MORECare Capacity Statement

4th August 2020

Adults living with serious illness are too often prevented from participating in research because of impaired capacity to give informed consent.  The MORECare-Capacity Statement published this week in BMC Medicine seeks to address this. The statement details 20 solutions to recruit adults lacking capacity nearing the end of life in research. The statement is derived from a synthesis of findings from systematic review, transparent expert consultation using consensus methods and final expert think-tank.  

There is an urgent need for evidence on best practice in palliative care. The projected increases in global serious health-related suffering demand immediate action. By 2060, an estimated 48 million people will die globally with serious health-related suffering, representing an 87% increase from 26 million in 2016. Failing to respond will see 80% of people globally with little or no access to palliative care services and treatment.

A major barrier in research on palliative care is ethical concerns about the perceived vulnerability of adults with serious illness and including them in research, particularly if the person also has impaired mental capacity. New interventions require robust evaluation to examine benefit and potential of harm for patients. Studies, especially clinical trials in palliative care, are often compromised by insufficient sample size to detect change and there is a lack of understanding of the legislation governing research involving adults with impaired capacity.

The MoreCare research team have examined the ethical challenges of recruiting patients with impaired capacity, within palliative care, dementia, mental health and intensive care. Their findings show that conducting research involving adults with impaired capacity is feasible and acceptable, and it is ethically unjust to exclude them.

The MORECare_Capacity statement provides solutions underpinned by carefully considered evidence on involving and supporting consultees, consent processes across the capacity spectrum, and decision-making with adaptations for relevant care settings. The solutions have applicability for vulnerable patient populations in palliative care and beyond such as mental health and emergency medicine.

The researchers add that recommendations require consideration within the relevant jurisdiction’s legislative framework and note that future research is required on the applicability of the MORECare_C statement for non-Western cultures and low- to middle-income countries.

Evans CJ,  Yorganci E, Lewis P, Koffman J, Stone K, Tunnard I, Wee B, Bernal W, Hotopf M, Higginson IJ.  Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement). BMC Med 18, 221 (2020). https://doi.org/10.1186/s12916-020-01654-2