A collaborative model for research on decisional capacity and informed consent in older patients with schizophrenia: bioethics unit of a geriatric psychiatry intervention research center

Abstract

Rationale: The numbers of older persons with psychiatric disorders are expected to rise rapidly in coming decades, yet most studies of the safety and efficacy of treatments for such disorders have focused on younger adults. A substantial expansion in research involving older patients is needed to meet the treatment needs of this fast growing group. A critical issue in intervention research is ensuring a patient's decision-making capacity. Considerable heterogeneity exists in this regard even within diagnostic groups. Cognitive changes as well as increased complexity of medication regimens in elderly patients may make it particularly difficult for some older persons to fully understand, appreciate, and/or reason about the risks and benefits of participating in any particular study.

Objectives: Empirical research into assessing and possibly improving decisional capacity is warranted in older people with severe mental illness. Such research may be accomplished through collaborations among specialists from various related disciplines and, importantly, with active involvement of community partners.

Methods: We present one model of this type of collaboration, the Bioethics Unit of an Intervention Research Center, comprising a multi-disciplinary team along with a Community Advisory Board.

Results: Preliminary studies in our Center suggest that older individuals with psychotic disorders vary considerably in their decisional capacity, and many subjects appear to be fully capable for consenting to research projects. Furthermore, the patients' level of understanding of the consent material can be improved significantly through repetition and clarification of key elements in the consent form.

Conclusions: The decisional capacity for a given research protocol is not necessarily an unmodifiable trait, but can be enhanced with improvements in consenting procedures, even in older persons with psychotic disorders.