Informed consent in the psychosis prodrome: ethical, procedural and cultural considerations

Abstract

Research focused on the prodromal period prior to the onset of psychosis is essential for the further development of strategies for early detection, early intervention, and disease pre-emption. Such efforts necessarily require the enrollment of individuals who are at risk of psychosis but have not yet developed a psychotic illness into research and treatment protocols. This work is becoming increasingly internationalized, which warrants special consideration of cultural differences in conceptualization of mental illness and international differences in health care practices and rights regarding research participation. The process of identifying and requesting informed consent from individuals at elevated risk for psychosis requires thoughtful communication about illness risk and often involves the participation of family members. Empirical studies of risk reasoning and decisional capacity in young people and individuals with psychosis suggest that most individuals who are at-risk for psychosis can adequately provide informed consent; however ongoing improvements to tools and procedures are important to ensure that this work proceeds with maximal consideration of relevant ethical issues. This review provides a discussion of these issues in the context of international research efforts.

Ethical considerations of theory-driven and disorder-driven practice.

“…Other individuals are often involved with informed consent for specific disorder-based (and age-based) treatments. For example, during the prodromal phase of psychotic disorders, pharmacotherapy studies do not support the broad use of medications for at-risk individuals (Morris & Heinssen, 2014). Family members or others acting as a support system should become aware of the possible progression of symptoms, be able to assess the illness risk, and should receive permission to obtain information from the clinician through the informed consent process.…”

“…Finally, Morris and Heinssen (2014), summarizing a National Institute of Mental Healthsponsored workshop, presented three areas that should be included in informed consent discussions and documents when conducting research in psychosis disorder risk, though the areas seem relevant with clinical treatment. These areas include a discussion that (a) individuals in a prodromal phase, who can arrive with existing depression, cognitive and social impairments, and anxiety, can be fairly reliably assessed, though accurately predicting who will further develop a psychotic disorder is not possible; (b) further development into a psychotic state is not inevitable, and patients can present with other socioemotional concerns; and (c) no definitive treatments currently exist for individuals at risk to develop psychosis, though family therapy, CBT, substance abuse prevention, and cognitive restructuring are promising.…”

Strategies to minimize further stigmatization of communities experiencing stigma: A guide for qualitative researchers.

“…These findings represent inaccurate perceptions of the DC of people with mental illness. For example, research suggests that people at risk for psychosis possess adequate DC (Morris & Heinssen, 2014). Further, the existing literature suggests that DC for participation in clinical research among youth and/or other vulnerable and stigmatized populations (e.g., people with mental illness or diminished neuropsychological functioning) can improve with intervention (Basso et al, 2010; Jeste et al, 2009; Moser et al, 2006; O’Lonergan & Forster-Harwood, 2011).…”

European Psychiatric Association policy paper on ethical aspects in communication with patients and their families

“…Psychiatrists should bear in mind that proper informed consent requires patients to be "competent," meaning they are capable of understanding, remembering, and grasping information, and able to evaluate the impact of any decisions made and to communicate their decision. Accordingly, ethical concerns as to the validity of informed consent may arise in patients who are cognitively impaired [63], affected by acute mental disorder [64], or suffering from psychotic prodromal states [65]. Relatives may receive information unless they have been expressly prohibited from being notified of any relevant information relating clinical conditions of the patients and prescribed treatments.…”