Abstract
Background
For the potential benefits of trials to reach all that they should, trials must be designed to ensure that those taking part reflect the population who will receive the intervention. However, adults with impaired capacity to consent are frequently excluded from trials — partly because researchers are unfamiliar with the legal and ethical frameworks and lack the necessary methodological expertise. Researchers identified a need for guidance on designing more inclusive trials. Building on the NIHR INCLUDE initiative, we developed the INCLUDE Impaired Capacity to Consent Framework to help researchers design inclusive trials.
Methods
The framework was developed over five phases: (1) establishing the scope and content of the framework and adapting the INCLUDE Ethnicity Framework for this population; (2) scoping the relevance of the framework to different populations and piloting in a range of trials; (3) consulting people living with impairing conditions and carers to explore their views about the framework and identify missing content areas; (4) refining the framework; and (5) the development of an implementation toolkit of resources to support researchers using the framework.
Results
The framework has two parts: a set of four key questions to help researchers identify who should be included in their trial, and a series of worksheets covering intervention design, recruitment and consent processes, data collection and analysis, and public involvement and dissemination. It is supported by a summary of the ethical and legal frameworks and a website of resources on capacity and consent. Implementation resources include infographics and animations, a library of completed frameworks, and facilitated workshops for researchers.
The framework and toolkit were launched at a webinar (November 2022), with polling demonstrating an increase in attendees’ awareness about research involving adults lacking capacity. A post-webinar survey found that stakeholders viewed the framework and toolkit as valuable tools to facilitate greater inclusion of this under-served population in trials. The framework is available online: https://www.capacityconsentresearch.com/include-impaired-capacity-to-consent-framework.html.
Conclusions
The INCLUDE Impaired Capacity to Consent Framework and implementation toolkit can support researchers to design more inclusive trials and other types of research studies. Further engagement, including with funders who are key to ensuring uptake, and evaluation is needed.
For the potential benefits of trials to reach all that they should, trials must be designed to ensure that those taking part reflect the population who will receive the intervention. However, adults with impaired capacity to consent are frequently excluded from trials — partly because researchers are unfamiliar with the legal and ethical frameworks and lack the necessary methodological expertise. Researchers identified a need for guidance on designing more inclusive trials. Building on the NIHR INCLUDE initiative, we developed the INCLUDE Impaired Capacity to Consent Framework to help researchers design inclusive trials.
Methods
The framework was developed over five phases: (1) establishing the scope and content of the framework and adapting the INCLUDE Ethnicity Framework for this population; (2) scoping the relevance of the framework to different populations and piloting in a range of trials; (3) consulting people living with impairing conditions and carers to explore their views about the framework and identify missing content areas; (4) refining the framework; and (5) the development of an implementation toolkit of resources to support researchers using the framework.
Results
The framework has two parts: a set of four key questions to help researchers identify who should be included in their trial, and a series of worksheets covering intervention design, recruitment and consent processes, data collection and analysis, and public involvement and dissemination. It is supported by a summary of the ethical and legal frameworks and a website of resources on capacity and consent. Implementation resources include infographics and animations, a library of completed frameworks, and facilitated workshops for researchers.
The framework and toolkit were launched at a webinar (November 2022), with polling demonstrating an increase in attendees’ awareness about research involving adults lacking capacity. A post-webinar survey found that stakeholders viewed the framework and toolkit as valuable tools to facilitate greater inclusion of this under-served population in trials. The framework is available online: https://www.capacityconsentresearch.com/include-impaired-capacity-to-consent-framework.html.
Conclusions
The INCLUDE Impaired Capacity to Consent Framework and implementation toolkit can support researchers to design more inclusive trials and other types of research studies. Further engagement, including with funders who are key to ensuring uptake, and evaluation is needed.
| Original language | English |
|---|---|
| Article number | 83 |
| Number of pages | 19 |
| Journal | Trials |
| Volume | 25 |
| Early online date | 25 Jan 2024 |
| DOIs | |
| Publication status | Published - 25 Jan 2024 |
Bibliographical note
AcknowledgementsThe 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.
Keywords
- Trial methodology
- Inclusivity
- Under-served groups
- Adults lacking capacity to consent
- cognitive impairment