Center for Bioethics Papers Copyright (c) 2013 University of Pennsylvania All rights reserved. http://repository.upenn.edu/bioethics_papers Recent documents in Center for Bioethics Papers en-us Wed, 23 Jan 2013 18:04:19 PST 3600 Desktop Medicine http://repository.upenn.edu/bioethics_papers/72 http://repository.upenn.edu/bioethics_papers/72 Fri, 13 Jan 2012 08:11:32 PST Jason Karlawish Failing Those at Ground Zero… Again: American Public Health Responses to AIDS and 9/11 http://repository.upenn.edu/bioethics_papers/71 http://repository.upenn.edu/bioethics_papers/71 Wed, 21 Sep 2011 09:45:10 PDT Autumn Fiester et al. The Queering of HIV Testing Practices and the Reinforcement of Stigma http://repository.upenn.edu/bioethics_papers/70 http://repository.upenn.edu/bioethics_papers/70 Wed, 21 Sep 2011 09:45:07 PDT Lance Wahlert et al. The Principlist Paradigm and the Problem of the False Negative: Why the Clinical Ethics We Teach Fails Patients http://repository.upenn.edu/bioethics_papers/69 http://repository.upenn.edu/bioethics_papers/69 Tue, 07 Dec 2010 11:22:50 PST The clinical ethics framework that is typically taught to medical students and residents is deeply flawed, and the result of using this framework exclusively to resolve ethical conflicts at the bedside is compromised patient care. The author calls this framework the principlist paradigm and maintains that it blinds clinicians from seeing the full set of moral obligations they have to the patient and limits the range of options they see as available to navigate through ethical conflicts. Although it is important for the moral obligations it does recognize (e.g., those based on the principles of autonomy, beneficence, nonmaleficence, and justice), the principlist paradigm should not be used as the only moral template for case analysis. The author illustrates the paradigm’s limitations with a clinical case study, in which the treating clinicians failed to recognize three important moral obligations to the patient: the obligation to express regret, the obligation to apologize, and the obligation to make amends. The failure to recognize these widely accepted moral obligations can have tragic consequences. The principlist paradigm undertrains clinicians for the complex ethical dilemmas they face in practice, and medical ethics educators need to rethink the tools they offer student clinicians to guide their ethical analysis. The author advocates a reexamination of this standard approach to teaching clinical ethics.

]]> Autumn Fiester Justifying a Presumption of Restraint in Animal Biotechnology Research http://repository.upenn.edu/bioethics_papers/68 http://repository.upenn.edu/bioethics_papers/68 Tue, 07 Dec 2010 11:22:43 PST Articulating the public’s widespread unease about animal biotechnology has not been easy, and the first attempts have not been able to provide an effective tool for navigating the moral permissibility of this research. Because these moral intuitions have been difficult to cash out, they have been belittled as representing nothing more than fear or confusion. But there are sound philosophical reasons supporting the public’s opposition to animal biotechnology and these arguments justify a default position of resistance I call the Presumption of Restraint. The Presumption of Restraint constitutes a justificatory process that sets out the criteria for permitting or rejecting individual biotechnology projects. This Presumption of Restraint can be overridden by compelling arguments that speak to a project’s moral and scientific merit. This strategy creates a middle-of-the-road stance that can embrace particular projects, while rejecting others. The Presumption of Restraint can also serve as a model for assessing moral permissibility in other areas of technological innovation.

]]> Autumn Fiester Voting by Elderly Persons with Cognitive Impairment: Lessons from Other Democratic Nations http://repository.upenn.edu/bioethics_papers/67 http://repository.upenn.edu/bioethics_papers/67 Wed, 29 Sep 2010 13:38:19 PDT Jason Karlawish et al. Addressing the Ethical, Legal, and Social Issues Raised by Voting by Persons with Dementia http://repository.upenn.edu/bioethics_papers/66 http://repository.upenn.edu/bioethics_papers/66 Wed, 29 Sep 2010 13:38:18 PDT This article addresses an emerging policy problem in the United States participation in the electoral process by citizens with dementia. At present, health care professionals, family caregivers, and long-term care staff lack adequate guidance to decide whether individuals with dementia should be precluded from or assisted in casting a ballot. Voting by persons with dementia raises a series of important questions about the autonomy of individuals with dementia, the integrity of the electoral process, and the prevention of fraud. Three subsidiary issues warrant special attention: development of a method to assess capacity to vote; identification of appropriate kinds of assistance to enable persons with cognitive impairment to vote; and formulation of uniform and workable policies for voting in long-term care settings. In some instances, extrapolation from existing policies and research permits reasonable recommendations to guide policy and practice. However, in other instances, additional research is necessary.

]]> Jason H. Karlawish et al. The Search for a Coherent Language: The Science and Politics of Drug Testing and Approval http://repository.upenn.edu/bioethics_papers/65 http://repository.upenn.edu/bioethics_papers/65 Mon, 10 May 2010 06:42:46 PDT Jason Karlawish Older Adults’ Attitudes Toward Enrollment of Noncompetent Subjects Participating in Alzheimer’s Research http://repository.upenn.edu/bioethics_papers/64 http://repository.upenn.edu/bioethics_papers/64 Thu, 14 Jan 2010 06:57:29 PST OBJECTIVE: Research that seeks to enroll noncompetent patients with Alzheimer’s disease without presenting any potential benefit to participants is the source of substantial ethical controversy. The authors used hypothetical Alzheimer’s disease studies that included either a blood draw or a blood draw and lumbar puncture to explore older persons’ attitudes on this question.

METHOD: Face-to-face interviews were conducted with 538 persons age 65 and older. Questions explored participants’ understanding of research concepts, their views on enrolling persons with Alzheimer’s disease in research, and their preferences regarding having a proxy decision maker, granting advance consent, and granting their proxy leeway to override the participant’s decision. Additional questions assessed altruism, trust, value for research, and perceptions of Alzheimer’s disease.

RESULTS: The majority (83%) were willing to grant advance consent to a blood draw study, and nearly half (48%) to a blood draw plus lumbar puncture study. Most (96%) were willing to identify a proxy for research decision making, and most were willing to grant their proxy leeway over their advance consent: 81% for the blood draw study and 70% for the blood draw plus lumbar puncture study. Combining the preferences for advance consent and leeway, the proportion who would permit being enrolled in the blood draw and lumbar puncture studies, respectively, were 92% and 75%. Multivariate models showed that willingness to be enrolled in research was most strongly associated with a favorable attitude toward biomedical research.

CONCLUSIONS: Older adults generally support enrolling noncompetent persons with Alzheimer’s disease into research that does not present a benefit to subjects. Willingness to grant their proxy leeway over advance consent and a favorable attitude about biomedical research substantially explain this willingness.

]]> Jason Karlawish et al. Right to reform http://repository.upenn.edu/bioethics_papers/63 http://repository.upenn.edu/bioethics_papers/63 Tue, 27 Oct 2009 11:42:05 PDT Health reform is not in the details. Think I am wrong? How far did we get this summer wallowing around in claims about co-ops, public plans, death panels, rationing, and cost savings? Health reform is in the ethics.

]]> Arthur L. Caplan Does the biomedical revolution spell the end of sport? http://repository.upenn.edu/bioethics_papers/62 http://repository.upenn.edu/bioethics_papers/62 Wed, 27 May 2009 11:31:23 PDT Arthur L. Caplan A Proposed Ethical Framework for Vaccine Mandates: Competing Values and the Case of HPV http://repository.upenn.edu/bioethics_papers/61 http://repository.upenn.edu/bioethics_papers/61 Fri, 19 Sep 2008 12:06:40 PDT Debates over vaccine mandates raise intense emotions, as reflected in the current controversy over whether to mandate the vaccine against human papilloma virus (HPV), the virus that can cause cervical cancer. Public health ethics so far has failed to facilitate meaningful dialogue between the opposing sides. When stripped of its emotional charge, the debate can be framed as a contest between competing ethical values. This framework can be conceptualized graphically as a conflict between autonomy on the one hand, which militates against government intrusion, and beneficence, utilitarianism, justice, and nonmaleficence on the other, which may lend support to intervention. When applied to the HPV vaccine, this framework would support a mandate based on utilitarianism, if certain conditions are met and if herd immunity is a realistic objective.

]]> Robert I. Field et al. The Triumph of Autonomy in Bioethics and Commercialism in American Healthcare http://repository.upenn.edu/bioethics_papers/60 http://repository.upenn.edu/bioethics_papers/60 Fri, 19 Sep 2008 08:23:50 PDT Justifying his proposal for "health savings accounts," which would allow individuals to set aside tax-free dollars against future healthcare needs, President Bush has said that "Health savings accounts all aim at empowering people to make decisions for themselves." Who could disagree with such a sentiment? Although bioethicists may be among those who express skepticism that personal health savings accounts will be part of the needed "fix" of our healthcare financing system, self determination has long been part of their mantra. Indeed, the field of bioethics played an important role in advancing this idea in the medical world when physician paternalism was regnant. Has its popularity caused it to become so vapid as to be ripe for misuse?

]]> Jonathan Moreno Re-examining ethical obligations in the intensive care unit: HIV disclosure to surrogates http://repository.upenn.edu/bioethics_papers/59 http://repository.upenn.edu/bioethics_papers/59 Thu, 23 Aug 2007 08:17:30 PDT Physicians treating newly incapacitated patients often must help navigate surrogate decision-makers through a difficult course of treatment decisions, while safeguarding the patient's autonomy. We offer guidance for intensive care physicians who must frequently address the difficult questions concerning disclosure of confidential information to surrogates. Three clinical vignettes will highlight the ethical challenges to physician disclosure of a critically ill patient's HIV status. Two key distinctions are offered that influence the propriety of disclosure: first, whether HIV infection represents a 'primary cause' for the patient's critical illness; and second, whether the surrogate may be harmed by failure to disclose HIV status. This balanced consideration of the direct duties of physicians to patients, and their indirect duties to surrogates and third-party contacts, may be used as a framework for considering other ethical obligations in the intensive care unit. We also provide a tabulation of individual US state laws relevant to disclosure of HIV status.

]]> Anthony T. Vernillo et al. Bioethics Inside the Beltway: IRBs Under the Microscope http://repository.upenn.edu/bioethics_papers/58 http://repository.upenn.edu/bioethics_papers/58 Fri, 08 Jun 2007 11:24:21 PDT The spring and summer of 1998 were seasons in the sun for institutional review board (IRB) aficionados. Rarely have the arcana of the local human subjects review panels been treated to so much attention in both the executive and the legislative branches of government, not only at the federal but also at the state level. And it looks as if the attention will continue for some time. The spate of interest is due to a series of coincidences: a powerful House of Representatives subcommittee held hearings after its chairman learned about the IRB system during a previous session on research in underdeveloped communities; the Department of Health and Human Services's Inspector General (DHHS-IG) released a report on IRBs; the National Institutes of Health (NIH) Office of Extramural Research completed a report on clinical trial monitoring; the National Bioethics Advisory Commission (NBAC) readied a report on research involving persons with mental disorders; the states of Maryland and New York completed studies of research with subjects who lack decision-making capacity; and advocacy groups protested a psychiatric research project involving inner city children.

]]> Jonathan Moreno A Taxonomy of Value in Clinical Research http://repository.upenn.edu/bioethics_papers/57 http://repository.upenn.edu/bioethics_papers/57 Tue, 29 May 2007 12:49:51 PDT Medical research that involves human subjects presents what appears to be an intractable ethical problem: patients are exposed to risks in order to create valuable knowledge. A central goal of research is to produce knowledge that is "important," "fruitful," or that will have "value." Indeed, federal regulations require that research risks be reasonable in proportion to potential benefits, and in proportion to the importance of the knowledge to be gained (45 CFR 46.111(a)(z)). Moreover, one reason that subjects participate inresearch is to produce knowledge that will benefit others.

]]> Jonathan Moreno Human Experiments and National Security: The Need to Clarify Policy http://repository.upenn.edu/bioethics_papers/56 http://repository.upenn.edu/bioethics_papers/56 Tue, 29 May 2007 12:28:26 PDT On September 4, 2001, press reports indicated that the Defense Intelligence Agency of the U.S. Department of Defense (DOD) planned to reproduce a strain of anthrax virus suspected of being held in Russian laboratories. According to the same reports, the Central Intelligence Agency (CIA), under the auspices of Project Clear Vision, is engaged in building replicas of bomblets believed to have been developed by the former Soviet Union. These small bombs were designed to disperse biological agents, including anthrax. Government attorneys were said to be confident that, because these projects were designed to develop defensive measures, they were not in violation of the 1972 Biological and Toxin Weapons Convention.

]]> Jonathan Moreno The Failure of the Consult Model: Why "Mediation" Should Replace "Consultation" http://repository.upenn.edu/bioethics_papers/55 http://repository.upenn.edu/bioethics_papers/55 Tue, 22 May 2007 08:32:02 PDT Ellen Fox and her colleagues (Fox, Myers and Pearlman 2007) have generated a rich set of data about ethics consultations in US hospitals that raise serious concerns about this mode of conflict resolution. Using the data they have collected, I want to highlight several issues that question the ethical legitimacy of the ethics consult service (ECS) model, and I want to argue that it may be time to replace ethics consultation with ethics mediation.

]]> Autumn Fiester Why the Omega-3 Piggy Should Not Go to Market http://repository.upenn.edu/bioethics_papers/54 http://repository.upenn.edu/bioethics_papers/54 Tue, 22 May 2007 08:21:29 PDT The paper in your April issue by Lai et al. entitled "Generation of cloned transgenic pigs rich in omega-3 fatty acids" (Nat. Biotechnol. 24, 435–436, 2006) perfectly captures the fundamental problem with American biotech research. That problem is that scientists pursue their research agenda to further scientific knowledge - all well and good - but when the project succeeds they invent problems for which their research results can be marketed as a solution. This unreflective move from 'pure science' to commercialization may end up as biotech's undoing.

]]> Autumn Fiester What Are Gene Patents and Why Are People Worried about Them? http://repository.upenn.edu/bioethics_papers/53 http://repository.upenn.edu/bioethics_papers/53 Mon, 21 May 2007 12:36:27 PDT This article examines what it means to patent a gene. Numerous ethical concerns have been raised about the effects of such patents on clinical medical practice as well as on research and development. We describe what kinds of inventions are covered by human gene patents, give several examples and summarize the small body of empirical research performed in the US examining the effects of these patents. There is little evidence that early fears about gene patenting placing substantial restraints on research and clinical medicine have come to fruition. Nonetheless, there are areas of concern, and policy makers, physicians and the public should be alert to ensure that the net social benefits of patenting human genes are maintained.

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