A goodness-of-fit ethic for informed consent.

AuthorFisher, Celia B.
PositionPeople with mental retardation

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.

  1. 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. When such efforts are insufficient to insure adequate consent, individuals should be encouraged to either select a consent partner, or to yield decision-making to a consent surrogate who can help arrive at a decision that best reflects the patient's wishes and concerns.

    From a relational perspective, autonomy involves not only an obligation to self, but also to others. (11) Thus, when individuals with impaired decisional capacity choose to use a consent partner or surrogate, the patient and the partner/surrogate are obligated to understand and respect each other's concerns and values. Thus, a goodness-of-fit ethic encourages an exchange of views between persons with mental disorders and their formal or informal consent partners that illuminates, rather than eliminates, the moral positions of each. This exchange of views in turn leads to a consent decision that accommodates, rather than subjugates, these values. (12)

  2. INFORMED, RATIONAL, AND VOLUNTARY PERSON-CONTEXT CONSENT

    Informed consent to medical treatment and research represents a mutual agreement between a practitioner and patient, the validity of which requires that the consent be informed, rational, voluntary, and competent. (13) The informed aspect of consent requires that practitioners provide information about the purpose, procedures, potential risks and benefits, and alternative options of treatment or research sufficient for an individual to make a reasoned decision. Such information, however, may not be sufficient for individuals with mental disorders who either lack general knowledge about health care treatments and patient rights, or who have not had the opportunity to make autonomous decisions. In these situations, a goodness-of-fit between the person and consent context might require modifying consent procedures to include "reasonable disclosure" of practical information about those general aspects of health care, or research essential for a knowledgeable decision to be made. (14)

    To meet the rational requirement of informed consent, an individual needs to be able to understand the information presented and appreciate the consequences to oneself of agreeing or declining treatment or research participation. (15) Although impairments in abstract reasoning can limit this ability, matching the language level of consent information to that of a patient/participant with a mental disorder, and modifying those aspects of the consent setting that may be stress provoking for that particular individual, can reduce person-context consent vulnerability.

    The voluntary requirement of consent is meant to insure that individuals are not coerced into participation, and are free to withdraw from treatment or biomedical research at any time. (16) In some contexts people with mental disorders may be particularly vulnerable to coercion and exploitation. (17) For example, they may fear disapproval from family caretakers or may feel that they must be compliant in deference to the authority of the requesting practitioner. Some may have had little...

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