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Activities require IRB review if they meet the federal definitions of research with human subjects as defined by the Office for Human Research Protections or clinical investigations with human subjects as defined by the FDA.
Even if a clinical investigation is IND exempt, it may still be subject to other FDA Regulations involving human subject protections, conflict of interest, and IRB requirements.
Even if a clinical investigation is IDE exempt, it may still be subject to other FDA Regulations involving human subject protections, conflict of interest, and IRB requirements.
