Central IRB Review For Institutional Sites: A Toolkit For Sponsors And CROs

Having all sites use a central IRB builds efficiencies and results in significant resource savings for everyone involved in the research study and improves human subject protections. The benefits include:

• Reduces the sponsor/CRO workload of managing submissions to multiple IRBs throughout the life of the study.
• Reduces overall cost of study conduct.
• Frees up institutional resources to focus on patient/subject care and managing training, audits, and other research-related activities.
• Improves study activation time and recruitment, as a more efficient central IRB review process allows investigators to begin recruiting earlier and compete successfully with other study sites.
• Creates more opportunities for institutional sites to conduct industry-sponsored research. Some sponsors will not work with, or will limit the number of, institutions who only accept local IRB review.
• FDA and OHRP agree that centralized IRB review increases efficiencies and reduces duplication and administrative burden.
• Improves human subject protection through consistent single IRB review and uniform subject information and study conduct (informed consent, recruitment materials, protocol information, etc.).