Consenting trends during a pandemic: How COVID-19 has affected clinical research

Background: Hospitals worldwide have been severely impacted by the COVID-19 pandemic resulting in adjustments to clinical and research endeavors such as postponement of elective surgical procedures and remote working for non-essential staff members. The BioRepository and Precision Pathology Center (BRPC) plays a vital role in clinical research at Duke University by biobanking tissue and facilitating biospecimen collections from eligible patients. Methods: Data were retrospectively analyzed in order to understand the impact of COVID-19 on clinical research. Two separate time periods were evaluated during COVID-19 (2020) and pre-COVID-19 (2019) and consent events were compared to evaluate the effects of COVID-19 on clinical research. Results: A total of 103 consenting events were recorded in the pre-COVID-19 group from 03/16/2019 to 05/14/2019, with an overall success rate of 95.1%. The same dates in 2020 with peak COVID-19 impact recorded 6 consenting events with an overall consent success rate of 100%. A total of 369 consenting events were recorded in the pre-COVID-19 group from 05/15/ 2019 to 10/31/2019 with an overall success rate of 94.3%. The same dates in 2020 representing an adjusted workflow yielded 297 consent events with 91.2% success rate. There was a 94.2% and 19.5% decrease respectively in patients consented for participation in tissue biobanking and clinical trials during the peak COVID-19 and adjusted workflow COVID-19 period. Conclusion: Postponement of elective surgeries from mid- March to May resulted in a precipitous decline in consenting events, the long-term impact of which needs to be investigated further. BRPC effectively changed the workflow and implemented new consenting procedures accommodating the COVID-19 restrictions, and staff and patients' safety needs. These changes include electronic consent via REDCap software and ''Cold Call Approval'' policy which allows us to contact patients except those who have opted out of research participation. The ability to contact patients via electronic media and telephone significantly increased the efficiency of patient recruitment. This has enabled us to continue the mission of our biospecimen repository by successfully mitigating the impact of the COVID-19.