The Psychology of Competence and Informed Consent: Understanding Decision-Making with Regard to Clinical Research

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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)

I. 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. …