0088 Remote clinical research operations during COVID-19: Lessons learned and recommendations

Abstract

Abstract Introduction As a result of the global COVID-19 pandemic, there have been significant challenges conducting clinical sleep research. Participant recruitment has been a particular challenge due to federal safety guidelines and institutional directives. The purpose of this project is to describe the adaptation of an in-person study protocol (of sleep problems among military service members and their families) to an entirely remote approach. Methods Prior to COVID-19, planned research methods included in-person recruitment, enrollment, and study support; approved by the Institutional Review Board (IRB) of Walter Reed National Military Medical Center (WRNMMC), Fort Belvoir Community Hospital (FBCH), and the University of Maryland, Baltimore (UMB). As COVID-19 restrictions increased, the research team adapted to a fully remote approach (via phone/email) and developed a “research call center” to replace in-clinic recruitment/enrollment. Detailed operating procedures were standardized, including shipping study materials (wearable device) via FedEx. Following enrollment, participants completed multiple assessments, sleep diaries 2x/day over 10 days, and a post-monitoring satisfaction survey. Results Thirty-five participants between the ages of 18-75 years (M= 46 years, SD= 15.8) were successfully recruited from the Internal Medicine clinic and Sleep Disorders Center at WRNMMC. Following data collection, the research team debriefed and developed recommendations to execute a successful remote study protocol. Three key operational domains were identified: research team, remote procedures, and data management. Recommendations included 1) prioritizing consistent communication, mutual support, and personal wellbeing among the research team, 2) advancing recruitment by establishing and refining preferred recruitment pathways, and 3) providing critical attention to remote data management—allocating responsibilities to regulate the evolving changes of multiple data sources. In addition, partnering closely with IRB personnel was invaluable to refine procedures and maintain regulatory compliance. Conclusion Despite challenges associated with the on-going pandemic, researchers can conduct high-quality clinical research by transitioning to a fully remote study approach. These recommendations can help guide investigative teams to transition from in-person protocols to remote approaches, thus advancing the perpetuation of research activities through a pandemic. Support (If Any) This research was supported by an investigator-initiated research award from the Department of Defense (via the Medical Technology Enterprise Consortium) to the University of Maryland, Baltimore (PI: EMW).