Variations in Administrative Approvals During the COVID-19 Pandemic at Participating Sites in the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry: A Cross-Sectional Study

Vikas Bansal; Mayank Sharma; Neha Deo; Shahraz Qamar; Susan Lyman; Vishakha K Kumar; Allan Walkey; Aysun Tekin; Romil Singh; Marija Bogojevic; Pooja A Nawathe; Karen Boman; Lynn Retford; Ognjen Gajic; Rahul Kashyap

doi:10.1097/CCE.0000000000000822

Variations in Administrative Approvals During the COVID-19 Pandemic at Participating Sites in the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry: A Cross-Sectional Study

Crit Care Explor. 2022 Dec 16;4(12):e0822. doi: 10.1097/CCE.0000000000000822. eCollection 2022 Dec.

Authors

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
² Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN.
³ Mayo Clinic Alix School of Medicine, Rochester, MN.
⁴ Post-baccalaureate Research Education Program, Mayo Clinic College of Medicine and Science, Rochester, MN.
⁵ Legal Contract Administration, Mayo Clinic, Rochester, MN.
⁶ Society of Critical Care Medicine, Mount Prospect, IL.
⁷ The Pulmonary Center, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, and Evans Center of Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Boston, MA.
⁸ Department of Pediatrics/Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA.

Abstract

There is a paucity of literature regarding administrative approvals required for clinical studies during a pandemic. We aimed to evaluate variation in duration of administrative approvals within the Viral Infection and Respiratory illness Universal Study (VIRUS): A Global COVID-19 Registry.

Design setting and subjects: Survey analysis of 188 investigators who participated in the VIRUS: COVID-19 registry, a prospective, observational global registry database of 287 sites.

Interventions: None.

Measurements and main results: For each study site approved through December 8, 2020, we assessed the duration in days: 1) from institutional review board (IRB) submission to IRB approval, 2) from IRB approval to Research Electronic Data Capture (REDCap) access, 3) from REDCap access to first patient data entry in REDCap, and 4) total duration from IRB submission to first patient data entry in REDCap. Analysis of variance and Wilcoxon rank-sum test were used to compare time durations. Of 287 sites, 188 sites (United States = 155, non-United States = 33) provided complete administrative data. There was considerable variability in duration from IRB submission to first patient data entry with median (interquartile range) of 28 days (16-50 d), with differences not significantly different by country (United States: 30 [17-50] vs non-United States: 23 d [8-46 d]; p = 0.08) or previous "multisite trial experience" (experienced: 27 [15-51] vs not experienced: 29 d [13-47 d]; p = 0.67). The U.S. sites had a higher proportion of female principal investigators (n = 77; 50%), compared with non-U.S. sites (n = 7; 21%; p = 0.002). Non-U.S. sites had a significantly shorter time to first patient data entry after REDCap access: 7 (1-28) versus 3 days (1-6 d) (p = 0.02).

Conclusions: In this Society of Critical Care Medicine global VIRUS: COVID-19 Registry, we identified considerable variability in time from IRB submission to first patient data entry with no significant differences by country or prior multicenter trial experience. However, there was a significant difference between US and non-U.S. sites in the time from REDCap access to first data entry.

Keywords: COVID-19; COVID-19 global registry; VIRUS; institutional review board; multi-center Research; pandemic crisis; research electronic data capture.