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 招募和招募合格的研究参与者进入临床试验是大多数国家面临的主要挑战。 临床环境，包括远程研究中心的知情同意。研究往往无法达到招生目标， 导致昂贵的时间延长、动力不足的结果，以及在某些情况下的提前终止。知情 同意是一个必要的过程，涉及训练有素的研究人员与参与者面对面， 这在忙碌的诊所时间表或在远程位置的招募期间可能是特别具有挑战性的。一个 开发了利用远程医疗技术（远程发送）的创新性知情同意方法， 南卡罗来纳州医科大学。研究人员可以：1）会面， 使用视频与潜在参与者虚拟讨论研究; 2）分享知情同意书 可以由参与者和人员实时协作填写的文档;以及3）生成 双方可立即下载或打印的电子签名知情同意书。 本提案的目的是评估两个机构在现实环境中的远程发送， MUSC和北卡罗来纳州的查佩尔山大学。这包括审查道德和隐私 利益相关者和社区的关注，并确定采用的障碍。目的是：（1）评估 远程发送对偏远地区（包括服务不足的社区）访问的可行性、道德规范和影响 以及对知情同意的理解; 2）评估技术的可用性及其对 研究工作流程，无论是在本地（协调中心或研究人员的家庭机构），以及在远程 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实用性，确定采用的潜在障碍， 在其他研究环境中的信息实施。一个积极的结果应该提供一个途径， 提高招募/入组率，减少获得监管批准的相关负担， 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， 对知情同意过程产生负面影响。