11 - Enhancing Post-Approval Monitoring: A Gap Analysis Approach to Foster Collaboration Among Regulatory Research Stakeholders

Background: The Post-Approval Monitoring (PAM) programs ensure the continued oversight of regulatory research after approval from the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), and the Institutional Review Board (IRB), as required by regulations and guidelines. Since institutions can employ different methods in their PAM programs tailored to their specific regulatory research portfolio, The University of Texas Rio Grande Valley (UTRGV) aimed to determine the structure that best aligns with its operations and ensures all stakeholders are involved.

Program

Description: UTRGV, a ten-year restructured academic research institution currently classified as R2, has recently added a medical school, clinics, specialized research centers, and several new doctoral programs, resulting in a rapidly changing research portfolio. Aspiring to become an R1 institution, UTRGV employed a compliance gap analysis approach to understand and evaluate our post-approval monitoring beyond regulatory requirements in our institution for the Institutional IACUC, IBC, and IRB. This evaluation included a comparison of the program's infrastructure, regulatory research portfolio, and policies with the desired best practices, as well as consultation with stakeholders. We identified mechanisms of post approval monitoring and best practices, reviewed the institutional practices and stakeholders, and identified areas for improvement. Subsequently, UTRGV developed and implemented a formal and independent PAM program focusing on overall program assessment and education, incorporating all stakeholders. Performance metrics, researcher feedback, and program goals were assessed to evaluate the program.

Program

Assessment: Our findings highlighted the necessity to develop an independent PAM program and enhanced collaboration among stakeholders—a collaboration aiming to maximize institutional resources and better support each stakeholder's compliance responsibility. The program needed to shift from a compliance-driven to a quality-driven culture. As a result, our PAM program collaborates with stakeholders to oversee and facilitate IACUC, IBC, and IRB-approved research. The independent PAM program collaborated directly with regulatory committees and four other areas (Laboratory Animal Resources, Environmental Health and Safety and Risk Management, Clinical Research, and Research Integrity/Conflict of Interest) and indirectly with six other areas (Graduate School, School of Medicine, Privacy Officers (HIPAA/FERPA), Records Management, and Research Contract and Industrial Agreements). The pilot program involved reviewing 42 protocols across the three regulatory committees, with each review averaging 37 days (SD = 16). All researchers either agreed or strongly agreed that they understood the program, and 88% felt they had enough information to understand it. Overall, 88% agreed that the PAM process helped evaluate compliance within their research programs, and 82% viewed the program as educational and beneficial, demonstrating the achievement of program goals.

Limitations: During the program's implementation, UTRGV identified several areas - such as review notification, researchers' self-assessment, and the review-meeting process - that required modification or postponement and were thus excluded from analysis until we could establish a more efficient mechanism. Some processes needed clarification or structuring to facilitate the experience for researchers. However, due to the fast-growing research portfolio, potential institutional restructurings and personnel changes, regulatory requirement changes, research methodologies advancements, and stakeholder priority shifts, the program design may be limited to accommodate the current research portfolio and commitments of existing stakeholders.

Discussion: In conclusion, UTRGV promotes a collaborative PAM to improve compliance and support the dynamic needs of regulatory research. This approach ensures strong oversight and fosters ongoing enhancements in compliance practices. Based on feedback from researchers, the program has been instrumental in helping them evaluate their procedures, which has contributed to the maintenance and enhancement of the quality and integrity of their research. Many researchers find the process educational and beneficial for their research programs. Additionally, the PAM program must remain flexible in adapting to institutional and regulatory requirement changes by regularly revisiting the gap analysis.