IRB reliance: An informatics approach.

Area of Science:

• Health Services Research
• Clinical Research Administration
• Health Informatics

Background:

• Multi-site Institutional Review Board (IRB) reviews are critical for clinical research but are often complex and delayed by incompatible systems.
• Disparate, non-interoperable systems hinder efficient management of IRB applications across multiple institutions.

Purpose of the Study:

• To harmonize IRB application workflows and data models through a shared Software-as-a-Service (SaaS) platform.
• To facilitate cooperative IRB reviews and enhance inter-institutional reliance for clinical research projects.

Main Methods:

• Development of a shared IRB platform integrating five institutions in South Carolina.
• Identification and harmonization of a core data model for IRB applications, accommodating institutional commonalities and differences.
• Modification of the system to support collaborative reviews within existing IRB workflows.

Main Results:

• Approximately 80% of IRB application content was harmonized across participating institutions.
• A foundation for streamlined cooperative review and reliance was established.
• Since 2011, 49 applications underwent cooperative reviews over three years, with most involving two institutions.

Conclusions:

• The developed shared IRB platform demonstrates the feasibility of harmonizing IRB processes and data.
• This initiative provides a model for a common IRB data model, enabling interoperability and promoting reliance.
• The findings support a federated approach to sharing IRB reviews, crucial for advancing translational research.