{"id":2053,"date":"2021-05-10T13:55:15","date_gmt":"2021-05-10T13:55:15","guid":{"rendered":"http:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/?p=2053"},"modified":"2022-04-13T13:59:09","modified_gmt":"2022-04-13T13:59:09","slug":"unnecessary-harm-caused-by-informed-consent","status":"publish","type":"post","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/unnecessary-harm-caused-by-informed-consent\/","title":{"rendered":"Unnecessary Harm Caused by Informed Consent"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><em>The Medical Research Council (MRC) has funded a project to reduce unnecessary harm caused by the way potential trial harms are communicated to potential patients.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Making informed consent more ethical<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Patients need to be informed about potential risks of taking part in clinical trials. A problem is that there are no standards telling researchers or ethics committees how these risks need to be communicated. The research team\u2019s background research suggests that the way harms are communicated can actually increase the risks of the harms occurring. Over half of their sample of&nbsp;250,000 patients who took placebo pills (like sugar pills) in clinical trials reported some negative side effect (like pain or nausea but also more serious things). Their sample of information leaflets provided to patients also found that potential trial benefits were sometimes not mentioned, with potential harms being emphasized.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The MRC has funded the team, based at Cardiff University (and including researchers from Manchester University, and the University of Aberdeen) to investigate ways to share potential trial harms honestly and completely, yet in a balanced way that does not actually cause unnecessary harms. With input from real patients, trial researchers, industry, and legal experts, they will develop new ways of sharing information about potential trial benefits and harms. They will then test these in five clinical trials, to see whether they reduce harms.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The output of the project will be a set of&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/www.cardiff.ac.uk\/centre-for-trials-research\/research\/studies-and-trials\/view\/principil\" target=\"_blank\"><strong>Princ<\/strong>iples for&nbsp;<strong>P<\/strong>atient&nbsp;<strong>I<\/strong>nformation&nbsp;<strong>L<\/strong>eaflets (<strong>PrinciPILs<\/strong>)<\/a>, which will help trialists design information about potential trial risks and benefits in an ethical and balanced way that does not cause unnecessary harm. PrinciPILs will also save time because researchers and ethics committees won\u2019t have to reinvent the wheel whenever they are thinking about ways to present potential trial risks and benefits. As one of the reviewers of this project stated, this&nbsp;\u2018should have been addressed years ago\u2019.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">The Nocebo effect<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to share intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which such risk information is shared. The magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside the principle of autonomy when obtaining (ethical) informed consent.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Funding<\/strong><strong><\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Medical Research Council, award number&nbsp;MR\/V020706\/1<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Notes<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">For further information or comment, please contact Dr Jeremy Howick, (senior research and principal investigator HowickJ@cardiff.ac.uk) or Professor Kerry Hood (HoodK1@cardiff.ac.uk).<\/p>\n","protected":false},"excerpt":{"rendered":"The Medical Research Council (MRC) has funded a project to reduce unnecessary harm caused by the way potential trial harms are communicated to potential patients. Making informed consent more ethical [&hellip;]","protected":false},"author":6830,"featured_media":2055,"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-2053","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-x7","jetpack-related-posts":[{"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":2053,"position":0},"title":"Recruitment for Critical Care Trials \u2013 What Strategies Work Best? Findings From an Intercalated Medical Student Project","author":"Victoria Shepherd","date":"February 3, 2021","format":false,"excerpt":"Timia Raven-Gregg writes:\u00a0\u00a0Following my fourth year at medical school, I decided that I wanted to gain a better understanding of clinical research and have the opportunity to undertake a research project myself. For this reason, I chose to\u00a0intercalate\u00a0in a degree in Population Medicine. The idea of better understanding research conducted\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":"IV Pump","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2021\/02\/Vicky-Blog-IV-Pump-scaled.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\/2021\/02\/Vicky-Blog-IV-Pump-scaled.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2021\/02\/Vicky-Blog-IV-Pump-scaled.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\/2021\/02\/Vicky-Blog-IV-Pump-scaled.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2021\/02\/Vicky-Blog-IV-Pump-scaled.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2021\/02\/Vicky-Blog-IV-Pump-scaled.jpg?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":2053,"position":1},"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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Sepsis, blood poisoning, septicaemia\u2026whatever word you are familiar with, it remains one of the most common complications of infection seen in hospital Emergency Departments (ED)s across the UK and is characterised by an unregulated host response to bacterial infection. Optimal treatment for sepsis includes prompt antibiotics into\u2026","rel":"","context":"In &quot;Antibiotics&quot;","block_context":{"text":"Antibiotics","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/antibiotics\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/img.youtube.com\/vi\/H3x-rNVlwJI\/0.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2594,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/enceph-ig-trial-the-challenges-of-running-a-rare-disease-trial\/","url_meta":{"origin":2053,"position":3},"title":"ENCEPH-IG Trial: The Challenges Of Running A Rare Disease Trial","author":"Paula Foscarini-Craggs","date":"June 19, 2023","format":false,"excerpt":"Autoimmune encephalitis is swelling of the brain caused by the immune system attacking the body in error. It can cause people to become confused, drowsy, exhibit changes in behaviour, and have seizures. It affects around 1 in 100,000 people per year in the UK and because of its rarity and\u2026","rel":"","context":"In &quot;inflammation and immunity&quot;","block_context":{"text":"inflammation and immunity","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/inflammation-and-immunity\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2023\/06\/ENCEPH-IG.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":1645,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/clinical-trials-as-a-catalyst-for-change-in-the-big-easy-the-40th-society-for-clinical-trials-annual-meeting-new-orleans-usa\/","url_meta":{"origin":2053,"position":4},"title":"Clinical Trials As A Catalyst For Change In The \u2018Big Easy\u2019 \u2013 The 40th Society For Clinical Trials Annual Meeting, New Orleans, USA","author":"Victoria Shepherd","date":"June 13, 2019","format":false,"excerpt":"By Victoria Shepherd and Nigel Kirby A taste of New Orleans At times New Orleans felt very much like Wales\u2026\u2026 wet. 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The French Quarter is a vibrant place\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\/2019\/06\/New-Orleans-SCT.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\/2019\/06\/New-Orleans-SCT.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/06\/New-Orleans-SCT.png?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":2961,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/my-pronto-journey-world-sepsis-day-2024\/","url_meta":{"origin":2053,"position":5},"title":"My PRONTO Journey &#8211; World Sepsis Day 2024","author":"Joanne Euden","date":"September 13, 2024","format":false,"excerpt":"-Blog by Julie Carman As World Sepsis day comes round again, I invite you to join me as I share my thoughts and observations as the Patient and Public Involvement (PPI) representative on working with the PRONTO trial research team. 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