Any changes or modifications to non-exempt research must first be approved by the IRB before the change is implemented.

Changes include:

  • Targeted population
  • Recruitment plans
  • Research procedures
  • Study instruments
  • Study sites
  • Research personnel

Implementing changes without prior IRB approval is considered a protocol violation and subject to a noncompliance review. Pre-approval may not be required if the change is made in order to eliminate an immediate hazards to participants. In the case of changes implemented to eliminate immediate hazards to the subjects, these must be reported to the IRB using a Reportable Event submission.

How to Submit a Change

To submit a change, click the “New Change” button in the study workspace. You will need to complete both a change form and modify the application to reflect the changes you are proposing, including uploading any revised documents.

See Helpful Tips for Submitting Changes of Protocol
  1. Modifications to study documents:
    • Accept all previously approved tracked changes and resolve all previous comments in study documents (e.g., consent, protocol, recruitment materials) before making updates for the current change submission. Only the changes relevant to the current submission should be tracked.
    • Upload revised documents to the Modified Application, not the Change Form.
    • Use the “Upload Revision” feature in ARROW to replace existing documents in the modified application. Do not use “Delete” and “Add”.
  2. Completing the Change Form:
    • Clearly describe how the study is changing. For example, write, “We are increasing enrollment from 50 to 100 participants” instead of simply, “Increasing enrollment.” Rather than, “Adding a new study aim,” include a description of the new aim in the change form.
    • If you have several changes, number them. Use consistent numbering in other responses in the Change Form.
    • Provide a complete response when asked about any changes to the study’s overall risk/benefit ratio. Indicate whether the ratio will change, and if not, explain why it remains unchanged. A response of, “No change” is not sufficient.
    • Do not repeat changes that have already been described when completing the “Revised Documents” and “Other Changes” pages.

For more tips, review the pre-recorded presentation on submitting changes of protocol.

Changes to Research Determined to be Exempt

Since some changes to research determined to be exempt may alter the category(ies) under which the exemption was granted, certain modifications to the applications may need to be submitted for review. For more information on what kind of exempt changes need review, see the Exemption Change Table.

Resources

We recommend reviewing the following documents from the HRPP Toolkit Library:

  • Investigator Manual (HRP-103)
    Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Wisconsin-Madison.