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  1. Risk, Double Effect and the Social Benefit Requirement.Robert C. Hughes - forthcoming - Journal of Medical Ethics:medethics-2019-106034.
    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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  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. 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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  4. 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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  5. 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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  6. 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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  7. 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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  8. 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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  9. 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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  10. 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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  11. 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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  12. 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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  13. 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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  14. 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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  15. 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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  16. Why IACUCs Need Ethicists.Nathan Nobis - 2020 - ILAR 1.
    Some animal research is arguably morally wrong, and some animal research is morally bad but could be improved. Who is most likely to be able to identify wrong or bad animal research and advocate for improvements? I argue that philosophical ethicists have the expertise that makes them the likely best candidates for these tasks. I review the skills, knowledge and perspectives that philosophical ethicists tend to have which makes them ethical experts. I argue that, insofar as IACUCs are expected to (...)
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  17. 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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  18. 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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  19. 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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  20. 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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  21. Emergency Care Research Ethics in Low- and Middle-Income Countries.Joseph Millum, Blythe Beecroft, Timothy C. Hardcastle, Jon Mark Hirshon, Adnan A. Hyder, Jennifer A. Newberry & Carla Saenz - 2019 - BMJ Global Health 4:e001260.
    A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research to improve emergency (...)
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  22. Ethics Surrounding Human Embryonic Stem Cell Research.Joseph Nkang Ogar - 2019 - International Social Mentality and Researcher Thinkers Journal 5 (22).
    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 (...)
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  23. Ethical Perspectives on Advances in Biogerontology.Jean Woo, David Archard, Derrick Au, Sara Bergstresser, Alexandre Erler, Timothy Kwok, John Newman, Raymond Tong & Tom Walker - 2019 - Aging Medicine 2 (2):99-103.
    Worldwide populations are aging with economic development as a result of public health initiatives and advances in therapeutic discoveries. Since 1850, life expectancy has advanced by 1 year for every four. Accompanying this change is the rapid development of anti‐aging science. There are three schools of thought in the field of aging science. One perspective is the life course approach, which considers that aging is a good and natural process to be embraced as a necessary and positive aspect of life, (...)
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  24. An Ethics Framework for Big Data in Health and Research.Vicki Xafis, G. Owen Schaefer, Markus K. Labude, Iain Brassington, Angela Ballantyne, Hannah Yeefen Lim, Wendy Lipworth, Tamra Lysaght, Cameron Stewart, Shirley Sun, Graeme T. Laurie & E. Shyong Tai - 2019 - Asian Bioethics Review 11 (3):227-254.
    Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and (...)
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  25. Consent and the Ethical Duty to Participate in Health Data Research.Angela Ballantyne & G. Owen Schaefer - 2018 - Journal of Medical Ethics 44 (6):392-396.
    The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional (...)
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  26. Educational Equipoise and the Educational Misconception; Lessons From Bioethics.Gil Hersch - 2018 - Teaching and Learning Inquirey 6 (2):3-15.
    Some advances in bioethics regarding ethical considerations that arise in the context of medical research can also be relevant when thinking about the ethical considerations that arise in the context of SoTL research. In this article, I aim to bring awareness to two potential ethical challenges SoTL researchers might face when playing a dual role of teacher and researcher that are similar to the challenges physicians face in their dual role of physician and researcher. In this article, I argue that (...)
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  27. Ethical and Moral Concerns Regarding Artificial Intelligence in Law and Medicine.Soaad Hossain - 2018 - Journal of Undergraduate Life Sciences 12 (1):10.
    This paper summarizes the seminar AI in Medicine in Context: Hopes? Nightmares? that was held at the Centre for Ethics at the University of Toronto on October 17, 2017, with special guest assistant professor and neurosurgeon Dr. Sunit Das. The paper discusses the key points from Dr. Das' talk. Specifically, it discusses about Dr. Das' perspective on the ethical and moral issues that was experienced from applying artificial intelligence (AI) in law and how such issues can also arise when applying (...)
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  28. The Duty to Rescue and Randomized Controlled Trials Involving Serious Diseases.Joseph Millum & David Wendler - 2018 - Journal of Moral Philosophy 15 (3):298-323.
    During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unethical to carry out a study that withheld a potential treatment from affected individuals with such a serious, untreatable disease. As a result, the initial trials of experimental treatments did not have control arms, despite important scientific reasons for their inclusion. In this paper, we consider whether the duty to rescue entails that it would be unethical to withhold an experimental treatment from patient-participants with serious diseases (...)
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  29. Consent in Clinical Research.Collin O'Neil - 2018 - In Andreas Müller & Peter Schaber (eds.), The Routledge Handbook of the Ethics of Consent. New York, USA: Routledge. pp. 297-310.
    This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under what conditions consent is (...)
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  30. Code-Consistent Ethics Review: Defence of a Hybrid Account.G. Owen Schaefer - 2018 - Journal of Medical Ethics 44 (7):494-495.
    It is generally unquestioned that human subjects research review boards should assess the ethical acceptability of protocols. It says so right on the tin, after all: they are explicitly called research ethics committees in the UK. But it is precisely those sorts of unchallenged assumptions that should, from time to time, be assessed and critiqued, in case they are in fact unfounded. John Stuart Mill's objection to suppressers of dissent is instructive here: “If the opinion is right, they are deprived (...)
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  31. Advance Research Directives in Germany: A Proposal for a Disclosure Standard.Matthé Scholten - 2018 - GeroPsych: The Journal of Gerontopsychology and Geriatric Psychiatry 31 (2):77-86.
    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. (...)
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  32. Etică și integritate academică.Emanuel Socaciu, Constantin Vica, Emilian Mihailov, Toni Gibea, Valentin Muresan & Mihaela Constantinescu - 2018 - Bucharest: Editura Universității din București.
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  33. Informed Consent to HIV Cure Research.Danielle Bromwich & Joseph R. Millum - 2017 - Journal of Medical Ethics 43 (2):108-113.
    Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and (...)
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  34. Pharmacogenomic Inequalities: Strategies for Justice in Biomedical Research and Healthcare.Giovanni De Grandis - 2017 - Diametros 51:153-172.
    The paper discusses the possibility that the benefits of pharmacogenomics will not be distributed equally and will create orphan populations. I argue that since these inequalities are not substantially different from those produced by ‘traditional’ drugs and are not generated with the intention to discriminate, their production needs not be unethical. Still, the final result is going against deep-seated moral feelings and intuitions, as well as broadly accepted principles of just distribution of health outcomes and healthcare. I thus propose two (...)
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  35. The Practical Implications of the New Metaphysics of Race for a Postracial Medicine: Biomedical Research Methodology, Institutional Requirements, Patient–Physician Relations.Joanna K. Malinowska & Tomasz Żuradzki - 2017 - American Journal of Bioethics 17 (9):61-63.
    Perez-Rodriguez and de la Fuente (2017) assume that although human races do not exist in a biological sense (“geneticists and evolutionary biologists generally agree that the division of humans into races/subspecies has no defensible scientific basis,” they exist only as “sociocultural constructions” and because of that maintain an illusory reality, for example, through “racialized” practices in medicine. Agreeing with the main postulates formulated in the article, we believe that the authors treat this problem in a superficial manner and have failed (...)
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  36. Ancillary Care Obligations in Light of an African Bioethic: From Entrustment to Communion.Thaddeus Metz - 2017 - Theoretical Medicine and Bioethics 38 (2):111–126.
    Henry Richardson has recently published the first book ever devoted to ancillary care obligations, which roughly concern what medical researchers are morally required to provide to participants beyond what safety requires. In it Richardson notes that he has presented the ‘only fully elaborated view out there’ on this topic, which he calls the ‘partial-entrustment model’. In this article, I provide a new theory of ancillary care obligations, one that is grounded on ideals of communion salient in the African philosophical tradition (...)
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  37. Transplanting the Body: Preliminary Ethical Considerations.Lantz Fleming Miller - 2017 - The New Bioethics 23 (3):219-235.
    A dissociated area of medical research warrants bioethical consideration: a proposed transplantation of a donor’s entire body, except head, to a patient with a fatal degenerative disease. The seeming improbability of such an operation can only underscore the need for thorough bioethical assessment: Not assessing a case of such potential ethical import, by showing neglect instead of facing the issue, can only compound the ethical predicament, perhaps eroding public trust in ethical medicine. This article discusses the historical background of full-body (...)
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  38. ¿Es la medicalización un fenómeno negativo? Un análisis de las consecuencias que suelen atribuirse a la medicalización?Alberto Oya - 2017 - Daimon: Revista Internacional de Filosofía (71):7-18.
    En este artículo expondré un análisis de la valoración negativa de las consecuencias que suelen atribuirse al fenómeno de la medicalización y, partiendo de aquí, mi objetivo básico será mostrar que la medicalización no es en sí mismo un fenómeno negativo. Sólo lo será cuando se obtenga un valor negativo del cálculo entre, por un lado, la efectividad de la propuesta médica para solucionar el problema y, por otro lado, el balance entre los beneficios de dicha propuesta médica y sus (...)
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  39. Un llamado ético a la inclusión de mujeres embarazadas en investigación: Reflexiones del Foro Global de Bioética en Investigación.Carla Saenz, Jackeline Alger, Juan Pablo Beca, José Belizán, María Luisa Cafferata, Julio Arturo Canario Guzman, Jesica Candanedo, Lissette Duque, Lester Figueroa, Ana Garcés, Lionel Gresh, Ida Cristina Gubert, Dirce Guilhem, Gabriela Guz, Gustavo Kaltwasser, Roxana Lescano, Florencia Luna, Alexandrina Cardelli, Ignacio Mastroleo, Irene Melamed, Agueda Muñoz del Carpio Toia, Ricardo Palacios, Gloria Palma, Sofía Salas, Xochitl Sandoval, Sergio Surugi de Siqueira, Hans Vásquez & Bertha Villela de Vega - 2017 - Revista Panamericana de Salud Pública 41 (e13):1-2.
    El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera ética, fortalecer la ética de la investigación en salud, particularmente en países de ingresos bajos y medios, y promover colaboración entre países (...)
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  40. How Autonomy Can Legitimate Beneficial Coercion.Lucie White - 2017 - In Jakov Gather, Tanja Henking, Alexa Nossek & Jochen Vollmann (eds.), Beneficial Coercion in Psychiatry? Foundations and Challenges. Münster: Mentis. pp. 85-99.
    Respect for autonomy and beneficence are frequently regarded as the two essential principles of medical ethics, and the potential for these two principles to come into conflict is often emphasised as a fundamental problem. On the one hand, we have the value of beneficence, the driving force of medicine, which demands that medical professionals act to protect or promote the wellbeing of patients or research subjects. On the other, we have a principle of respect for autonomy, which demands that we (...)
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  41. MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines. Guidance Document. Version 1.0, December 2016.Carmen Aldinger, Barbara Bierer, Rebecca Li, Luann Van Campen, Mark Barnes, Eileen Bedell, Amanda Brown-Inz, Robin Gibbs, Deborah Henderson, Christopher Kabacinski, Laurie Letvak, Susan Manoff, Ignacio Mastroleo, Ellie Okada, Usharani Pingali, Wasana Prasitsuebsai, Hans Spiegel, Daniel Wang, Susan Briggs Watson & Marc Wilenzik - 2016 - The Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard (MRCT Center).
    I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...)
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  42. Why High-Risk, Non-Expected-Utility-Maximising Gambles Can Be Rational and Beneficial: The Case of HIV Cure Studies.Lara Buchak - 2016 - Journal of Medical Ethics (2):1-6.
    Some early phase clinical studies of candidate HIV cure and remission interventions appear to have adverse medical risk–benefit ratios for participants. Why, then, do people participate? And is it ethically permissible to allow them to participate? Recent work in decision theory sheds light on both of these questions, by casting doubt on the idea that rational individuals prefer choices that maximise expected utility, and therefore by casting doubt on the idea that researchers have an ethical obligation not to enrol participants (...)
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  43. Neurosurgery for Psychopaths? An Ethical Analysis.Dietmar Hübner & Lucie White - 2016 - American Journal of Bioethics Neuroscience 7 (3):140-149.
    Recent developments in neuroscience have inspired proposals to perform deep brain stimulation on psychopathic detainees. We contend that these proposals cannot meet important ethical requirements that hold for both medical research and therapy. After providing a rough overview of key aspects of psychopathy and the prospects of tackling this condition via deep brain stimulation, we proceed to an ethical assessment of such measures, referring closely to the distinctive features of psychopathic personality, particularly the absence of subjective suffering and a lack (...)
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  44. Modelo de reciprocidad democrática: una justificación de la continuidad de tratamiento beneficioso en la investigación clínica.Ignacio Mastroleo - 2016 - Journal of Science Humanities and Arts 3 (7):1-33.
    En este trabajo desarrollo un modelo normativo sobre la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación desde la perspectiva de la justicia social o distributiva, inspirado en la teoría de la justicia de John Rawls. Llamo a esto, el modelo de reciprocidad democrática. La idea original del modelo de reciprocidad democrática es defender que la obligación de continuidad de tratamiento beneficioso tiene como derecho correlativo el derecho a la salud. Así, dentro del marco rawlsiano, argumento que (...)
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  45. Post‐Trial Obligations in the Declaration of Helsinki 2013: Classification, Reconstruction and Interpretation.Ignacio Mastroleo - 2016 - Developing World Bioethics 16 (2):80-90.
    The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to (...)
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  46. Should Research Ethics Encourage the Production of Cost-Effective Interventions?Govind Persad - 2016 - In Daniel Strech & Marcel Mertz (eds.), Ethics and Governance of Biomedical Research: Theory and Practice. Springer. pp. 13-28.
    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 (...)
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  47. Against Permitted Exploitation in Developing World Research Agreements.Danielle M. Wenner - 2016 - Developing World Bioethics 16 (1):36-44.
    This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all relevant parties, and both research (...)
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  48. Understanding, Interests and Informed Consent: A Reply to Sreenivasan.Danielle Bromwich - 2015 - Journal of Medical Ethics 41 (4):327-331.
    It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant's consent to research (...)
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  49. Can Informed Consent to Research Be Adapted to Risk?Danielle Bromwich & Annette Rid - 2015 - Journal of Medical Ethics 41 (7):521-528.
    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 (...)
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  50. Clinical Research: Should Patients Pay to Play?Ezekiel J. Emanuel, Steven Joffe, Christine Grady, David Wendler & Govind Persad - 2015 - Science Translational Medicine 7 (298):298ps16.
    We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
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