{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:12:16Z","timestamp":1777543936182,"version":"3.51.4"},"reference-count":17,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2013,12,2]],"date-time":"2013-12-02T00:00:00Z","timestamp":1385942400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2014,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Methods for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The format of the ICAI was based on the language and structure of the United States National Cancer Institute\u2019s IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p &gt; 0.07). When the responses to the first and the second ICAI questions were compared, 15% or more of participants had conflicting answers to 5 of the 10 questions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Limitations<\/jats:title>\n                    <jats:p>The ICAI uses dichotomous responses, leading to a 50% chance of guessing the correct answers. Two questions were asked only of women. Finally, only 6 of the 10 questions on the current version of the ICAI apply to most trials; others are trial-specific.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The ICAI may be adapted to an individual trial and may prove to be a useful tool following a consent discussion to identify issues not fully understood by the research participants, thus prompting study staff to re-explain topics, possibly in a more elementary manner.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1740774513509316","type":"journal-article","created":{"date-parts":[[2013,12,2]],"date-time":"2013-12-02T22:08:25Z","timestamp":1386022105000},"page":"70-76","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":19,"title":["Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process"],"prefix":"10.1177","volume":"11","author":[{"given":"Fernanda","family":"Mexas","sequence":"first","affiliation":[{"name":"Departmento de Cl\u00ednica M\u00e9dica, Instituto de Doen\u00e7as do T\u00f3rax, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Efron","sequence":"additional","affiliation":[{"name":"Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronir Raggio","family":"Luiz","sequence":"additional","affiliation":[{"name":"Departamento de Bioestat\u00edstica, Instituto de Estudos em Sa\u00fade Coletiva, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle","family":"Cailleaux-Cezar","sequence":"additional","affiliation":[{"name":"Departmento de Cl\u00ednica M\u00e9dica, Instituto de Doen\u00e7as do T\u00f3rax, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard E","family":"Chaisson","sequence":"additional","affiliation":[{"name":"Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcus B","family":"Conde","sequence":"additional","affiliation":[{"name":"Departmento de Cl\u00ednica M\u00e9dica, Instituto de Doen\u00e7as do T\u00f3rax, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2013,12,2]]},"reference":[{"key":"bibr1-1740774513509316","unstructured":"US Government Printing Office. 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Available at: http:\/\/www.wma.net\/en\/30publications\/10policies\/b3\/"},{"key":"bibr5-1740774513509316","unstructured":"The Council for International Organization of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. Available at: http:\/\/www.cioms.ch\/publications\/layout_guide2002.pdf (2002, accessed 20 August 2010)."},{"key":"bibr6-1740774513509316","first-page":"15","volume":"4","author":"Minist\u00e9rio da Sa\u00fade Conselho Nacional de Sa\u00fade","year":"1996","journal-title":"Bio\u00e9tica"},{"key":"bibr7-1740774513509316","unstructured":"Laporte JR. Princ\u00edpios b\u00e1sicos de investigaci\u00f3n cl\u00ednica: el ensayo cl\u00ednico controlado. Barcelona, Astrazeneca, 2001, pp. 43\u201347."},{"key":"bibr8-1740774513509316","first-page":"57","volume-title":"Consentimento informado e sua pr\u00e1tica na assist\u00eancia e pesquisa no Brasil","author":"Clotet J","year":"2000"},{"key":"bibr9-1740774513509316","doi-asserted-by":"publisher","DOI":"10.1001\/jama.292.13.1593"},{"key":"bibr10-1740774513509316","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1497.2006.00535.x"},{"key":"bibr11-1740774513509316","doi-asserted-by":"publisher","DOI":"10.1002\/j.1875-9114.1996.tb03004.x"},{"key":"bibr12-1740774513509316","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.57.6.533"},{"key":"bibr13-1740774513509316","doi-asserted-by":"publisher","DOI":"10.1093\/geront\/47.1.69"},{"key":"bibr14-1740774513509316","doi-asserted-by":"crossref","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 6(10): 1\u201310. Available at: http:\/\/www.plosone.org (2011, accessed 16 February 2012).","DOI":"10.1371\/journal.pone.0022696"},{"key":"bibr15-1740774513509316","unstructured":"Dorman SE. A phase II randomized, open-label trial of a rifapentine plus moxifloxacin-based regimen for intensive phase treatment of smear-positive pulmonary tuberculosis. 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