The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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The article comprises a conceptual framework to analyze the strengths and weaknesses of a global health convention. The analyses are inspired by Lawrence Gostin's suggested Framework Convention on Global Health. ⋯ We conclude that a global health convention could be an appropriate instrument to deal with some of the problems of global health. We also show that some of the tasks preceding a convention approach might be to muster international support for supra-national health regulations, negotiate compromises between existing stakeholders in the global health arena, and to utilize WHO as a platform for further discussions on a global health convention.
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The field of global health has reached a critical juncture, where both its visibility and the complexity of its challenges are unprecedented. The World Health Organization, as the only global health actor possessing both democratic and formal legal legitimacy, is best positioned to capitalize on this new, precarious situation in public health and respond with the governance innovation that is needed to bring the increasingly chaotic network of activities and entities affecting health outcomes under the fold of a centralized, standard-setting agency. One such proposed innovation to guide normative and strategic coordination in global health is the creation of a Committee C of the World Health Assembly that would promote consensus building and multi-stakeholder decision-making within the unique convening power of the World Health Organization.
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Clinical evidence suggests that many patients undergo surgery that they would decline if fully informed. Failure to communicate the relevant risks, benefits, and alternatives of a procedure violates medical ethics and wastes medical resources. Integrating shared decision-making, a method of communication between provider and patient, into medical decisions can satisfy physicians' ethical obligations and reduce unwanted procedures. This article proposes a three-step process for implementing a nationwide practice of shared decision-making: (1) create model integration programs; (2) provide legal incentives to ease the transition; and (3) incorporate shared decision-making into medical necessity determinations.
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This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products ("compassionate use"); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases.