{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T09:35:03Z","timestamp":1791365703582,"version":"4.3.1"},"reference-count":24,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"<jats:sec><jats:title>Importance<\/jats:title><jats:p>Few studies are available on informed consent (IC) among detained persons, even with ethics being a critical aspect of prison research. In IC research, audiovisual material seems to improve understanding and satisfaction compared with conventional paper-based material, but findings remain unclear.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To compare audiovisual and paper-based materials for 1-time general IC for research in prisons.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>This cross-sectional randomized clinical trial was conducted in 2 corrections facilities in Switzerland (an adult prison and a juvenile detention center). The study was conducted from December 14, 2019, to December 2, 2020, in the adult prison and from January 15, 2020, to September 9, 2021, in the juvenile detention center. In the adult prison, study participation was offered to detained persons visiting the medical unit (response rate, 84.7%). In the juvenile detention center, all newly incarcerated adolescents were invited to participate (response rate, 98.0%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Participants were randomized to receive paper-based conventional material or to watch a 4-minute video. Materials included the same legal information, as required by the Swiss Federal Act on Research Involving Human Beings.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>The main outcome was acceptance to sign the IC form. Secondary outcomes included understanding, evaluation, and time to read or watch the IC material.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The study included 190 adults (mean [SD] age,\u200935.0 [11.8] years; 190 [100%] male) and 100 adolescents (mean [SD] age, 16.0 [1.1] years; 83 [83.0%] male). In the adult prison, no significant differences were found between groups in acceptance to sign the IC form (77 [81.1%] for paper-based material and 81 [85.3%] for audiovisual material; <jats:italic>P<\/jats:italic>\u2009=\u2009.39) and to evaluate it (mean [SD] correct responses, 5.09 [1.13] for paper-based material and 5.01 [1.07] for audiovisual material; <jats:italic>P<\/jats:italic>\u2009=\u2009.81). Understanding was significantly higher in the audiovisual material group (mean [SD] correct responses, 5.09 [1.84]) compared with the paper-based material group (mean [SD] correct responses, 4.61 [1.70]; <jats:italic>P<\/jats:italic>\u2009=\u2009.04). In the juvenile detention center, individuals in the audiovisual material group were more likely to sign the IC form (44 [89.8%]) than the paper-based material group (35 [68.6%], <jats:italic>P<\/jats:italic>\u2009=\u2009.006). No significant difference was found between groups for understanding and evaluation. Adults took a mean (SD) of 5 (2) minutes to read the paper material, and adolescents took 7 (3) minutes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Relevance<\/jats:title><jats:p>Given the small benefit of audiovisual material, these findings suggest that giving detained adults and prison health care staff a choice regarding IC material is best. For adolescents, audiovisual material should be provided. Future studies should focus on increasing understanding of the IC process.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/show\/NCT05505058\">NCT05505058<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2022.35888","type":"journal-article","created":{"date-parts":[[2022,10,11]],"date-time":"2022-10-11T15:05:20Z","timestamp":1665500720000},"page":"e2235888","source":"Crossref","is-referenced-by-count":12,"title":["Comparison of Audiovisual and Paper-Based Materials for 1-Time Informed Consent for Research in Prison"],"prefix":"10.1001","volume":"5","author":[{"given":"St\u00e9phanie","family":"Baggio","sequence":"first","affiliation":[{"name":"Division of Prison Health, Geneva University Hospitals & University of Geneva, Geneva, Switzerland"},{"name":"Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"G\u00e9taz","sequence":"additional","affiliation":[{"name":"Division of Prison Health, Geneva University Hospitals & University of Geneva, Geneva, Switzerland"},{"name":"Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauriane","family":"Giraudier","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of Geneva, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lilian","family":"Tirode","sequence":"additional","affiliation":[{"name":"Division of Prison Health, Geneva University Hospitals & University of Geneva, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Urrutxi","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of Geneva, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Carboni","sequence":"additional","affiliation":[{"name":"Clinical Research Center, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurore","family":"Britan","sequence":"additional","affiliation":[{"name":"Clinical Research Center, Geneva University Hospitals, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robbie l\u2019Anson","family":"Price","sequence":"additional","affiliation":[{"name":"Geneva Finance Research Institute, University of Geneva, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Wolff","sequence":"additional","affiliation":[{"name":"Division of Prison Health, Geneva University Hospitals & University of Geneva, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Heller","sequence":"additional","affiliation":[{"name":"Division of Prison Health, Geneva University Hospitals & University of Geneva, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2022,10,11]]},"reference":[{"issue":"1","key":"zoi221011r1","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1186\/s12914-018-0180-4","article-title":"Words matter: a call for humanizing and respectful language to describe people who experience incarceration.","volume":"18","author":"Tran","year":"2018","journal-title":"BMC Int Health Hum Rights"},{"issue":"9769","key":"zoi221011r2","doi-asserted-by":"publisher","first-page":"956","DOI":"10.1016\/S0140-6736(10)61053-7","article-title":"The health of prisoners.","volume":"377","author":"Fazel","year":"2011","journal-title":"Lancet"},{"issue":"9","key":"zoi221011r3","doi-asserted-by":"publisher","first-page":"871","DOI":"10.1016\/S2215-0366(16)30142-0","article-title":"Mental health of prisoners: prevalence, adverse outcomes, and interventions.","volume":"3","author":"Fazel","year":"2016","journal-title":"Lancet Psychiatry"},{"issue":"9","key":"zoi221011r4","doi-asserted-by":"publisher","first-page":"862","DOI":"10.1001\/journalofethics.2017.19.9.peer3-1709","article-title":"\u201cTeach-to-goal\u201d to better assess informed consent comprehension among incarcerated clinical research participants.","volume":"19","author":"Ahalt","year":"2017","journal-title":"AMA J Ethics"},{"issue":"2A","key":"zoi221011r5","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1353\/hpu.2016.0051","article-title":"A call to action: a blueprint for academic health sciences in the era of mass incarceration.","volume":"27","author":"Ferguson","year":"2016","journal-title":"J Health Care Poor Underserved"},{"issue":"2","key":"zoi221011r6","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1002\/hast.2017.47.issue-2","article-title":"Enrolling in clinical research while incarcerated: what influences participants\u2019 decisions?","volume":"47","author":"Christopher","year":"2017","journal-title":"Hastings Cent Rep"},{"issue":"4","key":"zoi221011r7","doi-asserted-by":"publisher","first-page":"246","DOI":"10.1136\/medethics-2012-101059","article-title":"Prisoners as research participants: current practice and attitudes in the UK.","volume":"42","author":"Charles","year":"2016","journal-title":"J Med Ethics"},{"issue":"4","key":"zoi221011r8","doi-asserted-by":"publisher","first-page":"184","DOI":"10.1080\/17449200802473107","article-title":"Ethics in research involving prisoners.","volume":"4","author":"Pont","year":"2008","journal-title":"Int J Prison Health"},{"issue":"1","key":"zoi221011r10","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.comppsych.2003.09.009","article-title":"Coercion and informed consent in research involving prisoners.","volume":"45","author":"Moser","year":"2004","journal-title":"Compr Psychiatry"},{"issue":"3","key":"zoi221011r11","doi-asserted-by":"publisher","first-page":"420","DOI":"10.1016\/j.amjsurg.2009.02.010","article-title":"Informed consent: how much and what do patients understand?","volume":"198","author":"Falagas","year":"2009","journal-title":"Am J Surg"},{"issue":"2","key":"zoi221011r12","doi-asserted-by":"publisher","first-page":"117","DOI":"10.2149\/tmh.2014-36","article-title":"Understanding of essential elements required in informed consent form among researchers and institutional review board members.","volume":"43","author":"Koonrungsesomboon","year":"2015","journal-title":"Trop Med Health"},{"issue":"1","key":"zoi221011r13","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1016\/j.pec.2013.08.019","article-title":"Systematic review and meta-analysis of audio-visual information aids for informed consent for invasive healthcare procedures in clinical practice.","volume":"94","author":"Farrell","year":"2014","journal-title":"Patient Educ Couns"},{"issue":"1","key":"zoi221011r14","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1186\/s12910-021-00585-8","article-title":"Digital tools in the informed consent process: a systematic review.","volume":"22","author":"Gesualdo","year":"2021","journal-title":"BMC Med Ethics"},{"issue":"5","key":"zoi221011r15","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD003717.pub3","article-title":"Audio-visual presentation of information for informed consent for participation in clinical trials.","author":"Synnot","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"issue":"20","key":"zoi221011r16","doi-asserted-by":"publisher","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.","volume":"310","author":"World Medical Association","year":"2013","journal-title":"JAMA"},{"issue":"7540","key":"zoi221011r17","doi-asserted-by":"publisher","first-page":"544","DOI":"10.1136\/bmj.332.7540.544","article-title":"One-time general consent for research on biological samples.","volume":"332","author":"Wendler","year":"2006","journal-title":"BMJ"},{"issue":"5","key":"zoi221011r19","doi-asserted-by":"publisher","first-page":"561","DOI":"10.1007\/s11606-008-0520-5","article-title":"Validation of screening questions for limited health literacy in a large VA outpatient population.","volume":"23","author":"Chew","year":"2008","journal-title":"J Gen Intern Med"},{"issue":"4","key":"zoi221011r20","doi-asserted-by":"publisher","first-page":"289","DOI":"10.1016\/0197-2456(88)90045-1","article-title":"Statistical properties of randomization in clinical trials.","volume":"9","author":"Lachin","year":"1988","journal-title":"Control Clin Trials"},{"issue":"0","key":"zoi221011r22","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/01621459.2021.1981338","article-title":"Model-robust inference for clinical trials that improve precision by stratified randomization and covariate adjustment.","volume":"0","author":"Wang","year":"2021","journal-title":"J Am Stat Assoc"},{"issue":"4","key":"zoi221011r23","doi-asserted-by":"publisher","first-page":"329","DOI":"10.1037\/ppm0000203","article-title":"Trends in U.S. adolescents\u2019 media use, 1976\u20132016: the rise of digital media, the decline of TV, and the (near) demise of print.","volume":"8","author":"Twenge","year":"2019","journal-title":"Psychology of Popular Media Culture"},{"issue":"5","key":"zoi221011r24","doi-asserted-by":"publisher","first-page":"911","DOI":"10.1542\/peds.2010-1443","article-title":"Educational effectiveness of an HIV pretest video for adolescents: a randomized controlled trial.","volume":"127","author":"Calderon","year":"2011","journal-title":"Pediatrics"},{"key":"zoi221011r21","author":"Kelsey","year":"1996"},{"key":"zoi221011r9","unstructured":"van Westendorp? M. Walk the line [masterpaper]. University of Leuven. 2017. Accessed September 3, 2022. https:\/\/www.scriptiebank.be\/sites\/default\/files\/thesis\/2017-10\/Masterpaper%20-%20Research%20Involving%20Prisoners%20-%20Scriptieprijs_0.pdf"},{"key":"zoi221011r18","unstructured":"Robbie I\u2019Anson Price webpage. Accessed September 3, 2022. https:\/\/www.lostlikebeesinrain.com"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2797193\/baggio_2022_oi_221011_1664551392.29889.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,11]],"date-time":"2022-10-11T15:05:23Z","timestamp":1665500723000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2797193"}},"subtitle":["A Randomized Clinical Trial"],"short-title":[],"issued":{"date-parts":[[2022,10,11]]},"references-count":24,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2022,10,3]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2022.35888","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,11]]}}}