Investigating teleconsent to improve clinical research access in remote communities

研究远程同意以改善偏远社区的临床研究机会

• 批准号: 9389723
• 负责人: Jihad S Obeid
• 金额: $ 23.81万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9389723
• 关键词: Address; Adoption; Area; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Communities; Comprehension; Consent; Consent Forms; Development; Effectiveness; Eligibility Determination; Enrollment; Environment; Ethics; Evaluation; Focus Groups; Goals; Home environment; Human Resources; Informatics; Informed Consent; Institution; Institutional Review Boards; Interview; Lead; Medical; Methods; North Carolina; Outcome; Paper; Participant; Personnel Management; Privacy; Procedures; Process; Productivity; Qualitative Methods; Recruitment Activity; Research; Research Assistant; Research Personnel; Research Training; Role; Schedule; Site; South Carolina; Surveys; System; Technology; Telemedicine; Time; Training; Travel; Universities; Visit; Work; base; cost; feeding; health literacy; improved; informant; innovation; meetings; member; multi-site trial; new technology; novel; novel strategies; prospective; remote communities; remote location; satisfaction; screening; usability; virtual

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.

项目摘要 在大多数 临床环境，包括在远程站点的知情同意。研究通常无法实现入学目标， 导致昂贵的时间延长，功率不足的结果以及在某些情况下提前终止。通知 同意是一个重要的过程，涉及训练有素的研究人员与参与者面对面会议， 在繁忙的诊所时间表或在偏远地区招募时，这可能特别具有挑战性。一个 创新的知情同意方法，即利用远程医疗技术（Teletonsent）是在开发的 南卡罗来纳州医科大学（MUSC）。电信允许研究人员：1）见面和 实际上，使用视频供稿与潜在参与者讨论研究； 2）分享知情同意 参与者和人员可以实时填写可以协作的文件； 3）生成 具有电子签名的知情同意书，可供双方立即下载或打印。 该提案的目的是评估两个机构的现实环境中的电信： MUSC和北卡罗来纳大学教堂山。这包括对道德和隐私的检查 利益相关者和社区的担忧，并确定采用障碍。目的是：1）评估 电信对包括服务不足社区在内的偏远站点的访问的可行性，道德和影响 以及知情同意理解； 2）评估技术的可用性及其对 研究工作流程，无论是在本地（协调中心还是研究人员的家庭机构）以及远程工作流程 位置（远程诊所或其他招聘设施）。 如果成功，这项工作将显示这项新技术的实用性，确定潜在的采用障碍和 告知其他研究环境中的实施。积极的结果应为 提高招聘/入学率，减轻与获得监管批准相关的负担 远程站点，降低远程注册成本，并将研究扩展到服务欠缺的地区，而没有 对知情同意程序产生负面影响。