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.
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)
: 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.
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)
: 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)
: 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)
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)
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.
It seems to me that those who place great value on the right to human freedom can be badly divided on the question of the use of force by states to defend the liberties of those who are not citizens of that particular state. Concerned about the liberties to be defended, they might be enthusiastic supporters of the use of such force by liberty-loving countries throughout the world. Concerned about the liberties that might be violated when the state marshals its (...) forces for use internationally, they might adopt a more isolationist approach to this issue. This paper is an attempt to help clarify this conflict by looking at some of the philosophical issues it raises. Because I wish to avoid factual debates about current conflicts, I will give no real-life examples. However, they are on my mind, and I hope the reader will keep them in mind as well. (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)
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 a recent article (Brody 2010), I analyzed the debates surrounding charges of biopiracy, that is, charges that developed countries use biotechnology patents to expropriate the biological/genetic heritage of less developed countries. Such charges often are accompanied by the additional charge that biotechnology patents are used to expropriate the traditional knowledge about the use of these resources possessed by indigenous communities in less developed countries. It is this second charge that is the focus of this essay, which will develop both (...) narrative and normative claims. The narrative claim is that various context specific principles about justice relating to traditional knowledge were adopted during the .. (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.
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)