Last Updated: July 7
Clinical Research Ramp Up
Current status: (Orange)
As of June 6, 2020, clinical research can begin ramping up from Red to Orange level.* PIs can develop their plans, and if approved, may begin implementing them. PIs should carefully read the two documents below “Considerations in Re-Starting a Clinical Research Study” and “Guidelines for Clinical Research Transitions – Red Level to Orange Level”.
However, if conditions or the situation changes, Washington University leadership may decide to return to the Clinical Research – Red Level, and PIs and research teams should be prepared for this eventuality.
Guidelines and Ramp Up Plans
- Guidelines for Clinical Research Transitioning from Red to Orange
- Considerations in Restarting a Clinical Research Study
Non-Clinical Research Ramp Up
Current status: (Orange)
Non-clinical human subjects research is defined for this purpose as fundamental, basic research that occurs mostly in laboratories or offices, and involves human participants. Research that only involves using existing samples is not included in this definition.
As of July 7, non-clinical human subjects research can begin transitioning from Red to Orange level. PIs can develop their plans, and if approved, may begin implementing them. See the PI guidelines for ramping up non-clinical research in Box.
Human Subjects Research Guidance
See the following documents for guidance on Human Subjects Research during alternate operations.
- Guidance for Clinical and Human Subjects Research during COVID-19 (PDF) – May 6, 2020
- HRPO and IRB FAQs (PDF) – June 8, 2020
- New – Human Subjects Research Monitoring during COVID-19 – July 1, 2020
- New – COVID-19 Toolkit – Templates to document protocol deviations and consent processes during COVID-19 – July 1, 2020
- Consenting Hospitalized Patients by Phone or Video Conference for Clinical Trials While on Isolation for Confirmed/Suspected COVID-19 (PDF) – May 19, 2020
- Required Updates to Clinicaltrials.gov Records During COVID-19 Pandemic – May 5, 2020
- Human Subject Telecommuting Guidance (PDF) – March 2020
- Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 – March 16, 2020
HRPO has set up a dedicated phone line and email account for questions about IRB requirements related to COVID-19.
COVID-19 Research Studies
Washington University Institute of Clinical and Translational Sciences is coordinating Washington University COVID-19 research activities to provide the logistical support necessary to ensure rapid and successful completion of studies. Research teams planning COVID-19 studies should submit a description of their work.