COVID-19 Clinical Research Center | COVID-19 Research Involving Participant Interaction
COVID-19 Research Involving Participant Interaction
WHAT TO KNOW BEFORE YOU BEGIN:
- Review the COVID Research Checklist for Inpatient and Outpatient Studies. This checklist was developed by the COVID-19 Research Center Implementation Committee to provide study teams will a list of, and links to, many of the required elements needed for COVID study start-up. The links guide users to documents and resources needed for IRB submission, Contracts & Budgeting, order set creation, and other resources for study implementation.
- Institutional review is required even where an external IRB is the reviewing IRB for the study. An external IRB application must be submitted to the responsible JHU IRB in these cases.
- There are many ancillary reviews required for COVID research before studies may be approved. Be sure to review Section 3 below.
- Studies that will include patient data requests (such as from JH-CROWN) may require review from the CADRE Review Committee. Studies that involve the use of stored specimens may require review by the Biospecimen Oversight Committee.
- Study teams should be working on the IRB application concurrently while receiving approval from committees–most of the ancillary review processes require an IRB number and can be initiated simultaneously with IRB review.
- Once the team has received approval from the COVID-19 Clinical Research Coordinating Committee, the IRB application can be submitted, with CCRC letter of approval.
- Develop Concept and Consult COVID-19 Clinical Research Coordinating Committee about Research Recruitment Priority COVID19ResearchCtr@jhmi.edu
- Learn about Optional Protocol Development Resources
- Anticipate Ancillary Reviews Before Submitting to IRB
- Explore Research Implementation Planning Resources
- Start IRB application and reach out to Departmental Contracts and Finance personnel to begin ORA budget and contracts processes. Do not wait for IRB approval to start the ORA process.
- Review IRB, CRU, and ORA COVID-19-Specific Requirements
- Upon IRB Approval:
- Inpatient PIs must contact Stephanie Swords to be added to the Inpatient COVID Research Group on Microsoft Teams: COVID19ResearchCtr@jhmi.edu
- Approved studies are ranked for recruitment priority by the COVID-19 Clinical Research Coordinating Committee. Upon receiving IRB approval, investigators must present the study to the Committee for recruitment priority ranking. To schedule with the committee, email COVID19ResearchCtr@jhmi.edu
- Finalize implementation resources