A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent.
A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent.
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基于REDCAP的电子同意模型（ECONTENT）：朝着更个性化的同意迈进。
DOI：
10.1017/cts.2020.30
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发表时间：
2020-04-03
影响因子：
2.6
通讯作者：
Harris PA
中科院分区：
文献类型：
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作者：
Lawrence CE;Dunkel L;McEver M;Israel T;Taylor R;Chiriboga G;Goins KV;Rahn EJ;Mudano AS;Roberson ED;Chambless C;Wadley VG;Danila MI;Fischer MA;Joosten Y;Saag KG;Allison JJ;Lemon SC;Harris PA
对于人类受试者研究，最新的通用规则要求同意书“以‘简明扼要’的关键信息开始，这些信息最有可能帮助某人决定是否参加研究”（Menikoff, Kaneshiro, Pritchard）。《新英格兰医学杂志》2017；376(7): 613 - 615)。我们利用社区参与的技术开发方法，在REDCap软件平台中提供以电子同意（eConsent）的收集和存储为中心的功能选项，以解决知情同意的透明度、临床试验效率和法规遵从性问题（Harris等）。生物医学信息学杂志2009；42(2): 377 - 381)。eConsent还可以通过解决以下问题来改善临床研究的招募和保留：(1)通过促进远程同意来访问农村人口的障碍；(2)通过包括可选的解释材料（例如，用光标悬停在术语上定义术语）或根据参与者的种族、民族或教育水平选择显示不同的视频/图像来解决文化和识字障碍（Phillippi等）。产科、妇科和新生儿护理杂志。2018；47(4): 529 - 534)。我们开发了eConsent框架并对其进行了试点测试，以提供个性化的同意体验，用户可以通过使用头像、上下文术语表信息补充和视频的同意文档进行指导，以促进信息交流。eConsent框架包括八个功能组合，由社区利益相关者审查，并在两个学术医疗中心进行了测试。这个eConsent框架的早期采用和使用已经证明是可接受的。接下来的步骤将强调测试功能的有效性，以提高参与者在同意过程中的参与度。
The updated common rule, for human subjects research, requires that consents “begin with a ‘concise and focused’ presentation of the key information that will most likely help someone make a decision about whether to participate in a study” (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613–615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377–381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant’s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529–534.). We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.
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DOI：
10.1097/acm.0000000000000794
发表时间：
2015-12
期刊：
Academic medicine : journal of the Association of American Medical Colleges
影响因子：
--
作者：
Joosten YA;Israel TL;Williams NA;Boone LR;Schlundt DG;Mouton CP;Dittus RS;Bernard GR;Wilkins CH
通讯作者：
Wilkins CH
DOI：
10.1177/1740774515594362
发表时间：
2015-12
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Lorell BH;Mikita JS;Anderson A;Hallinan ZP;Forrest A
通讯作者：
Forrest A
影响因子：
39.2
作者：
Houston, Thomas K.;Allison, Jeroan J.;Hullett, Sandral
通讯作者：
Hullett, Sandral
影响因子：
2.2
作者：
Schallhorn, Steven C.;Hannan, Stephen J.;Schallhorn, Julie M.
通讯作者：
Schallhorn, Julie M.
影响因子：
6.2
作者：
Koyfman, Shlomo A.;Reddy, Chandana A.;Kodish, Eric D.
通讯作者：
Kodish, Eric D.