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Competence and vulnerability in biomedical research

Bielby, Phil



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, I develop 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, I argue 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.


Bielby, P. (2008). Competence and vulnerability in biomedical research. The University of Hull.

Book Type Authored Book
Publication Date 2008
Deposit Date Dec 19, 2014
Journal International library of ethics, law, and the new medicine
Peer Reviewed Not Peer Reviewed
Book Title International Library of Ethics, Law, and the New Medicine
ISBN 9781402086038; 9781402086045
Keywords Bioethics, Medical Law,
Public URL