3. Expedited Review

The Secretary of the Department of Health and Human Services and the Food and Drug Administration have established and published in the Federal Register a list of categories of research that may be reviewed by the IRB through an expedited review procedure (45 CFR §46.110). This policy describes the categories and IRB procedure for expedited review.

The CSS IRB requires that human subject research activities be reviewed in accordance with federal regulations (CFR 45 §46.109 (e) (f)) and at intervals appropriate to the degree of risk.

The new provision for limited IRB review (45 CFR §46.104 d(2)(3), §46.111 (a)(7)). review allows certain research to be categorized as exempt, even when the identifiable information might be sensitive or potentially harmful if disclosed. In order to qualify for exemption, the study must meet the standards of the limited IRB review.