COVID-19 Clinical Research Center | IRB and ORA COVID-19 Submission Requirements

IRB, CRU, and ORA COVID-19 Submission Requirements

**Begin IRB and ORA processes concurrently

**eIRB and COEUS submissions require approval from the COVID Clinical Research Coordinating Committee, along with other Ancillary Review processes.

 

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
APPLYING TO USE A COVID OUTPATIENT CRU

As part of the IRB submission, investigators select a COVID-19 CRU, which prompts an application for CRU use.

Select an outpatient CRU in the IRB application:

  • For Greenspring, choose ICTR-Other, and type in: Greenspring COVID CRU
  • For Bayview, choose ICTR-Other, and type in: Bayview COVID+ CRU

Following eIRB submission notification, the CRU application will appear in CRUOnline for completion and submission.
Learn More

ORA COVID-19 RESEARCH REQUIREMENTS

 

IRB Number
Required for ORA submission

 

Budget:  Budget assistance is available upon request: CRSS@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:

  • COVID-19 Clinical Research Coordinating Committee approval is required for contract  submission
  • 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

 

Grant Submission Requirements:

    • COVID-19 Clinical Research Coordinating Committee approval is required for grant  submission
    • There are no COVID research-specific grant requirements.
    • Investigators should work with their departmental grants 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.
    • Contacts: Tom Burns: tburns11@jhmi.edu   |   Sharel Brown: sbrown80@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.