Human Subjects Research Guidance
Given the rise in COVID-19 cases in our area and the St. Louis County “Safer at Home” order starting November 17, 2020, Principal Investigators performing in-person human subjects research should consider the safety of their study participants. PIs should consider cancelling or postponing some human subjects research visits to Danforth and Medical Center campuses that occur solely for the purposes of research. Participant research visits can continue when it is believed the benefit of participating is greater than the risk, including:
- potential benefit to the welfare of the participant (including direct benefits to the participant or indirect wider benefits to people with their condition), and
- the research visit is needed to prevent substantial compromise to the integrity of the study, thereby invalidating the participants’ previous service to the study.
These judgements should be made by the PI of each study.
With the COVID patient population rapidly increasing in our hospitals, many clinical procedures are being cancelled and clinical staff are being redeployed. Therefore, it is more important than ever that researchers ensure that clinical space, equipment and/or clinical personnel that are needed for the research have the capacity to accommodate the research prior to sending a participant to a clinical area.
- HRPO and IRB FAQs (PDF) – July 13, 2020
- COVID-19 Personal Protection Equipment (PPE) Update – December 17, 2020
- Human Subjects Research Monitoring during COVID-19 – July 1, 2020
- 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) – September 23, 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
Clinical Research Ramp Up
Current status: Yellow
Researchers can transition from orange to yellow when their school/department is ready, they have carefully developed their plans, and have all preparations in place. We anticipate that this transition will take a few weeks for most groups.
PIs can develop their plans, and if approved, may begin implementing them. PIs should carefully read the two documents below “Guidelines for Clinical Research Transitions – Orange to Yellow” and “Considerations in Re-Starting a Clinical Research Study”.
However, if conditions or the situation changes, Washington University leadership may decide to return to the Clinical Research – Orange or Red Level, and PIs and research teams should be prepared for this eventuality.
Guidelines and Ramp Up Plans
- Guidelines for Clinical Research Transitioning from Orange to Yellow
- Considerations in Restarting a Clinical Research Study
Non-Clinical Research Ramp Up
Current status: Yellow
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 August 5, non-clinical human subjects research can begin transitioning from Orange to Yellow level. PIs can develop their plans, and if approved, may begin implementing them. See the guidelines for ramping up non-clinical research in Box.
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.
HRPO has set up a dedicated phone line and email account for questions about IRB requirements related to COVID-19.
Amanda Cashen, MD
IRB Executive Chair
Suresh Vedantham, MD
Assistant Dean for Clinical Research