The Enterprise of Informed Consent

Abstract

Our aim has been to develop a sense of informed consent as a useful tool for medical management, an intervention that would change outcomes at the bedside for the better. We initially found that the law offered no such implement, focused as it was, for all its rhetoric, on the ways that tort law might identify actionable departures from minimally adequate informed consents. Whatever minimal goals the law legitimately chose to pursue, it was simply not adequate to the ethical and clinical goods and values that were at stake. Moreover, the law proceeded in terms of a presumption regarding competence, and a primary focus on a “bits and pieces” sense of understanding, that did not reflect the actual capacities or needs of patients in the situation of illness, nor did it reflect the ways in which such factors varied from situation to situation, and patient to patient. Finally, even if one accepted the narrower focus of the law’s approach, it failed to provide sufficient operational guidance to determine how to satisfy its agendas, e.g. in its standards for disclosure or for the assessment of competence.