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

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dc.contributor.authorShepherd, Victoria
dc.contributor.authorJoyce, Katherine
dc.contributor.authorLewis, Amanda L.
dc.contributor.authorFlynn, Samantha
dc.contributor.authorClout, Madeleine
dc.contributor.authorNocivelli, Brittany
dc.contributor.authorSegrott, Jeremy
dc.contributor.authorTreweek, Shaun
dc.contributor.institutionUniversity of Aberdeen.Aberdeen Centre for Evaluationen
dc.contributor.institutionUniversity of Aberdeen.Institute of Applied Health Sciencesen
dc.date.accessioned2024-01-26T09:41:03Z
dc.date.available2024-01-26T09:41:03Z
dc.date.issued2024-01-25
dc.descriptionAcknowledgements The authors would like to thank the members of the lay advisory group who provided invaluable insight and support for this project, including the Thinklusive Advisory Group who are experts by experience who co-designed the Easy Read guide with Maximilian Clark from Thinklusive. We would like to thank the wider contributors to the development of the INCLUDE Impaired Capacity to Consent Framework who kindly helped to pilot the Framework (including Amy M Russell, Lindsay Mizen, Nicola Farrar, Julia Wade, Edward Carlton, Clare Clements, Holly McKeon, Liz Coulthard, Laura Goodwin, Sarah Voss, Anna Mulvihill, Jennifer McAnuff, Phillip Whitehead, Tim Rapley, Adwoa Parker, Alexandra Dean, Callum Kaye, Liz Cook, Joanne Laycock, Anne Cochrane, Ashley Scrimshire, Marian Brady, Donna C. Tippett, Jonathan Hewitt, Ceri Battle, Paul Dark, Matthew Costa, and Khalid Ali) and members of the Inclusivity subgroup of the MRC-NIHR Trial Conduct Working Group who have participated in discussions at various stages of this work. 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.en
dc.description.statusPeer revieweden
dc.format.extent19
dc.format.extent1430939
dc.identifier283714728
dc.identifier9ff40553-6c1f-4c0f-90f1-134ce6c7e88a
dc.identifier85182989987
dc.identifier.citationShepherd, V, Joyce, K, Lewis, A L, Flynn, S, Clout, M, Nocivelli, B, Segrott, J & Treweek, S 2024, 'Improving the inclusion of an under-served group in trials : development and implementation of the INCLUDE Impaired Capacity to Consent Framework ', Trials, vol. 25, 83. https://doi.org/10.1186/s13063-024-07944-xen
dc.identifier.doi10.1186/s13063-024-07944-x
dc.identifier.issn1745-6215
dc.identifier.otherORCID: /0000-0002-7239-7241/work/186968417
dc.identifier.urihttps://hdl.handle.net/2164/22640
dc.identifier.vol25en
dc.language.isoeng
dc.relation.ispartofTrialsen
dc.subjectTrial methodologyen
dc.subjectInclusivityen
dc.subjectUnder-served groupsen
dc.subjectAdults lacking capacity to consenten
dc.subjectcognitive impairmenten
dc.subjectR Medicineen
dc.subjectMedical Research Council (MRC)en
dc.subjectMR/S014357/1en
dc.subjectNational Institute for Health Research (NIHR)en
dc.subjectNIHR-FS(A)-2021en
dc.subjectSupplementary Dataen
dc.subject.lccRen
dc.titleImproving the inclusion of an under-served group in trials : development and implementation of the INCLUDE Impaired Capacity to Consent Frameworken
dc.typeJournal articleen

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