58 - Ensuring Regulatory Compliance in Longitudinal Research Studies: Establishing a Monitoring and Auditing Program for a Government Research

Background: A NIH contracted organization leads a Monitoring and Audit program to provide impartial investigation of activities at research sites. Staff interviews, regulatory documentation, and general research observation methods are used to determine human subjects research compliance. In-depth Monitoring and Auditing Program has been developed to bolster compliance and identify site challenges.

Program

Description: The Monitoring and Auditing Program has established guidelines to monitor and audit a government research program’s sites to ensure regulatory compliance and adherence to the program Core Protocol, ISIA, program policies, IRB policies, and relevant regulatory requirements. Monitoring visits consist of pre-launch (site initiation), periodic (interim), and closure visits. Auditing visits include targeted and random audits. Targeted audits are conducted in response to incidents at sites. Randomly selected audits are chosen using a randomizing generator. Both follow the same audit procedures. The contracted organization assesses whether the program achieved its goals by using feedback surveys to gather comments from sites regarding the visit. Sites have an opportunity to provide feedback to the organization about the pre-visit checklists, pre-visit information meetings, and the site visit, which the organization will utilize and continue to improve the program.

Program

Assessment: During the Monitoring and Auditing Program Pilot phase, the contracted organization conducted in-person monitoring visits at two universities, and virtual visits at a Health System. Before the contractor conducts a visit, monitors provide a pre-visit checklist to assist sites with preparing the regulatory documents and hold informative pre-visit meetings regarding the process. Monitors conveyed that conducting in-person visits empowered frontline staff to provide candid and unbiased feedback about the program. Monitors stated that they were able to identify privacy and safety concerns regarding enrollment and retention activities. Pilot sites provided positive feedback indicating the value of the visits. Specifically, the feedback survey results indicated that sites found the pre-visit checklist resourceful. The successful results of the pilot phase highlights the necessity of the Monitoring and Auditing Program for assessing the research program’s overall health and supporting regulatory compliance. Incorporating the Monitoring and Auditing Program into the program is crucial for its future success.

Limitations: The research program’s monitoring has only recently been piloted. The massive scale of research sites throughout the U.S., along with the diversity of collected information, poses monitoring challenges. Additionally, the shortage of regulatory personnel limits the frequency of monitoring and auditing visits. Lastly, due to the unpredictability of site closures, the pilot phase was unable to conduct a closure visit during this time. Evaluating the feasibility of the closure visits has not been possible

Discussion: The pilot phase of the research program’s Monitoring and Auditing Program emphasized the need for oversight in the research program. During this monitoring period, several key findings and strategies were identified to require additional IRB approval. Additionally, monitors discovered areas where research institutions could benefit from additional training. By standardizing procedures, devising a comprehensive plan, and providing accompanying templates, the Monitoring and Auditing Program can easily be implemented throughout the Consortium sites.