An NHSR determination is made by a qualified reviewer (not the investigator). Common examples include quality improvement, case reports of three or fewer patients, and analyses of fully de-identified or coded data without access to identifiers.
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Glossary Term
Not Human Subjects Research (NHSR)
Review & Determinations
Also known as: NHSR, not human subjects, not human-subjects research
An activity that does not meet the regulatory definition of research with human subjects, so no IRB oversight is required.
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