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Table 4 Recommendations for addressing the barriers to conducting trials with adults with impaired capacity to consent

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

Recommendations by stakeholder group

Funders

 1. Funding committees should consider whether issues around capacity and consent have been appropriately considered by applicants proposing research involving populations where these issues may be encountered. This may include requesting justification for their exclusion if appropriate.

 2. Funders should include signposting to information and guidance on the design and conduct of trials involving adults with impaired capacity to consent for researchers developing applications involving these populations.

 3. Funders should acknowledge the additional resources needed to recruit under-served populations, such as those where capacity may be impaired, and ensure adequate provision for these ‘missing’ costs. This should also be considered when making comparisons between the cost-effectiveness of applications where under-served populations are included.

 4. Funders should ensure appropriate provision is made to support public involvement with people who have a cognitive impairment, beyond generic support for public involvement. Enabling and supporting these groups to access and contribute to public involvement opportunities requires additional resources such as developing appropriately accessible materials and activities, arranging smaller group interactions which may involve multiple short meetings, and additional funding for carers or other forms of support for the person with cognitive impairment.

 5. Funders should take into account that, in addition to these trials being more resource intensive, they are often conducted in care settings with less access to research infrastructure support, such as care homes. The increased resource needs should also be considered in relation to the application of funding ceiling caps or tiers.

Research ethics committees (RECs)

 6. REC members should ensure they are familiar with the ethical requirements for research involving adults lacking capacity and the practical application of the legal frameworks governing the different types of studies (CTIMPs and non-CTIMPs).

 7. When reviewing studies, RECs should consider whether issues around capacity and consent have been appropriately considered by researchers. This applies to all trials not just those explicitly including adults lacking capacity, or just ‘flagged’ RECs. This may include requesting justification for the exclusion of adults who lack capacity rather than only justification for their inclusion as required by the legal frameworks.

 8. RECs should consider whether researchers have appropriate arrangements in place in the event that capacity is lost or may change or fluctuate during a trial, which may include all trials not just those intending to recruit adults lacking capacity.

 9. Enabling consultation and communication between RECs, the HRA, and research teams prior to submission of an application may ensure that any questions or issues are addressed at the earliest opportunity and reduce subsequent delays in applications receiving a favourable opinion.

Policy/governance/infrastructure leads

 10. Organisations with oversight or responsibility for ethical review processes should seek to address inconsistencies in the review of studies involving adults lacking capacity and the quality of the advice provided to researchers.

 11. Research governance and ethical review processes should be harmonised and streamlined across the UK to reduce the impact of a dual REC submission and to enable research involving adults lacking capacity to have equal parity in time taken to review with studies involving people who are able to provide consent.

 12. R&D infrastructure and support should be reformed to take account of the complexities encountered in the delivery of trials involving adults lacking capacity. For example, metrics and associated accruals should be revised to take account of the additional time and resources required to recruit adults lacking capacity.

 13. Co-ordinated and comprehensive training on the fundamental principles underpinning research involving adults lacking capacity to consent should be available to all those who design, review, and conduct these trials, with access to supplementary modules containing context-specific information where appropriate.

 14. System-wide initiatives are needed to build capacity and competence in research involving adults lacking capacity. This requires investment to recruit and retain staff with appropriate skills and experience and support for building long-term relationships. This will ensure that future trials can successfully recruit and retain these populations thereby avoiding research waste, as well as addressing fundamental issues around their exclusion.

Trial teams

 15. Research teams should ensure they have access to methodological expertise and/or input from people with experience of designing and conducting trials involving adults lacking capacity to consent and an understanding of how the legal provisions for adults lacking capacity are implemented in practice.

 16. Flexibility and inclusivity should be ‘designed into’ trials from the outset which may include the use of alternative consent arrangements (e.g. remote consultation with personal consultees and legal representatives via telephone or video conferencing, enabling verbal or electronic consent/agreement) with adaptations made in line with feedback from recruiting sites.

 17. Research teams should consider trial designs that enable the collection of additional data to inform the design and ongoing conduct of the trial, such as early qualitative work with synchronous analysis and feedback to enable changes to consent processes and/or enhanced consent training provided to recruiting staff.

 18. Research teams should ensure that meaningful public involvement is planned and implemented, including supporting people with impairing conditions and their carers to become and remain involved. This may include ensuring that costs for extra care provision are available to carers so that they are able to attend meetings and ensuring that materials and methods used in the public involvement activities are accessible. This will require additional resources and time and should therefore be built into funding applications.

 19. Researchers should include additional resources (e.g. enhanced research nurse time) in funding applications in order to meet the additional requirements to provide tailored information and support to participants with impaired capacity, assess capacity if indicated, and identify and approach consultees or legal representatives if required. Resources to support revisiting of consent and capacity throughout the trial will also be required.

 20. Trials that are reliant on remote contact only during a trial (e.g. postal recruitment or follow-up) may need to consider alternative methods of contacting participants and ensuring that data can be collected. This may include recruiting participant-carer dyads and including statements in documents to encourage reporting of any cognitive difficulties and clarify who is completing documents.

 21. Complex and lengthy Participant Information Sheets that are not cognitively or linguistically accessible should be avoided, and researchers should ensure that accessible trial information (e.g. easy-read, pictorial, brief summary version) is available for all trials where cognitive and/or communication difficulties may be encountered, with layering of information as appropriate to the person’s needs.

 22. Trials should explicitly include processes for assessing capacity (e.g. when and by whom will assessments be conducted, what training and documentation is required), the involvement of consultees and legal representatives with provision of corresponding study documents, arrangements in the event of a change in a participant’s capacity status during a trial, and arrangements for managing data in the event of a participant’s discharge, transfer or death before consent can be sought, for example when using a ‘deferred consent’ model).

 23. As capacity may be lost during a trial, researchers should consider making prospective arrangements for the participant to continue in the trial (if considered appropriate to the trial context), such as including an explicit statement on the consent form. Trials may wish to consider asking the participant to identify a family member or friend who is willing and agrees to be approached to act as consultee or legal representative.

 24. The dissemination of research fundings must be designed in a way that takes account of any context and population-specific barriers to dissemination, for example ensuring summaries are provided in cognitively and linguistically accessible formats. Alternative and purposive dissemination pathways may be needed to ensure that information about the findings reach participants and their carers, and may need to ‘mirror’ recruitment arrangements.

 25. As part of reporting trials, researchers should detail the consent model and recruitment approach used and describe the trial population included (e.g. proportion who lacked capacity to consent), to ensure the results are viewed in the context of the representativeness of the trial. Any challenges encountered and lessons learned to overcome these should also be shared in order to create community-sourced evidence about the effectiveness of different strategies that can inform future trials.

Research staff who recruit participants

 26. Additional training and support may benefit those recruiting adults with impaired capacity to ensure they have appropriate skills and confidence to involve these populations. This may include ways to enhance communication about trials to people with cognitive impairments and support their decision-making, assess capacity where required (including remote assessment of capacity which may be more challenging), appropriately revisit consent as required, and optimise strategies to approach family members to act as consultee or legal representative.

 27. Staff who are less familiar with populations or contexts where there may be particular challenges around capacity to consent may benefit from peer support or the opportunity to shadow colleagues with greater experience with these populations. This might include learning from approaches used in speech and language therapy (SLT), with specialist input by SLT where required.

 28. Involving family members and usual carers at an early stage will help to identify any additional communication or support needs the potential participant might have, including language requirements, and their involvement will help to support the person with cognitive impairment to make a decision about research participation. Research staff should consider including family members in discussions about research where appropriate.

 29. Prospectively planning and having clear processes in place for involving professionals as consultees or legal representatives (if required/permitted) may reduce unnecessary delays in the process. This might be particularly important for trials in emergency settings. This may include creating a list of clinical care team members who are able and willing to be approached to act as nominated consultee or professional legal representative, with appropriate information being available.

 30 Staff should ensure that there is regular communication with the participant’s care team and/or contact with the participant so that any changes in capacity are recognised in a timely manner, and that consent and consultation can be revisited appropriately.