Associate Director, Research Foundations CITI Program
Background: : Research enterprises often face fragmented oversight, complicating compliance for human and nonhuman studies. Disconnected processes and poor design of materials could obscure risks across HRPP/IRB, ACU/IACUC, IBC, COI, export control, RBR, accessibility, SBER, and leadership, necessitating well-designed compliance program processes and materials to foster a culture of compliance and accountability.
Program
Description: : To foster an enterprise-wide culture of compliance through both visual and operational design, a system unified oversight and financial accountability for human and nonhuman research. Intentionally designed processes and materials aligned HRPP/IRB, ACU/IACUC, IBC, COI, export control, RCR, accessibility, and SBER under the seven elements of an effective compliance program (U.S. Sentencing Guidelines): compliance officer, risk assessment, policies and procedures, education, auditing and monitoring, response, and enforcement. Methods included designing educational workshops to the work of the audience, integrating or creating parallel workflows, and utilizing advanced technology-driven tools for clinical trial billing. Clear policies and accessible training materials were important, as well. Leadership designed overall accounting processes to prevent fraud, waste, and abuse. The system promoted ethical research through design, with assessments through surveys, billing audits, and noncompliance tracking showing a much higher rate of compliance across the enterprise after utilizing thoughtful, plain language design of materials and processes.
Program
Assessment: : The institution showed that the coordination across HRPP/IRB, ACU/IACUC, and IBC, potentially streamlining protocol reviews through unified workflows. Clinical trial billing benefited from AI-driven tools, which flagged discrepancies and promoted accountability. Plain language COI and export control guidelines strengthened centralized monitoring, while RCR education materials fostered ethical awareness. Accessible processes and SBER guidelines clarified community interactions. Leadership prioritized resources via clear policies, though resistance to new designs occurred. The expected results included transparent accounting processes, preventing fraud, waste, and abuse in human research billing and nonhuman research operations. A consistent ethical framework emerged across the entity. Challenges might involved scaling AI tools. Overall, the institution unified the entity through design, fostering a culture of compliance, with ongoing assessments to refine processes and support ethical research enterprise-wide.
Limitations:: Evaluation of the how design benefits compliance could be affected by inconsistent engagement with new processes, potentially skewing feedback. Resource constraints might limit advanced technology tool development, impacting billing assessments. Variations in HRPP/IACUC/IBC priorities could challenge unified metrics, risking incomplete insights. Staff transitions might disrupt training adoption. These factors could influence conclusions about effectiveness as compared through different research departments.
Discussion: : Thoughtful design of policies and procedures, review guides, education, other compliance materials, and processes could foster an enterprise-wide culture of ethics compliance by uniting different oversight units under shared, accessible processes. Departments like HRPP/IRB or ACU/IACUC could manage specific tasks, with the compliance department ensuring unified accountability. This model might streamline oversight, clarify financial processes, and prevent noncompliance across programs. Other enterprises could adopt this approach by using design concepts plus the seven elements of an effective compliance program to enhance collaboration and integrity, making it a scalable solution for unifying research compliance.
