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  1. added 2019-01-14
    No Going Back? Reversibility and Why It Matters for Deep Brain Stimulation.Jonathan Pugh - forthcoming - Journal of Medical Ethics:medethics-2018-105139.
    Deep brain stimulation (DBS) is frequently described as a ‘reversible’ medical treatment, and the reversibility of DBS is often cited as an important reason for preferring it to brain lesioning procedures as a last resort treatment modality for patients suffering from treatment-refractory conditions. Despite its widespread acceptance, the claim that DBS is reversible has recently come under attack. Critics have pointed out that data are beginning to suggest that there can be non-stimulation-dependent effects of DBS. Furthermore, we lack long-term data (...)
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  2. 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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  3. added 2018-12-03
    Evidence-Based Neuroethics, Deep Brain Stimulation and Personality - Deflating, but Not Bursting, the Bubble.Jonathan Pugh, Laurie Pycroft, Hannah Maslen, Tipu Aziz & Julian Savulescu - forthcoming - Neuroethics:1-12.
    Gilbert et al. have raised important questions about the empirical grounding of neuroethical analyses of the apparent phenomenon of Deep Brain Stimulation ‘causing’ personality changes. In this paper, we consider how to make neuroethical claims appropriately calibrated to existing evidence, and the role that philosophical neuroethics has to play in this enterprise of ‘evidence-based neuroethics’. In the first half of the paper, we begin by highlighting the challenges we face in investigating changes to PIAAAS following DBS, explaining how different trial (...)
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  4. added 2018-12-03
    Ewolucja koncepcji świadomej zgody w kontekście badań naukowych z użyciem ludzkiego materiału biologicznego.Jakub Pawlikowski - 2015 - Diametros 44:89-109.
    The development of research based on human biological material has contributed to a lively debate on the concept of informed consent in these studies, particularly its scope, form and length of validity. The biggest disputes and doubts concern the range of consent for research that will be conducted in the future, whose aim and place are unknown at the time of the sample collection, as are the future researchers and the ability to use the previously collected materials again. This situation (...)
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  5. added 2018-11-16
    Criminalization of Scientific Misconduct.William Bülow & Gert Helgesson - forthcoming - Medicine, Health Care and Philosophy.
    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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  6. 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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  7. added 2018-10-25
    Experimental Design: Ethics, Integrity and the Scientific Method.Jonathan Lewis - forthcoming - In Ron Iphofen (ed.), Handbook of Research Ethics and Scientific Integrity. Berlin and Heidelberg:
    Experimental design is one aspect of the scientific method. A well-designed, properly-conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximise internal validity, support causal inferences and guarantee reliable results. Traditionally employed in the natural sciences, experimental methodologies have become an important part of research in the social and behavioural sciences. They are also touted as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts associated with (...)
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  8. 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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  9. added 2018-09-07
    The Right to Know: A Revised Standard for Reporting Incidental Findings.G. Owen Schaefer & Julian Savulescu - 2018 - Hastings Center Report 48 (2):22-32.
    The “best-medical-interests” standard for reporting findings does not go far enough. Research subjects have a right to know about any comprehensible piece of information about them that is generated by research in which they are participating. An even broader standard may sometimes be appropriate: if subjects agree to accept information that they may not understand, then all information may be disclosed.
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  10. 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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  11. 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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  12. added 2018-09-07
    "Making More Sense of" Minimal Risk".Deborah Barnbaum - 2002 - IRB: Ethics & Human Research 24 (3):10-13.
    The product rule has been used to calculate the risk of a research study, in which the risk of harm is calculated as the product of the degree of harm multiplied by the likelihood that the harm will occur. This article challenges the product rule, especially when used to calculate "minimal risk" studies.
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  13. added 2018-08-25
    Research in Disaster Settings: A Systematic Qualitative Review of Ethical Guidelines.Signe Mezinska, Péter Kakuk, Goran Mijaljica, Marcin Waligóra & Dónal P. O’Mathúna - 2016 - BMC Medical Ethics 17 (1):62.
    Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method. We performed a systematic qualitative review of disaster research ethics guidelines to (...)
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  14. added 2018-07-21
    Challenging Medical Ghostwriting in the U.S. Courts.Leemon McHenry, Xavier Bosch & Bijan Esfandiari - 2012 - Plos Medicine 9 (1):e1001163.
    Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers. In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
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  15. added 2018-07-17
    Extending Ethical Strides: From Tribal IRBs to the Bronx Community Research Review Board.Phoebe Friesen, Lisa Kearns, Barbara K. Redman & Arthur L. Caplan - 2017 - American Journal of Bioethics 17 (11):W5-W8.
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  16. added 2018-07-17
    Rethinking the Belmont Report?Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan - 2017 - American Journal of Bioethics 17 (7):15-21.
    This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...)
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  17. added 2018-07-17
    A Place for Subjectivity in Psychiatry.Phoebe Friesen - 2017 - American Journal of Bioethics Neuroscience 8 (2):116-117.
  18. 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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  19. added 2018-04-27
    Ancillary Care Obligations in Light of an African Bioethic: From Entrustment to Communion.Thaddeus Metz - 2018 - In Augustine Frimpong-Mansoh & Caesar Atuire (eds.), Bioethics in Africa: Theories and Praxis. Vernon Press. pp. 59-78.
    Reprint of an article that appeared in Theoretical Medicine and Bioethics (2017).
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  20. added 2018-04-04
    Gibt Es Ein Recht Auf Medizinische Forschung?Bert Heinrichs - 2005 - Allgemeine Zeitschrift für Philosophie 30 (1):27-46.
    As a negative protective right, freedom of science is – within the limits marked by other fundamental liberty rights – widely accepted. This also applies, pars pro toto, to the field of medical research. It is far less clear, however, whether a positive claim to medical research can be justified as well. Research of this kind could be articu- lated by potential beneficiaries of its applications as a welfare right. If one bases pub- lic obligations on the concept of fostering (...)
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  21. added 2018-03-29
    Letter to the Editor: Dealing with Socially Constructed Concepts in an Ontology.David Koepsell & Barry Smith - 2009 - Journal of Empirical Research on Human Research Ethics 4 (2):75-76.
  22. 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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  23. 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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  24. added 2018-02-18
    A Non-Paternalistic Model of Research Ethics and Oversight: Assessing the Benefits of Prospective Review.Alex John London - 2012 - Journal of Law, Medicine and Ethics 40 (4):930-944.
    This paper offers a non-paternalistic justification for prospective research review as providing a credible social assurance that the institutions of scientific advancement respect and affirm the moral equality of all community members and as creating a “market” in which stakeholders working to advance diverse ends also advance the common good.
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  25. added 2018-02-17
    IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence-Based Research Ethics Review.Emily E. Anderson & James M. DuBois - 2012 - Journal of Law, Medicine and Ethics 40 (4):951-969.
    Here we describe the five steps of evidence-based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo-controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision-making.
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  26. added 2018-02-17
    What Research Ethics Should Learn From Genomics and Society Research: Lessons From the ELSI Congress of 2011.Gail E. Henderson, Eric T. Juengst, Nancy M. P. King, Kristine Kuczynski & Marsha Michie - 2012 - Journal of Law, Medicine and Ethics 40 (4):1008-1024.
    Research on the ethical, legal, and social implications (ELSI) of human genomics has devoted significant attention to the research ethics issues that arise from genomic science as it moves through the translational process. Given the prominence of these issues in today's debates over the state of research ethics overall, these studies are well positioned to contribute important data, contextual considerations, and policy arguments to the wider research ethics community's deliberations, and ultimately to develop a research ethics that can help guide (...)
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  27. 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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  28. added 2018-02-02
    Ética e Innovación Tecnológica.Fernando Lolas (ed.) - 2006 - Santiago: Centro Interdisciplinario de Estudios En Bioética (Cieb), Vicerrectoría de Investigación y Desarrollo, Universidad de Chile.
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  29. added 2018-02-02
    Historia de la ética en investigación con seres humanos.Jorge Álvarez, Fernando Lolas & Delia Outomuro - 2006 - In Fernando Lolas, Alvaro Quezada & Eduardo Rodríguez (eds.), Investigación En Salud: Dimensión Ética. Santiago: Cieb, Universidad de Chile. pp. 39-46.
    Una mirada a la historia de la investigación con seres humanos nos revela que la ética (al menos entendida como el ethos de una comunidad) ha estado siempre presente de uno u otro modo. No obstante, también son numerosas las situaciones en las que las pautas morales son sistemáticamente transgredidas.
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  30. 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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  31. added 2018-01-06
    Validation: Is Thy Name Research?Ramalingam Sankaran & Sudha Ramalingam - 2009 - Asian Bioethics Review 1 (3):288-291.
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  32. added 2017-11-27
    Priority, Prediction and the Ethical Research Enterprise.Spencer Phillips Hey - 2017 - Journal of Medical Ethics 43 (12):812-813.
    In their essay, ‘When Clinical Trials Compete: Prioritizing Study Recruitment’, Gelinas et al describe a collective action problem that can arise if multiple trials at a single institution are all trying to recruit participants from the same patient population. Each trial may be addressing an important question, and each will need a certain number of participants to provide an informative answer. But because these trials are all recruiting from the same population, it is possible that there will not be enough (...)
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  33. 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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  34. 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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  35. added 2017-09-04
    Advance Directives and the Descendant Argument.Jukka Varelius - 2018 - HEC Forum 30 (1):1-11.
    By issuing an advance treatment directive, an autonomous person can formally express what kinds of treatment she wishes and does not wish to receive in case she becomes ill or injured and unable to autonomously decide about her treatment. While many jurisdictions and medical associations endorse them, advance treatment directives have also been criticized. According to an important criticism, when a person irreversibly loses her autonomy what she formerly autonomously desired ceases to be of importance in deciding about her treatment. (...)
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  36. added 2017-09-04
    Concerns About Eroding the Ethical Barrier to in Vitro Eugenics: Lessons From the hESC Debate.Jonathan Pugh - 2014 - Journal of Medical Ethics 40 (11):737-738.
    In his discussion of in vitrogametogenesis, Rob Sparrow claims that an ethical barrier to development of this technology is that many jurisdictions currently prohibit the practice of creating embryos solely for the purpose of research. However, he suggests that this ethical barrier will soon be eroded, in view of the fact that in vitro gametogenesis could serve as a powerful new technology to overcome infertility. In this commentary, I argue that Sparrow is being overly optimistic in his analysis here. I (...)
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  37. 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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  38. added 2017-08-25
    Research in Epidemic and Emergency Situations: A Model for Collaboration and Expediting Ethics Review in Two Caribbean Countries.Derrick Aarons - 2018 - Developing World Bioethics 18 (4):375-384.
    Various forms of research are essential in emergency, disaster and disease outbreak situations, but challenges exist including the long length of time it takes to get research proposals approved. Consequently, it would be very advantageous to have an acceptable model for efficient coordination and communication between and among research ethics committees/IRBs and ministries of health, and templates for expediting ethical review of research proposals in emergency and epidemic situations to be used across the Caribbean and in other low and middle (...)
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  39. 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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  40. 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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  41. added 2017-07-08
    Moral Duties of Parents and Nontherapeutic Clinical Research Procedures Involving Children.Terrence Ackerman - 1980 - Journal of Medical Humanities 2 (2):94-111.
    Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent writers misconceive (...)
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  42. added 2017-05-21
    Constructing a Coherent Philosophical Basis for Research Ethics.Lucie White - 2017 - Dissertation, Australian National University
    The purpose of this dissertation is to identify some of the most pressing problems in the dominant contemporary approach to research ethics, and to devise an alternative approach that avoids these problems. I contend that the fundamental ethical values invoked in human research are often appealed to in contradictory or ambiguous ways, or in ways that do not adequately capture or do not show an adequate understanding of the specific ethical concerns of human research. One significant problem in this domain (...)
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  43. added 2017-05-11
    Reprioritizing Research Activity for the Post‐Antibiotic Era: Ethical, Legal, and Social Considerations.Spencer Phillips Hey & Aaron S. Kesselheim - 2017 - Hastings Center Report 47 (2):16-20.
    Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research—including clinical trials and regulatory requirements—to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the 2016 (...)
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  44. added 2017-05-11
    Do We Know Whether Researchers and Reviewers Are Estimating Risk and Benefit Accurately?Spencer Phillips Hey & Jonathan Kimmelman - 2016 - Bioethics 30 (8):609-617.
    Accurate estimation of risk and benefit is integral to good clinical research planning, ethical review, and study implementation. Some commentators have argued that various actors in clinical research systems are prone to biased or arbitrary risk/benefit estimation. In this commentary, we suggest the evidence supporting such claims is very limited. Most prior work has imputed risk/benefit beliefs based on past behavior or goals, rather than directly measuring them. We describe an approach – forecast analysis – that would enable direct and (...)
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  45. 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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  46. added 2017-03-21
    Three Problems Regarding Medical Triage.T. R. Girill - 1980 - Metamedicine 1 (2):135-153.
    This paper presents preliminary solutions to three conceptual problems posed by the use of triage to sort candidates for scarce medical resources: (1) By what criteria are the candidates grouped? (2) To what extent can triage be justified? (3) Under what conditions are different versions of triage equivalent? Four explicit methods of applying triage are described and compared, with the aid of examples. The extent to which they either maximize expected utility or show cost-benefit dominance is discussed. And cases in (...)
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  47. 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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  48. 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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  49. 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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  50. 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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