Annual continuing review is generally required for protocols approved by the fully convened IRB committee. An annual continuing review may also be necessary for the following types of protocols:
- Projects involving Native American or Indigenous Populations;
- Principal Investigator has received serious or continuing non-compliance determinations in the past two years;
- Projects that involve deception but do not receive the subject’s prior authorization to be deceived before engaging in the deception;
- A Conflict of Interest Management Plan exists;
- FDA-regulated research eligible for Expedited review under Expedite Category 1 on approved drugs or devices;
- Projects deemed Expedited Category 9; or
- As determined by the IRB on a project basis depending on the risks in the research project.
As a courtesy, eIRB notifications are sent to investigators several weeks before the approval end date for protocols needing a continuing review. A continuing review submission must be submitted in eIRB at least 4-6 weeks before the approval end date. If the protocol is not granted continuing approval before expiration, all research activities must pause until reapproval.
Please review HSPP Guidance, Continuing Review of Human Research for more information.