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.

项目总结。 知情同意是医疗保健和研究中的法律和道德要求，确保个人 有权根据自己的意愿做出知情的护理和研究决定，不受胁迫或 不适当的影响，并对其风险、收益和责任有合理的了解 就像他们当面做决定一样。获得知情同意是一项必要但具有挑战性的要求， 可能会阻碍参与卫生保健和临床研究。由于新冠肺炎大流行， 远程医疗已被证明是远程向患者提供健康和研究服务的有效方式。 然而，提供者和研究人员(“同意人”)仍然需要获得知情同意并将其记录在案。 来自患者和研究参与者(“受试者”)。传统的知情同意方法不是 与远程医疗兼容，提供后勤、技术和安全障碍，如差旅和成本 负担、低理解、困惑和不满、临床工作流程的改变、遵从性 挑战和对临床平衡的担忧。TeleconSent是一种创新且经过验证的解决方案， 获取由Dox.me，Inc.和南卡罗来纳医科大学开发的远程知情同意。 TeleconSent允许同意者(1)通过视频与同意者会面并讨论知情同意 远程医疗平台，(2)实时共享并协同完成同意书，(3) 生成双方立即下载的同意书的电子签名副本。我们的第一阶段 STTR研究确定了一些增强功能，如改进的移动接口、协议方接口 构建和管理同意书，并使被同意者能够提前阅读同意书。优化 满足用户需求的远程发送至关重要，特别是在这个前所未有的时代 当大多数人从事远程护理和研究时，新冠肺炎就会流行。这一阶段的目标 II建议提炼和扩展远程发送功能，并通过doxy.me大规模部署。至 为了实现这一目标，我们将通过迭代的用户体验资产来改进原型远程发送增强功能 使用正式的可用性方法设计和评估它们(目标1)；构建增强的、可扩展的 远传接口采用大规模Scrum原理，并通过正式测试新的远传功能 用户验收测试计划(AIM 2)；与doxy.me提供商大规模实施远程发送 以及研究人员使用成功的量化指标(AIM)来确定绩效和衡量影响 3)。实现这些目标以扩展远程发送功能并进行大规模实施将 增加同意人的能力，以提高远程知情同意的效率，这将 改进招聘、简化同意工作流程并增强远程医疗参与度。