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Research Related Injury Language

The Northwestern University IRB Office requires that studies that are greater than minimal risk include research-related injury language, also referred to as subject injury language, in the "What else do I need to know?" section of the Northwestern biomedical consent document.

Please ensure that sponsors understand that Northwestern's subject injury language cannot be altered. The template language must be used verbatim. In rare cases we can accept additional language, provided it is not exculpatory and does not conflict with the required template language. The IRB reserves the right to modify the language to meet this requirement. Note: prior approval does not prevent the IRB from later modifying or disapproving non-template language.

This requirement also applies to studies where Northwestern has ceded IRB review to an external IRB.