{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T02:14:42Z","timestamp":1787019282915,"version":"build-2736575974"},"reference-count":51,"publisher":"SAGE Publications","issue":"1-2","license":[{"start":{"date-parts":[[2021,8,19]],"date-time":"2021-08-19T00:00:00Z","timestamp":1629331200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000049","name":"National Institute on Aging","doi-asserted-by":"publisher","award":["R01AG058254"],"award-info":[{"award-number":["R01AG058254"]}],"id":[{"id":"10.13039\/100000049","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","award":["UL1TR002345"],"award-info":[{"award-number":["UL1TR002345"]}],"id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Empirical Research on Human Research Ethics"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:p>Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.<\/jats:p>","DOI":"10.1177\/15562646211037546","type":"journal-article","created":{"date-parts":[[2021,8,19]],"date-time":"2021-08-19T08:50:10Z","timestamp":1629363010000},"page":"177-192","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":13,"title":["Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials"],"prefix":"10.1177","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3295-0698","authenticated-orcid":false,"given":"Erin D.","family":"Solomon","sequence":"first","affiliation":[{"name":"Washington University School of Medicine, St Louis, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Mozersky","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, St Louis, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew P.","family":"Wroblewski","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, St Louis, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kari","family":"Baldwin","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, St Louis, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meredith V.","family":"Parsons","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, St Louis, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8932-624X","authenticated-orcid":false,"given":"Melody","family":"Goodman","sequence":"additional","affiliation":[{"name":"New York University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James M.","family":"DuBois","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine, St Louis, MO, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,8,19]]},"reference":[{"key":"bibr1-15562646211037546","doi-asserted-by":"publisher","DOI":"10.2307\/3564117"},{"key":"bibr2-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1016\/0749-5978(91)90020-T"},{"key":"bibr3-15562646211037546","unstructured":"Association of American Medical Colleges. (2020). AAMC Medical School Members. https:\/\/members.aamc.org\/eweb\/DynamicPage.aspx?site=AAMC&webcode=AAMCOrgSearchResult&orgtype=Medical%20School."},{"key":"bibr4-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.10.3341"},{"key":"bibr5-15562646211037546","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-155-2-201107190-00005"},{"key":"bibr6-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1016\/S0738-3991(03)00162-9"},{"key":"bibr7-15562646211037546","doi-asserted-by":"publisher","DOI":"10.17265\/2159-5313\/2016.09.003"},{"key":"bibr8-15562646211037546","volume-title":"Research design: Qualitative, quantitative, and mixed methods approaches","author":"Creswell J. 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(2011).\n                      How to Write Clearly\n                      . https:\/\/doi.org\/10.2782\/29211."},{"key":"bibr13a-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1097\/ACM.0000000000001966"},{"key":"bibr13b-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1007\/s11948-015-9681-x"},{"key":"bibr13c-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1007\/s11948-015-9667-8"},{"key":"bibr13d-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1007\/s11948-017-9896-0"},{"key":"bibr14-15562646211037546","volume-title":"A history and theory of informed consent","author":"Faden R. R.","year":"1986"},{"key":"bibr15-15562646211037546","unstructured":"Fixsen D., Naoom S. F., Blase K. A., Friedman R. M., Wallace F. 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(2005).\n                      National Assessment of Adult Literacy (NAAL)\n                      . https:\/\/nces.ed.gov\/NAAL\/PDF\/2006470.PDF."},{"key":"bibr28-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12253"},{"key":"bibr29-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2017.296"},{"issue":"3","key":"bibr30-15562646211037546","first-page":"229","volume":"13","author":"Leiner D. J.","year":"2019","journal-title":"Survey Research Methods"},{"key":"bibr31-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1007\/s10488-007-0144-9"},{"key":"bibr32-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1111\/jnu.12097"},{"key":"bibr33-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2020.1"},{"key":"bibr34-15562646211037546","unstructured":"National Institute on Aging. (2019). Alzheimer\u2019s Disease Research Centers. https:\/\/www.nia.nih.gov\/health\/alzheimers-disease-research-centers."},{"key":"bibr35-15562646211037546","unstructured":"National Institutes of Health. (2019). Inclusion across the lifespan. https:\/\/grants.nih.gov\/policy\/inclusion\/lifespan.htm."},{"key":"bibr36-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6939-14-28"},{"issue":"4","key":"bibr37-15562646211037546","first-page":"12","volume":"35","author":"Paasche-Orlow M. K.","year":"2013","journal-title":"IRB: A Review of Human Subjects Research"},{"key":"bibr38-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-349-12582-1_9"},{"key":"bibr39-15562646211037546","unstructured":"The Plain Language Action and Information Network. (2011). Federal Plain Language Guidelines. https:\/\/www.plainlanguage.gov\/guidelines\/."},{"key":"bibr40-15562646211037546","unstructured":"Plain Language Association International. (2008). PLAIN. plainlanguagenetwork.org."},{"key":"bibr41-15562646211037546","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-148-6-200803180-00005"},{"key":"bibr42-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1080\/07317115.2016.1201714"},{"key":"bibr43-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1097\/JGP.0b013e3181dd1c3b"},{"key":"bibr44-15562646211037546","volume-title":"The coding manual for qualitative researchers","author":"Salda\u00f1a J.","year":"2016","edition":"3"},{"key":"bibr45-15562646211037546","unstructured":"The Secretary's Advisory Committee on Human Research Protections. (2018).\n                      New \u201cKey Information\u201d Informed Consent Requirements\n                      . https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/attachment-c-november-13-2018\/index.html."},{"key":"bibr46-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1067\/mno.2001.120517"},{"key":"bibr47-15562646211037546","doi-asserted-by":"publisher","DOI":"10.1111\/j.1532-5415.2011.03847.x"}],"container-title":["Journal of Empirical Research on Human Research Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15562646211037546","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/15562646211037546","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15562646211037546","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T00:38:44Z","timestamp":1777509524000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/15562646211037546"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8,19]]},"references-count":51,"journal-issue":{"issue":"1-2","published-print":{"date-parts":[[2022,2]]}},"alternative-id":["10.1177\/15562646211037546"],"URL":"https:\/\/doi.org\/10.1177\/15562646211037546","relation":{},"ISSN":["1556-2646","1556-2654"],"issn-type":[{"value":"1556-2646","type":"print"},{"value":"1556-2654","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,8,19]]}}}