A protocol exception is a one-time, intentional action or process that departs from the IRB-approved study protocol for one participant in the study.
Protocol exceptions must be approved by the IRB prior to implementation of the exception. A departure from the protocol that is submitted to the IRB after the action or process has occurred is considered noncompliance that must be reported to the IRB as new information.
To submit an exception request, submit a modification in ETHOS.
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. - 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.