When to Submit an Application to Amend Previously Approved Research:
All changes to originally approved 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 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 is feasible and an Unanticipated Problems Involving Risks to Participants or Others reporting form within one business day of the change. The Application to Amend Previously Approved Research can be found on IRBNet in the document library.
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 using a new package in IRBNet. A package is a digital file folder within a project in IRBNet.
1. 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 and any supporting materials to a new package. (IRBNet will produce a new tracking number 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.