Introducing our new Staff Analyst – Jamie Hawkins!

We’re happy to announce that the IRB’s Minimal Risk Research team recently welcomed a new analyst- you may have seen her at recent committee meetings.

Jamie Hawkins has a bachelor’s in sociology, as well as a master’s in human ecology from UW-Madison. She previously worked as a consultant for Co-Create, doing collaborative research and evaluation projects and worked as a project assistant at the UW Child Development Lab and the Wisconsin HOPE Lab. 

We’re excited to have Jamie bringing her skills and experience to the IRB Office. Welcome, Jamie! 

Member Evaluations

Since 2022 the IRB office has evaluated IRB Members on an annual basis, as part of our annual evaluation of the Human Research Protection Program (HRPP). Now that we have settled in to our 8 panel structure (6 HS panels, 2 MRR panels) and IRB member turnover has decreased, we are moving this evaluation to a bi-annual schedule. This means that there will be no evaluations this year!

📬Communication Reminders: Emails from the IRB Office

IRB members should regularly check for emails from the IRB office, as these messages often contain time-sensitive information related to study reviews, determinations, and required actions. Communications related to IRB review processes will come from irbreview@hsirb.wisc.edu—these emails require a response to ensure timely and effective review workflows.

In addition, ARROW generates automated emails to notify you when meeting agendas are ready or when minutes have been assigned for an upcoming meeting. These messages do not require a response but may require action in ARROW, as they are system-generated reminders to help you stay organized.

Prompt attention to these communications supports regulatory compliance and smooth IRB operations. If you’re ever unsure about the content or what action is needed, please reach out to the IRB office for clarification or assistance.

Continuing Education: Monitoring Services Available to Study Teams

Study teams at UW–Madison have access to several monitoring services that promote subject safety, research integrity, and regulatory compliance. These services offer tailored oversight and educational support to help researchers meet institutional and federal requirements.

🔍 ICTR Data Monitoring Committee (DMC)

The DMC provides independent safety and compliance oversight for investigator-initiated studies. Using REDCap, study teams report accrual, outcomes, adverse events, and demographics, enabling the DMC to make informed recommendations to the PI. Teams not using REDCap must prepare reports manually, with support available from the DMC manager.

🧪 CTI Central Monitoring Service (CMS)

The CMS offers fee-based monitoring for FDA-regulated, investigator-initiated trials. Customized monitoring plans include study initiation, routine visits, and close-out reviews. CMS ensures proper documentation, informed consent, eligibility verification, protocol adherence, and data accuracy.

📋 Post-Approval Monitoring (PAM) Program

The PAM Program enhances the Human Research Protection Program (HRPP) by providing education and oversight for studies approved by a UW–Madison IRB or ceded to an external IRB. PAM monitors meet with study teams to review study conduct and records, offering guidance and tools to improve compliance and reduce institutional risk. A post-visit report outlines findings and recommended educational resources.

As part of their review responsibilities, IRB committees may assess whether a study’s proposed monitoring plan is appropriate given the level of risk and complexity. In cases of noncompliance or other concerns, the IRB may recommend new or additional monitoring—such as engagement with the DMC, CMS, or PAM Program—as part of a corrective action plan to support study improvement and participant protection.