How to enhance the informed consent process in persons unable to consent? Experiences from different contexts and settings

Background: Informed consent is the most scrutinized and controversial aspect of clinical research ethics. In palliative and end-of-life care, assessing decision-making capacity may be challenging. Patients, particularly those with cognitive impairment, deserve special attention when developing, implementing, and evaluating the informed consent process. Respecting patients’ autonomy in research includes obtaining informed consent; facilitating and supporting patients’ choices about research options; allowing patients to refuse participating in research; disclosing comprehensive and truthful information; and maintaining privacy and confidentiality. An autonomous decision requires that participants/patients have the capacity to provide informed consent. Aim: To explore how to enhance the informed consent process in persons unable to consent (e.g., persons with cognitive impairment, dementia, severe and persistent mental illness, and/or at the end-of-life) to increase equity and fair participant selection. Methods: This presentation is based on a series of systematic reviews and international research projects. It combines theoretical frameworks and ethical principles with empirical research conducted in different contexts and settings. Results: The informed consent process involves both consent and assent, which should be monitored throughout the research process. Informed consent must be an ongoing process of communication, understanding and decision-making that involves a wide range of key stakeholders (the patient and potential participant, possible surrogates, clinicians, and researchers) throughout the course of the study. Cognitive impairment, and other disorders affecting cognition, may have a negative impact on patients’ capacity to provide consent to research participation. Also, stereotypes among researchers can contribute to failures in the informed consent process. This might prevent patients with limited decision-making capacity from participating in relevant research. Conclusions: This presentation provides an overview of ethical frameworks and principles linked to the informed consent process and decision-making capacity in palliative care research, particularly in patients with cognitive impairment and/or limited decision-making capacity. A core set of ethical questions and recommendations is drawn to aid researchers, institutional review boards and potential research participants in the process of obtaining informed consent for palliative and end-of-life care research.