Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey

Abstract

ObjectiveTo examine health and social care professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales.MethodsA cross-sectional online survey was conducted using a series of vignettes. Participants were asked to select the legally authorised decision-maker in each scenario and provide supporting reasons. Responses were compared with existing legal frameworks and analysed according to their level of concordance.ResultsOne hundred and twenty-seven professionals participated. Levels of discordance between responses and the legal frameworks were high across all five scenarios (76%–82%). Nearly half of the participants (46%) provided responses that were discordant in all scenarios. Only two participants (2%) provided concordant responses across all five scenarios.DiscussionParticipants demonstrated a lack of knowledge about the legal frameworks, the locus of authority and the legal basis for decision-making. The findings raise concern about the accessibility of research for those who lack capacity, the ability to conduct research involving such groups and the impact on the evidence base for their care.ConclusionThis is the first study to examine health and social care professionals’ knowledge and understanding of the dual legal frameworks in the UK. Health and social care professionals’ understanding and attitudes towards research involving adults with incapacity may warrant further in-depth exploration. The findings from this survey suggest that greater training and education is required.

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)

“…New interventions require robust evaluation to examine benefit and potential of harm for the population intending to benefit [5,6]. Studies, especially clinical trials in palliative care, are often compromised by insufficient sample size to detect change [7][8][9][10][11][12][13], and impaired understanding of legislation governing research involving adults with impaired capacity [14]. The ethical challenges of recruiting individuals with impaired capacity are examined across fields involving adults with serious illness including palliative care [15], dementia [16][17][18], mental health [19], and intensive care [20].…”

An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent

“…Ensuring the protection of the groups considered most vulnerable to potential harm is an important aim of research ethics, and also those with professional responsibility to care for groups unable to protect their interests through informed consent. However, our survey of health and social care professionals, which explored their knowledge about the legislation governing research involving adults lacking capacity, revealed a deeper and more worrying issue about their attitudes towards the inclusion of people with impaired decision-making capacity in medical research [29]. A number of participants stated that people who lack capacity should never be included in research, both from an ethical and a legal perspective, and some voiced concerns that only the person's medical practitioner or an appointed judge should have the authority to decide about research participation, and only when it is determined to be in their best interests to take part [29].…”

“…However, our survey of health and social care professionals, which explored their knowledge about the legislation governing research involving adults lacking capacity, revealed a deeper and more worrying issue about their attitudes towards the inclusion of people with impaired decision-making capacity in medical research [29]. A number of participants stated that people who lack capacity should never be included in research, both from an ethical and a legal perspective, and some voiced concerns that only the person's medical practitioner or an appointed judge should have the authority to decide about research participation, and only when it is determined to be in their best interests to take part [29]. There was a widespread lack of understanding that the decision about research participation should not be based on a determination of best interests [52] and should instead be based on what the person's wishes and feelings about taking part would be, which can only be determined through consulting with those that know them well.…”

“…A number of studies have found a widespread lack of knowledge and understanding about the legal frameworks by health care professionals and researchers, including in the UK [29], US [40], and Canada [41], leading to calls for greater education and awareness about the legal frameworks. The UK survey I led found that health and social care professionals caring for populations who lack capacity did not understand that decision-making processes about research participation differed from usual care and treatment decisions (research decisions are based on the person's 'presumed will' and not what was in their best interests), differed between different types of research (a legal representative provides consent for CTIMPs whereas a consultee merely provides advice to researchers for other types of studies), and who could act as a personal legal representative or consultee (family members regardless of any legal arrangements such as having Power of Attorney, or someone such as themselves acting in a professional capacity in the absence of a family member or friend) [29]. Our recent research found similar misconceptions and misunderstandings were evident in study documents that had been designed by trial teams and undergone review by research ethics committees (RECs) and received a favourable opinion [30].…”

“…This commentary discusses and expands on some of the issues raised by Griffiths et al, drawing on a nonsystematic review of the literature, experience of conducting trials with populations with impaired capacity [13,27,28], and recent findings from a series of studies exploring the involvement of adults who lack the capacity to consent [25,[29][30][31][32]. The aim is to articulate for the first time some of the wider methodological, structural, and systemic barriers to the inclusion of adults lacking capacity as a first step towards identifying and addressing some of the potentially modifiable factors.…”