Post-approval monitoring

–Effective January 2018–

The IRB will conduct post-approval monitoring visits for selected studies. This means that we will schedule a time with you to review your study processes and files.

The purpose is to verify that the IRB-approved protocol is being followed, which in turn ensures that human subjects are protected. These reviews will also help us identify areas where we can improve our IRB processes, guidance, and training.

For more details, visit our post-approval review page: https://uwm.edu/irb/submission/post-approval-review/

What studies will be reviewed?

  • Any study that has received full board or expedited approval may be selected.
  • Initially, however, we will focus on the following types of studies:
  • More than minimal risk;
  • Federally funded; or
  • Where problems have been reported.

Who will review my study?

  • One or more of the IRB office staff (Melissa, Melody, & Leah), and typically an IRB member as well.

How often will my studies be reviewed?

  • No more than one review per year for any PI, unless there is a for-cause reason to review a study. We assume that you will extrapolate any lessons learned to other studies you oversee, so conducting more than one review per PI per year would not be an efficient use of time and resources.

How does the process work?

  • Before: If you are selected for a review, we will contact you to schedule a mutually convenient date and time. We’ll send you detailed information about what to expect, what documents we’ll review, and a request for any additional information we might need.
  • The day of the meeting: We’ll come to your location and review the study files, asking questions as we go. Before we leave, we’ll give you an oral summary of our review. This will include things you are doing well, any issues that need to be resolved, and friendly suggestions that might make future studies easier. We also welcome your input for how we can improve our processes.
  • In conjunction with the review of your files: We will review our own IRB files for accuracy, completeness, and to ensure we followed our processes properly. We want this to be a learning and improvement exercise for all of us.
  • After: We’ll write up our summary and send it to you. If any corrective actions are needed, we’ll request a written response to explain how you have resolved, or will resolve, the issue(s). We’ll upload both our letter and your response to the study file in IRBManager.

For IRB Members

We will ask you to perform a maximum of 1 review per semester with us. You’ll receive all the same checklists and information that we send to the researchers.