FAQ: What kinds of changes to my approved IRB project require submission of a Revision Application?

Any proposed change (revision) to an approved, non-exempt IRB project that affects human subjects (with certain limited exceptions) must be reviewed and approved by the Institutional Review Board prior to implementation of the change. These changes can be minor or non-minor changes.

This includes, but is not limited to:

  • Alteration of study design, methodology, or recruitment methods
  • Changes to any instruments, including surveys and questionnaires
  • Changes to consent documents
  • Changes to the study population
  • Changes in funding
  • Addition or removal of study personnel
  • Addition or removal of research performance sites

More information can be found in the HRPP Manual Section 8-6, Revisions to an Approved Project.