Amendment

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)

Adding personnel is a two-step process:

1. Add them to Section 3.0., Assign key study personnel (KSP) access to the study, Once added the submission will show on their personal dashboard.
2. But also do not forget to add them to Section 5.0, IRB New Protocol Application Form, to declare Conflict of Interest for each staff added.
   1. This step will not be able to be completed until they are granted access to the submission in Section 3.0.

If they are not found in the directory, then they do not have an iRIS account.