Victoria Shepherd

Background Research in emergency and critical care is essential to improve outcomes for critically ill patients, yet many patients lack capacity to provide informed consent at the point of enrolment. Alternative consent models, including research without prior consent, are therefore commonly used. When a patient dies before research participation can be discussed or consent sought, bereaved relatives may be unaware of research involvement. Despite this, few emergency and intensive care trial protocols include a process for informing bereaved families about research involvement before death, creating ethical and practical challenges for clinicians and researchers. Methods The ENHANCing Communication with bEreaved relatives about emergency and critical care trials (ENHANCE) study, collected evidence on the perspectives of bereaved relatives, clinical and research staff and medical examiners with relevant experience. Sixty-five participants took part between June 2023 and May 2024. This evidence was used to develop good practice guidance which is presented in this paper to support clinical and research staff in communicating with bereaved relatives, when a patient dies following enrolment in emergency or critical care research without prior consent. Results Research and/or clinical teams, with knowledge of the study, should discuss emergency or critical care research involvement with bereaved relatives as soon as appropriate after enrolment. We present recommendations for researchers to consider when designing emergency or critical trials including: 1) What should the research team consider at the study design stage? 2) Who should notify families and what information should they provide? 3) Could this communication form part of bereavement information materials? and 4) What should I consider when discussing research without prior consent with bereaved relatives? Conclusions The ENHANCE guidance addresses an important gap in current trial practice and supports transparent, compassionate communication aligned with the professional duty of candour.

Introduction: Older adults, particularly those with multiple long-term conditions (MLTCs) and other intersectional characteristics, are under-represented in clinical trials. This includes digitally enabled trials as older people may be less likely to engage with digital methods. We embedded a ‘Study Within a Project’ (SWAP) in TIPTOE, a UK randomised controlled trial evaluating a self-management support intervention for older adults with knee and/or hip osteoarthritis and MLTCs. Osteoarthritis is a musculoskeletal condition that is more common with age. The aim of the SWAP was to understand the barriers to including older people with MLTCs, rapidly develop strategies to support inclusion, and provide methodological guidance for future trials including those that are digitally enabled and/or decentralised. Methods: The mixed-methods SWAP spanned three trial phases: (1) set-up, process mapping to establish recruitment pathways and characteristics of local clinical populations; (2) pilot, interviews with recruiting staff to explore attitudes, skills and confidence when recruiting participants from under-served groups; (3) transition to main trial, interviews with participants to explore their experiences of taking part. Rapid analysis enabled changes to be made to trial processes during the early stages of the trial. Results: Process mapping identified a diversity of populations and accessibility considerations (e.g. language, unfamiliarity with digital technology). Interviews with recruiting staff ( n = 12) identified potential recruitment challenges including concerns that older people may be less inclined to participate due to lower digital literacy or lack of understanding about the trial. Interviews with participants ( n = 25) found even those with digital access preferred human support and were concerned about being ‘scammed’ when receiving trial communications. Strategies were introduced such as lowering the eligibility age and creating tailored materials and messaging. Recommendations for future trials include ensuring person-centred support for participants, which has resourcing implications. Conclusion: Embedding a SWAP in TIPTOE enabled a greater understanding about recruiting older people who experience intersectional barriers to inclusion. Approaches to support recruitment included providing telephone support for those less confident navigating digital consent and data collection processes and the creation of guidance for sites. The findings could support future trials to better include older people with MLTCs and other under-served groups. Trial registration: ISRCTN 16024745. Registered on October 16, 2023.

Background: Inclusive clinical research requires that all prospective participants are provided with accessible, comprehensible information to support informed decision-making regarding trial participation. However, people with limited English proficiency (LEP) remain disproportionately excluded from trials in English-speaking countries, largely due to insufficient translation and interpretation support. This exclusion compromises equity, participant safety, and the integrity and generalisability of trial findings. Main body: This commentary highlights why language support must be considered across the entire clinical trial lifecycle, rather than limited to recruitment and consent stages. We examine challenges including identifying which languages and materials require translation; quality assurance of translations; budgeting complexities; reliance on underqualified interpreters; and variability in provision across sites. Practical implications span recruitment, informed consent, outcome measures, intervention delivery, monitoring recruitment and retention, safety reporting, and communication to participants throughout the trial. We emphasise the need for early planning, transparent budgeting, robust quality standards, and researcher training. Drawing on existing frameworks and recent evidence, we provide recommendations on how sponsors, funders, healthcare providers, research teams, and research governance organisations can move towards more systematic and equitable approaches to translation and interpretation. Conclusion: Addressing linguistic diversity in clinical trials requires a coordinated, lifecycle-wide strategy that goes beyond providing translated materials at the recruitment consultation. System-level changes, such as clear national standards, centralised models of provision, and better training are essential to reduce inequities and enhance the reliability of trial outcomes. Ensuring that people with LEP are supported throughout their participation will strengthen trust, improve safety, and contribute to more representative evidence for healthcare decision-making.

Objectives Clinical research in emergency and critical care is vital, but recruitment and consent are complex. Research may be conducted without prior consent when patients are critically ill, and interventions are time critical. Some patients may die before research participation can be discussed with relatives, leaving the bereaved unaware of their involvement. This study explored potential communication strategies for informing bereaved relatives when a patient has died following enrolment into an emergency or critical care study without prior consent. Design and setting A mixed-methods study using a telephone survey and semi-structured interviews conducted simultaneously. The survey was conducted within a National Health Service Trust in North West England with relatives of deceased study participants. Semi-structured interviews were conducted with bereaved relatives and research and clinical staff across the UK, and medical examiner (ME)/ME officers based in England and Wales. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis. Data were synthesised using a constant comparison approach. Participants 11 bereaved relatives completed the survey. 53 individuals (21 research and clinical staff, 18 relatives and 14 MEs/officers) participated in semi-structured interviews. Results Although many trials do not include a process for notifying bereaved relatives about research participation, most relatives valued the opportunity to learn about their family member’s participation, emphasising the importance of transparency and trust. However, some raised concerns over the potential burden of automatic disclosure by the ME service. Offering bereaved relatives the option to receive sensitively worded information about research involvement at an appropriate time, soon after death, was recommended. Conclusion Bereaved relatives should have the choice to be informed about research participation without prior consent. Our findings support the need for transparent and sensitive communication and will contribute to future guidance for the design and conduct of adult emergency and critical care studies.

People with a learning disability are frequently excluded from clinical trials, with around two thirds of trials either directly or indirectly excluding th

Background: Improving the inclusion of under-served groups in clinical trials is increasingly being seen as a priority area for research funders and regulators. Adults who lack capacity to make an informed decision about taking part in trials are recognised as an under-served group. Researchers struggle to navigate the complex ethical, legal, and methodological issues surrounding trials involving adults lacking capacity to consent, leading to frequent exclusion of this population. Researchers have identified a need for greater knowledge about designing and conducting trials involving this population. Building on the CONSULT research programme, we developed stakeholder-informed training to help researchers design more inclusive trials. Methods: The CONSULT e-learning was developed in collaboration with a group of researchers with topic expertise and a lay advisory group with lived experience. It was developed over four phases: (1) establishing researchers’ training needs using an online survey; (2) developing the e-learning content including illustrative case studies, videos, and links to resources and further reading; (3) iterative piloting and refining of the content; (4) dissemination of the e-learning and initial evaluation. A set of informational materials about the e-learning were also developed. Results: Informed by the stakeholder survey ( n = 82), the CONSULT e-learning consists of four key modules covering the legal and ethical frameworks, consent and consultation processes, and methodological considerations, with the key role of public involvement threaded throughout. It was launched at a webinar (December 2024), with a post-webinar survey ( n = 29) showing an increase in awareness about the importance of including adults lacking capacity in trials where they are a relevant population. Researchers also signalled their commitment to changing their research practice, suggesting that the e-learning has a role in facilitating greater inclusion of this under-served population in trials. The CONSULT e-learning is available online: www.capacityconsentresearch.com/training . Conclusions: Alongside tools such as the INCLUDE Impaired Capacity to Consent Framework, the CONSULT e-learning course aims to support researchers to develop the knowledge and skills needed to design and conduct higher-quality trials that are more inclusive of adults who lack capacity to consent. Further engagement, including with funders who increasingly require inclusion as a condition of funding, is needed.

Background: Trials involving adults who lack capacity to consent can be challenging, partly due to the involvement of ‘proxy’ decision-makers. This is usually a family member, who advises the researchers about the person’s wishes. Families can find decision making difficult and some experience a decisional burden. Following the development of a decision aid for family members making trial participation decisions, we are conducting a mixed-methods randomised Study Within a Trial (SWAT) to evaluate its (cost-)effectiveness. This paper reports the feasibility stage conducted in one host study to inform delivery of the main SWAT. Methods: Family members approached to act as a consultee for the host study were randomised 1:1 to receive the decision aid booklet alongside standard study information (intervention), or standard information plus a blank notebook (control), and asked to complete the CONCORD scale (Combined Scale for Proxy Informed Consent Decisions) questions about their experience and take part in a semi-structured interview. Acceptability of the SWAT was assessed through exploring recruitment rates and data completeness, and qualitatively through interviews with family members and research staff. Interviews were analysed using a rapid qualitative approach. Results: In total, 92 family members were randomised to the SWAT and 16 completed the CONCORD questionnaire. Interviews were conducted with consultees (n = 4), and host study staff (n = 3) who also provided resource use data. Differences in time staff spent with consultees were small. Key themes included (1) setting up the SWAT and balancing priorities with the host study, (2) differences when recruiting consultees to a SWAT, (3) feasibility and acceptability of the SWAT, (4) challenges of measuring decision quality and (5) views and experiences of the decision support intervention. Conclusion: The CONSULT SWAT is feasible, but changes to study processes are needed in advance of the main SWAT. The findings suggest that attempting to seamlessly integrate the SWAT into the host study may have inadvertently led to it becoming ‘invisible’ to consultees. The small number of trials involving participants lacking capacity limits opportunities for developing the evidence-base. Recruitment of host trials continues, with a focus on evaluating the intervention in a broad range of populations and settings. Trial registration: The SWAT is registered as SWAT #159 with the Northern Ireland Hub for Trials Methodology Research SWAT repository (registered 09.08.2020).

Background Trials involving adults who lack capacity to consent can be challenging, partly due to the involvement of ‘proxy’ decision-makers. This is usually a family member, who advises the researchers about the person’s wishes. Families can find decision making difficult and some experience a decisional burden. Following the development of a decision aid for family members making trial participation decisions, we are conducting a mixed-methods randomised Study Within a Trial (SWAT) to evaluate its (cost-)effectiveness. This paper reports the feasibility stage conducted in one host study to inform the delivery of the main SWAT. Methods Family members approached to act as a consultee for the host study were randomised 1:1 to receive the decision aid booklet alongside standard study information (intervention), or standard information plus a blank notebook (control), and asked to complete the CONCORD scale (Combined Scale for Proxy Informed Consent Decisions) questions about their experience and take part in a semi-structured interview. Acceptability of the SWAT was assessed through recruitment rates, data completeness, and qualitatively through interviews with family members and research staff. Interviews were analysed using a rapid qualitative approach. Results In total, 92 family members were randomised to the SWAT and 16 completed the CONCORD scale. Interviews were conducted with consultees (n=4), and host study staff (n=3) who also provided resource use data. Mean CONCORD scores were higher in the control group (94.5 on a 100-point scale) compared with the intervention group (87.5), indicating higher decision quality, Differences in time staff spent with consultees were small. Key themes identified included 1) setting up the SWAT and balancing priorities with the host study, 2) differences when recruiting consultees to a SWAT, 3) feasibility and acceptability of the SWAT, 4) challenges of measuring decision quality, 5) views and experiences of the decision support intervention. Conclusion The CONSULT SWAT is feasible, but changes to study processes are needed in advance of the main SWAT. The small number of trials involving participants lacking capacity limits opportunities for developing the evidence-base. Recruitment of host trials continues, with a focus on evaluating the intervention in a broad range of populations and settings. Trial Registration The SWAT is registered as SWAT #159 with the Northern Ireland Hub for Trials Methodology Research SWAT repository (registered 09.08.2020).