61 - An HRPP & Local IRB's Journey Through the Single IRB World

Background: : Our institution relies on external IRBs for approximately 10% of our clinical research portfolio. To prepare for the expected increase on reliance of external IRBs due to the FDA’s proposed rule for cooperative research, the HRPP initiated an assessment of our sIRB procedures to identify areas for improvement.

Program

Description: : Members of the HRPP leadership team met regularly to identify areas for improvement and brainstorm implementable solutions within the sIRB space. The team administered a survey to the office members to identify areas where additional education was needed. In addition, the team looked at the number of and reasons for pre-review submission returns during the first quarter of 2025. As a result, the team created an sIRB 101 training to summarize the roles and responsibilities of the HRPP office when we rely on an external IRB and for when we are the IRB of record for other entities. The team created a pre-review guide and checklists for HRPP staff and research teams to ensure consistent understanding of key items regarding external IRB submissions. Lastly, the team is creating a comprehensive guide outlining the unique requirements for external IRBs as a resource for the research community.

Program

Assessment: : First quarter of 2025, there were 87 amendments submitted to the HRPP in which an external IRB oversees the study. In submission to HRPP for acknowledgment and local context review, 71 of those amendments were returned a total of 97 times to the PI/research team with pre-review comments. The most common reason for returns (27%) were due to confusion about whether an amendment involved acknowledging an external IRB approval or required Privacy Board review. The second most common reason for returns (23%) were due to missing external IRB approval letters or questions about the determination documentation. This data highlighted the need for increased education about the workflows for amendments when the institution is the relying on an external IRB. These 71 amendments were for studies relying on 10 different IRBs, highlighting the need for increased IRB-specific guidance. The data also aligned with the HRPP office survey results noting the need for additional guidance on how to account for varying external IRB requirements.

Limitations:: The HRPP team focused their efforts on the workflows for when the institution is relying on an external IRB of Record. The creation of the sIRB 101 training, pre-reviewer checklist and guidance documents, and comprehensive IRB guide were rolled out over several months, leading to difficulties identifying an immediate impact. The team expects to see a trend of improvement in amendment pre-reviews over time.

Discussion: : As a result of the survey and amendment analysis, we identified gaps in understanding and areas for improvement. These guided our efforts to increase the knowledge base surrounding single-IRB policies and workflows for the HRPP staff. In addition, this highlighted the need for increased education of the research staff on the responsibilities of reviewing and relying IRBs. Lastly, this endeavor highlighted the need for IRB-specific guidance to improve HRPP and research staff confidence and understanding in the process. Implementing these changes will help the institution face the proposed changes in the FDA regulations with greater ease.