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What role does the IRB play in determining the nonsignificant risk (NSR) status of a study?

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About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

A sponsor's preliminary determination that a medical device study presents an NSR is subject to IRB approval. The effect of the IRB's NSR decision is important to research sponsors and investigators because significant risk (SR) studies require sponsors to file an Investigational Device Exemption (IDE) with FDA before they may begin. NSR studies, however, may begin as soon as the IRB approves the study. The sponsor, usually through the clinical investigator, provides the IRB with information necessary to make a judgment on the risk of a device study.

While the investigational plan and supporting materials usually contain sufficient information to make a determination, the IRB can request additional information if needed. If the IRB believes that additional information is needed, it may contact the sponsor directly, but it should keep the clinical investigator apprised of the request. While making the SR/NSR determination, any of the three parties may ask FDA to provide a risk assessment.

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