Teleconsent: Enabling informed consent for remote care and research

远程同意：为远程护理和研究提供知情同意

• 批准号: 10654869
• 负责人: Brandon M Welch
• 金额: $ 86.8万
• 依托单位: DOXY.ME, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10654869
• 关键词: Academia; Agreement; COVID-19 pandemic; Caring; Clinical; Clinical Research; Coercion; Collaborations; Communication; Comprehension; Computer software; Confusion; Consent; Consent Forms; Development; Engineering; Equipoise; Ethics; Feedback; Goals; Grant; Health; Health Personnel; Healthcare; Hybrids; Individual; Industry; Informed Consent; Legal; Licensing; Measures; Medical; Methods; Outcome; Participant; Patients; Performance; Persons; Phase; Process; Provider; Research; Research Personnel; Respondent; Risk; Security; Services; Small Business Technology Transfer Research; South Carolina; Telemedicine; Testing; Time; Travel; Universities; Volition; Work; base; cost; decision research; design; experience; handheld mobile device; improved; innovation; novel; preference; pressure; programs; prospective; prototype; recruit; remote consent; remote health care; response; sociodemographics; success; teleconsent; undue influence; usability; virtual consent

PROJECT SUMMARY . Informed consent is legal and ethical requirement in health care and research that assures that individuals have the autonomy to make informed care and research decisions at their own volition, under no coercion or undue influence, and with reasonable understanding of the risks, benefits, and responsibilities of their decisions as they would in-person. Obtaining informed consent is a required yet challenging requirement that can impede participation in health care and clinical research. As a result of the COVID-19 pandemic, telemedicine has proven to be an effective way to deliver health and research services to patients remotely. Yet, providers and researchers (“consenters”) are still required to obtain and document informed consent from patients and research participants (“consentees”). Conventional informed consent approaches are not compatible with telemedicine presenting logistical, technical and security barriers such as travel and cost burdens, low comprehension, confusion and dissatisfaction, alterations in clinical workflows, compliance challenges, and concern over clinical equipoise. Teleconsent is an innovative and proven solution for obtaining remote informed consent developed by Doxy.me, Inc and Medical University of South Carolina. Teleconsent allows consenters to (1) meet and discuss the informed consent by video with consentees over a telemedicine platform, (2) share and collaboratively complete the consent document in real-time, and (3) generate electronically signed copies of the consent for immediate download by both parties. Our Phase I STTR research identified enhancements such as an improved mobile interface, interface for consenters to build and manage consent forms, and the ability for consentees to read consent forms in advance. Optimizing teleconsent to meet the demands of its users is critical, especially during these unprecedented times of the COVID-19 pandemic when most individuals engage in remote care and research. The objective of this Phase II proposal is to refine and expand teleconsent features and deploy them on a large-scale via doxy.me. To achieve this objective, we will refine prototype teleconsent enhancements via iterative user experience assets design and evaluate them employing formal usability methods (Aim 1); build an enhanced, scalable teleconsent interface using Large-Scale Scrum principles and test the new teleconsent features via a formal user acceptance testing program (Aim 2); and implement teleconsent at a large scale with doxy.me providers and researchers to determine performance and measure impact using quantitative metrics for success (Aim 3). Achieving these aims to expand teleconsent features and conduct a large-scale implementation will increase the capacity of consenters to improve the efficiency of the remote informed consent, which will improve recruitment, simplify consent workflows, and enhance telemedicine engagement.

项目摘要。 知情同意是医疗保健和研究中的法律和道德要求，可以确保个人 具有自主权，以自己的意愿做出明智的护理和研究决定，没有强制或 剥夺影响，并合理理解其风险，福利和责任 他们会像面对面的决定。获得知情同意是必需的挑战要求 可以阻碍参与医疗保健和临床研究。由于Covid-19大流行的结果， 事实证明，远程医疗是向患者提供健康和研究服务的有效方法。 但是，仍需要提供者和研究人员（“同意”）获得并记录知情同意书 来自患者和研究参与者（“同意”）。传统知情同意方法不是 与远程医疗兼容，呈现后勤，技术和安全障碍，例如旅行和成本 伯伦斯，低理解，混乱和不满，临床工作流程的改变，合规性 挑战和对临床平衡的关注。电信是一种创新且可靠的解决方案 获得由Doxy.me，Inc和南卡罗来纳州医科大学开发的远程知情同意。 电信允许（1）与同意者在 远程医疗平台（2）共享和协作实时完成同意文件，（3） 生成同意书的电子签名副本，以立即由双方下载。我们的第一阶段 STTR研究确定了增强功能，例如改进的移动界面，界面的同意界面 构建和管理同意书，以及同意书提前阅读同意书的能力。优化 满足用户需求的电信至关重要，尤其是在这些前所未有的时期 当大多数人从事远程护理和研究时，Covid-19-大流行。这个阶段的目的 II提案是完善和扩展电信功能，并将其部署在大规模的Doxy.me中。到 实现这一目标，我们将通过迭代用户体验资产来完善原型电信增强功能 使用正式的可用性方法设计和评估它们（AIM 1）；建立增强的，可扩展的 使用大规模的Scrum原理进行远程界面，并通过以前的 用户接受测试计划（AIM 2）；并用doxy.me提供商大规模实施电信 研究人员使用定量指标来确定性能并衡量成功的影响（AIM 3）。实现这些旨在扩大违规功能并进行大规模实施的目的 提高同意的能力提高远程知情同意的效率，这将 改善招聘，简化同意工作流程并增强远程医疗参与度。