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.


Use the following resources to prepare a modification:

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