Teleconsent: A Novel Approach to Obtain Informed Consent for Research.
Teleconsent: A Novel Approach to Obtain Informed Consent for Research.
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DOI：
10.1016/j.conctc.2016.03.002
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发表时间：
2016-08-15
影响因子：
1.5
通讯作者：
Obeid J
中科院分区：
文献类型：
--
作者：
Welch BM;Marshall E;Qanungo S;Aziz A;Laken M;Lenert L;Obeid J
缺乏合格的研究参与者的招募仍然是临床试验的一个重大瓶颈，往往导致昂贵的时间延长，结果不足，在某些情况下提前终止。招募不理想的一些原因包括费力的同意过程和接触偏远地点的参与者。虽然新的电子同意技术（eConsent）有助于克服与可读性和同意管理有关的挑战，但它们不能充分解决与远程访问有关的挑战。为了解决这个问题，我们开发了一种称为“远程发送”的创新解决方案，它将知情同意过程嵌入远程医疗会议。研究人员可以通过同意书与潜在的研究参与者进行远程视频会议，实时显示和交互式指导参与者。完成后，研究者和参与者可以电子签署同意书，并打印或下载签署的文件存档。这一过程可以消除与远程站点人员的旅行和管理有关的挑战。已在多项临床试验中成功实施了该技术。通过减少与知情同意相关的障碍，同时保留人际互动，自愿参与可以改善研究招募。
Lack of recruitment of qualified research participants continues to be a significant bottleneck in clinical trials, often resulting in costly time extensions, underpowered results, and in some cases early termination. Some of the reasons for suboptimal recruitment include laborious consent processes and access to participants at remote locations. While new electronic consents technologies (eConsent) help overcome challenges related to readability and consent management, they do not adequately address challenges related to remote access. To address this, we have developed an innovative solution called “teleconsent”, which embeds the informed consent process into a telemedicine session. Teleconsent allows a researcher to remotely video conference with a prospective research participant, display and interactively guide participants in real-time through a consent form. When finished, the researcher and participant can electronically sign the consent form and print or download the signed document for archiving. This process can eliminate challenges related to travel and management of personnel at remote sites. Teleconsent has been successfully implemented in several clinical trials. Teleconsent can improve research recruitment by reducing the barriers related to informed consent, while preserving human interaction.