COVID-19 Clinical Research

The CCSC is currently only reviewing prospective interventional clinical studies that plan to enroll inpatients at BJH or SLCH. Investigators for such studies should still submit study details to the CCSC and await feedback prior to completing their IRB submission. In general, studies will be reviewed in a format similar to an NIH study section, with proposals receiving a priority score and overall CCSC disposition. Final committee feedback will be provided in a communication to the lead investigator (with cc to HRPO/IRB staff) from the CCSC and ICTS leadership. For some potentially meritorious studies that have concerns identified, the CCSC may invite revision and re-submission. We expect investigators to receive feedback within approximately 2-4 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. Investigators should be aware that IRB fees are charged for IRB/HRPO work irrespective of whether studies are approved.

If the CCSC approves a study proposal, the IRB review process will proceed. Interventional studies approved by the CCSC and IRB will undergo subsequent review by the COVID-19 Clinical Studies Prioritization Committee to determine enrollment prioritization relative to other active interventional trials.

Minimum Requirements for CCSC Review

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.

In addition, the following documents are also helpful for review:

• Informed consent document, if available
• If study involves drug, the Investigator Brochure and/or Pharmacy Manual
• Any other relevant study documentation as available

In an attempt to reduce the potential for burden on our patients and staff and ensure enrollment in the highest priority studies, the University Executive Faculty approved the formation of a COVID-19 Clinical Studies Prioritization Committee (CSPC). The CSPC is tasked with reviewing all IRB-approved prospective interventional clinical studies that plan to enroll inpatients at BJH or SLCH to determine a ranked prioritization for enrollment. Additional details on the prioritization scheme and process will be shared to ensure the utmost transparency for all investigators.

Study investigators will be contacted after prioritization has been assigned. Investigators should check this page regularly for additional updates.

Mission Statement

The mission of the Clinical Studies Prioritization Committee is to assign priorities for subject enrollment for all interventional clinical studies related to COVID-19 being carried out at Washington University Medical Center. The principal aims are:

1. to support meritorious studies to define therapeutic approaches;
2. to provide a framework for streamlining subject enrollment in IRB-approved COVID-19 clinical studies;
3. to minimize stress and confusion potentially generated by uncoordinated approaches to patients and families asking for participation in multiple studies; and
4. to amplify the public health impact of ongoing COVID-19 research by ensuring timely and complete subject enrollment in prioritized studies.

Guiding Principles

1. In general, studies funded by the NIH will have top priority, followed by Washington University investigator-initiated studies, followed by industry-funded studies.
2. Clinical importance and scientific quality will be heavily weighed, including the assessment of the COVID-19 Clinical Studies Committee.
3. Multi-center trials that are likely to answer important questions will be prioritized.
4. Potential for enrolling subjects across the socio-demographic spectrum will be considered.
5. The impact of studies on resource utilization will be considered.
6. Emphasis will be placed on achieving a balanced portfolio of research studies that will maximize enrollment from the range of COVID-19 patient groups encountered at the medical center; e.g. ambulatory emergency room, hospitalized non-ICU, ICU non-mechanically ventilated, ICU requiring mechanical ventilation.
7. There will be commitment to transparency in processes and outcomes.
8. Evaluations will be objective and non-biased.
9. Patients will be approached for participation in research studies only with the approval of their primary attending physician or an appropriate representative of the care team if the primary attending physician is not available. 
10. Patient autonomy will be respected. Patients will be approached first regarding participation in the study with highest priority for their patient group as defined in item 6. If the patient is found not to be eligible, or participation is declined, the patient will be provided the opportunity to participate in other research studies for which they meet the eligibility requirements.