Changes that require a Modification form

All changes in study procedures, documents or personnel must be submitted and approved by the IRB before being implemented. The only exception is when there is an apparent, immediate hazard to subjects. If there are subject safety concerns, contact an IRB Chair immediately. Submit the Modification form immediately after implementing the change in study procedures.

Submit a Modification form in HawkIRB to make any changes in study design or procedures. Creating a draft Modification form opens the IRB-approved application for editing. You may add, revise or delete content in the application and/or attachments. The HawkIRB application should accurately reflect current study procedures. Add any new procedures and remove any procedures that are not being conducted.

Close of Enrollment

When reporting the close of enrollment in a Modification or Continuing Review form, remove Informed Consent Documents and recruitment materials that are no longer needed. Alternately, you may provide justification in Section XIII for why the consent documents should remain attached to the application (i.e. for subjects transferring to the site). 

Projects with Exempt Status

The requirements for the submission of a Modification form is different for projects that qualify for exempt status. The Modification form is only required for changes that affect the study’s eligibility for exemption. Minor changes do not require IRB review:

  • Adding research team members who are not Key Personnel
  • Minor changes to recruitment materials (i.e. contact information or a new method using an approved recruitment message)
  • Minor changes to survey, interview or focus group instruments

A Modification form is required for changes in the PI, Key Personnel, funding source, purpose or procedures, compensation, study population, identifiability of data, or risks to subjects.

For additional information, see the UI IRB Standard Operating Procedures and Researcher Guide,

  • Section I, Part 13 (Modifications to an Exempt Application)
  • Section II, Part 19 (PI Responsibilities after initial IRB Approval)

Starting a Modification form

  • Log into HawkIRB.  HawkIRB Delegates should click on delegate login and select the PI.
  • Under Projects, click on the IRB number of the study you wish to modify.
  • In the Create Form box, click on Modification/Update Form.  If you wish to submit a Continuing Review at the same time, click on Modification/Update + Continuing Review Form.
  • On the Modification Index, the Frequent Mods tab provides links to areas of the application that are often modified.  
  • The Project Index tab provides links to the entire application by section.
  • The Attachment Changes tab shows all IRB-approved documents for the study. Use the “Edit” link  to modify attachments. Click the link below the current attachments to attach new documents or delete documents.

Modifying attachments

When preparing a Modification form or during the IRB review process, follow the three-step process to edit a document. To initiate the process, click “edit” on the right side of the screen. That opens a yellow box with instructions:

Step 1: Click the link provided in this step to open the document. Save it to your local drive. Use a short, document-specific name to help you upload the correct edited version.

Step 2: Turn on track changes under the “Review” tab in a Word document and make any necessary changes and save the document. If you are unable to track changes (in a pdf or Excel spreadsheet), describe the changes in Section XIII of a Modification form or attach a separate document outlining the changes.

Step 3: Upload the revised document. This will save it as a new version on top of the previous version.

The Edit process creates a historical account of the documents being altered.  To view past versions of documents,

  1. Open the Project Summary page
  2. Click a previous New Project or Modification form
  3. Click the + sign to the left of the attachment name to see all previous versions

If you are using a Mac, follow the instructions for how to configure a Mac to open rich text format (RTF) documents.