The psychology of competence and informed consent: understanding decision-making with regard to clinical research.

AuthorRosenfeld, Barry

INTRODUCTION

The role of psychology and related mental health disciplines in the informed consent process has gradually evolved from an essentially non-existent role into a central and important one. The importance of informed consent as a mechanism for protecting patient autonomy cannot be overstated. Both the ethical principals of psychologists as well as countless legal decisions have emphasized the importance of patient autonomy. (1) Rooted in the constitutional right to privacy, the importance of autonomy as a guiding principal in medical decision making (as in other forms of decision making) has been well established and is essentially unchallenged. (2)

  1. INFORMED CONSENT

    As is perhaps common knowledge for many clinicians and legal scholars, the doctrine of informed consent requires three elements to be present in order to validate medical treatment decisions. (3) The decision must be knowledgeable (i.e., the treatment provider must have disclosed relevant information to the prospective patient), voluntary (i.e., a decision made of the patient's own free will), and competent (i.e., by an individual with an adequate level of decision making ability). Although psychologists have been involved in providing research and clinical expertise to virtually all aspects of the informed consent process, psychology's role is most important in determining whether the patient is competent to make a treatment decision. (4)

    The burden of the first element of informed consent, the "knowledge" element, rests with the treating clinicians. Specifically, the doctor must provide a reasonable amount of information regarding the known risks and benefits of a recommended treatment, as well as the risks and benefits of treatment alternatives. Not surprisingly, the volume of information necessary to make an informed decision varies depending on the nature and complexity of the decision at hand. Furthermore, different patients will certainly differ in the amount of information they desire. In general, however, a standard has emerged that is consistent with numerous other areas of the law: the "reasonable person" standard, or that amount of information that the typical person would find adequate and/or necessary to make such a decision. (5) Although psychologists have begun to use research tools to clarify the boundaries of the reasonable person standard, literature has not yet focused squarely on informed consent. (6) Instead, most mental health research has addressed the impact of disclosed information on treatment decisions or methods to improve comprehension and retention of disclosed information. (7)

    Voluntariness, the second element of informed consent, pertains to the patient's decision making process. Individuals must be free to make their own decisions without undue coercion from others. Although studies of the patient's perceptions of coercion and the factors that influence this perception have begun to emerge in the psychology literature, this issue remains largely outside the domain of psychology. (8) Instead, defining the contours of voluntariness occurs primarily in the courts. Even so, no clear definitions or standards have been forthcoming. (9)

    Competence, the final aspect of informed consent, is arguably the most important element of consent. Although only recently identified as a topic worthy of scientific scrutiny, the competence question has increasingly attracted the attention of the psychological sciences. (10) While the burden of competence falls primarily upon the decision maker, the clinician or researcher is responsible for ensuring that this requirement has been satisfied. (11) Importantly, the law presumes that every adult is competent to make decisions for themselves unless proven otherwise; for many individuals the burden of demonstrating competence may shift as a practical matter, if not a legal one. Mentally ill, mentally retarded, severely medically ill, and even healthy elderly adults share this burden, in that many individuals perceive their competence to be questionable. (12) This discussion focuses on three scenarios in which questions of competence, and the role of the mental health professional, play a central role.

  2. LEGAL STANDARDS, CLINICAL ASSESSMENTS

    Separating legal theory and clinical decision-making is necessary to any discussion of legal and ethical principals guiding real-world situations. Among the many crucial distinctions, few are as important as the distinction between law and clinical practice. (13) Although the decision-making capacity is clinical, determinations of competence are legal conclusions that are based only partially on clinical input. (14) Until a judge has declared an individual incompetent, the law's presumption of competence remains. (15) Moreover, when determinations of incompetence are rendered, they are typically situation-specific, pertaining to only a single issue or decision (although some individuals might be declared incompetent for a broad range of purposes). (16) Third, although the responsibility for determining whether an individual is competent or incompetent rests with a judge, formal proceedings to determine competence are relatively rare. Instead, most questions about competence are handled in a more informal manner. (17) For example, the treating clinician may simply defer to the wishes of an available family member whenever a patient's competence is deemed inadequate. (18) Finally, decisions regarding a patient's decision-making capacity are often heavily influenced by the input and opinions of a psychologist or psychiatrist. (19) Most judges look toward mental health professionals for guidance to determine when an impairment exists and the extent of such an impairment. (20) With these facts in mind, exploring the role of psychologists in resolving what appears to be complex ethical dilemmas becomes somewhat clearer.

    The hypothetical cases that serve as the focal point for this analysis have been previously described by Celia Fisher in this Volume and are only summarized in brief here. (21) These cases highlight several of the issues noted above. The cases outline the parameters of "competence" by illustrating the methodologies used in making these determinations, distinguishing between ethical and legal issues in the assessment of competence, and reviewing the procedures for surrogate decision making when competence is deemed impaired.

    1. Case One--Deteriorating Competence Over the Course of Study Participation

      The first case described concerns a mentally ill woman, (whom we refer to as "Alice"), who has agreed to participate in a research study in which the standard treatment for her disorder, antipsychotic medications, are being withheld. In this scenario, the participant's parents have requested that her participation be terminated because of their fears that her condition has deteriorated. The dilemma facing the study's investigators is whether or not to accede to the parents' wishes, or to respect Alice's initial consent (which, conveniently, furthers their own research interests)...

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