WUSTL COVID-19 Research Request Form
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. 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. 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 that plan to enroll inpatients at BJH or SLCH 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 with a particular focus on the burden they pose to patients, front-line providers, and resources.
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.
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 Tera Jarvis at email@example.com