When to Submit an Application for Continuing Review:
Researchers must submit an Application for Continuing Review to continue research with human participants or analysis of their private, identifiable information past an expiration date. The IRB requests that all Applications for Continuing Review be submitted at least two weeks prior to the project expiration date for exempt and expedited review and one month prior to the expiration date for projects that were reviewed by the full board. If you answer YES to all of the following statements, your project may not need continuing review and you should contact the IRB office:
- The research project is closed to all recruitment;
- All participants have completed all research-related interactions or interventions with the researcher(s);
- The researcher(s) is not planning any follow-up with any participants;
- Collection of any private, identifiable information is complete;
- All data has been completely de-identified; and
- Analysis of any private, identifiable information is complete.
Please note that it is the investigator's responsibility to watch their project in IRBNet, pay attention to any expiration notices, and know when it will expire.
Expiration of IRB Approval:
IRB approval expires within one year of the approval date. The IRB has the authority to require continuing review for intervals less than one year, which often depend on the nature and severity of risk to participants involved in the study. Researchers will be informed of the project expiration date when they receive their IRB approval letter. To continue human subjects research beyond the expiration date, an Application for Continuing Review (and any supporting forms, such as an updated consent form) must be submitted at least two weeks prior to the expiration date. If expiration occurs without continuing review, the project will be closed and all contact with human subjects and their private, identifiable information must cease immediately.
How to Submit an Application for Continuing Review:
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 a document 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 opened for new research studies.