Bmc Med Ethics
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Randomized Controlled Trial
How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania.
HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. ⋯ Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings.
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The overwhelming scarcity of organs within renal transplantation forces researchers and transplantation teams to seek new ways to increase efficacy. One of the possibilities is the use of personalized medicine, an approach based on quantifiable and scientific factors that determine the global immunological risk of rejection for each patient. Although this approach can improve the efficacy of transplantations, it also poses a number of ethical questions. ⋯ The participants see the benefits of including the calculation of the global immunological risk within transplantation. Such data, being more precise and rigorous, could be of help in their clinical work. However, in spite of the use of such scientific data, a place must be retained for the clinical judgment that allows a physician to make decisions based on medical data, professional expertise and knowledge of the patient. To act in the best interests of the patient is key to whether the calculation of the global immunological risk is employed.
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Currently, intensive care medicine strives to define a generally accepted way of dealing with end-of-life decisions, therapy limitation and therapy discontinuation.In 2006 a new advance directive legislation was enacted in Austria. Patients may now document their personal views regarding extension of treatment. The aim of this survey was to explore Austrian intensive care physicians' experiences with and their acceptance of the new advance directive legislation two years after enactment (2008). ⋯ A response rate of almost 60% proves the great interest of intensive care professionals in making patient-oriented end-of-life decisions. However, as long as patients do not make use of their right of co-determination, the enactment of the new law can be considered only a first important step forward.
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An important principle underlying the Dutch Euthanasia Act is physicians' responsibility to alleviate patients' suffering. The Dutch Act states that euthanasia and physician-assisted suicide are not punishable if the attending physician acts in accordance with criteria of due care. These criteria concern the patient's request, the patient's suffering (unbearable and hopeless), the information provided to the patient, the presence of reasonable alternatives, consultation of another physician and the applied method of ending life. To demonstrate their compliance, the Act requires physicians to report euthanasia to a review committee. We studied which arguments Dutch physicians use to substantiate their adherence to the criteria and which aspects attract review committees' attention. ⋯ Dutch physicians substantiate their adherence to the criteria in a variable way with an emphasis on physical symptoms. The information they provide is in most cases sufficient to enable adequate review. Review committees' control seems to focus on (unbearable) suffering and on procedural issues.
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Multidisciplinary study groups have produced documents in an attempt to support decisions regarding whether to resuscitate "at risk" newborns or not. Moreover, there has been an increasingly insistent request for juridical regulation of neonatal resuscitation practices as well as for clarification of the role of parents in decisions regarding this kind of assistance. The crux of the matter is whether strict guidelines, reference standards based on the parameter of gestational age and authority rules are necessary. ⋯ Concerning the decision to interrupt or not to initiate resuscitation procedures on low gestational age newborns, physicians do not need rigid rules based on inflexible gestational age and birth weight guidelines. Guidance in addressing the difficult and trying issues associated with infants born at the margins of viability with a realistic assessment of the infant's clinical condition must be based on the infant's best interests, with clinicians and parents entering into what has been described as a "partnership of care".