Once research has been approved by the IRB, investigators must notify the Board of ANY changes in the original protocol. The Application for Request for Change is available in NUgrant.
All changes must be documented.
Examples of minor changes with minimal risk to participants:
- Change of telephone number(s)
- Addition/deletion of staff
- Correction of typographical errors
Examples of major changes that don’t require immediate implementation to reduce hazards to participants:
- Changing the intervention, condition, or treatment
- Revising eligibility requirements
Examples of significant changes that require immediate implementation to decrease risk to participants and that require immediate disclosure to participants:
- Addition of a major risk resulting from a reported adverse event
- Major changes enacted to reduce risk to participants
