The ethics of consent in delirium studies.

BACKGROUND: Delirium is a syndrome of acute, fluctuating confusion, which affects older people who are unwell. Although common and associated with significant poor outcomes, little is known about its pathophysiology, prevention, or treatment. Delirium research could potentially deliver important benefits for patients and is urgently required. However, such research is challenging as it inevitably involves the recruitment of patients who have impaired capacity to consent, due to the nature of delirium itself and the fact that it is people with dementia or severe illness who are most at risk. AIM: This article explores the ethical tensions inherent in the need to protect vulnerable participants in delirium research and the urgent need for high-quality research in a neglected condition.
CONCLUSIONS: The current research regulations are unnecessarily stringent and may impede good-quality delirium research. There is in particular the danger that they lead to the recruitment of unrepresentative study populations. We suggest a number of changes to the regulations, such as extending the use of the existing European Union procedures for registered medical practitioner proxy consent. We invite comments and feedback from the research community.