Status of a Submitted Application

  1. I​ am on the research team for an upcoming study that has not yet been submitted to the IRB.  I am unable to view the draft application that the PI has been working on.  What can I do?
  2. I submitted a New Project application a couple of weeks ago, and would like to know the status of that application.  Can I find anything out about it through HawkIRB?
  3. How can I view the project or a workflow routing slip as a research team member?
  4. I submitted my IRB application but now I see that I need to add / change a couple things.  Can it be sent back to me?

I am on the research team for an upcoming study that has not yet been submitted to the IRB.  I am unable to view the draft application that the PI has been working on.  What can I do?

Only the PI and delegates for the PI can view and edit an application that is in draft form (has not yet been submitted).  Once the application is submitted into HawkIRB workflow, you will be able to view the application as a research team member.  To do this:

  • Log into HawkIRB.
  • Under Projects, change the filter to: where <hawkID> is a research team member and project status is Any.
  • Click on the IRB number to access the project summary page.
  • Under History, you can click on the links under Form (to access the application) and Status (to see the status of the review and any workflow correspondence).

I submitted a New Project application a couple of weeks ago, and would like to know the status of that application.  Can I find anything out about it through HawkIRB?

Yes.  Log in to HawkIRB and click on the IRB number of your study under Pending Forms.  You will be able to see where the application is at in the review process.  

These are the possible baskets the application could be in:

  • PI Review - The application is in the PI's inbox.  There are questions that need to be addressed by the PI before the application can be returned to the HSO for review by the IRB.
  • Admin Prescreen - This is the first stage of the review process.  The application will be prescreened for basic requirements before being forwarded for a more thorough screening.  An application is not considered "accepted" into the review process until a project moves beyond the Admin Prescreen basket
  • HSO Staff Review - The application is screened for content, consistency, and UI and IRB requirements.  During this step, an HSO Application Analyst communicates with the PI in HawkIRB if there are any questions.
  • IRB Chair Review - The IRB chairs (or member designee) determine whether the project is eligible for exempt status, expedited review, or requires full board review.  During this step, an application can be routed to PI Review, Pre-Meeting Prep, HSO Staff Review, or Approved.
  • Pre-Meeting Prep - The application is ready to be scheduled to a full board meeting.
  • Scheduled - The application has been scheduled to a full board meeting.  You can view the date of the meeting in the Project Summary page in HawkIRB, under Agenda Date.  The IRB member assigned to be the primary reviewer of the study may contact the PI for clarification of application aspects prior to the meeting date.  Any requests for revisions will come from the full board itself after the meeting.
  • Post-Meeting Prep - The project has been reviewed by the full board and is now waiting for minutes from the meeting to be written and approved by an IRB chair.  After the minutes are finalized by the IRB chair, they are sent to the Investigator and arrive in the PI’s inbox.
  • Approved - The project has been approved by the IRB Chair or full board.  However, no research activities may begin until the approval materials are released to the investigator.

ADDITIONAL RESOURCES:

  • UI Investigator’s Guide
    • - Chapter 6. New Project Applications and IRB Review and Approval, Section E. Application Processing/Workflow

How can I view the project or a workflow routing slip as a research team member?

You can view the routing slip as a research team member, but you are not able to respond to it unless the PI makes you a delegate.  Here's how to view it:

  • Log into HawkIRB.
  • Under Projects, change the Filter to read: where <hawkID> is a research team member and project status is Pending, and click on Go.
  • Click on the appropriate IRB number to be routed to the Project Summary page.
  • Under the History section, click on Pending.
  • You can now see the questions that were sent back.

I submitted my IRB application but now I see that I need to add / change a couple things.  Can it be sent back to me?

Depending on where the application is at in the review process, it may be possible to send the application back to you to make further edits or additions.  Contact the HSO to find out: 319/335-6564 or irb@uiowa.edu.