Clinical research reactivation during the COVID-19 pandemic: An academic center process and lessons for the future.

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.

Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges.

Despite multiple initiatives in post-acute and long-term nursing home care settings (NHs) to improve the quality of care while reducing health care costs, research in NHs can prove challenging. Extensive regulation for both research and NHs is designed to protect a highly vulnerable population but can be a deterrent to conducting research. This article outlines regulatory challenges faced by NHs and researchers, such as protecting resident privacy as well as health information and obtaining informed consent.

The Emergency Medicine Specimen Bank: An Innovative Approach To Biobanking In Acute Care.

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.

Institutional review board training when patients and community members are engaged as researchers.

Background: Patient engagement efforts often rely on a participatory research approach, which means engaging patients and community members in all aspects of research. As research team members, they require familiarity with the principles of human subject protection, privacy, and institutional review boards (IRB). However, the time required for individual IRB training may be a barrier to engaging community members in participatory research.