Cognitive Vulnerability and Consent to Biomedical Research in England and Wales
Until recently, the status of first person contemporaneous legal competence (FPCLC) to consent to medical research in England and Wales was in considerable disarray. The absence of a legislative measure combined with ambiguous ethical guidelines and confusing terminology, created a situation fraught with uncertainty. To a considerable extent, this confusion persists despite efforts to systematize the law. Whilst competence and capacity are two of the most widely used concepts in relation to English medical law, they are also two of the least understood and most poorly employed. In part, this has arisen due to inadequate attention paid to assessments and judgments of decisional competence.
The purpose of this chapter is to survey the legal position in England and Wales and selected ethical guidelines issued by professional bodies in the UK. It will also consider the significance of European regulation in generating norms of decisional competence judgment that have influenced the English legal position or may do so in time. Throughout, we will assess the prospects for compatibility between the regulatory position and precautionary task or decisional competence judgment (PTDCJ). In particular, we will consider the differences that exist between ‘mental capacity’ and ‘legal capacity’, the current legal status of decisional competence to consent to medical research in England and Wales and ethical guidance on decisional competence to consent to medical research. As our focus is on FPCLC, we will not consider the position of decisionally incompetent individuals (frequently known as ‘mentally incapacitated’ or ‘mentally incompetent’ individuals) as they will in all probability lack FPCLC.
KeywordsIntellectual Disability Clinical Trial Regulation Mental Capacity Cognitive Vulnerability General Medical Council
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