The Human Subjects Core (HSC) is an essential infrastructure component of the UF Sepsis and Critical Illness Research Center (SCIRC).
The HSC supervises all clinical in-hospital research activities for patients who agree to participate in the SCIRC sepsis research program. Specifically, it coordinates interactions with the subjects to maximize research efficiency through carefully designed schedules for clinical data collection, biological sample acquisition, performance measurements and interventions. Additionally, the HSC is designed to optimize the well-being of the patients and their families as they progress through the research protocols by assuring compliance with evidence-based clinical protocols for critical illness management and directing the coordination of all SCIRC core and research project patient interactions.
The main functions of the HSC include:
- Enroll surgery and trauma ICU patients as research subjects who screen positive for sepsis and are managed by computerized clinical decision support (CCDS)-driven early sepsis management protocol (“Sepsis Protocol”).
- Obtain, record and securely store clinical and laboratory data from consented research subjects using the REDCapTM data management system in conjunction with the Data Management and Biostatistics Core (DMBC).
- Obtain and initially process blood and urine samples from consented research subjects at preset time points.
- Implement, monitor, and optimize compliance to standard operating procedures (SOPs) for ICU care to control the confounding effects of variable clinical care on outcome.
- Establish an individualized research subject retention plan to maximize data collection through long-term follow-up.
- Assure safety of human research subjects, including IRB approval of research protocols, and informed consent to participate as human research subjects.
- Facilitate and execute adverse event reporting and safety monitoring of designated IRB-approved protocols.
The HSC provides the infrastructure to implement institutional and multi-institutional, interventional clinical trials in sepsis.