Competence and Vulnerability in Biomedical Research by Philip BielbyCompetence and Vulnerability in Biomedical Research by Philip Bielby

Competence and Vulnerability in Biomedical Research

byPhilip Bielby

Paperback | November 25, 2010

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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.

Dr Phil Bielby is a lecturer in the Law School and a member of the Institute of Applied Ethics at The University of Hull. He holds a PhD from The University of Sheffield and has published in the fields of bioethics, medical law and critical legal education.
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Title:Competence and Vulnerability in Biomedical ResearchFormat:PaperbackDimensions:236 pages, 23.5 × 15.5 × 0.01 inPublished:November 25, 2010Publisher:Springer NatureLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:9048179319

ISBN - 13:9789048179312

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Table of Contents

Acknowledgments; Contents; Main abbreviations; Note on the text; Introduction; Chapter One; Five concepts of competence;Agency competence; Task competence;Societal competence;Decisional competence;Risk-relative (asymmetrical) competence;Decision-relative competence;Legal competence;First sense of legal competence (first person contemporaneous legal competence);Second sense of legal competence (delegable legal competence);Third sense of legal competence (fiduciary legal competence) Chapter Two: 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?; Chapter Three: 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;(i) John Rawls;(ii) David Gauthier;Summary; Chapter Four:Proportionality, precaution and judgments of competence;The Principle of Proportionality (PP);Precautionary reasoning;Ostensible agents;Apparent partial agents;Ostensible intermittent agents;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;Ostensible agents;Ostensible intermittent agents;(i) Ostensible intermittent agents who are close to having the capacities needed to be an agent in a standing fashion;(ii) Ostensible intermittent agents who are less close to having the capacities needed to be an agent in a standing fashion;Apparent partial agents;Summary; Chapter Five:The competences of cognitivelyvulnerable groups;Older children and adolescents;Adults with intellectual disabilities;Adults with depression;Adults with schizophrenia;Adults with Alzheimer's disease and other dementias;Summary; Chapter Six: 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; Chapter Seven: 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; Chapter Eight: 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;Making Health Care Decisions 1982);Research Involving Individuals with Questionable;Capacity to Consent (1997);Research Involving Persons with Mental Disorders;That May Affect Decisionmaking Capacity (1998);NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects (1998);Summary; Conclusion;References.

Editorial Reviews

From the reviews:"'Competence and Vulnerability in Biomedical Research' develops a framework for evaluating the decisional competence of potential study subjects and providing appropriate support for those with impaired competence. Given the practical and ethical challenges of obtaining consent from the cognitively vulnerable, such a framework is welcome. The book studies five aspects of competence -- agency, task, decisional, societal and legal . . the text is very technical and best suited to bioethicists, attorneys and psychiatrists with an interest in the area." (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 7 (9), September, 2011)