Facilitating The Informed Consent Process Using Teleconsent: A Study Protocol (Preprint)

Abstract

<sec> <title>BACKGROUND</title> Informed consent is among the biggest challenges in recruiting participants for clinical research studies. Researchers face many challenges in conducting clinical trials, some of which include budgetary restrictions, lack of trained personnel, and difficulty recruiting study participants--particularly minorities and participants from rural communities. </sec> <sec> <title>OBJECTIVE</title> The objective of this study is to utilize telemedicine to improve the informed consent process for the clinical trials and studies. </sec> <sec> <title>METHODS</title> This study will be conducted separately yet concurrently at two institutions, the Medical University of South Carolina (MUSC) and the University of North Carolina at Chapel Hill (UNC), in order to compare results both within and across institutions. </sec> <sec> <title>RESULTS</title> Enrollment for Phase 1 began in March of 2018 and concluded in May 2018. Data transcription and analysis will be conducted through June and September of 2018. </sec> <sec> <title>CONCLUSIONS</title> In this paper, we present a novel approach to conducting the informed consent using a new telemedicine modality namely, teleconsent. Teleconsent presents the ability to conduct a live interaction among clinical research coordinators and potential participants while synchronously presenting the consent form on the screen and obtaining participant’s signature through doxy.me, the teleconsent system. The aim of this research is to assess the feasibility and efficacy of the teleconsent intervention among residents in urban and rural settings. Teleconsent provides potential to improve obtaining informed consent from potential clinical trial participants. </sec>

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