Laura Bilek (University of NE Medical Center); Kara M Smith (University of NE Medical Center); Melissa Cole (University of NE Medical Center)
Issue: Reducing COVID risk in your human-subjects research The development of a research study requires investigators to minimize risk to human subjects. With the outbreak of COVID-19, this challenge is expanded.
Methods: Our Spry Belt study utilizes visits to a hospital-based radiology clinic and includes imaging, blood draws and an office meetings with a coordinator. To improve safety, the research team integrated clinic COVID-19 requirements and expert recommendations to prevent the spread of COVID.
Observations/Outcomes: Specific changes implemented include sending the COVID-19 symptom screening questionnaire to the subject the day prior to the study visit, minimizing face-to-face time between participant and coordinator, adding PPE for specific study events, and implementing enhanced, detailed cleaning protocols. Study visits were resumed upon permission from the university regulatory affairs office. Thirty-six in-person study visits were successfully completed within two weeks using the revised study protocol.
Conclusion: Detailed planning, teamwork, and quality COVID resources provided a smooth transmission to conduct safe clinical trial study visits. Subjects reported comfort with participation.
Download PowerPoint slides here. Recording will be available early next week.
