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  1. added 2020-09-26
    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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  2. added 2020-08-27
    Why IACUCs Need Ethicists.Nathan Nobis - forthcoming - ILAR.
    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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  3. added 2020-06-10
    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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  4. added 2020-05-30
    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...
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  5. added 2020-05-20
    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. added 2020-05-13
    Coronavirus Pandemic: Philosophers in Lockdown جائحة كورونا ... فلاسفة في العُزلة.Salah Osman - manuscript
    كان يمشي في الأرض مرحًا، مُصعرًا خده للطبيعة، ومُنتشيًا برفاهيات حضاراته؛ أو يخطو فوق أديمها مهمومًا بضنك العيش، يعتصره ألم البحث عن قوت يومه، قبل أن يُفاجئه الفيروس التاجي ليقلب حياته رأسًا على عقب. إنه الإنسان، ذلك المجهول لنفسه، الجاهل بعلمه، المغرور بعقله، الضعيف بقوته، المتناقض مع ذاته، الفقير بثرواته الضخمة! فجأة باتت تعتمل بداخله مشاعر الحيرة والخوف والقلق، تؤرقه تساؤلات تسخر من عجزه الصارخ عن الإجابة عنها: ما أصل هذا الفيروس؟ هل هو نبتٌ طبيعي أم مؤامرة من بني جلدته؟ (...)
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  7. added 2020-05-07
    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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  8. added 2020-05-06
    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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  9. added 2020-04-30
    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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  10. added 2020-04-01
    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.
    BackgroundSeveral 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 textThis paper clarifies how the public interest criterion can be defensibly deployed. We first explain the ethical basis for (...)
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  11. added 2020-03-10
    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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  12. added 2020-02-25
    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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  13. added 2020-02-17
    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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  14. added 2020-02-14
    Different Context, Similar Motives: External Influences on Motivation.Aisha Y. Malik - 2015 - American Journal of Bioethics 15 (11):26-28.
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  15. added 2020-01-11
    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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  16. added 2020-01-04
    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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  17. added 2019-11-27
    ¿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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  18. added 2019-11-21
    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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  19. added 2019-09-09
    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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  20. added 2019-08-21
    Methodological and Inducement Manipulation.Collin O’Neil - 2013 - American Journal of Bioethics 13 (11):55-57.
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  21. added 2019-08-19
    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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  22. added 2019-07-29
    “The Animal” After Derrida: Interrogating the Bioethics of Geno-Cide.Norman Swazo - 2013 - Les Ateliers de L'Éthique 8 (1):91-123.
    Bioethics tends to be dominated by discourses concerned with the ethical dimension of medical practice, the organization of medical care, and the integrity of biomedical research involving human subjects and animal testing. Jacques Derrida has explored the fundamental question of the “limit” that identifies and differentiates the human animal from the nonhuman animal. However, to date his work has not received any reception in the field of biomedical ethics. In this paper, I examine what Derrida’s thought about this limit might (...)
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  23. added 2019-06-28
    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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  24. added 2019-06-24
    Teaching Medical Ethics and Law Within Medical Education: A Model for the UK Core Curriculum.Richard Ashcroft & Donna Dickenson - 1998 - Journal of Medical Ethics 24:188-192.
    Consensus statement by UK teachers of medical ethics and law.
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  25. added 2019-06-06
    Research Ethics: Ethics and Methods in Surgical Trials.C. Ashton, N. Wray, A. Jarman, J. Kolman & D. Wenner - 2009 - Journal of Medical Ethics 35 (9):579-583.
    This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical (...)
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  26. added 2019-01-08
    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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  27. added 2018-10-26
    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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  28. added 2018-10-25
    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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  29. added 2018-10-04
    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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  30. added 2018-09-07
    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. added 2018-09-07
    The Obligation to Participate in Biomedical Research.G. Owen Schaefer, Ezekiel J. Emanuel & Alan Wertheimer - 2009 - Journal of the American Medical Association 302 (1):67-72.
    The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty to participate. The (...)
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  32. added 2018-05-24
    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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  33. added 2018-03-23
    Synthetic Biology and the Ethics of Knowledge.T. Douglas & J. Savulescu - 2010 - Journal of Medical Ethics 36 (11):687-693.
    Synthetic biologists aim to generate biological organisms according to rational design principles. Their work may have many beneficial applications, but it also raises potentially serious ethical concerns. In this article, we consider what attention the discipline demands from bioethicists. We argue that the most important issue for ethicists to examine is the risk that knowledge from synthetic biology will be misused, for example, in biological terrorism or warfare. To adequately address this concern, bioethics will need to broaden its scope, contemplating (...)
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  34. added 2018-02-27
    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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  35. added 2018-02-16
    Conflicts Among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions.Jacob M. Kolman, Nelda P. Wray, Carol M. Ashton, Danielle M. Wenner, Anna F. Jarman & Baruch A. Brody - 2012 - Journal of Law, Medicine and Ethics 40 (1):99-121.
    Utilizing a sorted compendium of international clinical trial standards, investigators identified 15 conflicts among ethical and methodological guidance. Analysis distinguishes interpretational issues, lack of clarity, and contradiction as factors to be addressed if international trial guidance is to be improved.
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  36. added 2018-01-23
    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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  37. added 2017-11-09
    Standard of Care, Institutional Obligations, and Distributive Justice.Douglas MacKay - 2015 - Bioethics 29 (4):352-359.
    The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. I examine (...)
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  38. added 2017-10-24
    The Right to Withdraw From Research.G. Owen Schaefer & Alan Wertheimer - 2010 - Kennedy Institute of Ethics Journal 20 (4):329-352.
    The right to withdraw from participation in research is recognized in virtually all national and international guidelines for research on human subjects. It is therefore surprising that there has been little justification for that right in the literature. We argue that the right to withdraw should protect research participants from information imbalance, inability to hedge, inherent uncertainty, and untoward bodily invasion, and it serves to bolster public trust in the research enterprise. Although this argument is not radical, it provides a (...)
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  39. added 2017-08-29
    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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  40. added 2017-07-25
    Giving Patients Granular Control of Personal Health Information: Using an Ethics ‘Points to Consider’ to Inform Informatics System Designers.Eric M. Meslin, Sheri A. Alpert, Aaron E. Carroll, Jere D. Odell, William M. Tierney & Peter H. Schwartz - 2013 - International Journal of Medical Informatics 82:1136-1143.
    Objective: There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective was to develop a structured ethics framework to accomplish this. -/- Methods: We reviewed existing literature on the ethical and policy issues, developed an ethics framework called a “Points to (...)
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  41. added 2017-07-25
    To Be or Not to Be – A Research Subject.Eric M. Meslin & Peter H. Schwartz - 2010 - In Thomasine Kushner (ed.), Surviving Health Care: A Manual for Patients and their Families. Cambridge: Cambridge University Press. pp. 146-162.
    Most people do not know there are different kinds of medical studies; some are conducted on people who already have a disease or medical condition, and others are performed on healthy volunteers who want to help science find answers. No matter what sort of research you are invited to participate in, or whether you are a patient when you are asked, it’s entirely up to you whether or not to do it. This decision is important and may have many implications (...)
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  42. added 2017-05-09
    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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  43. added 2017-02-27
    Traducción de la Disposición 12792/2016 ANMAT: Procedimiento Para la Solicitud de Importación de la Medicación/ Tratamiento /Materiales Para El Acceso Post-Estudio (Selección, Versión 1.0).Mastroleo Ignacio - manuscript
    Translation from Spanish to English of ANMAT’s procedure for import of post-trial access provisions. This is a regulatory mechanisim to comply with post-trial provisions requirement in Declaration of Helsinki, paragraph 34. The translation it is based on a selection of the text of ANMAT’s Provision 12792/2016. -/- .
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  44. added 2017-02-21
    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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  45. added 2017-02-21
    Support for Full Disclosure Up Front.Felicitas Holzer & Ignacio Mastroleo - 2015 - Hastings Center Report 45 (1):3-3.
    A commentary on “Models of Consent to Return of Incidental Findings in Genomic Research” by Paul S. Appelbaum, Erik Parens, Cameron R. Waldman, Robert Klitzman, Abby Fyer, Josue Martinez, W. Nicholson Price II, and Wendy K. Chung, in the July-August 2014 issue, http://www.thehastingscenter.org/Publications/HCR/Detail.aspx?id=6964.
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  46. added 2017-02-16
    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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  47. added 2017-02-06
    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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  48. added 2017-01-25
    Der biomedizinische Fortschritt: Chancen, Grenzen und Verantwortung.Paul Gottlob Layer - 2003 - Darmstädter Interdisziplinäre Beiträge 8:63-76.
    Berge von brennenden Tieren, Bilder vom „Keulen“, Bilder vom geklonten Menschen. Aber auch Euphorisches: nach der Aufklärung des menschlichen Genoms schöpfen Krebs- und AIDS-Kranke, Querschnittsgelähmte und Alzheimer-Patienten neue Hoffnung. Bilder auch von Börsenkursen: vom neuen Markt der Informations- und Biotechnologien hängt unsere ökonomische Zukunft ab. Hinter allem stecken die „Life Sciences“, und oft wird man mit schrägem Blick gefragt, was das für Leute sind, diese Bio- bzw. Lebenswissenschaftler? Die Frage nach den Möglichkeiten und dem wahren Wert des biomedizinischen Fortschritts, nach (...)
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  49. added 2016-12-12
    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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  50. added 2016-10-05
    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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