Competence and Vulnerability in Biomedical Research

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.