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

Abstract

Background Trials involving adults who lack capacity to consent encounter a range of ethical and methodological challenges, resulting in these populations frequently being excluded from research. Currently, there is little evidence regarding the nature and extent of these challenges, nor strategies to improve the design and conduct of such trials. This qualitative study explored researchers’ and healthcare professionals’ experiences of the barriers and facilitators to conducting trials involving adults lacking capacity to consent. Methods Semi-structured interviews were conducted remotely with 26 researchers and healthcare professionals with experience in a range of roles, trial populations and settings across the UK. Data were analysed using thematic analysis. Results A number of inter-related barriers and facilitators were identified and mapped against key trial processes including during trial design decisions, navigating ethical approval, assessing capacity, identifying and involving alternative decision-makers and when revisiting consent. Three themes were identified: (1) the perceived and actual complexity of trials involving adults lacking capacity, (2) importance of having access to appropriate support and resources and (3) need for building greater knowledge and expertise to support future trials. Barriers to trials included the complexity of the legal frameworks, the role of gatekeepers, a lack of access to expertise and training, and the resource-intensive nature of these trials. The ability to conduct trials was facilitated by having prior experience with these populations, effective communication between research teams, public involvement contributions, and the availability of additional data to inform the trial. Participants also identified a range of context-specific recruitment issues and highlighted the importance of ‘designing in’ flexibility and the use of adaptive strategies which were especially important for trials during the COVID-19 pandemic. Participants identified a need for better training and support. Conclusions Researchers encountered a number of barriers, including both generic and context or population-specific challenges, which may be reinforced by wider factors such as resource limitations and knowledge deficits. Greater access to expertise and training, and the development of supportive interventions and tailored guidance, is urgently needed in order to build research capacity in this area and facilitate the successful delivery of trials involving this under-served population.

Recruitment interventions for trials involving adults lacking capacity to consent: methodological and ethical considerations for designing Studies Within a Trial (SWATs)

“…In our recent qualitative study to explore the feasibility of conducting the SWAT, research teams expressed concern about the need to seek additional consent for the SWAT in an already complex consent encounter [ 22 ]. Therefore, in the CONSULT SWAT, rather than having separate consent documents, return of the completed questionnaire by SWAT participants will be taken as an indication of their consent to participate in the SWAT.…”

“…Resource use will include that incurred by the team (research costs) such as time to deliver the intervention and printing/postage costs where relevant and those incurred by the proxy as SWAT participant (participant costs) such as internet use if receiving the intervention remotely. Whilst some of these costs will be similar to those encountered in SWATs and trials involving participants who provide their own consent, trials involving adults lacking capacity are more resource-intensive [ 27 ] and involve more specialised members of research teams [ 22 ]. It is therefore important to determine the cost of conducting these studies because this could have implications for the affordability and decisions about whether or not to proceed with future SWATs in these populations.…”

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

“…The need for more guidance for RECs who are reviewing emergency and urgent care trials and support for consent processes for patients and members of the public who join research teams and advise on studies, has also been highlighted [106,109,117].…”

Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial

“…To inform the development of the CONSULT SWAT, we conducted a qualitative study (CONSULT-ENABLE) to explore researchers' and healthcare professionals' views about the acceptability and feasibility of conducting the SWAT, and how the DA might be implemented in practice. The study also explored the barriers and facilitators to conducting trials involving adults lacking capacity, the design of the qualitative study and ndings relating to this aspect have been previously reported [33]. Interviews were conducted with 26 UK researchers and healthcare professionals with experience in a range of roles, trial populations and settings.…”