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.

All prospective interventional studies must submit a description of their work below and will be reviewed by the COVID Clinical Studies Committee (CSC) and other applicable committees within the ICTS research governance structure. The CSC will review clinical studies in the context of scientific rationale, technical merit, feasibility, impact on shared resources, and budget requirements. If your proposed research does not involve an interventional component, there is no need to submit for review.

For prospective interventional clinical studies above minimal risk, investigators are strongly encouraged to submit study details to the CSC and await feedback prior to completing their IRB submission. Please note that prospective interventional clinical studies above minimal risk will require an approval letter from the CSC before they will be advanced to full board IRB review. Studies will be reviewed in a format similar to an NIH study section, with all proposals receiving a priority score and overall CSC disposition. Final committee feedback will be provided in a letter to the lead investigator from the CSC and ICTS leadership. For some potentially meritorious studies that have concerns identified, the CSC may invite revision and re-submission. We expect investigators to receive feedback within approximately 2 weeks of ICTS survey completion, PROVIDED sufficient information is submitted to enable a quality review. Review times will be highly dependent on the level of detail provided.

At a minimum, the following study details will be required before a review will be initiated:

1) An updated study protocol, or if not available, details on the following:

  • The study hypothesis and objectives, participant eligibility criteria (including whether they are COVID positive, under evaluation for COVID, in convalescent phase, or other status).
  • The locations and means by which participants will be recruited. The nature (drug, device, biologic, other) and regulatory status (approved indication, off-label use, investigational) of the intervention.
  • Targeted recruitment goal (at WU site specifically) with brief statistical justification.
  • Nature (in-person visits, remote visits, blood/imaging/other testing methods) and duration of follow-up assessments.
  • Safety precautions and monitoring.
  • Ways in which COVID-19 infection of the participants, research workers, and others will be avoided.

2) Informed consent document, if available

3) Any other relevant study documentation as available

Please complete this form for your planned COVID-19 research projects at Washington University in St. Louis. Complete a form for each individual research project involving an intervention.

Please view the COVID-19 Clinical Research page for more information about the submission of interventional clinical studies.

If there are questions about the review process or required study documents, please contact Heather Wilkins at wilkins.h@wustl.edu

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