{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T14:57:25Z","timestamp":1790866645757,"version":"4.1.0"},"reference-count":32,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Bioethical Inquiry"],"DOI":"10.1007\/s11673-026-10588-y","type":"journal-article","created":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T14:20:59Z","timestamp":1790864459000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Ethical and Linguistic Quality of Participant Information Sheets and Their Association with Recruitment Outcomes"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-6584-8453","authenticated-orcid":false,"given":"Francis","family":"Osei","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,1]]},"reference":[{"key":"10588_CR1","doi-asserted-by":"crossref","unstructured":"Abu-Heija, A.A., M. Shatta, M. Ajam, U. Abu-Heija, N. Imran, and D. Levine. 2019. Quantitative readability assessment of the internal medicine online patient information on Annals.org. Cureus 11(3): e4184.","DOI":"10.7759\/cureus.4184"},{"key":"10588_CR2","doi-asserted-by":"publisher","DOI":"10.1016\/j.oor.2024.100662","volume":"12","author":"SK Ahmed","year":"2024","unstructured":"Ahmed, S.K. 2024. How to choose a sampling technique and determine sample size for research: A simplified guide for researchers. Oral Oncology Reports 12: 100662.","journal-title":"Oral Oncology Reports"},{"issue":"3","key":"10588_CR3","doi-asserted-by":"publisher","DOI":"10.1136\/bmjoq-2025-003523","volume":"14","author":"J Altaf","year":"2025","unstructured":"Altaf, J., A. Hasan Ashfaq, N. Riaz, and F. Faraz. 2025. Informed consent: Is it more than a formality? A quality improvement project in surgical practice. BMJ Open Quality 14(3): e003523.","journal-title":"BMJ Open Quality"},{"issue":"1","key":"10588_CR4","doi-asserted-by":"publisher","first-page":"81","DOI":"10.31486\/toj.19.0105","volume":"21","author":"LA Bazzano","year":"2021","unstructured":"Bazzano, L.A., J. Durant, and P.R. Brantley. 2021. A modern history of informed consent and the role of key information. Ochsner Journal 21(1): 81\u201385.","journal-title":"Ochsner Journal"},{"issue":"1","key":"10588_CR5","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1186\/s12910-025-01348-5","volume":"26","author":"C Bernardi","year":"2025","unstructured":"Bernardi, C., D. Wolff, F. L\u00fccke, et al. 2025. How to improve informed consent processes in clinical trials with cancer patients: A qualitative analysis of multidisciplinary experts\u2019 perspectives. BMC Medical Ethics 26(1): 171.","journal-title":"BMC Medical Ethics"},{"issue":"1","key":"10588_CR6","doi-asserted-by":"publisher","DOI":"10.1136\/bmjhci-2024-101248","volume":"32","author":"C Cosma","year":"2025","unstructured":"Cosma, C., A. Radi, R. Cattano, et al. 2025. Potential role of ChatGPT in simplifying and improving informed consent forms for vaccination: A pilot study conducted in Italy. BMJ Health & Care Informatics 32(1): e101248.","journal-title":"BMJ Health & Care Informatics"},{"issue":"11","key":"10588_CR7","first-page":"159","volume":"284","author":"N Derevianchenko","year":"2018","unstructured":"Derevianchenko, N., O. Lytovska, D. Diurba, and I. Leshchyna. 2018. Impact of medical terminology on patients\u2019 comprehension of healthcare. Georgian Medical News 284(11): 159\u2013163 .","journal-title":"Georgian Medical News"},{"issue":"9","key":"10588_CR8","doi-asserted-by":"publisher","first-page":"601","DOI":"10.20344\/amp.20570","volume":"37","author":"PL Ferreira","year":"2024","unstructured":"Ferreira, P.L., A. Barradas, and I. Ribeiro. 2024. Quality of informed consent in phase III clinical trials in Portugal: The participants\u2019 perspective. Acta Medica Portuguesa 37(9): 601\u2013608.","journal-title":"Acta Medica Portuguesa"},{"key":"10588_CR9","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2025.108749","volume":"136","author":"SG Ghotane","year":"2025","unstructured":"Ghotane, S.G., C. Holt, S.J. Challacombe, P. Don-Davis, D. Kamara, and J.E. Gallagher. 2025. Pictorial art for gaining informed consent in low-literacy settings. Patient Education and Counseling 136: 108749.","journal-title":"Patient Education and Counseling"},{"issue":"1","key":"10588_CR10","doi-asserted-by":"publisher","DOI":"10.1111\/xen.70016","volume":"32","author":"EJ Gordon","year":"2025","unstructured":"Gordon, E.J., M.K. Gusmano, J. Gacki-Smith, et al. 2025. Patients\u2019 information needs for informed consent to participate in first-in-human pig kidney xenotransplant clinical trials: A mixed methods study. Xenotransplantation 32(1): e70016.","journal-title":"Xenotransplantation"},{"issue":"3","key":"10588_CR11","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2024-089447","volume":"15","author":"E Gourlay","year":"2025","unstructured":"Gourlay, E., T. Felton, M. Bafadhel, et al. 2025. Readability and complexity of written information presented to hospitalised patients for trial consent during the COVID-19 pandemic in the UK: A retrospective document analysis. BMJ Open 15(3): e089447.","journal-title":"BMJ Open"},{"issue":"1","key":"10588_CR12","doi-asserted-by":"publisher","first-page":"217","DOI":"10.1007\/s11701-025-02389-z","volume":"19","author":"KK Gupta","year":"2025","unstructured":"Gupta, K.K., A. Simons, S. Mortimore, et al. 2025. Consensus regarding transoral robotic surgery (TORS) com plications for use in a proposed standardised consent form. Journal of Robotic Surgery 19(1): 217.","journal-title":"Journal of Robotic Surgery"},{"key":"10588_CR13","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 2025. ICH harmonised guideline: Guideline for good clinical practice E6(R3). Last modified January 6. https:\/\/database.ich.org\/sites\/default\/files\/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf."},{"key":"10588_CR14","doi-asserted-by":"publisher","first-page":"1540948","DOI":"10.3389\/fphar.2025.1540948","volume":"16","author":"J Klein","year":"2025","unstructured":"Klein, J., T. van Iersel, D. de Vries, Y. Donazzolo, and I. Klingmann. 2025. Healthy participant engagement in early clinical trials: Results from the European EUFEMED survey. Frontiers in Pharmacology 16: 1540948.","journal-title":"Frontiers in Pharmacology"},{"key":"10588_CR15","doi-asserted-by":"crossref","unstructured":"Li, L., M.A. Rysavy, G. Bobashev, and A. Das. 2024. Comparing methods for risk prediction of multicategory outcomes: Dichotomized logistic regression vs. multinomial logit regression. BMC Medical Research Methodology 24(1): 261.","DOI":"10.1186\/s12874-024-02389-x"},{"issue":"30","key":"10588_CR16","doi-asserted-by":"publisher","first-page":"E941","DOI":"10.1503\/cmaj.250500","volume":"197","author":"H Longstaff","year":"2025","unstructured":"Longstaff, H., B. Lucas, B. Schichter, S. Murthy, and J. Flamenbaum. 2025. Core elements of consent documentation for clinical research in Canada: Guidance for policy. CMAJ 197(30): E941\u2013E952.","journal-title":"CMAJ"},{"issue":"9","key":"10588_CR17","doi-asserted-by":"publisher","first-page":"e3173","DOI":"10.1210\/clinem\/dgaf305","volume":"110","author":"T Lu","year":"2025","unstructured":"Lu, T., W. Zhang, F.W. Hamilton, et al. 2025. No more free lunch: Challenges to Mendelian randomization due to sample selection and complex methods. The Journal of Clinical Endocrinology & Metabolism 110(9): e3173\u2013e3177.","journal-title":"The Journal of Clinical Endocrinology & Metabolism"},{"issue":"3","key":"10588_CR18","doi-asserted-by":"publisher","first-page":"1037","DOI":"10.1002\/ijgo.16100","volume":"169","author":"SM Maila","year":"2025","unstructured":"Maila, S.M., C. Castelyn, and S. Adam. 2025. Informed consent and ethical issues pertaining to female sterilisation\u2014Scoping review. International Journal of Gynecology & Obstetrics 169(3): 1037\u20131064.","journal-title":"International Journal of Gynecology & Obstetrics"},{"issue":"3","key":"10588_CR19","doi-asserted-by":"publisher","first-page":"284","DOI":"10.1177\/18632521231156435","volume":"17","author":"C Michel","year":"2023","unstructured":"Michel, C., C. Dijanic, G. Abdelmalek, et al. 2023. Readability assessment of patient educational materials for pediatric spinal conditions from top academic orthopedic institutions. Journal of Children\u2019s Orthopaedics 17(3): 284\u2013290.","journal-title":"Journal of Children\u2019s Orthopaedics"},{"issue":"2","key":"10588_CR20","doi-asserted-by":"publisher","first-page":"254","DOI":"10.1097\/SLA.0000000000006324","volume":"282","author":"MB Mitchell","year":"2025","unstructured":"Mitchell, M.B., G. Lin, K. Prasad, D.R.S. Habib, and A. Langerman. 2025. Overlapping surgery verbiage in informed consent documents. Annals of Surgery 282(2): 254\u2013257.","journal-title":"Annals of Surgery"},{"key":"10588_CR21","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2025.127953","volume":"68","author":"N Nahar","year":"2025","unstructured":"Nahar, N., S. Parveen, E.S. Gurley, et al. 2025. Community interpretation of a consent form and willingness to participate in a Nipah virus vaccine trial in Bangladesh. Vaccine 68: 127953.","journal-title":"Vaccine"},{"issue":"3","key":"10588_CR22","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1002\/eahr.60022","volume":"47","author":"KL Nellis","year":"2025","unstructured":"Nellis, K.L., R. Lichtman, J. Birnbaum, S. Friedman, and E. Zwicklbauer. 2025. Incorporating gender-neutral language in IRB materials: Perceptions of IRB professionals. Ethics & Human Research 47(3): 30\u201339.","journal-title":"Ethics & Human Research"},{"issue":"5","key":"10588_CR23","first-page":"354","volume":"107","author":"J Norvill","year":"2025","unstructured":"Norvill, J., C. Bent, J.A. Mawhinney, and N. Johnson. 2025. Role of procedure-specific consent forms in clinical practice: A systematic review. The Annals of the Royal College of Surgeons of England 107(5): 354\u2013363.","journal-title":"The Annals of the Royal College of Surgeons of England"},{"key":"10588_CR24","first-page":"397","volume":"18","author":"OM Peycheva","year":"2025","unstructured":"Peycheva, O.M., L.R. Ainsworth, G. Fujimori-Petrikova, and W.T. Lee. 2025. Enhancing informed consent forms for medical devices: International regulatory guidance and ethical recommendations. Medical Devices: Evidence and Research 18: 397\u2013411.","journal-title":"Medical Devices: Evidence and Research"},{"issue":"1","key":"10588_CR25","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuchi.2024.101608","volume":"71","author":"J Raymond","year":"2025","unstructured":"Raymond, J. and T.E. Darsaut. 2025. Understanding statistical populations and inferences. Neurochirurgie 71(1): 101608.","journal-title":"Neurochirurgie"},{"key":"10588_CR26","unstructured":"Shah, P., I. Thornton, N.L. Kopitnik, and J.E. Hipskind. 2024. Informed consent. In StatPearls, edited by M. Abdelsattar, L.T. Abernethy, W.B. Ackley, et al. Treasure Island, Florida: StatPearls Publishing. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK430827\/."},{"issue":"3","key":"10588_CR27","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2024-091896","volume":"15","author":"A Siriwardana","year":"2025","unstructured":"Siriwardana, A., B. Smyth, and M. Jardine. 2025. Waiver of informed consent in clinical research: A summary of contemporary guide lines and a resource for researchers. BMJ Open 15(3): e091896.","journal-title":"BMJ Open"},{"issue":"2","key":"10588_CR28","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1002\/eahr.60015","volume":"47","author":"CD Speight","year":"2025","unstructured":"Speight, C.D., O.M. Adeoye, S.I. Davis, M.J. Linke, A.R. Mitchell, and N.W. Dickert. 2025. Stakeholder views on novel consent forms for an acute stroke trial. Ethics & Human Research 47(2): 16\u201325.","journal-title":"Ethics & Human Research"},{"issue":"2","key":"10588_CR29","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1002\/ase.70060","volume":"19","author":"GC Stephens","year":"2025","unstructured":"Stephens, G.C. 2025. \u201cBecause everybody\u2019s different\u201d: Co-designing body donor program consent processes. Anatomical Sciences Education 19(2): 201\u2013217.","journal-title":"Anatomical Sciences Education"},{"issue":"1","key":"10588_CR30","doi-asserted-by":"publisher","first-page":"149","DOI":"10.1186\/s12910-024-01147-4","volume":"25","author":"A Twimukye","year":"2024","unstructured":"Twimukye, A., S. Nabukenya, A.N. Kawuma, et al. 2024. \u2018Some parts of the consent form are written using complex scientific language\u2019: Community perspectives on informed consent for research with pregnant and lactating mothers in Uganda. BMC Medical Ethics 25(1): 149.","journal-title":"BMC Medical Ethics"},{"key":"10588_CR31","unstructured":"U.S. National Library of Medicine. No date. Clinicaltrials.gov. https:\/\/clinicaltrials.gov\/."},{"issue":"3","key":"10588_CR32","doi-asserted-by":"publisher","DOI":"10.1016\/j.semperi.2025.152055","volume":"49","author":"EM Weiss","year":"2025","unstructured":"Weiss, E.M., B.S. Wilfond, and S.A. Kraft. 2025. Towards better enrollment decision-making for perinatal clinical research: Reconsidering recruitment and consent processes to support family values and preferences. Seminars in Perinatology 49(3): 152055.","journal-title":"Seminars in Perinatology"}],"container-title":["Journal of Bioethical Inquiry"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11673-026-10588-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11673-026-10588-y","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11673-026-10588-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T14:21:05Z","timestamp":1790864465000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11673-026-10588-y"}},"subtitle":["An Empirical Bioethics Study of Clinical Trials"],"short-title":[],"issued":{"date-parts":[[2026,10,1]]},"references-count":32,"alternative-id":["10588"],"URL":"https:\/\/doi.org\/10.1007\/s11673-026-10588-y","relation":{},"ISSN":["1176-7529","1872-4353"],"issn-type":[{"value":"1176-7529","type":"print"},{"value":"1872-4353","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,1]]},"assertion":[{"value":"20 July 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 May 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 October 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Not applicable. The analysis used publicly accessible and anonymized trial documents and involved no human participants or identifiable personal data.","order":1,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":3,"name":"Ethics","label":"Materials availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The author is employed by Bayezian Limited, which develops analytical tools that include large language model-based methods. The study did not promote or commercially evaluate any specific product, and no financial interest is linked to the findings.","order":4,"name":"Ethics","label":"Conflict of interest\/Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}]}}