New Model for Managing IRB Submissions Leads to Faster Approvals

By Linnea Anderson and Felicia Mroczkowski, U of M Human Research Protection Program

Because we are often so busy doing our work, it can be difficult to make space to think about how we do our work. The University of Minnesota’s Human Research Protection Program (HRPP) office has implemented and absorbed tremendous change over the last several years—implementing a new technical solution to manage our work, changes to the regulations that govern our work and significant growth of our office. As our “new normal” began to feel merely normal and not so new, we decided we wanted to focus on two seemingly contradictory goals—improving turnaround time and increasing employee engagement.

Piloting for Success

The Institutional Review Board (IRB) office, part of the HRPP, receives approximately 1,200 submissions per month. Each new submission is triaged to one of our 11 analysts to evaluate and determine next steps. As we reviewed the analysts’ queues, however, we realized some analysts had 20 items in their queue, while others had only two. The oldest item in one analyst’s queue might be two days, while another might have a submission over a week old. There are many legitimate reasons why these differences exist but, for the researcher waiting anxiously for IRB approval before they can begin their study, they are focused on time.

The first step was changing how we think about the work. Once an item was assigned to an analyst, it became their work. We decided to break that thinking and ask that, though assigned to a specific person, we think of all of the work as our collective responsibility. To do so, the following changes were required:

  • On a daily basis, focus on what is aging and, if necessary, reassign or avoid assigning new work so an analyst can catch up.
  • Provide support, when needed, on problematic submissions.
  • Let help be help—accessing support from peers isn’t negative and providing help is not punitive.
  • Share and implement best practices regarding queue management.

These changes required significantly more vigilance of all the queues. To provide this, we piloted a new role, the senior IRB analyst. The senior analyst checks in daily with their coworkers, reassigns work if necessary, answers questions, and confirms items are moving through all of the queues at a reasonable pace.

Transformational Results

Preliminary results of the pilot activities are transformational. Efficiencies were gained and turnaround times radically improved. The senior analyst role offered support to more junior analysts but also created capacity for our managers, allowing them to complete more quality checks and make those checks more substantive. Staff feel more supported knowing they have ready access to someone who can answer their questions or help with a problem submission. This position also creates another opportunity for advancement for analysts.

HRPP is conducting final evaluations of these pilot activities and anticipates incorporating formal changes into the staffing model given the successes experienced as part of the pilot.