基于REDCap的工作流程评估，以支持联邦电子知情同意指南
Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent.
作者信息
Chen Cindy, Turner Scott P, Sholle Evan T, Brown Scott W, Blau Vanessa L I, Brouwer Julianna P, Lewis Alicia N, Cole Curtis L, Nanus David M, Shah Manish A, Leonard John P, Campion Thomas R
机构信息
Information Technologies & Services Department, Weill Cornell Medicine, New York, NY.
Department of Medicine, Weill Cornell Medicine, New York, NY.
出版信息
AMIA Jt Summits Transl Sci Proc. 2019 May 6;2019:163-172. eCollection 2019.
Adoption of electronic informed consent (eConsent) for research remains low despite evidence of improved patient comprehension, usability, and workflow processes compared to paper. At our institution, we implemented an eConsent workflow using REDCap, a widely used electronic data capture system. The goal of this study was to evaluate the extent to which the REDCap eConsent solution adhered to federal guidance for eConsent. Of 29 requirements derived from sixteen recommendations from the United States Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA), the REDCap eConsent solution supported 24 (86%). To the best of our knowledge, this is among the first studies to evaluate an eConsent approach's support for federal guidance. Findings suggest use of REDCap may help other institutions overcome barriers to eConsent adoption, and that OHRP and FDA expand guidance to recommend eConsent solutions integrate with enterprise clinical and research information systems.
尽管有证据表明，与纸质知情同意书相比，电子知情同意书（eConsent）在患者理解、可用性和工作流程方面有所改进，但研究中电子知情同意书的采用率仍然很低。在我们机构，我们使用广泛应用的电子数据采集系统REDCap实施了一种电子知情同意书工作流程。本研究的目的是评估REDCap电子知情同意书解决方案符合联邦电子知情同意书指南的程度。从美国人类研究保护办公室（OHRP）和食品药品监督管理局（FDA）的16项建议中得出29项要求，REDCap电子知情同意书解决方案支持其中24项（86%）。据我们所知，这是最早评估电子知情同意书方法对联邦指南支持情况的研究之一。研究结果表明，使用REDCap可能有助于其他机构克服采用电子知情同意书的障碍，并且OHRP和FDA应扩大指南范围，建议电子知情同意书解决方案与企业临床和研究信息系统集成。
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