Continuing Review for Studies Approved Under Expedited and Full Review
When to Submit an Application for Continuing Review
If a project approved under expedited or full review is expiring, researchers must submit an Application for Continuing Review to continue research with human participants or analysis of their private, identifiable information. Most expedited and full projects expire within one year of approval. The IRB requests that all Applications for Continuing Review be submitting 30 days prior to the expiration date. If you answer yes to all of the following statements, your project may not require continuing review and you should contact the IRB office for assistance:
- The research project is closed to all recruitment;
- Participants have completed all research-related interactions or interventions with the researcher(s);
- The researchers are not planning follow-up with participants;
- Collection of all private, identifiable data is complete and there are no plans to collect future data;
- All data has been completely de-identified; and
- Analysis of any private, identifiable information is complete.
Expiration of IRB Approval Prior to Continuing Review
It is the principal investigator's responsibility to watch their project in IRBNet, pay attention to any expiration notices sent through IRBNet, and know when the project will expire.
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. If expiration occurs prior to continuing review, the project must be closed and all contact with human subjects and analysis of their private, identifiable information must cease immediately.
How to Submit an Application for Continuing Review
To add an Application for Continuing Review and supporting 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. The Application for Continuing Review form and other supporting documents are available in the IRBNet Document Library. All continuation requests must include the Application for Continuing Review form.
1. After you have logged 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 a document to a new package (click "Create a New Package"). IRBNet will increase the tracking number by one for each package you create within a project. For example, if your original IRBNet 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. Projects should be opened for new research studies only.