700-29-Amendments/Changes to Protocol
| Title: |
Amendments/Changes to Protocol |
| Owner: |
IRB |
| Last Update/Revised: |
05/01/2024 |
Policy: During the period for which determination/approval has already been given, any changes to the protocol may not be initiated without prior IRB review, except where necessary to eliminate apparent immediate hazards to human subjects.
Investigators must submit requests for proposed changes to the IRB using an Amendment Form. Amendment forms should be submitted as soon as changes have occurred and within 10 days upon receipt of changes from sponsors, collaborators, etc.
During amendment review, the IRB determines whether the proposed changes continue to meet the regulatory criteria for determination/approval and whether any other applicable requirements are met. Amendments to submissions that were deemed either not human subject research or exempt are evaluated to determine whether changes alter the original determination. Determinations are made using the appropriate IRB Reviewer Checklist.
If an investigator makes necessary changes to eliminate apparent immediate hazards, a protocol deviation outlining the circumstances and any documents used must be submitted to the IRB (see 700-32: Protocol Deviations).
Purpose: This policy aims to outline how amendments are processed.
Procedures:
- Investigator (or the chair for a doctoral student) will submit the amendment form within 10 days of a change in protocol to the IRB via a Google Form.
- The IRB Chair or designee will use the appropriate checklist to determine if the project determination/study approval can be renewed as is, or if a board meeting is required.
- In the case that a board meeting is required, 700-23: Full Board Review is followed.
Scope: This policy applies only to projects/research that received previous determinations/approval but have a change in protocol.
Documents and Forms:
Amendment Form
IRB Reviewer Checklist (available on IRB Google Drive)