambridge:
    This book makes an important contribution to ongoing efforts in the fields of medical law and bioethics to answer the challenges posed by the limitations of the principle of respect for autonomy, especially as these pertain to human research ethics. The principle of respect for autonomy seems to have become firmly embedded in human research ethics since its inclusion in the 1947 Nuremberg Code, which was a response to atrocities committed by Nazi doctors. Nonetheless, there is an increasing awareness of (...)
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  48. Dignity, Being and Becoming in Research Ethics.David G. Kirchhoffer - 2019 - In D. Kirchhoffer & B. Richards (eds.), Beyond Autonomy: Limits and Alternatives to Informed Consent in Research Ethics and Law. Cambridge:
    Since the end of World War II, most guidelines governing human research seem to have relied on the principle of respect for autonomy as a key, though not sole, criterion in assessing the moral validity of research involving human participants.1 One explanation for this apparent reliance on respect for autonomy may be that respect for autonomy, made effective through the practice of obtaining informed consent, functions as a useful proxy when dealing with competent adults for the more complex principle of (...)
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  49. Beneficence in Research Ethics.David G. Kirchhoffer, C. Favor & C. Cordner - 2019 - In D. Kirchhoffer & B. Richards (eds.), Beyond Autonomy: Limits and Alternatives to Informed Consent in Research Ethics and Law. Cambridge:
    This chapter examines the explicit and implicit roles that the concept of beneficence plays in the guidelines that govern biomedical research involving humans. We suggest that the role beneficence is actually playing in the guidelines is more comprehensive than is commonly assumed. The broader conceptualisation of beneficence proposed here clarifies the relationship of beneficence to respect for autonomy. It does this by showing how respect for autonomy is at the service of beneficence rather than in tension with it.
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  50. Beyond Autonomy: Limits and Alternatives to Informed Consent in Research Ethics and Law.David G. Kirchhoffer & Bernadette J. Richards (eds.) - 2019 - Cambridge: Cambridge University Press.
    Respect for autonomy has become a fundamental principle in human research ethics. Nonetheless, this principle and the associated process of obtaining informed consent do have limitations. This can lead to some groups, many of them vulnerable, being left understudied. This book considers these limitations and contributes through legal and philosophical analyses to the search for viable approaches to human research ethics. It explores the limitations of respect for autonomy and informed consent both in law and through the examination of cases (...)
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