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)
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- 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
- Protocol Synopsis Template for COVID-19 Related Interventional Research
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
- 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:
- 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:
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- 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.