![\"\"](\"http:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2026\/04\/Exclusion-quote.png\")
<\/figure>\nNeed to address consent-based exclusion<\/h2>\n
All populations should have the opportunity to be included in research that is relevant to them. There is a growing recognition of the impact that the lack of inclusivity in health and care research has on health inequalities and evidence-based care. As a result, improving inclusion of under-served groups in research is a priority topic for research funders, regulators, and policymakers. Questions about exclusion are commonly considered with respect to gender and ethnicity, but this must be extended to consider communication disabilities and cognitive impairment where the issues encountered are ethically complex.<\/p>\n
Complexity of navigating the ethical and legal frameworks<\/h2>\n
Regulation of research involving adults lacking capacity sits in the intersection between mental capacity legislation, which is intended to empower people and protect their interests, and regulatory frameworks designed to harmonise research processes. With differing frameworks depending on the type of research and where in the UK it is being conducted, it is no surprise that they are widely misunderstood.<\/p>\n Our previous research, CONSULT<\/a>, funded by Health and Care Research Wales, showed that this gap in understanding directly impacts researchers, practitioners, and research governance members\u2019 beliefs and behaviours, with some avoiding the \u2018black box of horrendousness<\/a>\u2019 entirely and others adopting a more rigid approach<\/a> than the law permits. Both of which can limit inclusion. We need to improve our understanding in order to ensure research is better able to meet tomorrow\u2019s health and care needs.<\/p>\n A new 8-year project ACCORD<\/a>, funded by the Wellcome Trust<\/a>, will continue the work of CONSULT through opening up the \u2018black box of horrendousness\u2019 by exploring how the ethical and legal frameworks for research involving adults lacking capacity to consent are currently being implemented, and developing behavioural-informed interventions to improve inclusion. In the first work package we will identify the ethico-legal issues that limit inclusion and how they are navigated by those involved in designing, approving, and conducting research. We will then co-design interventions in collaboration with public and professional stakeholders to target individual-level and system-wide barriers. Inclusivity, and involvement of diverse communities, is embedded throughout the project. Engagement with policymakers and focusing on implementation will help ensure national and international impact.<\/p>\n","protected":false},"excerpt":{"rendered":"Consent as a barrier to inclusion in research A global ageing population brings a rise in the number of people living with conditions and disabilities that can affect their ability […]","protected":false},"author":1143,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[110],"tags":[],"class_list":["post-6603","post","type-post","status-publish","format-standard","hentry","category-inclusivity"],"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p7dIou-1Iv","jetpack-related-posts":[{"id":3044,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/addressing-the-knowledge-gap-developing-consult-e-learning-on-trials-involving-adults-lacking-capacity-to-consent\/","url_meta":{"origin":6603,"position":0},"title":"Addressing The Knowledge Gap \u2013 Developing CONSULT E-learning On Trials Involving Adults Lacking Capacity To Consent","author":"Victoria Shepherd","date":"December 9, 2024","format":false,"excerpt":"Historically, trials have focused on the number of participants who take part without paying too much attention to whowas being included - or rather, being excluded. More recently, however, there has been growing attention on ensuring that trials are inclusive of groups who are under-served by research. This has led\u2026","rel":"","context":"In "Dissemination Event"","block_context":{"text":"Dissemination Event","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/dissemination-event\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/12\/Image-of-CONSULT-training.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/12\/Image-of-CONSULT-training.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/12\/Image-of-CONSULT-training.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/12\/Image-of-CONSULT-training.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/12\/Image-of-CONSULT-training.png?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":1991,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/recruitment-for-critical-care-trials-what-strategies-work-best-findings-from-an-intercalated-medical-student-project\/","url_meta":{"origin":6603,"position":1},"title":"Recruitment for Critical Care Trials \u2013 What Strategies Work Best? 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It has quickly become a global phenomenon reaching over 22 countries. The\u2026","rel":"","context":"In "Events"","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2018\/05\/Slide-1-Title.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2018\/05\/Slide-1-Title.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2018\/05\/Slide-1-Title.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2018\/05\/Slide-1-Title.png?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2282,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/unpacking-the-black-box-of-horrendousness\/","url_meta":{"origin":6603,"position":3},"title":"Unpacking the \u2018Black Box Of Horrendousness\u2019","author":"Victoria Shepherd","date":"June 23, 2022","format":false,"excerpt":"How can we address the challenges of conducting trials with adults with impaired capacity to consent? Anyone who has been involved in developing or conducting trials involving people who are unable to provide their own consent to take part (or who has been around researchers involved in these trials) will\u2026","rel":"","context":"In "Events"","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/06\/CONSULT-logo_title.JPG.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/06\/CONSULT-logo_title.JPG.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/06\/CONSULT-logo_title.JPG.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/06\/CONSULT-logo_title.JPG.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/06\/CONSULT-logo_title.JPG.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/06\/CONSULT-logo_title.JPG.png?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":2448,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/bridging-the-gap-can-advance-research-planning-help-address-some-of-the-challenges-of-research-with-adults-with-impaired-capacity-to-consent\/","url_meta":{"origin":6603,"position":4},"title":"Bridging The Gap \u2013 Can Advance Research Planning Help Address Some Of The Challenges Of Research With Adults With Impaired Capacity To Consent?","author":"Victoria Shepherd","date":"December 6, 2022","format":false,"excerpt":"Bridging The Gap \u2013 Can Advance Research Planning Help Address Some Of The Challenges Of Research With Adults With Impaired Capacity To Consent? In order to include people in research who are unable to provide their own consent to participate, someone close to them is approached to help make a\u2026","rel":"","context":"In "Events"","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/12\/CONSULT.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/12\/CONSULT.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/12\/CONSULT.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/12\/CONSULT.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/12\/CONSULT.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/12\/CONSULT.png?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":2550,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/nurses-midwives-and-allied-healthcare-professionals-nmahp\/","url_meta":{"origin":6603,"position":5},"title":"Our Nurses, Midwives and Allied Healthcare Professionals (NMAHP)","author":"Nicola Ivins","date":"March 28, 2023","format":false,"excerpt":"The Nurses, Midwives and Allied Healthcare Professionals (NMAHP) are an established group within the Centre for Trials Research (CTR), who contribute clinical and research expertise to a wide range of studies, including leading the implementation and delivery of studies. 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<\/figure>\n![\"\"](\"http:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2026\/04\/Researcher-quote.png\")
<\/figure>\nOpening up the \u2018black box of horrendousness\u2019<\/h2>\n