In this time of unprecedented research need, the Washington University Institute of Clinical and Translational Sciences is coordinating Washington University COVID-19 research activities to prioritize, promote, and actively support the most promising studies, and enhance patient safety.
The COVID-19 pandemic has caused major changes to the conduct of patient care and research at Washington University (WU) and BJC hospitals. In this environment, we must ensure that key resources, including COVID-19 patients, biospecimens, personal protective equipment (PPE), and research staff, are expended only on studies with the highest projected clinical impact, clear real-world feasibility, and maximum respect for on-the-ground clinical providers. For basic and clinical/translational research alike, study design and conduct must comply with WU/BJC policies on COVID-19 infection prevention, and should reflect federal, state, local, and University recommendations on avoiding unnecessary in-person contact. One goal of our oversight is to establish enduring resources that can accelerate COVID-19 research, including but not limited to a biorepository with genomic and clinical phenotypic data that can be mapped to outcomes. We also wish to prioritize clinical studies with the highest projected patient care impact and precautions that optimize participant safety. Institutional leadership has invested the ICTS with the additional responsibility and authority to determine which COVID-19 studies may go forward, and which merit prioritized support.
Studies that will require IRB approval and access to patients and/or their families, biospecimens, or health record data must submit a description of their work below. Experts in the areas of basic, clinical, and informatics research will use the submitted information to work with the Human Research Protection Office and Joint Research Office of Contracts to expedite studies of immediate scientific importance.
Please note, the WU Infectious Disease Clinical Research Unit is participating in NIH-supported vaccine network trials that will begin in the summer of 2020. Due to NIH restrictions, WU is not able to actively enroll in more than one vaccine trial concurrently. As such, additional Phase III vaccine studies will not be approved, and all studies involving prevention of COVID-19 infection will be carefully scrutinized for their potential to compete with accrual to the NIH-supported vaccine studies.
Please view the COVID-19 Clinical Research page for more information about the submission of interventional and observational clinical studies.