University of Maryland

The IRB Process

Institutional Review Board ∙ irb@umd.edu ∙ 301-405-4212 ∙ 1204 Marie Mount Hall ∙ Hours: 8:30 AM – 4:30 PM

How to Submit to the IRB
  1. Step 0: Confirm if your project is considered Human Subject Research
  2. Step 1: Complete CITI training
  3. Step 2: Create an IRBNet account + Add your completed CITI Training to your User Profile
  4. Step 3: Create your project in IRBNet and attach project materials
  5. Step 4: Share the project with the project team
  6. Step 5: Link CITI training records for all investigators
  7. Step 6: Request project signatures in IRBNet
  8. Step 7: Submit your application materials
During IRB Review
  1. How the IRB approval process works
    1. Pre-Review: When the IRB receives a new project, it is routed based on the Review Paths. If there are administrative items missing (e.g. missing forms, signatures, or CITI training certificates), the application will be unlocked in IRBNet within one business day and the investigators will be notified of what is missing (see below for more information on the Lock Status). If components are missing, this will delay your review and approval.
    2. Ready for Review: When the complete submission is received, it is added to a ready to review queue for an analyst to pick up and review. Projects are reviewed in the order in which they are received. If there are modifications needed, the analyst will unlock the application and inform the investigators of the next steps.
  2. What is the Lock Status? What does “locked” and “unlocked” mean?
    1. Locked: A project has been submitted and is currently under review by the IRB.
    2. Unlocked – Revisions Pending: The IRB requested revisions be made to a project. By unlocking, the IRB has stopped their review until the edits are complete.
    3. Locked – Revisions Complete: The investigators have addressed the requested modifications and the IRB can continue their review.
  3. What are Messages & Alerts in IRBNet?
    1. The Messages & Alerts function, located at the bottom of the left side toolbar, presents a complete history for each individual protocol. Any messages that are sent between investigators or between investigators and the IRB office can be found here. If modifications are requested, they can be found here.
  4. How do I change documents previously submitted?

    1. When making modifications to documents in IRBNet, please click the paper icon located on the right side of the document, in the Designer page. This will open the version of the document that was submitted to the IRB on your computer. Make the requested changes. Once the documents have been revised, save it to your computer. Click the pencil icon to upload the new, revised form.

      Please follow this process for all documents except for the Part 1 Application, which must be revised within IRBNet by clicking on the pencil icon. To edit Part 1, click the pencil icon to the right of the document title on the Designer page. Then, use the “Jump” button in the upper right-hand corner to navigate each section you wish to edit. Be sure to click “Save and Exit” when the edits are complete.

  5. What do I do when I have addressed the modifications?

    1. Once you have completed modifications requested by the IRB, you must Mark Revisions Complete to notify the IRB that they may continue the review of your application. To do so:

      1. Go to the Designer page, located under the Project Administration menu on the left hand side.
      2. At the top of the page, you will see “Package” followed by the package number and lock status; the status will read “Unlocked – Revisions Pending” and the lock will be red.
      3. To Mark Revisions Complete, click the second link to the right of the Lock Status, “Mark Revisions Complete.”
      4. The lock will then turn green and read “Locked – Revisions Complete.”
  6. Time to IRB Review
    1. Estimates for time to IRB review for HSRD submissions and studies undergoing exempt and expedited review are below. Most studies at UMCP meet the definition of minimal risk and thus receive exempt or expedited determinations – these studies are reviewed on a continuous basis and are generally NOT subject to the Full Board deadlines below:
      Application Type Time to IRB Review*
      Initial Application (NOT Full Board) 2-3 weeks from completed submission
      Amendment 1-2 weeks from completed submission
      Human Subject Research Determination (HSRD) 1 week from completed submission
    2. *Time to IRB review is the estimated time it takes from the date of completed submission to the time when modifications are requested by IRB staff. This is not the same as the time to approval.
    3. *Note that these are estimates and times may vary based upon timing in the semester and current volume of submissions. The busiest times of year at the IRB are: mid-Fall semester, prior to Thanksgiving break, prior to Winter Break, mid-Spring semester, and prior to Spring Break. Please also note that the IRB Office is closed when the University is closed.
    4. In general, completed submissions are reviewed in the order in which they are received. Investigators with urgent requests requiring immediate review should contact irb@umd.edu and briefly describe the specific circumstances. We will do our best to accommodate your request.
    5. Avoid Delays in Review
      1. Review the IRB Submission Tips (PDF) for required elements and suggestions for preparing materials.
      2. Respond to modifications promptly. The faster you are able to address modifications requested by the IRB staff, the faster the project will be moved forward to the final reviewer. In other words, projects with ongoing review are prioritized over new submissions.
After IRB Approval
  1. Save copies of all final approved materials
  2. Submit an amendment 
  3. Submit a continuing review application (if required)
  4. Submit any reportable events

    1. Reportable events include adverse events, unanticipated problems, and protocol deviations.
      To submit a reportable event, you will need to complete either the Adverse Event/Unanticipated Problem Report or the Deviation Report, depending on the type of event.

  5. Close your study
  6. Create a new package + submit