Reviews Required for IRB Submission

COVID-19 CLINICAL RESEARCH COORDINATING COMMITTEE

• Contact Committee at concept development
• Submit protocol for approval prior to IRB submission:
  • View/Print Application Form OR Submit Online

• Upload documentation of approval in Section 20, Item 2 of your eIRB application.
  • Following IRB approval, present to Committee for recruitment priority ranking
    • PowerPoint Template
    • Johns Hopkins Prioritization Checklist for Intervention/Therapeutic Clinical Trials
    • Current Priority Ranking for Enrolling Hospitalized Patients in COVID-19 Clinical Trials (JHED login required)

JHH NURSING REVIEW

• **START EARLY**
• For research involving staff resources from Johns Hopkins Health System (JHHS) Departments of Nursing, or for the inclusion of JHHS nursing staff as study participants
• The signed nursing form must be uploaded in the eIRB application. JHHS Nursing review is a required “pre-review” in eIRB and must be completed before the protocol is available for IRB assignment and review.

INSTITUTIONAL BIOSAFETY COMMITTEE

• **START EARLY**
• Registration Requirements
• Institutional Biosafety Committee Website

CONSIDER CREATING ORDER SETS IN EPIC

ED COMMITTEE REVIEW

• If recruiting from the ED or using ED patient records, contact Lauren Sauer: lsauer2@jhmi.edu

HOSPITAL EPIDEMIOLOGY AND INFECTION CONTROL (HEIC)

• Supplemental Form for COVID-19 Research (HEIC Form, on IRB website)
  Scroll approximately halfway down and it’s under Forms and Instructions for COVID-19 Related Research
• The Infection Control and PPE page offers resources for developing your HEIC plan

REVIEWS FOR COVID-19 STUDIES INVOLVING PATIENT DATA AND/OR STORED SPECIMENS