IRB and ORA COVID-19 Submission Requirements

**Begin IRB and ORA processes concurrently

Be aware of Ancillary Reviews required for COVID-19 research; the IRB requires approvals from various review committees.

IRB GUIDANCE AND FORMS FOR COVID-19 RESEARCH 
Scroll approximately halfway down to:

• COVID-Related Guidance and Research Requirements
• Forms and Instructions for COVID-19 Related Research
  • Guidance for Informed Consent for COVID-19 Related Research
  • Supplemental Form for COVID-19 Research (HEIC Form)

• • Protocol Synopsis Template for COVID-19 Related Interventional Research
    Required for COVID-19 applications involving therapeutic interventions. 
  • For Studies Recruiting Johns Hopkins Healthcare Workers
    • COVID-19 Study Information Sheet for Employees
    • COVID-19 Study Summary Form

ORA COVID-19 RESEARCH REQUIREMENTS

IRB Number
Required for ORA submission

Budget:  Budget assistance is available upon request: CRSS@jhmi.edu

• Budget Checklist & Budget Template
  • Scroll halfway down to Clinical Research Support Services
  • Contact: Karen Roz: rozka@jhmi.edu

• Prospective Reimbursement Analysis (PRA) Guidance and Checklist 
  • While ORA drafts the PRA as part of the IRB submission process, a PRA can be initiated earlier by investigators.
  • Scroll halfway down to Clinical Research Support Services for PRA Guidance and the Checklist.
    COVID PRA Contact: Leslie Woytowitz: lwolf10@jhmi.edu
  • Note: PRAs also require that an Electronic Research Insurance Clearance Form be submitted in CRMS prior to enrolling a participant

Commercial Contracting Submission Requirements:

• There are no COVID research-specific commercial contracting requirements.
• Investigators should work with their departmental contracts and finance management team to submit the COEUS application.
• The ORA Contracts process should be started concurrently with the IRB application, but will not be finalized until all paperwork, including budget and consent, is final.
• Contact: Mont Brownlee: fbrownl1@jhmi.edu

Proof of Completed Research Ethics and Compliance Training:
If training has already been completed, it will be pre-loaded into the submission. If not, proof of training will need to be submitted. Training can be found in JHED under myLearning

• Clinical Research Billing Orientation (CRBO): For PI and study team members responsible for consenting patients. Retraining is required every 3 years.
• Clinical Research Management Systems (CRMS): For PI and study team members responsible for data entry.