Integrating theory with case studies, this book examines the practical application of moral theory in clinical decision-making through 40 composite cases based on actual clinical experience. Complex, realistic, and challenging, these examples contain the multiplicity of factors faced in clinical crises, making this a superb exploration of the ways in which theory relates to actual life-or-death situations.
: Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. Before the benefits of pharmacogenetics can be realized, the ethical issues that arise in research and clinical application of pharmacogenetic technologies must be addressed. The ethical issues raised by pharmacogenetics can be addressed under six headings: regulatory oversight, confidentiality and privacy, informed consent, availability of drugs, access, and clinicians' changing responsibilities in the era of pharmacogenetic medicine. We (...) analyze each of these categories of ethical issues and provide policy approaches for addressing them. (shrink)
There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department of (...) Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)
Empirical research can aid ethical reflection in bioethics by identifying issues, by seeing how they are currently resolved, and by assessing the consequences of these current resolutions. This potential can be misused when the ethical issues in question are fundamentally non-consequentialist or when they are consequentialist but the empirical research fails to address the important consequences. An example of the former problem is some recent studies about bad consequences resulting from commercialized living kidney donor programs. These consequences could be avoided, (...) but the crucial non-consequentialist ethical issues about exploitation and commercialization would still remain. Examples of the latter problem are provided by recent studies of the allocation of ICU beds and of physician deception, where important consequences were not adequately studied. (shrink)
: In the development of biotechnology in the United States, many questions were raised about the appropriateness of applying to this area a traditional robust system of intellectual property rights. Despite these hesitations, the U.S. rejected suggested modifications. This was a mistake, and there is a need to develop a modified system that promotes more of the relevant ethical values.
Kripke has argued that proper names, as rigid designators, cannot be equivalent in meaning to definite descriptions. in this paper, i argue that definite descriptions are sometimes used rigidly and that proper names are equivalent to definite descriptions used rigidly.
Recent years have witnessed a proliferation of philosophical discussion about such concrete moral issues as just war, distribution of food aid, euthanasia, reverse discrimination, etc. Much of this discussion implicitly assumes that there are true and false positions on these issues, valid or invalid arguments for these positions, etc. Recent years have not witnessed, however, a proliferation of philosophical defenses of these assumptions. With the decline of metaethical discussions, these assumptions have remained just assumptions rather than the conclusions of a (...) philosophical argument. (shrink)
: Continuing the discussion begun in the March 2006 issue of the Kennedy Institute of Ethics Journal, this paper further documents the failure of the United States to adequately consider possible modifications in the traditional robust system of intellectual property rights as applied to biotechnology. It discusses concrete suggestions for alternative disclosure requirements, for exemptions for research tools, and for improved access to clinical advances. In each of these cases, the modifications might be more responsive to the full set of (...) relevant values. (shrink)
This paper identifies four major forms of scholarship in bioethics: empirical research, the articulation of mid-level principles of bioethics, the relating of these principles to fundamental moral theories, and discussions of the bioethical implications of legal principles and health delivery policies. It develops a reflective equilibrium approach to the relation between these four forms of scholarship. It then presents, in light of this approach, criteria for quality research in each of these forms of scholarship in bioethics. Keywords: quality of scholarship, (...) reflective equilibria in bioethics, research in bioethics CiteULike Connotea Del.icio.us What's this? (shrink)
Public statements by various international groups emphasize that decisions to undergo genetic screening, either for disease-carrier status or for predisposition-to-disease status, and decisions about the use of the resulting information should be made voluntarily by the party to be screened. For example, the World Medical Association, in its Declaration on the Human Genome Project, says, “One should respect the will of persons screened and their right to decide about participation and about the use of the information obtained.” Giving this principle (...) a name, “voluntarism,” the Council for International Organizations of Medical Sciences, in its Declaration of Inuyama , announced that “voluntarism should be the guiding principle in the provision of genetic services. (shrink)
: The European patent system allows for the introduction of moral issues into decisions about the granting of patents. This feature has greatly impacted European debates about the patenting of biotechnology. This essay explores the European experience, in both the European Union and the European Patent Organization. It argues that there has been great confusion surrounding these issues primarily because the Europeans have not developed a general theory about when exclusion from patentability is the best social mechanism for dealing with (...) morally offensive technologies. (shrink)
This paper argues, contrary to what has sometimes been claimed, that public commissions need to be more philosophical than they have been in analyzing crucial bioethical issues. It argues (a) that the failure of the President's Commission to develop and use even simple distinctions between life and personhood led to flaws in both its discussion of death and its discussion of persistent vegetative patients, and (b) that its treatment of access to health care fails to develop a coherent approach precisely (...) because it is based on no serious philosophical reflections about justice in health care. Keywords: justice in health care, life, persistent vegetative patients, personhood, President's Commission on Bioethics CiteULike Connotea Del.icio.us What's this? (shrink)
In recent years, bioethics has increasingly become an international area of inquiry with major contributions being made not only in North America but also in Europe and in the Pacific Rim countries. This general observation is particularly true for research ethics. Little attention has been paid, however, to this internationalization of bioethics in general and research ethics in particular, and there are few studies comparing what has emerged in the different countries.
BACKGROUND: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY DESIGN: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining (...) 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. RESULTS: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. CONCLUSIONS: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated. (shrink)
This essay challenges the view that the provision of health care must take place within a competitive-free system. The author argues that, presuming that there is a requirement to meet the demands of those who cannot pay for health care, a competitive market provides a good way to deal with injustices within the health care system. The author concludes that the demands for justice are best met when indigent individuals use some portion of the funds they receive from the government (...) to purchase one of the many competing forms of health care. This scheme requires a competitive market in the delivery of health care. (shrink)