21 - Enhancing IRB Operations Through Consistent Practices

Background: : HRPP staff, IRB members, and researchers comprise of a mixed pool of personnel from different backgrounds and varied exposure to regulatory practices governing HSR which constitutes a unique challenge. With the frequent turnover of personnel, establishing a comprehensive QI program was fundamental to achieve and maintain consistency in IRB operations.

Program

Description: : A comprehensive continuing Quality Improvement program for the IRB operation process was launched in 2022 with the aim to assess consistency at different stages of the IRB operation. The QI process was divided into 3 stages and parameters were developed under each of them.
1. Pre-review (IRB submissions and staff process)
2. IRB review (IRB review assignments and reviewer determinations)
3. Post-review (Ancillary reviews and IRB documentation)
10% of submissions and 30% of IRB meeting minutes for the period 2022-2024 were randomly selected for the assessment. Observations were categorized as follows.
• Major: Result in noncompliance with applicable regulations/institutional policies
• Moderate: Represent failure in following internal IRB procedures and may have an effect on the standards of the operation
• Minor: Do not impact the overall process but are complementary to the operation

Observations were reported by category, stage of the IRB operation, number of occurrences of similar observations.

Program

Assessment: : A total of 5 IRB meeting minutes and 38 submissions were selected for assessment: 7 initial, 7 amendments, 9 response to IRB comments, 10 continuing reviews, 4 closures, 1 reportable event.

39 observations in total were found: 26 minor, 13 moderate, 0 major. Out of the 13 moderate issues, 8 were noted in the IRB review, 2 in the post-review, and 3 in the pre-review stages of the operation. As for the 26 minor issues, 12 were noted in the post-review, 9 in the IRB review, and 5 in the pre-review stages of the operation. Finally, QI assessment of the minutes highlighted 7 moderate and 1 minor observations.

For every observation, a corrective and preventive (when applicable) action plan (CAPA) were proposed. Some observations required resolution on the submission in reference whereas others required an update to the internal process. The CAPA was shared with HRPP leadership before implementation. A close-out meeting with IRB staff was held to discuss the observations, agreed action plan and any process updates that resulted from the findings.

Limitations:: The QI process can be lengthy as some parameters require detailed review of documentation for staff and reviewers. Furthermore, the assessment must be performed by staff who have a good understanding of the internal process which can introduce a degree of bias. In our case, the HRPP/IRB manager performed the assessment. To minimize potential bias, findings were shared with the HRPP leadership for independent feedback of the observations before implementing the corrective and preventive actions.

Discussion: : This QI program is conducted every 2 years and is vital in standardizing internal processes, reducing variations in practices due to changes of staff or reviewers, and enhancing overall efficiency. Observations from this program also provide staff with insight into the areas that are positive and highlight the gaps. It is a useful tool when preparing for regulatory inspection or audits.

Measuring consistent quality practices is crucial for demonstrating the efficiency of IRB operations across the world. Consistent processes and decision making ensure fairness and fosters trust among researchers and participants and significantly enhance the quality of the operation.