If the IRB/HSO has feedback about your application, questions and requests for clarification are sent to the Investigator via HawkIRB workflow.  HawkIRB workflow satisfies a regulatory requirement to track correspondence between the IRB/HSO and the investigator. Workflow questions will contain links to make changes in the application or attached documents. Be sure to click one of the save buttons at the top or bottom of the page to save any changes in the form. The investigator or their HawkIRB Delegate returns the form to the IRB/HSO via workflow to continue the IRB review process. 

When an form is with the Investigator, it will appear in the Inbox section of the PI’s HawkIRB inbox. It will be visible when the PI or their HawkIRB delegate logs in to HawkIRB. Click the ‘wkflw’ link on the right side of the screen to view the workflow page and respond to requests from the IRB/HSO. Use the instructions provided for making changes in attachments using the Edit function.  The workflow page will include contact information for the HSO staff member or IRB Chair who sent the request.

When a form is routed back, the HawkIRB system sends an email to the PI, their HawkIRB Delegates, and contact persons on the research team. 

There are several other committees within the UI that may need to review your application, depending on your procedures. These committees are part of the Human Research Protection Program.  For a list of other committees and more information about their approval process please see Additional Approvals.

The HawkIRB application opens attachment categories for the required attachments based on the response to questions in the application.  For example, if the application indicates that subjects will be recruited via advertisements, a category for the advertisement will be opened on the attachment page.

In general, a complete HawkIRB application contains the following attachments (where applicable):

• Written protocol
  • This is only required if a protocol already exists at the time of submission.  
  • It is not necessary to create a protocol to attach to the HawkIRB application unless the study is a clinical trial.  
  • All research that is considered a clinical trial will require a protocol.
• Reports of prior investigations that provide relevant information to the review
• Assurance Document
• Informed Consent Document(s) or other consenting materials (based on the template available in the HawkIRB application)
• Sample Informed Consent Document(s) (for example, the DHHS or other sponsor sample consent, if available)
• Screenshots of e-consent documents
• Recruitment materials (including all content and graphic design elements to be used in the materials available for potential subjects)
• Surveys, interviews, or questionnaires
• Grant application (the full grant application is required)
• Letter of Agreement (to conduct the research in a facility or with an organization outside the University, and/or to use data from an outside entity)
• HIPAA Letter (if obtaining private health information from a non-UI entity without patient authorization)
• Investigator’s Brochure (for studies of an investigational drug)
• Other materials specific to the proposed study (e.g. sponsor correspondence with a regulatory agency such as the FDA regarding test article risk, etc.) 

Follow the instructions on the attachments page in HawkIRB to upload these documents to your application. There are also some templates that can be generated from the attachments page. 

The time to process an application depends on the complexity of the research study and the quality and completeness of the application submitted to the IRB.  Other variables include whether the application can be approved by the IRB Chair or Chair Designee (expedited review) or by the full board. Applications are reviewed by IRB/HSO staff in the order that they are received.

The most common problem with New Project applications is that not enough detail is provided for the IRB chair or full board to evaluate the study's purpose and/or procedures.  The more complete the initial description is, the less likely that your application will be routed back and forth between you and HSO staff or IRB chairs to fill in the details.  Read each question in the application carefully.  Provide a complete and accurate answer to each question, and make sure that details throughout the application are consistent.

Withdrawing or Pausing Review of Certain Forms

Specific workflow forms (new, modification, or HSRD) in HawkIRB will be put into a paused state if the form has reached 60 consecutive days of inactivity in a PI's HawkIRB inbox.  Under certain circumstances, HRPP leadership may also move the form into a paused state if lack of progress is apparent.  The paused state will withdraw the form from the current workflow path reflecting as "inactive" in the PI's inbox.  This allows the IRB\HSO to focus review on submissions ready to move forward in a timely manner.  The form will be saved in PI's inbox and the study team may reactivate the form and resubmit it once the team is ready for the HSO\IRB to resume its review. 

New project and HSRD forms will be assigned a new IRB# if it is reactivated.

To access a form that has been put in a paused state:

• Log in as the PI or their delegate
• Update the "project status" filter from open to any.
• Locate the paused form in the list. (a "reactivate" hyperlink will appear to the right of any form that has been moved to a paused state.
• Select "reactivate" and the form will appear in the pending forms of the PI's inbox.  The form can be accessed by scrolling to the pending forms section of the HawkIRB inbox.
• Complete all requested changes, review the form for completeness and return it to HSO for further processing.