Franciscan Children's FAQs for Investigators

A project requires IRB (Institutional Review Board) review when it involves research with human subjects—meaning you are collecting data about living individuals through interaction (e.g., surveys, interviews) or accessing identifiable private information. If the activity is designed to contribute to generalizable knowledge (like publication or presentation), IRB review is typically required. If in doubt, reach out to your IRB office for guidance.

Research is designed to generate generalizable knowledge (e.g., findings intended for publication or broader application), while quality improvement (QI) focuses on improving processes or outcomes within a specific organization or setting. If you’re unsure which category your project falls into, contact your IRB office for guidance.

Review timelines vary based on study components and completeness of the Application. There is an administrative component followed by the review itself, so please allow at least one week for an initial response. If a full review is required, timing will depend on board meeting schedules. You can always contact the IRB office for an estimate specific to your application.

Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are no greater than those encountered in daily life or during routine physical or psychological tests. This determination is made by the IRB, not the investigator—if in doubt, ask the IRB office for guidance.

To submit an amendment, go to the IRB application in the Forms and Templates tab and use the application form to submit your modifications. Include both tracked changes and clean versions of the protocol. All study personnel must have current, compliant training before submissions can be processed.

Continuing review is required for studies that are not eligible for exemption and require ongoing IRB oversight, such as those involving greater than minimal risk or specific regulatory requirements. It must be completed at least annually (or as specified by the IRB) and may be required more frequently if deemed necessary by the IRB to maintain approval. If you are unsure when your next due date is or whether your study requires continuing review, contact the IRB office for guidance.