Any changes or modifications to your study 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 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.
Resources
Use the following resources to prepare a modification:
- Submit a Modification: Quick Guide
High-level, step-by-step guide on how to submit a modification to an IRB-approved study. - Updating Documents
Step-by-step guide on how to update documents and using track changes in ETHOS. - Adding Funding
Step-by-step guide on how to add funding to a submission in ETHOS.
- How to Withdraw or Discard a Submission: Quick Guide
High-level, step-by-step guide on how to withdraw or discard a submission.
- Common Reasons for Stipulations and Deferrals
List of common reasons for stipulations and deferrals.
We also recommend reviewing the following documents from the HRPP Toolkit Library:
- Investigator Manual
Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Minnesota. - HRP-301: Pre-Review Worksheet
Used by IRB staff who are conducting screening of submission materials. - HRP-314: Criteria for Approval Worksheet
Used by IRB members who are reviewing research protocols that have been submitted.