Cognitive Vulnerability and Consent to Biomedical Research

Whether we can make a judgment about whether an agent possesses the competence to make a decision, or even has developable ability to make that decision, requires empirical investigation as well as moral argument.⁶⁴⁷ This requires us to consider relevant empirical studies into competence to consent to biomedical research. In this chapter, we will apply the theory of precautionary task or decisional competence judgment (PTDCJ) using the findings of psychiatric and psychological studies to establish which, if any, members of these five cognitively vulnerable groups we should judge competent to consent to biomedical research and the grounds on which we can make such a judgment.

In this book, we are less concerned with how a researcher or physician might go about assessing competence or the content of a competence assessment test than with the ethical and empirical considerations that should inform a judgment that decisional competence is present or absent. This is not to separate the two matters entirely, nor to suggest that competence assessments are value-free, but to place our focus on the morally laden judgment dimension of competence determinations rather than the clinically laden assessment dimension.650 Through an empirical investigation into the possibility of cognitively vulnerable individuals developing or exhibiting decisional competence to consent to research, we will be able to reach a more informed position under PTDCJ. Given the ultimate lack of certainty surrounding whether an entity we take to be an agent does actually possess a competence, this is the best we can aspire to. Before we turn to that, however, let us consider the central normative issue surrounding competence assessment that has a bearing on competence judgments.