Any changes or modifications to non-exempt research must first be approved by the IRB before the change is implemented.
- 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 harm to participants, such as a breach of confidentiality, death of the principal investigator, unresolved participant complaints, and change in labeling or withdrawal of marketing.
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.
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.
- Pre-Review (HRP-301, Worksheet)
Used by IRB staff who are conducting screening of submission materials.
- Criteria for Approval (HRP-314, Worksheet)
Used by IRB members who are reviewing research protocols that have been submitted.