Amendment

Investigators are responsible for promptly reporting any changes in a research activity to the IRB. 45 CFR 45.108(3)(iii).

Timing: Investigators must submit and receive approval prior to implementing changes.

Amendment Frequently Asked Questions
No. The regulations do not differentiate between major and minor changes when it comes to what needs to be reported to the IRB. All changes in a research activity must be reported.

The amendment's review path (e.g., full board, expedited, administrative) depends on the nature and level of the change. Substantive changes to a project previously reviewed by the full board most likely will require full board approval.

Minor amendments may be reviewed via an expedited or administrative (i.e., IRB staff) process. Examples of minor amendments include but are not limited to:

  • Addition or deletion of study team members
  • Addition of procedures that do not increase risk
  • Removal of procedures that would reduce risk to subjects
  • Addition of non-sensitive survey or interview questions
  • Addition of, or changes to, recruitment materials or recruitment strategies
  • Changes that do not modify the intent of the content (e.g., typographical error corrections, improvements for clarity)