A goodness-of-fit ethic for informed consent.

INTRODUCTION The orientation of legal advocates and social policy makers regarding the rights of the mentally infirm has shifted considerably over the years. Historically, adults with known mental disorders were presumed incompetent and restricted from opportunities to make decisions for themselves. (1) Disregard for the rights of institutionalized and impaired persons resulted in abuses, such as the infamous case at the Willowbrook State School, where biomedical researchers infected children identified as "mentally defective" with viral hepatitis without their knowledge, and with the questionable voluntary consent of their parents. (2) In the wake of Willowbrook, advocates for people with mental retardation have made significant legal gains for individuals with decisional impairments. This movement led to including policies requiring the deinstitutionalization of individuals whose futures had largely been relegated to severely restricted institutional living, regulations for intermediate care facilities, court decisions guaranteeing the right of persons with mental retardation to make their own decisions, and ultimately, recognition by the courts that a diagnosis of a mental disorder is not a presumption that the individual is incompetent to make decisions. (3) Despite these gains, balancing the obligation to respect the rights of those with mental impairments to be treated as autonomous members of the moral community with the need to ensure that ill-informed or incompetent decisions will not jeopardize their welfare remains an ongoing ethical challenge for legal advocates, practitioners, and family members. (4) This Essay argues that informed consent policies for adults with mental disorders need to reflect a relational approach that re-conceptualizes consent vulnerability in terms of a "goodness-of-fit" between patient characteristics and the consent context. I. CONSENT VULNERABILITY AS A RELATIONAL CONSTRUCT Adults with mental disorders, like all people, are linked to others in relationships of reciprocity and dependency. (5) Conceptualizing consent impairments as a product of the relationship between the person and the consent context shifts ethical inquiry away from an exclusive focus on the patient's or research participant's mental infirmities. Instead, it focuses on those aspects of the consent setting that are creating or exacerbating consent vulnerability, and considers how the setting can be modified to produce a consent process that best reflects and protects the patient's/participant's hopes, values, concerns, and welfare. (6) From a relational perspective, morally responsible informed consent practices require more than simply evaluating whether a patient/participant understands the nature, risks, and benefits of procedures for which consent is sought, toward a reconfiguration of the consent context itself. Such reconfigurations involve remedial efforts to enhance consent comprehension coupled with efforts to attain mutual understandings among consent stakeholders regarding their values and concerns. (7) Embedded in law and professional standards, the modern doctrine of informed consent is too often grounded in a limited definition of autonomy that is restricted to respect for an individual's right to self-governance and privacy. (8) However, as Professor James Childress has pointed out, the ideal of autonomy must be distinguished from the conditions for autonomous choice. (9) Within this framework autonomy need not be conceptualized as isolated or isolating, (10) but as an expression of connectedness to others. From this relational perspective, respect for autonomy requires that practitioners and investigators make every attempt to create a goodness-of-fit between the person and the consent context that maximizes opportunities for the individual to provide informed, rational, and voluntary decisions. …