Investigating teleconsent to improve clinical research access in remote communities

项目总结 招募和登记合格的研究参与者参加临床试验是MOST的主要挑战 临床环境，包括远程地点的知情同意。学习往往达不到招生目标， 导致昂贵的时间延长、动力不足的结果，并且在某些情况下提前终止。知情者 同意是训练有素的研究人员与参与者面对面会面的一个基本过程， 在繁忙的诊所日程安排或偏远地区的招聘期间，这可能特别具有挑战性。一个 利用远程医疗技术(远程发送)的创新知情同意方法是在 南卡罗来纳医科大学(MUSC)。远程发送使研究人员能够：1)会面并 使用视频订阅源与潜在参与者讨论研究；2)共享知情同意 可由参与者和人员实时协作填写的文档；以及3)生成 电子签署的知情同意书，可供双方立即下载或打印。 这项提议的目标是评估两个机构在现实世界环境中的远程通信， MUSC和北卡罗来纳大学教堂山分校。这包括对道德和隐私的审查 利益攸关方和社区的关切，并找出采用的障碍。其目的是：1)评估 远程通信在远程站点(包括服务不足的社区)访问的可行性、伦理和影响 和知情同意理解；2)评估技术的可用性及其对 研究工作流程，既在本地(协调中心或研究人员的家乡机构)，也在远程 地点(偏远诊所或其他招聘设施)。 如果成功，这项工作将展示这项新技术的效用，确定采用的潜在障碍，并 告知在其他研究环境中的实施情况。一个积极的结果应该提供一条途径 提高招聘/注册率，减轻与获得监管批准相关的负担 远程站点，降低远程注册的成本，并将研究扩展到服务不足的地区，而无需 对知情同意程序产生负面影响。

PROJECT SUMMARY Recruitment and enrollment of eligible research participants into clinical trials is a major challenge in most clinical settings, including informed consent at remote sites. Studies often fail to meet enrollment goals, resulting in costly time extensions, underpowered results, and in some cases early termination. Informed consent is an essential process involving trained research personnel meeting face-to-face with participants, which can be especially challenging during busy clinic schedules or recruitment at remote locations. An innovative informed consent approach that leverages telemedicine technology (teleconsent) was developed at the Medical University of South Carolina (MUSC). Teleconsent allows research personnel to: 1) meet and discuss the study with a prospective participant virtually using a video feed; 2) share an informed consent document that can be collaboratively filled out by participant and personnel in real-time; and 3) generate an electronically signed informed consent that is available for immediate download or print by both parties. The objective of this proposal is to evaluate teleconsent in real-world environments across two institutions, MUSC and the University of North Carolina at Chapel Hill. This includes the examination of ethical and privacy concerns by stakeholders and the community, and identifying barriers to adoption. The aims are to: 1) evaluate the feasibility, ethics, and impact of teleconsent on access at remote sites including underserved communities and on informed consent comprehension; 2) assess the usability of the technology and its impact on the research workflow, both at local (coordinating center or researcher's home institution) as well as at remote locations (remote clinics or other recruitment facilities). If successful, this work will show the utility of this new technology, identify potential barriers to adoption and inform implementation in other research environments. A positive outcome should provide an avenue to improve recruitment/enrollment rates, reduce the burden associated with obtaining regulatory approval for remote sites, lower the costs of remote enrollment, and extend research into underserved areas, without negatively impacting the informed consent process.