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.

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.

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, Appendix B-4 of the Investigator Manual.

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.