681 resultados para Informed consent


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Decisional capacity is a precious component of personhood and is progressively diminished in dementia. Conducting research with individuals with dementia demands a commitment to ensure the quest for knowledge does not overwhelm the rights of those it is intended to protect. The purposes of this article are to describe current understandings of the concept of decisional capacity, describe recent regulatory developments related to the consideration of additional protections for decisionally impaired adults, and provide recommendations for nurse investigators working with this vulnerable group.

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Although rarely referred to in litigation in the years that have followed the Ipp Review Report, there may well be some merit in more frequent judicial reference to the NHMRC guidelines for medical practitioners on providing information to patients 2004.

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A degree of judicial caution in accepting the assertion of a plaintiff as to what he or she would have done, if fully informed of risks, is clearly evident upon a review of decisions applying the common law. Civil liability legislation in some jurisdictions now precludes assertion evidence by a plaintiff. Although this legislative change was seen as creating a significant challenge for plaintiffs seeking to discharge the onus of proof of establishing causation in such cases, recent decisions suggest a more limited practical effect. While a plaintiff’s ex post facto assertions as to what he or she would have done if fully informed of risks may now be inadmissible, objective and subjective evidence as to the surrounding facts and circumstances, in particular the plaintiff’s prior attitudes and conduct, and the assertion evidence of others remains admissible. Given the court’s reliance on both objective and subjective evidence, statistical evidence may be of increasing importance.

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Both at common law and under the various civil liability acts, in deciding liability for breach of duty, the plaintiff always bears the onus of proving, on the balance of probabilities, any fact relevant to the issue of causation. For plaintiffs in medical negligence claims founded on negligent failure to provide sufficient information (informed consent cases), this onus involves persuading the court to make a favourable determination as to what a particular patient would have done (from a subjective perspective) in the hypothetical situation of the defendant not being negligent (that is, in the event that the medical practitioner had provided sufficient information to the patient)

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This article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. It focuses upon several case studies. In Moore v the Regents of the University Of California, a patient sued his physician for breach of fiduciary duty and lack of informed consent, because the doctor had obtained a patent on the patient's cell line, without the patient's authorisation. In Greenberg v Miami Children's Hospital, the research participants, the Greenbergs, the National Tay Sachs and Allied Diseases Association, and Dor Yeshorim brought a legal action against the geneticist Reubon Matalon and the Miami Children's Hospital over a patent obtained on a gene related to the Canavan disease and accompany genetic diagnostic test. PXE International entered into a joint venture with Charles Boyd and the University of Hawaii, and obtained a patent together for ‘methods for diagnosing Pseudoxanthoma elasticum’. In light of such case studies, it is contended that there is a need to reform patent law, so as to recognise the bioethical principles of informed consent and benefit-sharing. The 2005 UNESCO Declaration on Bioethics and Human Rights provides a model for future case law and policy-making.

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Using the example of an unconsented mouth swab I criticise the view that an action of this kind taken in itself is wrongful in respect of its being a violation of autonomy. This is so much inasmuch as autonomy merits respect only with regard to ‘critical life choices’. I consider the view that such an action is nevertheless harmful or risks serious harm. I also respond to two possible suggestions: that the action is of a kind that violates autonomy; and, that the class of such actions violates autonomy. I suggest that the action is wrongful in as much as it is a bodily trespass. I consider, and criticise, two ways of understanding how morally I stand to my own body: as owner and as sovereign. In respect of the latter I consider Arthur Ripstein’s recent defence of a sovereignty principle. Finally I criticise an attempt by Joel Feinberg to explain bodily trespass in terms of personal autonomy.

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It is generally held that doctors and researchers have an obligation to obtain informed consent. Over time there has been a move in relation to this obligation from a requirement to disclose information to a requirement to ensure that that information is understood.Whilst this change has been resisted, in this article I argue that both sides on this matter are mistaken.When investigating what information is needed for consent to be informed we might be trying to determine what information a person would need in order to consent at all, or we might be trying to determine what information a person needs in order to make an informed choice about whether or not to consent. I argue that the obligation to ensure understanding only applies to information generated by the ?rst type of enquiry; but that much of the information generally thought necessary in order for consent to be informed is only required if our concern is with the second type of enquiry. For this reason it is neither the case that doctors and researchers should ensure all the information they provide is understood, nor is it the case that their only obligation is to disclose it.

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It is required that patients are provided information about therapeutic possibilities, showing the risks, benefits, prognosis and costs of each possible and indicated alternative. This is an ethical and legal resolution. However, health professionals possess the clinical/technical/scientific knowledge and determine what information will be (or not) provided. The patient in question decides to undergo a treatment, providing his/her free and informed consent on the basis of the data presented. Unfortunately, some professionals may not provide all the information necessary for making an informed decision or, after obtaining the consent of the patient, may provide him information that causes the patient to give up on the treatment initially accepted. Such information, if relevant, and not a supervening fact, should have been provided initially. However, the information may not be entirely true, and bring the patient, for instance, to decide based on inadequately presented risks. The craniofacial rehabilitation of the temporomandibular joint (TMJ) by means of TMJ prosthesis, is indicated in many situations. Often, patients in need of such prostheses have aesthetic and functional problems and the rehabilitation expectations run high. This work presents a case and discusses ethical and legal issues, including the liability of partial and inadequate information to a patient.