Investigating teleconsent to improve clinical research access in remote communities

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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.