Modification

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.
  

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

• Investigator Manual (download)
  Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Minnesota.

• Pre-Review (HRP-301, Worksheet - download)
  Used by IRB staff who are conducting screening of submission materials.
  

• Criteria for Approval (HRP-314, Worksheet - download)
  Used by IRB members who are reviewing research protocols that have been submitted.