ABSTRACT
Background: Clinical research is a central mission of the University of Colorado Anschutz Medical Campus (CU-Anschutz). On March 18, 2020, due to rising COVID-19 rates and personal protective equipment (PPE) shortages, an emergency approval process for critical research essential to the care and safety of patients, including COVID-19 trials, was enacted. All other clinical research studies requiring face-to-face visits were placed on hold to protect participant and staff safety. Methods: A clinical research TaskForce was rapidly assembled, consisting of a cross- section of campus clinical research operations leaders, including affiliate hospitals. This group developed a guidance document and process where the primary prioritization factor was positive therapeutic benefit/risk (Groups 2-5). A REDCap form demarcating items including research visit types and safety plans was designed. A separate Space Plan Committee approval was required to gauge environmental health and safety. Results: A total of 654 protocols were approved over 31 weeks using this process. Group 2 review and approvals occurred within 5 days of campus reactivation, and 65 days after original clinical research hold. Groups 3 through 5 were opened for submission and review in a phased approach. The majority proactively submitted IRB protocol amendments to minimize face-to-face participant/staff contact. There were no cases of COVID-19 outbreak in research participants. Conclusion: Clinical research reactivation was rapidly implemented in a transparent, collaborative, broadly supported, and efficient process of staged reactivation while prioritizing the health and safety of participants and staff at CU-Anschutz. This model is practical and easily generalizable to other medical research campuses.
ABSTRACT
The Emergency Medicine Specimen Bank (EMSB) was developed to facilitate precision medicine in acute care. The EMSB is a biorepository of clinical health data and biospecimens collected from all adult English- or Spanish-speaking individuals who are able and willing to provide consent and are treated at the UCHealth-University of Colorado Hospital Emergency Department. The EMSB is the first acute care biobank that seeks to enroll all patients, with all conditions who present to the ED. Acute care biobanking presents many challenges that are unique to acute care settings such as providing informed consent in a uniquely stressful and fast-paced environment and collecting, processing, and storing samples for tens of thousands of patients per year. Here, we describe the process by which the EMSB overcame these challenges and was integrated into clinical workflow allowing for operation 24 hours a day, 7 days a week at a reasonable cost. Other institutions can implement this template, further increasing the power of biobanking research to inform treatment strategies and interventions for common and uncommon phenotypes in acute care settings.
