Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework.

"Declarations Ethics approval and consent to participateNo research data were collected for this paper. Consent for publicationNot applicable. Competing interestsST is an Editor-in-Chief of Trials. The other authors all declare that they have no competing interests. Competing interests ST is an Editor-in-Chief of Trials. The other authors all declare that they have no competing interests."

"Funding VS is supported by a National Institute of Health Research Advanced Fellowship (CONSULT) funded by the Welsh Government through Health and Care Research Wales (NIHR-FS(A)-2021). The implementation project was funded by Cardiff University through an Innovation for All award. This work was supported by the MRC-NIHR Trials Methodology Research Partnership (MR/S014357/1). The Centre for Trials Research is funded by Health and Care Research Wales and Cancer Research UK. The Bristol Trials Centre, a UKCRC registered clinical trials unit (CTU), is in receipt of NIHR CTU support funding. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates."