OPTIMISE-ing consent in clinical trials: recommendations for designing accessible consent processes to address communication and decision-making needs as a barrier to participation

Background People with communication and decision-making needs often encounter barriers to participating in research, particularly trials, due to complexity of study information and lack of appropriate support. With greater accessibility and the right support, people with impaired communication and decision-making are better able to make, or contribute to, decisions about participating in research. This protects their right to make their own decisions, ensures their views are heard, and potentially improves inclusivity of research. However, researchers are often uncertain about how to make consent more accessible. The aim of OPTIMISE was to develop a set of recommendations for designing more accessible trial consent processes. Methods OPTIMISE comprised a literature review and consultation with key stakeholders including those with lived experience, supported by two advisory groups. Searches of MEDLINE were conducted April-June 2025 and examples of enhanced consent processes for research or clinical practice were identified (n=26) alongside online searches for relevant regulatory, policy and guidance documents. Insights to inform inclusive consent recommendations were coded, summarised, and organised into preliminary domains. A workshop was held with stakeholders (n=21) purposively sampled based on their experience of either research, practice, or a lived experience perspective. World Café, an inclusive participatory method for reducing power imbalance was used to facilitate dialogue and seek agreement on key domains to be included. Recommendations were collated and refined to develop an overarching framework and linked to practical resources from the wider CONSULT research programme and other sources. Results OPTIMISE recommendations consist of three guiding principles that underpin inclusive consent - collaboration, ethics and reflection - and seven domains across which consent processes can be made more accessible, if appropriate action is taken. These include the content, language and format of information provided, as well as design, environment, and timing considerations, and communication and decision supports, with links to practical tools and examples. The recommendations can be accessed online: www.capacityconsentresearch.com/optimise Conclusions OPTIMISE developed a comprehensive framework of recommendations to ensure consent processes are ‘accessible by design’. The recommendations aim to support researchers, and those reviewing and approving studies, to conduct more inclusive research that reduces communication and decision-making barriers.