{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T16:37:07Z","timestamp":1770741427974,"version":"3.49.0"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,1,6]],"date-time":"2020-01-06T00:00:00Z","timestamp":1578268800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,1,6]],"date-time":"2020-01-06T00:00:00Z","timestamp":1578268800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"European Research Council","award":["ERC-2013-CoG 614739-A_HERO"],"award-info":[{"award-number":["ERC-2013-CoG 614739-A_HERO"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Ethics"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant\u2019s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 254 caregivers were assigned to receive (i) a pamphlet (<jats:italic>n<\/jats:italic>\u2009=\u200963), (ii) an oral information session (<jats:italic>n<\/jats:italic>\u2009=\u200962) or (iii) a pamphlet and an oral information session (<jats:italic>n<\/jats:italic>\u2009=\u200964) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (<jats:italic>n<\/jats:italic>\u2009=\u200965).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In contrast to the pamphlet, attending an information session significantly increased caregivers\u2019 knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study\u00a0procedures).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating\u00a0information need to be found to achieve a truly informed consent.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s12910-019-0441-3","type":"journal-article","created":{"date-parts":[[2020,1,6]],"date-time":"2020-01-06T17:02:55Z","timestamp":1578330175000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?"],"prefix":"10.1186","volume":"21","author":[{"given":"Marta S.","family":"Palmeirim","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Ross","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brigit","family":"Obrist","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ulfat A.","family":"Mohammed","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shaali M.","family":"Ame","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Said M.","family":"Ali","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0290-3521","authenticated-orcid":false,"given":"Jennifer","family":"Keiser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,1,6]]},"reference":[{"issue":"1","key":"441_CR1","doi-asserted-by":"publisher","first-page":"e0005327","DOI":"10.1371\/journal.pntd.0005327","volume":"11","author":"DJ Diemert","year":"2017","unstructured":"Diemert DJ, Lobato L, Styczynski A, Zumer M, Soares A, Gazzinelli MF. A comparison of the quality of informed consent for clinical trials of an experimental hookworm vaccine conducted in developed and developing countries. PLoS Negl Trop Dis. 2017;11(1):e0005327.","journal-title":"PLoS Negl Trop Dis"},{"key":"441_CR2","volume-title":"ICH tripartite guideline for good clinical practices E6 (R1)","author":"Harmonization ICo","year":"1996","unstructured":"Harmonization ICo: ICH tripartite guideline for good clinical practices E6 (R1). 1996."},{"issue":"2","key":"441_CR3","doi-asserted-by":"publisher","first-page":"124","DOI":"10.1200\/JOP.2010.000216","volume":"7","author":"AR Baer","year":"2011","unstructured":"Baer AR, Devine S, Beardmore CD, Catalano R. Clinical investigator responsibilities. J Oncol Pract. 2011;7(2):124\u20138.","journal-title":"J Oncol Pract"},{"issue":"8","key":"441_CR4","doi-asserted-by":"publisher","first-page":"721","DOI":"10.1056\/NEJMsa021212","volume":"348","author":"MK Paasche-Orlow","year":"2003","unstructured":"Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348(8):721\u20136.","journal-title":"N Engl J Med"},{"issue":"2","key":"441_CR5","doi-asserted-by":"publisher","first-page":"132","DOI":"10.5152\/balkanmedj.2014.13212","volume":"31","author":"M\u00d6 Ozhan","year":"2014","unstructured":"Ozhan M\u00d6, S\u00fczer MA, Comak I, Caparlar C\u00d6, Ayd\u0131n GB, E\u015fkin MB, Atik B, Ergin A, Cekmen N, Kurt E. Do the patients read the informed consent? Balkan Med J. 2014;31(2):132\u20136.","journal-title":"Balkan Med J"},{"issue":"3","key":"441_CR6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.2307\/3564107","volume":"12","author":"DR Young","year":"1990","unstructured":"Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. Irb. 1990;12(3):1\u20135.","journal-title":"Irb"},{"issue":"3","key":"441_CR7","doi-asserted-by":"crossref","first-page":"98","DOI":"10.4103\/2229-3485.71864","volume":"1","author":"A Pandiya","year":"2010","unstructured":"Pandiya A. Readability and comprehensibility of informed consent forms for clinical trials. Perspect Clin Res. 2010;1(3):98\u2013100.","journal-title":"Perspect Clin Res"},{"issue":"3","key":"441_CR8","doi-asserted-by":"crossref","first-page":"107","DOI":"10.4103\/picr.PICR_147_16","volume":"8","author":"RA Kadam","year":"2017","unstructured":"Kadam RA. Informed consent process: a step further towards making it meaningful! Perspect Clin Res. 2017;8(3):107\u201312.","journal-title":"Perspect Clin Res"},{"issue":"11","key":"441_CR9","doi-asserted-by":"publisher","first-page":"e324","DOI":"10.1371\/journal.pmed.0040324","volume":"4","author":"GE Henderson","year":"2007","unstructured":"Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, et al. Clinical trials and medical care: defining the therapeutic misconception. PLoS Med. 2007;4(11):e324.","journal-title":"PLoS Med"},{"issue":"6","key":"441_CR10","doi-asserted-by":"publisher","first-page":"625","DOI":"10.1111\/tmi.12288","volume":"19","author":"MO Afolabi","year":"2014","unstructured":"Afolabi MO, Okebe JU, McGrath N, Larson HJ, Bojang K, Chandramohan D. Informed consent comprehension in African research settings. Tropical Med Int Health. 2014;19(6):625\u201342.","journal-title":"Tropical Med Int Health"},{"issue":"3","key":"441_CR11","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 (London, England). 2006;3(3):306\u201313.","journal-title":"Clin Trials (London, England)"},{"issue":"12","key":"441_CR12","doi-asserted-by":"publisher","first-page":"2547","DOI":"10.1016\/j.socscimed.2004.03.037","volume":"59","author":"CS Molyneux","year":"2004","unstructured":"Molyneux CS, Peshu N, Marsh K. Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast. Soc Sci Med (1982). 2004;59(12):2547\u201359.","journal-title":"Soc Sci Med (1982)"},{"issue":"1","key":"441_CR13","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1111\/j.1471-8847.2006.00134.x","volume":"6","author":"AA Hyder","year":"2006","unstructured":"Hyder AA, Wali SA. Informed consent and collaborative research: perspectives from the developing world. Dev World Bioeth. 2006;6(1):33\u201340.","journal-title":"Dev World Bioeth"},{"issue":"6","key":"441_CR14","doi-asserted-by":"publisher","first-page":"356","DOI":"10.1136\/medethics-2011-100178","volume":"38","author":"A Mandava","year":"2012","unstructured":"Mandava A, Pace C, Campbell B, Emanuel E, Grady C. The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries. J Med Ethics. 2012;38(6):356\u201365.","journal-title":"J Med Ethics"},{"key":"441_CR15","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1016\/j.eclinm.2018.06.004","volume":"1","author":"Marta S. Palmeirim","year":"2018","unstructured":"Palmeirim MS, Ame SM, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of a single dose versus a multiple dose regimen of mebendazole against hookworm infections in children: a randomised, double-blind trial. E Clin Med. 2018;1:7.13.","journal-title":"EClinicalMedicine"},{"issue":"1","key":"441_CR16","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1111\/j.2517-6161.1995.tb02031.x","volume":"57","author":"Y Benjamini","year":"1995","unstructured":"Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc Ser B Methodol. 1995;57(1):289\u2013300.","journal-title":"J R Stat Soc Ser B Methodol"},{"issue":"1","key":"441_CR17","doi-asserted-by":"publisher","first-page":"359","DOI":"10.1007\/s13524-011-0077-5","volume":"49","author":"D Filmer","year":"2012","unstructured":"Filmer D, Scott K. Assessing asset indices. Demography. 2012;49(1):359\u201392.","journal-title":"Demography"},{"key":"441_CR18","unstructured":"The United Republic of Tanzania. Population and Housing Census: Basic Demographic and Socio-Economic Profile. National Bureau of Statistics, Ministry of Finance, Dar es Salaam and Office of Chief Government Statistician, Ministry of State, President\u2019s Office, State House and Good Governance, Zanzibar, 2014. http:\/\/tanzania.countrystat.org\/fileadmin\/user_upload\/countrystat_fenix\/congo\/docs\/2012%20Tanzania%20Population%20and%20Housing%20Census-Basic%20Demographic%20and%20Socio-Economic%20Profile.pdf."},{"issue":"9","key":"441_CR19","doi-asserted-by":"publisher","first-page":"447","DOI":"10.1258\/jrsm.2008.080149","volume":"101","author":"A Colledge","year":"2008","unstructured":"Colledge A, Car J, Donnelly A, Majeed A. Health information for patients: time to look beyond patient information leaflets. J R Soc Med. 2008;101(9):447\u201353.","journal-title":"J R Soc Med"},{"issue":"1","key":"441_CR20","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1016\/j.surge.2015.09.001","volume":"15","author":"N Bowers","year":"2017","unstructured":"Bowers N, Eisenberg E, Montbriand J, Jaskolka J, Roche-Nagle G. Using a multimedia presentation to improve patient understanding and satisfaction with informed consent for minimally invasive vascular procedures. Surgeon. 2017;15(1):7\u201311.","journal-title":"Surgeon"},{"issue":"5","key":"441_CR21","doi-asserted-by":"publisher","first-page":"262","DOI":"10.4103\/0970-258X.234392","volume":"30","author":"BH Figer","year":"2017","unstructured":"Figer BH, Chaturvedi M, Thaker SJ, Gogtay NJ, Thatte UM. A comparative study of the informed consent process with or without audio-visual recording. Natl Med J India. 2017;30(5):262\u20135.","journal-title":"Natl Med J India"},{"key":"441_CR22","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1016\/j.ahj.2018.03.006","volume":"200","author":"B Lattuca","year":"2018","unstructured":"Lattuca B, Barber-Chamoux N, Alos B, Sfaxi A, Mulliez A, Miton N, Levasseur T, Servoz C, Derimay F, Hachet O, et al. Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: a randomized trial. Am Heart J. 2018;200:67\u201374.","journal-title":"Am Heart J"},{"issue":"7","key":"441_CR23","doi-asserted-by":"publisher","first-page":"1463","DOI":"10.1016\/j.socscimed.2004.11.073","volume":"61","author":"CS Molyneux","year":"2005","unstructured":"Molyneux CS, Peshu N, Marsh K. Trust and informed consent: insights from community members on the Kenyan coast. Soc Sci Med (1982). 2005;61(7):1463\u201373.","journal-title":"Soc Sci Med (1982)"},{"issue":"10","key":"441_CR24","doi-asserted-by":"publisher","first-page":"e110139","DOI":"10.1371\/journal.pone.0110139","volume":"9","author":"D Purcaru","year":"2014","unstructured":"Purcaru D, Preda A, Popa D, Moga MA, Rogozea L. Informed consent: how much awareness is there? PLoS One. 2014;9(10):e110139.","journal-title":"PLoS One"},{"issue":"4","key":"441_CR25","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, Assadou MH, Kone M, Kamate B, Guindo O, 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":"5","key":"441_CR26","doi-asserted-by":"publisher","first-page":"1010","DOI":"10.1111\/bcp.12716","volume":"80","author":"A Paris","year":"2015","unstructured":"Paris A, Deygas B, Cornu C, Thalamas C, Maison P, Duale C, Kane M, Hodaj E, Cracowski JL. Improved informed consent documents for biomedical research do not increase patients\u2019 understanding but reduce enrolment: a study in real settings. Br J Clin Pharmacol. 2015;80(5):1010\u201320.","journal-title":"Br J Clin Pharmacol"},{"issue":"5","key":"441_CR27","doi-asserted-by":"crossref","first-page":"560","DOI":"10.1097\/01.qai.0000247225.37752.f5","volume":"43","author":"G Lindegger","year":"2006","unstructured":"Lindegger G, Milford C, Slack C, Quayle M, Xaba X, Vardas E. Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa. J Acquir Immune Defic syndr (1999). 2006;43(5):560\u20136.","journal-title":"J Acquir Immune Defic syndr (1999)"}],"container-title":["BMC Medical Ethics"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12910-019-0441-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12910-019-0441-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12910-019-0441-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T20:12:55Z","timestamp":1722283975000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmedethics.biomedcentral.com\/articles\/10.1186\/s12910-019-0441-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1,6]]},"references-count":27,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["441"],"URL":"https:\/\/doi.org\/10.1186\/s12910-019-0441-3","relation":{},"ISSN":["1472-6939"],"issn-type":[{"value":"1472-6939","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1,6]]},"assertion":[{"value":"5 April 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 December 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 January 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was approved by the the Zanzibar Medical Research and Ethical Committee (ZAMREC, reference number 0002\/May\/17) and the Ethics Committee of Northern and Central Switzerland (EKNZ, reference number 2017\u201300320). All participants provided written informed consent.","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":"1"}}