Protocol Amendments

When to Submit an Application to Amend Previously Approved Research

All changes to active human subjects research must be approved by the IRB before changes may be implemented by the investigator or research team. Applications to Amend Previously Approved Research for protocols that originally went through full review must also be reviewed by the full board if the amendment will change any participant interaction or intervention procedures, including but not limited to recruitment methods or information, interview or survey questions, and informed consent documents or procedures. Changes to the originally approved research protocol are allowed without approval of an amendment to address any immediate hazards to participants or others. In the case of changes due to immediate hazards, the investigator must submit an Application to Amend Previously Approved Research as soon as possible and an Unanticipated Problems Involving Risks to Participants or Others reporting form within one (1) business day of the change. The Application to Amend Previously Approved Research and reporting forms are available in the IRBNet Document Library or in Forms and Templates.

How to Submit an Application to Amend Previously Approved Research

To add new applications or materials to an existing project in IRBNet, investigators must submit materials by creating a new package. A package is a digital file folder within a project in IRBNet.

All amendments must include a completed Application to Amend Previously Approved Research form. 

1. After you log into your IRBNet account, click on the project you wish to submit documents for.

2. Click "Designer" and then "Add New Document." Follow the prompts to add your Application to Amend Previously Approved Research form and any supporting materials to a new package (click "Create a New Package"). IRBNet will increase the project tracking number by one for each package you create within a project. For example, if your original project package tracking number is 111222-1, the next package you open will be labeled 111222-2.

3. Obtain electronic signatures from the principal investigator, co-investigator(s), and research advisor(s).

4. Click "Submit this Package" to submit your materials to the IRB.

Please do not open a new project for continuing review or amendments. New projects should be created for new research studies only.