Competence to Give Informed Consent to Research Participation in Persons with Schizophrenia and Related Psychosis
Howe, Vivienne, Foister, Kellie, Jenkins, Kym, Keks, Nicholas, Skene, Loane, Copolov, David, Psychiatry, Psychology and Law
Over the last decade there has been escalating debate regarding the competency of patients with psychoses to give informed consent to participate in research. This debate has been made evermore complex by variations in the definition and evaluation of competency. Importantly, competency must meet both medical and legal standards, although the criteria for each of these are not always consistent and may be mediated by contextual factors. The matter of competency to give informed consent is further complicated in the case of patients with psychoses. As a result of their disorder, patients with psychoses develop a mental state where there is impairment of reality appreciation. The impact on competency however, is highly variable and can frequently be accommodated in the consent process. Establishing associations between particular psychotic symptoms and their severity, with competency to consent at different levels of risk is the central theme of research currently being conducted.
A Clinical Perspective
Informed consent is a multidimensional and contextually driven concept that forms the cornerstone of ethical practice. It is an assurance that relevant information is provided to and understood by the patient before an intervention of any kind is performed. This is not always a simple process and a number of steps are frequently taken to maximise the comprehension and retention of information, including the provision of plain language statements, pamphlets and consultation with other parties. Despite these provisions, the process of obtaining informed consent may not be possible due to impairment in the participant's level of competence.
Competence refers to the acquisition or maintenance of a baseline level of ability. It is a term that is contextually bound, where the ability under consideration must be clearly defined before competence can be determined. Although assessing competence requires appraisal of psychiatric, cognitive, functional and decision-making abilities, it has been noted that these areas are generally not integrated in the literature (Pepper-Smith, Harvey, & Silberfeld, 1996).
Competence to provide informed consent refers to more than the provision and comprehension of information. The legal rights of the patient, specifically their right to autonomy and self-determination, are also incorporated within this concept. This must be balanced, however, by ensuring that those who are incapable of making informed decisions are protected from any such decisions that may be harmful or would not otherwise be made (Etchells, Sharpe, Elliot & Singer, 1996).
A Legal Perspective
The notion of informed consent is a legal concept derived from the need to protect the interests of the patient. The common law concept of competence accepted in Australia is based primarily on two English cases, Re C (adult; refusal of medical treatment)  1 WLR 290;  1 All ER 819 and Re T (adult; refusal of medical treatment)  Fam 95;  4 All ER 649. Re T established the right of the patient to refuse treatment and that consent must be free and voluntary. The case of Re C is more specific to the concept of competence. C was a 68-year-old man with chronic paranoid schizophrenia, who developed gangrene in a foot while detained in a secure hospital. Initial consultation with a surgeon indicated he had a 15% chance of survival without amputation. C refused to consider the amputation, so antibiotics and conservative surgery were used. This conservative intervention was successful and averted the immediate threat. However, when C's solicitor sought confirmation that the hospital would not, at some future stage, amputate his foot, the hospital refused, on the ground that C's capacity to give a definitive decision was impaired by mental illness and that he did not appreciate the risk of death. C's symptoms included grandiose themes that he had an international career in medicine, during the course of which he had never lost a patient. …