Amendments involving changes to IRB-approved protocols generally require prior IRB review and approval before implementation. The only exception is when changes are necessary to eliminate apparent immediate hazards to the human subjects. In such urgent cases, the principal investigator (PI) may implement changes without prior IRB approval but must report these changes to the IRB as soon as possible, typically within 5 to 10 working days.
Key Points on Amendments and IRB Approval
- All protocol changes, even minor ones, usually need IRB review and approval before they can be implemented.
- Minor modifications with no more than minimal risk can sometimes be reviewed through expedited procedures but still require IRB approval beforehand.
- The exception for immediate hazard removal allows the PI to act without prior approval to protect subjects, but these changes must be reported promptly.
- Planned deviations or changes to the protocol without IRB approval are violations of federal regulations and institutional policies.
- Exempt research may allow minor changes without IRB notification, but substantive changes must be submitted.
Summary
- Prior IRB approval is required for all changes to IRB-approved protocols except for emergency changes that eliminate immediate hazards.
- Such emergency changes must be reported to the IRB promptly after implementation.
- Minor or administrative changes still require submission to IRB and appropriate review.
This guidance is consistent across many institutions and follows federal regulations including 45 CFR 46 and FDA regulations.