97 - Enhancing IRB Interactions: Lessons Learned from the Hybrid Open Office Hours Program

Background:  Researchers receive valuable support for protocol-related inquiries through our Hybrid Open Office Hours (HOOH) program. This program enhances front-facing resources (website and checklists), offers customized compliance and protocol guidance, and reduces protocol review time through accessible (in-person or online) meetings and support in navigating research compliance complexities with expert advice.

Program

Description:  Our Hybrid Open Office Hours (HOOH) program is a collaborative innovative program which streamlines the Institutional Review Board (IRB) process by dedicating time for researchers to engage with IRB staff. The program facilitates discussions on general and protocol-specific questions, reducing inconsistencies. While resource-intensive and not guaranteed to eliminate delays, it can expedite research design in alignment with compliance standards.
Our program aims to strengthen relationships between IRB staff and researchers, enhance trust and accessibility, address inquiries effectively, and conduct quality assurance for improved outcomes. Success depends on factors, including: preparation for the 15-30 minute HOOH meetings; check-in language including, "Did I answer your question?" to ensure efficiency; technological tools (share screen and live demos); and follow-up correspondence. We have developed Standard Operating Procedures (SOPs) for both IRB staff and researchers participating in HOOH, with excerpts and examples to be showcased in our poster design.

Program

Assessment:  The assessment of the HOOH program involved a comprehensive analysis of booking data, observations, informal feedback, and sample protocol tracing. Each data point is detailed as follows: (1) Scheduler: A formal scheduling platform is utilized for each open office hour, with meeting times recorded in the staff calendar. Analysis of this data revealed a positive trend in the number of Open Office Hour bookings, indicating the increasing popularity and accessibility of the meetings. (2) Observations: While most Open Office Hours are managed by one dispatcher, intermittently two IRB staff attend to validate information or deliberate over a topic. Observations indicated that researchers commonly expressed gratitude and used affirming language ("I understand"), showcasing their confidence and clarity in the information received. (3) Informal Feedback: Researchers openly expressed appreciation for the opportunity to discuss their projects and questions. (4) Sample Protocol Tracing: Projects discussed during open office hours were monitored, and their completeness upon protocol submission for review was documented. These samples illustrate the potential to streamline review processes as researchers address issues proactively before protocol submission.

Limitations: Addressing IRB inquiries is pivotal, however challenging researchers complicate interactions. Our SOP integrates conflict management, de-escalation, and redirection strategies vital for program operation. Nonetheless, attendees may overlook scheduling details and IRB resources, anticipating unrealistic outcomes, including official determinations and discussions on complex matters like protocol deviations, necessitating clear meeting expectations. Technical limitations include connectivity issues. Additionally, repeated no-shows prompted policy changes, limiting future bookings. Continuous refinement is necessary in upholding the program's research asset value.

Discussion:  While numerous institutions offer support programs for research compliance, our HOOH program distinguishes itself through its direct engagement and targeted support sessions, demonstrated to significantly enhance user experience and efficiency. To refine our approach and maintain a competitive edge, we propose implementing a ticketing system. Such a system would effectively manage inquiries, streamline scheduling, and provide precise tracking and resolution of issues, thereby augmenting responsiveness. Institutions looking to enhance or revamp their existing programs could adopt this framework to improve accessibility and effectiveness. Our program's adaptability to specific needs and challenges makes it a robust blueprint for others to follow.