Towards supported decision-making in biomedical research with cognitively vulnerable adults

This chapter has two connected aims. First, I argue that we can best understand the scope and limits of consent as a ‘procedural’ principle of empowerment. I ground this argument in a rationalist moral theory of human (or agency) rights devised by Alan Gewirth. Drawing on the recent work of Gewirthian legal theorists Beyleveld and Brownsword, I offer a defence of the ethical significance of consent as a procedural human rights value, which does not in itself constitute a substantive human right. My second aim is to propose a theory of supported decision-making in biomedical research that seeks to nurture the abilities of cognitively vulnerable participants to make decisions. This reframes consent as the basis of the empowerment of cognitively vulnerable adults. In the final section, I assess the legal prospects for supported decision-making, with particular reference to English law. Although no explicit provision for supported decision-making in research currently exists in English law, there appears to be some limited scope for accommodation