Competence and vulnerability in biomedical research / Phil Bielby

Livre

Bielby, Phil. Auteur

Edité par Springer - 2008

"Enhanced knowledge of the nature and causes of mental disorder have led increasingly to a need for the recruitment of 'cognitively vulnerable' participants in biomedical research. These individuals often fall into the 'grey area' between obvious decisional competence and obvious decisional incompetence and, as a result, may not be recognised as having the legal capacity to make such decisions themselves. At the core of the ethical debate surrounding the participation of cognitively vulnerable individuals in research is when, if at all, we should judge them decisionally and legally competent to consent to or refuse research participation on their own behalf and when they should be judged incompetent in this respect." "In this book, the author develops a novel justificatory framework for making judgments of decisional competence to consent to biomedical research with reference to five groups of cognitively vulnerable individuals - older children and adolescents, adults with intellectual disabilities, adults with depression, adults with schizophrenia and adults with dementia, including Alzheimer's disease. Using this framework, the author argues that we can make morally defensible judgments about the competence or incompetence of a potential participant to give contemporaneous consent to research by having regard to whether a judgment of competence would be more harmful to the 'generic rights' of the potential participant than a judgment of incompetence. The argument is also used to justify an account of supported decision-making in research, and applied to evaluate the extent to which this approach is evident in existing ethical guidelines and legal provisions. The book will be of interest to bioethicists as well as psychiatrists and academic medical lawyers interested in normative questions raised by the concepts of competence and capacity."--[Jaquette]

Five concepts of competence. Agency competence ; Task competence ; Decisional competence ; Societal competence ; Legal competence. Consent, vulnerability and research. Competence to give informed consent ; Individual autonomy ; Why biomedical "research"? ; The evolution of the rights of research participants ; The meaning of vulnerability ; Cognitive vulnerability and consent to biomedical research ; Why conduct biomedical research with cognitively vulnerable groups?. Gewirth's theory of agency rights. The argument to the PGC ; The methodology of the PGC ; Defining the content of agency rights ; Resolving conflicts of rights under the PGC ; Direct and indirect applications of the PGC ; Consent and the PGC ; An evaluation of the PGC against two alternative rationalist ethical theories ; Summary. Proportionality, precaution and judgments of competence. The principle of proportionality ; Precautionary reasoning ; Evidence of agency and duties of protection ; The criterion of avoidance of more probable harm ; Degrees of displaying GCAb and its relationship with task and decisional competences ; Summary. The competence of cognitively vulnerable groups. Older children and adolescents ; Adults with intellectual disabilities ; Adults with depression ; Adults with schizophrenia ; Adults with Alzheimer's disease and other dementias ; summary. Cognitive vulnerability and consent to biomedical research. Decisional competence and supported decision-making ; Older children and adolescents ; Adults with intellectual disabilities ; Adults with depression ; Adults with schizophrenia ; Adults with Alzheimer's disease and other dementias ; summary. Cognitive vulnerability and consent to biomedical research in England and Wales. Three approaches to determining FPCLC ; The meaning of FPCLC consent in England and Wales ; Adults ; Children ; Problems surrounding the use of capacity ; Towards supported decision-making? ; The significance of European regulation of capacity ; Ethical guidance on decisional competence in biomedical research in the UK ; Summary. Cognitive vulnerability and consent to biomedical research in the United States. The meaning of competence and capacity in the United States ; Federal law ; State law ; Policy documents on decisional competence ; Summary.

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