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)

Abstract

Background: Involving adults lacking capacity (ALC) in research on end of life care (EoLC) or serious illness is important, but often omitted. We aimed to develop evidence-based guidance on how best to include individuals with impaired capacity nearing the end of life in research, by identifying the challenges and solutions for processes of consent across the capacity spectrum. Methods: Methods Of Researching End of Life Care_Capacity (MORECare_C) furthers the MORECare statement on research evaluating EoLC. We used simultaneous methods of systematic review and transparent expert consultation (TEC). The systematic review involved four electronic databases searches. The eligibility criteria identified studies involving adults with serious illness and impaired capacity, and methods for recruitment in research, implementing the research methods, and exploring public attitudes. The TEC involved stakeholder consultation to discuss and generate recommendations, and a Delphi survey and an expert 'think-tank' to explore consensus. We narratively synthesised the literature mapping processes of consent with recruitment outcomes, solutions, and challenges. We explored recommendation consensus using descriptive statistics. Synthesis of all the findings informed the guidance statement.

Unpacking the ‘black box of horrendousness’: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent

“…The context-specific challenges identified in this study reflect those encountered in numerous previous studies exploring research in settings such as critical care [ 47 , 48 ] and care homes [ 49 ], and the issues surrounding capacity and consent in populations such as those receiving palliative and end of life care [ 50 ], people with aphasia [ 51 ] and people with learning disabilities and/or autism [ 52 ]. Our findings that highlight a universal knowledge deficit are also supported by previous studies which have examined understanding of the legal frameworks governing research involving adults who lack capacity by health and social care professionals [ 26 ], RECs [ 53 ] and researchers [ 54 , 55 ].…”

“…We have made a number of practice recommendations for specific stakeholder groups (see Table 4 ), including funders of health and care research, RECs, leads with responsibility in the areas of policy, governance, and infrastructure, trialists and teams who design and conduct trials, and research staff who recruit participants. These should be considered alongside more specific recommendations for recruiting adults with impaired mental capacity at the end of life in research from the MORECare Capacity project [ 50 ].…”

Patterns of unplanned hospital admissions among people with dementia: from diagnosis to the end of life

“…A strength of our study was the large sample, which was not limited to decedents and included people living at home and in care homes, with any dementia diagnosis and severity, thus reducing biases, which may be introduced by subject and time period selection [ 47 ]. Recruiting and retaining people with dementia in research studies is challenging [ 48 ]. Using routinely collected data permitted observation of trends for over 19,000 people of dementia of whom lived with a diagnosis for varying durations.…”

Assessment of Dementia Under Prevailing Indian Laws and Its Implications

“…In such situations, it is important to get the family members involved from the inception of the study design throughout the research. 39 It is the responsibility of the researchers to protect the rights of PwD participating in research. This aspect is being elaborated in another paper in this special issue of the journal.…”