As a Learning Health System, Denver Health creates, conducts and applies research to influence and improve the care we give to our patients. Our researchers and clinical care teams collaborate daily in the search for new diagnostic and technology-driven care that improves outcomes.
Patient consent is a fundamental tenet of medical research. Yet, consent requires the patient to be fully aware of the risks and benefits. In life-threatening emergencies, patients are often unconscious, confused or in serious distress, which limits their ability to provide consent. Consequently, identifying the best care for life-threatening conditions requires a different type of consent, which occurs through a process called “Exception from Informed Consent” (EFIC).
In an EFIC study, researchers spend months consulting with their patient community to explain the risks and benefits of the study, and, ultimately, to obtain consent for it. Once the patient community for a study has been consulted, doctors can then decide to include eligible patients in the study when patients cannot consent for themselves in the moment. Once family arrives or the patient has recovered from their illness, researchers discuss the study with them to get their consent to continue in the study. EFIC studies adhere to a process that is overseen by both the U.S. Food and Drug Administration (FDA) and an independent ethics committee called an institutional review board.
In 2024, Denver Health is conducting several EFIC studies. Please email our Office of Research with any general questions about these studies and feel free to contact the Primary Investigators (PIs) listed below.