Kennedy Institute of Ethics journal
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American society traditionally has assumed a univocal notion of "death," largely because we have only one word for it and, until recently, have not needed a more nuanced notion. The reality of death-processes does not preclude the reality of death events. Linguistically, "death" can be understood only as an event; there are other words for the process. ⋯ Depending on context, some death-related events may constitute a more obvious discontinuity than others and more justifiably may be considered "death" within that context. There is no reason to assume a priori that there must be an overarching, unitary concept of death from which all diagnostic criteria must derive. Regarding organ transplantation, the relevant question is not "Is the patient dead?" but rather "Can organs X, Y, Z ... be removed without causing or hastening death or harming the patient?"
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Kennedy Inst Ethics J · Jun 2004
Risk standards for pediatric research: rethinking the Grimes ruling.
In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U. S. federal regulations include risk standards for pediatric research, endorses its own risk standards. ⋯ The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well.
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Kennedy Inst Ethics J · Jun 2004
Social contract theory and just decision making: lessons from genetic testing for the BRCA mutations.
Decisions about funding health services are crucial to controlling costs in health care insurance plans, yet they encounter serious challenges from intellectual property protection--e.g., patents--of health care services. Using Myriad Genetics' commercial genetic susceptibility test for hereditary breast cancer (BRCA testing) in the context of the Canadian health insurance system as a case study, this paper applies concepts from social contract theory to help develop more just and rational approaches to health care decision making. Specifically, Daniel's and Sabin's "accountability for reasonableness" is compared to broader notions of public consultation, demonstrating that expert assessments in specific decisions must be transparent and accountable and supplemented by public consultation.
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Challenging the interpretation of Charles Fried's use of "equipoise" presented by Paul Miller and Charles Weijer in a recent issue of the Kennedy Institute of Ethics Journal, this commentary argues that Fried was in no way promoting the concept of equipoise. In fact, his key point was that patients have a right to know and to make their own decisions about participation in clinical trials, regardless of equipoise, however it is defined.
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In response to the preceding commentary by Jerry Menikoff in this issue of the Journal, the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the design and conduct of RCTs are in tension with physicians' duties of personal care to their patients. Although Fried does argue that the existence of equipoise cannot justify failure to obtain consent from research subjects, informed consent by itself does not supplant ill subjects' rights to personalized judgment and care embodied in Fried's equipoise.