67 - Enhancing Research Integrity and Compliance: Implementation and Assessment of a Quality Assurance Program at an Integrated Research Institution

Background:  The Human Research Protection Program (HRPP) at our institution identified a need for an enhanced quality assurance (QA) program to ensure compliance with federal regulations and uphold ethical standards. The absence of a structured QA program led to inconsistent review processes and oversight, affecting research integrity and participant safety.

Program

Description:  The institution implemented a comprehensive Quality Assurance Review (QAR) within its HRPP, FY2022. This initiative aimed at standardizing review processes, increasing transparency, and improving researcher education on ethical standards and regulatory compliance. The QAR integrated routine audits, feedback mechanisms, and targeted training sessions structured around key performance indicators (KPIs) to measure program effectiveness. These KPIs included audit turnaround times, compliance rates, and researcher satisfaction. Program implementation followed a phased approach, beginning with pilot audits with minimal risk reviews and ending with for-cause rollouts. Feedback loops were established to continually refine QA processes based on audit findings and stakeholder input.

Program

Assessment:  Preliminary observations from the QAR Program indicated an increase in compliance rates and a more uniform understanding of ethical guidelines among researchers. However, challenges such as resource allocation and researcher resistance to new procedures were encountered. While complete data on program outcomes is pending, initial feedback suggests improved research integrity and participant safety. The ongoing assessment includes comparing pre- and post-implementation audit results, tracking changes in non-compliance rates, and evaluating researcher feedback to identify areas for further improvement.

Limitations: The primary limitations of the program include resource constraints, particularly in funding for additional staff to increase the number of audits, and initial resistance from researchers accustomed to less stringent review processes. Additionally, the newness of the program means long-term outcomes are not yet measurable. Variations in departmental adherence also posed challenges in achieving uniform program implementation across the university.

Discussion:  The QAR program at the institution has shown promising initial results, suggesting it could serve as a model for other institutions seeking to enhance research integrity and compliance. Future directions include expanding the program to include more staffing resources, continuous refinement of QA processes based on ongoing assessments, and further engagement with the research community to foster a culture of compliance and ethical research. The relevance of implementing a similar program at other institutions lies in its potential to standardize research practices, enhance participant safety, and ensure adherence to ethical and regulatory standards.