View listings of Washington University investigators who are approved to conduct COVID-19 clinical research. These rosters will be updated regularly as new studies are approved.
COVID-19 Clinical Studies Committee
All clinical studies being submitted will be reviewed by the COVID Clinical Studies Committee (CSC) and other applicable committees within the ICTS research governance structure appointed to evaluate potential impact on shared resources and clinical environments, and to help determine which studies merit prioritized active support. The CSC will review clinical studies in the context of scientific rationale, technical merit, feasibility, impact on shared resources, and budget requirements.
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.
For observational clinical studies eligible for expedited IRB review, the ICTS will use an abbreviated review format. Investigators may proceed with their work once IRB approval is obtained. The applicable ICTS review committees will also conduct an abbreviated review. Investigators will be contacted by ICTS if additional information is needed, or if issues are identified in relation to participant interactions, biospecimens, or data queries. Investigators are expected to be responsive to these requests. If investigators have not heard from the ICTS within 7 days of their survey submission, they can assume no issues have been identified.
At a minimum, the following study details will be required before a review will be initiated:
- 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 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.
- Informed consent document, if available
- Any other relevant study documentation as available
If there are questions about the review process or required study documents, please contact Heather Wilkins at email@example.com