How Single IRB Review Mandates Help Research Sponsors

By Frank Conte, Vice President, Institutional Partnerships

Typically, clinical research oversight by the Food and Drug Administration is determined by the research type, rather than who is funding the study. For multisite studies, the FDA proposed single institutional review board (sIRB) mandates to support productivity and regularities. Previously, the sIRB was used for federally funded multisite research. However, if made into law for all clinical studies, the sIRB could substantially impact sponsors, contract research organizations (CROs), and institutions conducting multisite research.

Late last year, in September, the FDA released two Notices of Proposed Rule Making that intended to harmonize several current regulations with those set out by the Department of Health and Human Services. Broadly speaking, most industry-sponsored trials haven’t needed to comply with these requirements, giving institutions the flexibility to identify what their local IRB would review, versus what a single IRB would review centrally.

Discover how the recent mandate has simplified and expedited the IRB review process, reduced costs, and improved communication between study sites, as well as how research sponsors can leverage this mandate to streamline their study timelines and increase the efficiency of their research operations.