The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
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Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. ⋯ We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.
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Comparative Study
Aiming high for the U.S. health system: a context for health reform.
Policy officials often assert that the U. S. has the best health care system in the world, but a recent scorecard on U. S. health system performance finds that the U. ⋯ S. should aim higher by adopting a set of policies that will extend affordable health insurance to all; align financial incentives for health care providers to enhance value and achieve savings; organize the health care system around the patient to ensure that care is accessible and coordinated; meet and raise benchmarks for high-quality, efficient care; and ensure accountable national leadership and public-private collaboration. The incoming president and Congress should aspire to have the best health system in the world--not just assert it--and can do so by learning from examples of excellence within the U. S. and abroad.
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Human subject research involving brain imaging is likely to reveal significant incidental findings of abnormal brain morphology. Because of this fact and because of the fiduciary relationship between researcher and subject, board-certified or board-eligible radiologists should review the scans to look for any abnormality, the scans should be conducted in accordance with standard medical practice for reviewing the clinical status of the whole brain, and the informed consent process should disclose the possibility that incidental findings may be revealed and what consequences will follow. In the event such findings are revealed, qualified physicians should explain to the subject the significance of the findings and the alternatives available.
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Empirical studies and ethical-legal analyses have demonstrated that incidental findings in the brain, most commonly vascular in origin, must be addressed in the current era of imaging research. The challenges, however, are substantial. ⋯ Risks, including a blurring of boundaries between research and clinical practice, must be weighed against the possible benefit to subjects and a moral duty to inform. Identification and examination of these challenges have been met by scientific interest and a robust, interdisciplinary response resulting in the pragmatic recommendations discussed here.