{"id":2282,"date":"2022-06-23T11:35:03","date_gmt":"2022-06-23T11:35:03","guid":{"rendered":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/?p=2282"},"modified":"2022-06-23T15:11:47","modified_gmt":"2022-06-23T15:11:47","slug":"unpacking-the-black-box-of-horrendousness","status":"publish","type":"post","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/unpacking-the-black-box-of-horrendousness\/","title":{"rendered":"Unpacking the \u2018Black Box Of Horrendousness\u2019"},"content":{"rendered":"<p><em><strong>How can we address the challenges of conducting trials with adults with impaired capacity to consent?<\/strong><\/em><\/p>\n<p>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 recognise the challenging nature of these trials. Unfortunately, these challenges often lead to populations with impaired capacity to consent being <a href=\"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-019-3603-1\">excluded from trials<\/a>. Whilst the challenges are widely acknowledged in the research community, until now neither the nature of these barriers, nor ways to overcome them, have been identified.<\/p>\n<p>As part of the larger <a href=\"https:\/\/www.cardiff.ac.uk\/centre-for-trials-research\/research\/studies-and-trials\/view\/consult\">CONSULT project<\/a>, we conducted a qualitative study (CONSULT-ENABLE) to explore researchers and healthcare professionals\u2019 views about the barriers and facilitators to conducting trials with adults lacking capacity to consent. We interviewed 26 researchers and healthcare professionals with experience in a range of different roles, trial populations and settings across the UK in order to get a broad perspective. This included research nurses, trial managers, chief investigators, and other research team members.<\/p>\n<h2><strong>Barriers and facilitators occur at different stages of a trial<\/strong><\/h2>\n<p>Researchers described a number of barriers to conducting trials involving adults lacking capacity and outlines strategies they used to overcome them. These occurred at key stages in the design and conduct of the trial, including when making trial design decisions, navigating the process for obtaining ethical approval for the trial, assessing a participant\u2019s capacity to consent to a trial, identifying and involving alternative decision-makers (consultees and legal representatives), and when revisiting consent during a trial.<\/p>\n<p>They were grouped into three themes: 1) the perceived and actual complexity of trials involving adults lacking capacity, 2) importance of having access to appropriate support and resources, and 3) need for building greater knowledge and expertise to support future trials.<\/p>\n<figure id=\"post-2283 media-2283\" class=\"image align-center\"><img decoding=\"async\" src=\"http:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/06\/CONSULT_ENABLE-summary-of-key-stages-and-themes.png\" alt=\"\" \/><figcaption class=\"caption\">Diagram of key stages and themes<\/figcaption><\/figure>\n<h2><strong>Trials involving adults lacking capacity are challenging and complex<\/strong><\/h2>\n<p>Participants described trials involving adults lacking capacity as challenging. The legal frameworks and research governance process acted as a barrier to conducting trials, particularly when research teams had little or no experience in this area. For some, the concern about getting it \u2018wrong\u2019 impacted on how decisions were made about the inclusion adults of lacking capacity.<\/p>\n<p><em>\u201cAs a researcher it feels like just an <strong>insurmountable black box of horrendousness<\/strong> that I dare not go. It feels very much [that] if you get this wrong you will be illegal \u2026 and the ethics police will come for you or something\u201d<\/em><\/p>\n<h2><strong>Need for greater support<\/strong><\/h2>\n<p>Having public involvement throughout the trial was important, and using data from qualitative or feasibility studies to inform the trial design was also seen as beneficial. It was also important that tailored information and decision support was provided to participants and their families, and effective communication occurred between members of clinical and research teams. However, a lack of access to information and support about how to design and conduct trials involving adults with impaired capacity was considered to be a significant barrier.<\/p>\n<p><em>\u201cI\u2019ve been <strong>stabbing in the dark<\/strong> like \u2018where should I look for reliable information\u2019? A lot of it was <strong>potluck<\/strong>\u201c<\/em><\/p>\n<h2><strong>Recommendations to address the challenges<\/strong><\/h2>\n<p>Alongside recommendations for future research, we have made a number of practical recommendations for specific stakeholder groups including funders of health and care research, research ethics committees, research governance and infrastructure leads, trialists, and research staff who recruit participants. This includes the need for adequate resourcing of trials involving adults with impaired capacity, the need for greater consistency in ethics reviews, \u2018designing in\u2019 flexibility in consent processes, and system-wide initiatives to build capacity and competence in research involving adults lacking capacity.<\/p>\n<figure id=\"post-2284 media-2284\" class=\"image align-center\"><img decoding=\"async\" src=\"http:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/06\/CONSULT_ENABLE-summary-of-recommendations.png\" alt=\"\" \/><figcaption class=\"caption\">Diagram of key recommendations<\/figcaption><\/figure>\n<p>Further work is ongoing to develop resources to help support researchers, including a <a href=\"https:\/\/www.capacityconsentresearch.com\/\">website<\/a> which collates information about research involving adults lacking capacity and the development of the <a href=\"https:\/\/www.cardiff.ac.uk\/centre-for-trials-research\/research\/studies-and-trials\/view\/implementation-of-the-include-impaired-capacity-to-consent-framework-for-researchers\">INCLUDE Impaired Capacity to Consent Framework<\/a>.<\/p>\n<h2><strong>Published article<\/strong><\/h2>\n<p>The full findings from CONSULT-ENABLE study are available at: Shepherd, V., Hood, K. &amp; Wood, F. Unpacking the \u2018black box of horrendousness\u2019: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent. Trials 23, 471 (2022). <a href=\"https:\/\/doi.org\/10.1186\/s13063-022-06422-6\">https:\/\/doi.org\/10.1186\/s13063-022-06422-6<\/a><\/p>\n<p>A summery of the key findings and recommendations is available on the <a href=\"https:\/\/www.cardiff.ac.uk\/centre-for-trials-research\/research\/studies-and-trials\/view\/consult\">CONSULT<\/a> webpage.<\/p>\n<h2><strong>Acknowledgements<\/strong><\/h2>\n<p>CONSULT is an NIHR Advanced Fellowship funded by the Welsh Government through Health and Care Research Wales.<\/p>\n","protected":false},"excerpt":{"rendered":"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 [&hellip;]","protected":false},"author":1143,"featured_media":2286,"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":[7],"tags":[],"class_list":["post-2282","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events"],"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p7dIou-AO","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":2282,"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 &quot;Dissemination Event&quot;","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":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":2282,"position":1},"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 &quot;Events&quot;","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":6603,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/reaching-an-accord-addressing-consent-based-challenges-to-improve-inclusivity-in-research\/","url_meta":{"origin":2282,"position":2},"title":"Reaching an ACCORD? Addressing consent-based challenges to improve inclusivity in research","author":"Victoria Shepherd","date":"April 29, 2026","format":false,"excerpt":"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 to make decisions, including the ability to consent to research. Research is key to improving the health and well-being of\u2026","rel":"","context":"In &quot;Inclusivity&quot;","block_context":{"text":"Inclusivity","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/inclusivity\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":2396,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/centre-for-trials-research-at-ictmc2022-6th-international-clinical-trials-methodology-conference-ictmc\/","url_meta":{"origin":2282,"position":3},"title":"Centre for Trials Research At #ICTMC2022: 6th International Clinical Trials Methodology Conference (ICTMC)","author":"Cheney Drew","date":"October 27, 2022","format":false,"excerpt":"After a Covid related hiatus, so a year later than planned, the bi-annual International Clinical Trials Methodology Conference (ICTMC) was held in the beautiful spa town of Harrogate at the beginning of October 2022. The ICTMC meeting is a great opportunity to learn about all things methodological in the clinical\u2026","rel":"","context":"In &quot;Events&quot;","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\/10\/ICTMC-2022.jpg?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\/10\/ICTMC-2022.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/ICTMC-2022.jpg?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\/10\/ICTMC-2022.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/ICTMC-2022.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/ICTMC-2022.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":2902,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/our-nurses-our-future-reflections-on-the-power-of-research-as-we-celebrate-international-nurses-day\/","url_meta":{"origin":2282,"position":4},"title":"Our Nurses Our Future: Reflections on the Power of Research as we Celebrate International Nurses Day","author":"Nicola Ivins","date":"May 12, 2024","format":false,"excerpt":"This year we\u2019ll be celebrating International Nurses\u2019 Day (IND) on the 12th May 2024. 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