{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T01:12:40Z","timestamp":1784941960825,"version":"3.55.0"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T00:00:00Z","timestamp":1610582400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T00:00:00Z","timestamp":1610582400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients\u2019 comprehension of an informed consent\u2019s basic components shows that their level of understanding is limited.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients\u2019 comprehension of specific informed consent components.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators\u2019 blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>We found that participants\u2019 comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients\u2019 full and genuine involvement in a shared medical decision-making process.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-020-04969-w","type":"journal-article","created":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T11:03:19Z","timestamp":1610622199000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":220,"title":["The reality of informed consent: empirical studies on patient comprehension\u2014systematic review"],"prefix":"10.1186","volume":"22","author":[{"given":"Tomasz","family":"Pietrzykowski","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9167-1624","authenticated-orcid":false,"given":"Katarzyna","family":"Smilowska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,1,14]]},"reference":[{"issue":"1","key":"4969_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s12910-018-0340-z","volume":"20","author":"E Agozzino","year":"2019","unstructured":"Agozzino E, Borrelli S, Cancellieri M, Carfora FM, Di Lorenzo T, Attena F. Does written informed consent adequately inform surgical patients? A cross sectional study. BMC Med Ethics. 2019;20(1):1.","journal-title":"BMC Med Ethics"},{"issue":"10","key":"4969_CR2","first-page":"1337","volume":"53","author":"MJ Neff","year":"2008","unstructured":"Neff MJ. Informed consent: what is it? Who can give it? How do we improve it? Respir Care. 2008;53(10):1337\u201341.","journal-title":"Respir Care."},{"key":"4969_CR3","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-015-0823-2","volume":"15","author":"MA Durand","year":"2015","unstructured":"Durand MA, Moulton B, Cockle E, Mann M, Elwyn G. Can shared decision-making reduce medical malpractice litigation? A systematic review. BMC Health Serv Res. 2015;15:167.","journal-title":"BMC Health Serv Res."},{"issue":"2","key":"4969_CR4","doi-asserted-by":"publisher","first-page":"145","DOI":"10.1183\/20734735.001918","volume":"14","author":"S Manti","year":"2018","unstructured":"Manti S, Licari A. How to obtain informed consent for research. Breathe (Sheffield, England). 2018;14(2):145\u201352.","journal-title":"Breathe (Sheffield, England)."},{"key":"4969_CR5","doi-asserted-by":"publisher","first-page":"b2700","DOI":"10.1136\/bmj.b2700","volume":"339","author":"A Liberati","year":"2009","unstructured":"Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. Bmj. 2009;339:b2700.","journal-title":"Bmj."},{"key":"4969_CR6","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6939-9-15","volume":"9","author":"D Minnies","year":"2008","unstructured":"Minnies D, Hawkridge T, Hanekom W, Ehrlich R, London L, Hussey G. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Med Ethics. 2008;9:15.","journal-title":"BMC Med Ethics."},{"issue":"2","key":"4969_CR7","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0172957","volume":"12","author":"A Schumacher","year":"2017","unstructured":"Schumacher A, Sikov WM, Quesenberry MI, Safran H, Khurshid H, Mitchell KM, et al. Informed consent in oncology clinical trials: a Brown University Oncology Research Group prospective cross-sectional pilot study. PLoS One. 2017;12(2):e0172957.","journal-title":"PLoS One."},{"issue":"4","key":"4969_CR8","doi-asserted-by":"publisher","first-page":"611","DOI":"10.1016\/j.cct.2012.02.018","volume":"33","author":"SH Chu","year":"2012","unstructured":"Chu SH, Jeong SH, Kim EJ, Park MS, Park K, Nam M, et al. The views of patients and healthy volunteers on participation in clinical trials: an exploratory survey study. Contemp Clin Trials. 2012;33(4):611\u20139.","journal-title":"Contemp Clin Trials."},{"issue":"10","key":"4969_CR9","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0022696","volume":"6","author":"LH Chaisson","year":"2011","unstructured":"Chaisson LH, Kass NE, Chengeta B, Mathebula U, Samandari T. Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana. PLoS One. 2011;6(10):e22696.","journal-title":"PLoS One."},{"issue":"4","key":"4969_CR10","doi-asserted-by":"publisher","first-page":"868","DOI":"10.4269\/ajtmh.2010.10-0062","volume":"83","author":"RD Ellis","year":"2010","unstructured":"Ellis RD, Sagara I, Durbin A, Dicko A, Shaffer D, Miller L, et al. Comparing the understanding of subjects receiving a candidate malaria vaccine in the United States and Mali. Am J Trop Med Hyg. 2010;83(4):868\u201372.","journal-title":"Am J Trop Med Hyg."},{"issue":"17","key":"4969_CR11","doi-asserted-by":"publisher","first-page":"2627","DOI":"10.1016\/j.ejca.2008.08.013","volume":"44","author":"M Bergenmar","year":"2008","unstructured":"Bergenmar M, Molin C, Wilking N, Brandberg Y. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur J Cancer. 2008;44(17):2627\u201333.","journal-title":"Eur J Cancer."},{"issue":"6","key":"4969_CR12","doi-asserted-by":"publisher","first-page":"730","DOI":"10.1016\/j.cct.2007.04.005","volume":"28","author":"AM Bertoli","year":"2007","unstructured":"Bertoli AM, Strusberg I, Fierro GA, Ramos M, Strusberg AM. Lack of correlation between satisfaction and knowledge in clinical trials participants: a pilot study. Contemp Clin Trials. 2007;28(6):730\u20136.","journal-title":"Contemp Clin Trials."},{"issue":"3","key":"4969_CR13","doi-asserted-by":"publisher","first-page":"306","DOI":"10.1191\/1740774506cn150oa","volume":"3","author":"MT Krosin","year":"2006","unstructured":"Krosin MT, Klitzman R, Levin B, Cheng J, Ranney ML. Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clin Trials. 2006;3(3):306\u201313.","journal-title":"Clin Trials."},{"issue":"3","key":"4969_CR14","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1002\/art.11057","volume":"49","author":"LG Criscione","year":"2003","unstructured":"Criscione LG, Sugarman J, Sanders L, Pisetsky DS, St Clair EW. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Arthritis Rheum. 2003;49(3):361\u20137.","journal-title":"Arthritis Rheum."},{"issue":"4","key":"4969_CR15","first-page":"815","volume":"30","author":"JE Pope","year":"2003","unstructured":"Pope JE, Tingey DP, Arnold JM, Hong P, Ouimet JM, Krizova A. Are subjects satisfied with the informed consent process? A survey of research participants. J Rheumatol. 2003;30(4):815\u201324.","journal-title":"J Rheumatol"},{"issue":"4","key":"4969_CR16","doi-asserted-by":"publisher","first-page":"11","DOI":"10.7748\/paed.13.4.11.s16","volume":"13","author":"T McNally","year":"2001","unstructured":"McNally T, Grigg J. Parents\u2019 understanding of a randomised double-blind controlled trial. Paediatr Nurs. 2001;13(4):11\u20134.","journal-title":"Paediatr Nurs."},{"issue":"1","key":"4969_CR17","doi-asserted-by":"publisher","first-page":"107","DOI":"10.1038\/bjc.1997.344","volume":"76","author":"K Itoh","year":"1997","unstructured":"Itoh K, Sasaki Y, Fujii H, Ohtsu T, Wakita H, Igarashi T, et al. Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations. Br J Cancer. 1997;76(1):107\u201313.","journal-title":"Br J Cancer."},{"issue":"3","key":"4969_CR18","doi-asserted-by":"publisher","DOI":"10.1097\/00042560-199511000-00012","volume":"10","author":"K Harrison","year":"1995","unstructured":"Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10(3):386\u201390.","journal-title":"J Acquir Immune Defic Syndr Hum Retrovirol."},{"key":"4969_CR19","doi-asserted-by":"publisher","first-page":"108","DOI":"10.1016\/j.msard.2018.07.034","volume":"25","author":"M Ponzio","year":"2018","unstructured":"Ponzio M, Uccelli MM, Lionetti S, Barattini DF, Brichetto G, Zaratin P, et al. User testing as a method for evaluating subjects' understanding of informed consent in clinical trials in multiple sclerosis. Mult Scler Relat Disord. 2018;25:108\u201311.","journal-title":"Mult Scler Relat Disord."},{"issue":"3","key":"4969_CR20","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-019703","volume":"8","author":"MJ Page","year":"2018","unstructured":"Page MJ, McKenzie JE, Higgins JPT. Tools for assessing risk of reporting biases in studies and syntheses of studies: a systematic review. BMJ Open. 2018;8(3):e019703.","journal-title":"BMJ Open."},{"issue":"3","key":"4969_CR21","doi-asserted-by":"publisher","first-page":"186","DOI":"10.2471\/BLT.14.141390","volume":"93","author":"NT Tam","year":"2015","unstructured":"Tam NT, Huy NT, Thoa le TB, Long NP, Trang NT, Hirayama K, et al. Participants\u2019 understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ. 2015;93(3):186\u201398h.","journal-title":"Bull World Health Organ."},{"issue":"3","key":"4969_CR22","doi-asserted-by":"publisher","first-page":"420","DOI":"10.1016\/j.amjsurg.2009.02.010","volume":"198","author":"ME Falagas","year":"2009","unstructured":"Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420\u201335.","journal-title":"Am J Surg."},{"issue":"2","key":"4969_CR23","doi-asserted-by":"publisher","first-page":"89","DOI":"10.3109\/07853899409147334","volume":"26","author":"JE Idanpaan-Heikkila","year":"1994","unstructured":"Idanpaan-Heikkila JE. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med. 1994;26(2):89\u201394.","journal-title":"Ann Med."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04969-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-020-04969-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04969-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T11:15:43Z","timestamp":1610622943000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-04969-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,14]]},"references-count":23,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["4969"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-04969-w","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1,14]]},"assertion":[{"value":"29 May 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 December 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 January 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Not applicable.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"57"}}