Kennedy Institute of Ethics journal
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Kennedy Inst Ethics J · Jun 2009
Ethical norms and the international governance of genetic databases and biobanks: findings from an international study.
This article highlights major results of a study into the ethical norms and rules governing biobanks. After describing the methodology, the findings regarding four topics are presented: (1) the ownership of human biological samples held in biobanks; (2) the regulation of researchers' use of samples obtained from biobanks; (3) what constitutes "collective consent" to genetic research, and when it is needed; and (4) benefit sharing and remuneration of research participants. The paper then summarizes key lessons to be drawn from the findings and concludes by reflecting on the importance of such empirical research to inform future governance norms and practices.
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Kennedy Inst Ethics J · Jun 2009
The incoherence of determining death by neurological criteria: a commentary on "Controversies in the determination of death", a White Paper by the President's Council on Bioethics.
Traditionally the cessation of breathing and heart beat has marked the passage from life to death. Shortly after death was determined, the body became a cold corpse, suitable for burial or cremation. Two technological changes in the second half of the twentieth century prompted calls for a new, or at least expanded, definition of death: the development of intensive care medicine, especially the use of mechanical ventilators, and the advent of successful transplantation of vital organs. ⋯ The situation of these patients posed two ethical questions. Is it appropriate to stop life-sustaining treatment? If so, is it acceptable to retrieve vital organs for transplantation to save the lives of others before stopping treatment? In 1968, the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proposed that death could be determined on the basis of neurological criteria, thus providing a positive answer to these two questions (Ad Hoc Committee 1968). According to the position of this committee, patients diagnosed with the cessation of brain function are dead, despite the fact that they breathe and circulate blood with the aid of mechanical ventilation.
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Kennedy Inst Ethics J · Jun 2008
A proposed ethical framework for vaccine mandates: competing values and the case of HPV.
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. ⋯ 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.
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The "therapeutic misconception", described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic misconception, paying particular attention to assumptions and implications that clinical trial participation disadvantages research participants as compared with receiving standard medical care. After clarifying the ethical significance of the therapeutic misconception with respect to the decision making of patients, we offer policy recommendations for obtaining informed consent to participation in clinical trials.
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Kennedy Inst Ethics J · Jun 2006
Academic freedom and academic-industry relationships in biotechnology.
Commercial academic-industry relationships (AIRs) are widespread in biotechnology and have resulted in a wide array of restrictions on academic research. Objections to such restrictions have centered on the charge that they violate academic freedom. ⋯ On a consequentialist understanding of the value of academic freedom, they rely on unfounded empirical claims about the overall effects that AIRs have on academic research. And on a rights-based understanding of the value of academic freedom, they rely on excessively lavish assumptions about the kinds of activities that academic freedom protects.