Implementing a Central IRB Model in a Multicenter Research Network.

Area of Science:

• Health Policy
• Clinical Research Administration
• Human Subject Protection

Background:

• The National Institutes of Health (NIH) mandated a single Institutional Review Board (IRB) policy, shifting review paradigms.
• Institutions are re-evaluating processes for ceding review and local IRB considerations.
• Proactive implementation of a central IRB (CIRB) was initiated in 2012 by an NIH-funded network.

Purpose of the Study:

• To describe the experiences and lessons learned from implementing a central IRB (CIRB) model.
• To anticipate and adapt to the NIH's future single IRB mandate.
• To evaluate the impact of CIRB implementation on workflow and regulatory burden.

Main Methods:

• A description of an NIH-funded network's proactive CIRB implementation since 2012.
• Analysis of the learning curve and workflow adjustments for IRBs and participating sites.
• Examination of the shift in submission workload from study teams to a data coordinating center.

Main Results:

• A steep learning curve was encountered by IRBs and sites during initial CIRB implementation.
• Workload shifted to the data coordinating center, presenting challenges in preparing consent documents.
• Despite initial difficulties, the network is now fully operational under the CIRB model.

Conclusions:

• The transition to a CIRB model presented significant workflow challenges and a steep learning curve.
• The network successfully transitioned to a fully functioning CIRB model.
• Long-term evaluation is necessary to determine if the CIRB model effectively reduces duplicative review and regulatory burden.