Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 9, 2018
Open Peer Review Period: Jun 12, 2018 - Jul 30, 2018
Date Accepted: Jul 30, 2018
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Facilitating the Informed Consent Process Using Teleconsent: Protocol for a Feasibility and Efficacy Study
Background:
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.
Objective:
The objective of this study is to utilize telemedicine to improve the informed consent process for clinical trials and studies. We aim to assess the feasibility and efficacy of the teleconsent intervention among residents in urban and rural settings.
Methods:
This study will be conducted separately yet concurrently at two institutions, the Medical University of South Carolina and the University of North Carolina at Chapel Hill, to compare results within and across institutions.
Results:
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.
Conclusions:
In this paper, we present a novel approach for conducting 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. Teleconsent provides potential to improve obtaining informed consent from potential clinical trial participants.
International Registered Report:
RR1-10.2196/11239
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.