66 - Addressing Barriers to Sustained Monitoring

Background:  Monitoring IRB staff performance is a necessity. However, creating a sustainable monitoring program is a challenge. Prior efforts were unsuccessful due to staff limitations. Day-to-day work took precedence. Completed monitoring was stalled due to an overly complex approval process that involved individual team managers in addition to quality assurance staff.

Program

Description:  Our office launched a revamped staff monitoring program. Three key changes were instrumental in sustaining the program. First, hiring a dedicated full-time staff member. Second, shifting monitoring from staff member focused to issue focused. Previously, each staff member had a set number of submissions monitored for adherence to applicable regulations, institutional policies and operating procedures. The current program focuses on issues such as “research with children” or “Investigational device determinations.” This approach ensures areas of greater regulatory risk are monitored at the appropriate frequency and that the monitoring sample includes a sufficient volume of studies. Third, the process for gaining approval of the final monitoring report and providing feedback to was entirely reworked. Previously, finalizing the monitoring report suffered from “too many cooks in the kitchen.” Team managers were present when feedback was provided to staff. Staff felt “called out.” Monitoring activities are now overseen by the education team.

Program

Assessment:  Hiring a dedicated staff member eliminated the “competing demands” problem that plagued previous monitoring efforts. The expectation that staff divert time from screening and reviewing studies to conduct monitoring was unreasonable. Our revamped monitoring program has run for over 18 months without interruption.
Reframing monitoring efforts as issue based, ensured our ability to identify performance trends. Each quarter the management team receives a report evaluating the office’s collective ability to apply identified regulations and policies; the success of staff training; and ability to apply operating procedures appropriately. The monitoring program is run efficiently under the oversight of the Associate Director for Education & Compliance. The consensus and approval of multiple team managers is no longer required to finalize reports or initiate corrective actions such as re-education.
Staff are reassured the goal of monitoring is quality assurance/improvement by focusing on issues. When possible, re-education is delivered at the team level. Individual staff members are counseled by the Associate Director when needed. Separating their direct manager from this process increases the engagement of staff and alleviates tension.

Limitations: We have a need, a need for speed! Our program was designed to be run on a quarterly basis. Every quarter we look back to work performed the prior quarter. By the time all results are compiled and presented to leadership we are reviewing findings that occurred up to six months earlier. This system does provide leadership a “snapshot” of how the office is functioning; however, it does not provide staff timely feedback.

Discussion:  As an entirely remote staff, having a sustainable monitoring program is essential. The delivery of feedback to staff provides an additional avenue to touch base with one another. When feedback is delivered, staff have an opportunity to express concerns or suggestions for improvement related to monitoring findings (e.g., procedural improvements). It also provides, most importantly, an opportunity for office leadership to draw attention to areas where staff excel. This is especially true when there is the opportunity to highlight areas of improvement. Monitoring helps keep staff invested and engaged in the remote work environment.