Addressing the knowledge gap: development of stakeholder-informed training to improve the inclusion of adults with impaired capacity to consent in trials.
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| Názov: | Addressing the knowledge gap: development of stakeholder-informed training to improve the inclusion of adults with impaired capacity to consent in trials. |
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| Autori: | Shepherd V; Centre for Trials Research, Cardiff University, 6 Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. ShepherdVL1@cardiff.ac.uk., Svobodova M; Centre for Trials Research, Cardiff University, 6 Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK., Ivins N; Centre for Trials Research, Cardiff University, 6 Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK., Russell AM; Leeds Institute of Health Sciences, University of Leeds, Leeds, UK., Volkmer A; Division of Psychology and Language Sciences, University College London, London, UK., Jayes M; Faculty of Health and Education, Manchester Metropolitan University, Manchester, UK., Woolfall K; Institute of Population Health, University of Liverpool, Liverpool, UK., Clout M; Bristol Medical School, Bristol Trials Centre, University of Bristol, Bristol, UK., Munnery K; Centre for Trials Research, Cardiff University, 6 Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK., Treweek S; Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK. |
| Zdroj: | Trials [Trials] 2025 Oct 22; Vol. 26 (1), pp. 429. Date of Electronic Publication: 2025 Oct 22. |
| Spôsob vydávania: | Journal Article |
| Jazyk: | English |
| Informácie o časopise: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| Výrazy zo slovníka MeSH: | Informed Consent*/ethics , Research Personnel*/education , Research Personnel*/psychology , Stakeholder Participation* , Mental Competency* , Health Knowledge, Attitudes, Practice* , Patient Selection*/ethics , Clinical Trials as Topic*/methods , Clinical Trials as Topic*/ethics , Computer-Assisted Instruction* , Research Subjects*/psychology, Humans ; Adult ; Research Design |
| Abstrakt: | Competing Interests: Declarations. Ethics approval and consent to participate: No research data were collected for this paper. Consent for publication: Not applicable. Competing interests: ST is an Editor-in-Chief of Trials and has acted as a paid consultant on trial diversity to the NIHR Oxford Health Biomedical Research Centre and the NIHR Cambridge Biomedical Research Centre. The other authors all declare that they have no competing interests. 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. (© 2025. The Author(s).) |
| References: | J Environ Manage. 2025 Jan;373:123437. (PMID: 39642833) Age Ageing. 2019 Nov 1;48(6):903-909. (PMID: 31595291) Disabil Health J. 2022 Oct;15(4):101368. (PMID: 36123292) BMC Med Ethics. 2020 Jun 9;21(1):47. (PMID: 32517748) BMC Neurol. 2017 Dec 04;17(1):206. (PMID: 29202730) Am J Lifestyle Med. 2024 Aug 25;18(6):740-743. (PMID: 39507914) Trials. 2020 May 29;21(1):445. (PMID: 32471488) Trials. 2024 Jan 25;25(1):83. (PMID: 38273417) BMC Med Res Methodol. 2004 Nov 08;4:25. (PMID: 15533249) BMJ. 2025 Feb 12;388:q2873. (PMID: 39938949) J Am Geriatr Soc. 2012 Mar;60(3):413-9. (PMID: 22288835) Lancet. 2020 Feb 15;395(10223):e29. (PMID: 32061300) J Med Ethics. 2018 Sep;44(9):632-637. (PMID: 29695407) Trials. 2020 Aug 1;21(1):694. (PMID: 32738919) Trials. 2022 Nov 24;23(1):957. (PMID: 36434661) BMC Med Ethics. 2016 Jan 27;17:8. (PMID: 26818248) BMC Med. 2020 Jul 22;18(1):221. (PMID: 32693800) |
| Grant Information: | Harmonised Impact Accelerator Award UK Research and Innovation |
| Contributed Indexing: | Keywords: Adults lacking capacity to consent; Clinical trials; Cognitive impairment; Inclusivity; Under-served groups |
| Entry Date(s): | Date Created: 20251023 Date Completed: 20251023 Latest Revision: 20251030 |
| Update Code: | 20251030 |
| PubMed Central ID: | PMC12542349 |
| DOI: | 10.1186/s13063-025-09182-1 |
| PMID: | 41126290 |
| Databáza: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Competing Interests: Declarations. Ethics approval and consent to participate: No research data were collected for this paper. Consent for publication: Not applicable. Competing interests: ST is an Editor-in-Chief of Trials and has acted as a paid consultant on trial diversity to the NIHR Oxford Health Biomedical Research Centre and the NIHR Cambridge Biomedical Research Centre. The other authors all declare that they have no competing interests.<br />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.<br />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.<br />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 .<br />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.<br /> (© 2025. The Author(s).) |
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| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-025-09182-1 |