Informed consent, throughout bioethics and health law, has been based on a normative model of decision making, that has set unrealistic goals for consent, emphasising bureaucratic documentation, and often displacing institutional and professional responsibilities. Literature related to biobanks, and on consent to research, has begun to develop a heuristic understanding of decision making, in which informed consent is based on a conservation of cognitive effort: decision makers gauge the amount effort that they need to expend to make a decision. Much of this is pre-cognitive, blending the perceived importance of the decision with how trustworthy the people and contexts appear.
Provision of information in informed consent processes plays an important performative role in shaping the sense that trustworthiness is justified, but full comprehension or engagement with all of the details is not required for valid informed consent. Further, the classic rationalism model of informed consent has tended to shift responsibility for consequences of decisions onto the individual. The heuristic or relational model emphasises the elements of context and relationships that support trustworthiness. Informed consent’s role is therefore more modest than traditionally considered. The accuracy and completeness of disclosure is an important as an element of trustworthiness, but more important is ensuring that institutional contexts and the role of practitioners and researchers reflect, or correct, assumptions of trustworthiness. While the processes of informed consent might not change, the validity of informed consent cannot be assessed independent of verifying that institutional contexts and health practitioners/researchers meet conditions of their apparent trustworthiness.