56 - Optimizing Oversight: Efficient, Fit-for-Purpose, Remote Approach to Post Approval Monitoring (PAM) for Human Research Protection Program (HRPP) in a Large, Multi-State Health System

Background: : A multi-state, nonprofit health system recently centralized HRPP, Research Compliance and developed a PAM Program to ensure consistent oversight of research compliance, data integrity, and participant protections. The program features remote, risk-based reviews and check-ins utilizing existing platforms to assess both IRB and site compliance across the geographically diverse network.

Program

Description: : Following consolidation, the Research Integrity and Compliance (RIC) team established a remote, risk-based PAM program to oversee geographically dispersed research sites and HRPP staff. This fit-for-purpose approach tailors monitoring activities based on research design, regulatory requirements, and participant risk.

The RIC team developed standardized procedures and tools for various remote assessments, utilizing familiar, cost-effective institutional platforms like secure Google Docs/Folders. This minimized administrative and financial burdens for both the HRPP and research sites. After a successful pilot, the program was implemented system-wide. Post-review, both sites and the IRB receive feedback, including observations and recommendations. Sites also complete a satisfaction survey. The RIC team collects and analyzes metrics from reviews and surveys to ensure consistent oversight and identify areas for continuous improvement. A remote check-in for lower-risk protocols and those that do not require annual review has been implemented to expand program reach while balancing site burden.

Program

Assessment: : The PAM program's effectiveness was assessed via review of site and IRB observation reports and site surveys. Analysis of the first 15 completed PAM reviews revealed primarily minor site observations (68%), with 21% requiring immediate IRB reporting. Common findings were related to IRB/Regulatory review (27%) and informed consent (24%). PAM reviews incorporate detailed IRB file assessments, with PAM specialists providing recommendations to enhance compliance and efficiency. Just over half of the PAM remote reviews yielded IRB-related findings, with most (63%) being considered minor. Most observations (60%) were related to best practice recommendations and SOP adherence.

The program evaluation received favorable feedback from participating sites, characterized by high rates of perceived efficiency and usefulness. Specifically, 93% of respondents indicated the evaluation process was not too time-consuming, 80% reported it to be helpful, and a significant 87% stated they intended to modify their site processes as a result of the evaluation findings. These results suggest a successful implementation and a clear translation of evaluation insights into actionable IRB/HRPP and site-level improvements.

Limitations:: Program evaluation is limited by the number of reviews completed, due to its early stage, staffing, and restricting scope to high-risk, FDA-regulated studies. Future expansion to additional review activities and diverse study types is necessary for broader assessment. Despite initial concerns that sites would find the reviews too time-consuming, surveys showed high satisfaction in this area. The 47-day review completion average provides sites with valuable flexibility, but suggests potential for streamlining.

Discussion: : PAM allows institutions to ensure compliance, protect participants, improve research quality/integrity, identify systemic issues, and provide opportunity for education. Institutional oversight remains critical with transition to single IRBs and increasing QA responsibilities placed on sites.

Utilizing existing infrastructure, this remote, risk-based process was efficient and user-friendly, focusing resources on high-impact areas and minimizing administrative burden. Real-time feedback and targeted education to research sites and the IRB/HRPP staff fostered a culture of compliance, with results informing institution-wide training and initiatives. While developed for a multi-site health system, this program offers a transferable, resource-efficient framework that is adaptable to diverse operational settings.