13 - Evaluation and Harmonization of Convened Board Meeting Activities: Establishing Best Practices That Actually Work!

Background:  The six convened boards at a high-volume academic medical center IRB office are led by three co-chairs and supported by seven regulatory analysts who provide subject matter expertise and perform administrative tasks. The lack of standardization and harmonization in meeting activities led to inefficiencies and inconsistencies in meeting operations.

Program

Description:  IRB office leadership, who attends all convened board meetings, noticed inconsistent practices and initiated a project in collaboration with the regulatory analysts to harmonize board meeting activities and determine the best practices. A needs assessment was conducted among the analysts to identify the areas of inconsistency and inefficiency in the current meeting activities. All meeting activities were collected and grouped into pre, during, and post-meeting tasks. Each analyst was asked to describe actions specific to their board. This exercise identified the varying practices and prompted extensive discussion among the analysts. A final list of the harmonized best practices was created along with a weekly team meeting to provide a forum for ongoing communication and collaboration. During the meetings, the analysts shared any special scenarios that they witnessed at their respective meetings. The improved processes and communication among the analysts and convened board members demonstrated the success of this initiative.

Program

Assessment:  The objective of this project was to harmonize convened board meeting activities by developing best practices, establishing clear guidelines for the meeting activities, and promoting effective collaboration among regulatory analysts. Bringing together a group of analysts for a specific task they have been doing individually for many years was a challenge. However, the analysts reacted positively and supported the shared goal. Through initial discussions, the team identified various inconsistent tasks that were not previously identified. Although this project lasted about six months (May to Dec 2022) and is ongoing, the analysts started piloting the best practices as they were finalized and provided feedback. The analysts announced the new best practices to the convened board members. Partnerships with the respective co-chairs and board members also greatly assisted in adopting the new best practices. The following best practices were well received: monitoring the reviewer checklists prior to the board meeting, alerting the leadership of any controverted items before the board meeting, establishing standard Zoom etiquette, and eliminating redundant meeting notices.

Limitations: Before identifying new best practices, understanding the historical context of the existing workflows was important and challenging. Sometimes there were undefined internal guidelines, and sometimes there were unknown external requirements. In addition, when piloting new best practices, allowing all regulatory analysts to practice the proposed workflows is important and also a limitation. If a specific scenario does not occur in a reasonable timeline, it is a limitation to implement the best practices and ensure harmonization.

Discussion:  Harmonizing convened board meeting activities is critical for ensuring the ethical and responsible conduct of research involving human subjects. By implementing a programmatic approach to standardize and harmonize IRB board meeting activities, any IRB office can enhance the efficiency and effectiveness of IRB review processes. It also improves the relations with the researchers, convened board members, and other key stakeholders. With established best practices, periodic check-ins, and collaboration strategies, this program will continue to identify new and effective best practices to improve the review operations, promote compliance with regulatory requirements, and ultimately protect the rights and welfare of human subjects.