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.
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)
: 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)
: 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.
: 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)
Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused (...) great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. A working group of ethicists, clinical trial design experts, and clinical investigators examined the current state of knowledge of osteoporosis treatment and trials. They concluded that if placebo controls put subjects at substantial risk of serious outcomes, they are not ethically permissible. Placebo controls in osteoporosis trials with fracture as the measured outcome are permissible only under narrowly defined conditions. Placebo controls may be used if competent, well-informed patients refuse approved therapies for sound reasons, there is a reasonable basis for substantial disagreement or lack of consensus among professionals about whether approved treatments are better than placebos, or subjects are refractory to known effective agents. Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials. (shrink)
: 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: (1) regulatory oversight, (2) confidentiality and privacy, (3) informed consent, (4) availability of drugs, (5) access, and (6) 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)
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)
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)
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)
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.
This easy 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. Keywords: justice, competition, for-profit medicine CiteULike Connotea Del.icio.us What's this? (shrink)
In this paper questions are raised about the use of Halakhic material discussions of medical ethics. Three ways in which one might use Halakhic material in such discussions are distinguishes: (a) as a source for ideas about medical ethics which can be defended independently of their origin; (b) as a basis for mandating certain forms of behaviour for members of the Jewish faith; (c) as the basis for claims about the Jewish view on disputed topics in medical ethics. The first (...) two raise no methodical problems. The third use raises a number of theoretical and practical issues, with which the paper is concerned. Several problems stem from the fact that Halakhah distinguishes between obligations, fulfilment of which is required for all people. With rare exceptions, the obligations imposed up on the Jewish people are more stringent. The pitfall lurking the in third of the three uses is that authors using Halakhic material may correctly conclude that obligations that are supposed to fall only upon the Jewish people fall upon all people. An analysis of this problem follows, along with a plea for a responsible use of Halakhic material in the third way, so as to avoid certain real pitfalls. CiteULike Connotea Del.icio.us What's this? (shrink)
Morality based upon categorical imperatives. On a supposed right to tell lies from benevolent motives, by I. Kant.--Utilitarian morality, by H. Sidgwick.--What makes right acts right? by Sir D. Ross.--Utilitarianism, universalisation, and our duty to be just, by J. Harrison.--Extreme and restricted utilitarianism, by J. J. C. Smart.--What if everyone did that? by C. Strang.--Toward a credible form of utilitarianism, by R. B. Brandt.