Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent

Leveraging Tele-Critical Care Capabilities for Clinical Trial Consent
Kristina M. Ieronimakis, Janell A. Cain, Michael S. Switzer, David D. Odineal, Thomas K. Deacy, Michael T. O.  Stein, Rhonda E. Colombo, Christopher J. Colombo
Critical Care Explorations, July 2020; 2(7) e0167
Open Access
A severe coronavirus disease 2019 patient admitted to our institution for medical management was enrolled in a randomized placebo-controlled trial of an investigational therapeutic for coronavirus disease 2019. We leveraged existing video-telecommunication equipment to obtain informed consent. We found video-telecommunication use closely mirrored person-to-person contact for research consent by maintaining engagement and ensuring understanding. Video-telecommunication use facilitated clinical research while minimizing unnecessary exposure to coronavirus disease 2019 and conserving personal protective equipment. Prior to the coronavirus disease 2019 pandemic, research regulatory agencies were essentially silent on the matter of video-telecommunication consent. Regulatory guidance became available during the pandemic in response to increased isolation and social distancing practices. Virtual health and telemedicine use expanded greatly during the pandemic, and this increase will likely persist after the pandemic ends. We anticipate video-telecommunication adoption and implementation for research consent will also continue to grow after the coronavirus disease 2019 pandemic is over.

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