Table 1 Summary of key recommendations for future research to address methodological and ethical challenges surrounding trials involving complex and alternate consent pathways

Adults with communication, hearing, and sight disabilities

Explore the current practice regarding the inclusion/exclusion of people with communication disabilities in the informed consent process in trials, including exploring professional and participant views and experiences across a range of populations and settings.

Explore the experiences and support the needs of people with a range of different types of communication disabilities (e.g. people living with dementia or with other progressive neurological conditions) in order to enhance their opportunity to participate in trials.

Develop and evaluate additional tools, resources, and training interventions to support researchers to work with people with communication disabilities more easily and effectively during the informed consent process. Evaluation should include an exploration of usability, acceptability to professionals and participants, and cost-effectiveness.

Explore how researchers can form successful and equitable collaborations with people with communication disabilities as part of public and involvement activities in order to co-produce inclusive consent processes and materials for trials.

Adults with fluctuating capacity or where capacity is lost during a trial

Develop guidance for researchers on the actions and processes required if participants who provide consent subsequently lose capacity during follow-up. This should include the process for establishing the wishes of participants during the initial consent stages and the requirement for providing accessible information to support decision-making at all stages.

Generate better evidence on appropriate methods to assess the capacity to consent to trials and explore how best to support researchers to assess capacity where indicated.

Establish how to support researchers to design trials that are inclusive of adults whose capacity to consent may fluctuate during a trial, including through built-in protocols on how to manage consent processes and data collection procedures for those whose capacity does fluctuate.

Adults lacking the capacity to consent

Explore how the justification for the inclusion of adults who lack capacity is understood and interpreted by researchers and research ethics committees (RECs) and develop clear guidance for researchers and RECs to help aid consistency in ethical review processes and outcomes

Explore the role and experiences of health and social care professionals acting as nominated consultees and professional legal representatives in emergency and non-emergency trials and establish their informational and support needs. Develop guidance for health and social care professionals acting as consultees/legal representatives about their role and the legal basis for their decision.

Explore stakeholders’ views about extending the role of the welfare attorney in England and Wales to include decisions about research under the Mental Capacity Act and explore the wider policy and legislative implications.

Explore stakeholders’ views about the role of Lasting Power of Attorney (LPA) in decisions about research participation and explore relatives’ informational and support needs when making decisions about research when holding LPA.

Adults and children requiring emergency care

Identify strategies to communicate with relatives of critically ill patients about research, including in situations where a participant enrolled without prior consent subsequently dies.

Explore underserved populations’ views about research without prior consent where there are additional intersecting factors, for example, parents of critically ill children that are not proficient in the English language or who have additional language or communication needs.

Develop guidance on consent processes in emergency and urgent care trials for REC members undertaking the ethical review and for patients and members of the public who join research teams and advise on emergency and urgent care trials.