Addressing the knowledge gap: development of stakeholder-informed training to improve the inclusion of adults with impaired capacity to consent in trials

Shepherd, Victoria ORCID: https://orcid.org/0000-0002-7687-0817, Svobodova, Martina, Ivins, Nicola, Russell, Amy M, Volkmer, Anna, Jayes, Mark ORCID: https://orcid.org/0000-0002-0371-7811, Woolfall, Kerry, Clout, Madeleine, Munnery, Kim and Treweek, Shaun (2025) Addressing the knowledge gap: development of stakeholder-informed training to improve the inclusion of adults with impaired capacity to consent in trials. Trials, 26 (1). 429.

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Abstract

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.