HRPP Newsletter January 2024

Upcoming Course -- Change of Protocol: IRB Submission and Review  

Register here. 1/23/24, 10:00-11:00 CT, virtual. This course will describe the IRB submission and review process for Changes of Protocol. Topics covered will include: What constitutes a Change of Protocol? What is the difference between an expedited and full Change of Protocol? How should changes be presented in the ARROW application? What is the process once the change is submitted? The presenters will also touch on special topics, such as changes to multi-site studies (reliance considerations) and when a change may need to be accompanied by a Reportable Event. 

Updates to Advarra Consent Language  

The Advarra Participant Payments system launched in December 2023 and since that time, the IRB Office has updated its guidance on including language in the consent form: 

1. If your current consent document does not specify how participants are paid, updates may not be necessary. 
2. If your consent form currently specifies a different system you will want to update to reflect the use of Advarra. 
3. It is important that participants know their information is being shared with a third party.  This can be accomplished by adding a brief statement to the consent form OR can be communicated orally during the consent process or as part of the supplemental handouts describing how to access and manage the Advarra payment system. 

 If you have questions on whether a change of protocol is necessary, please contact asktheIRB@wisc.edu. 

Drop-in hours for researchers   

The IRB is hosting virtual office hours for researchers/study teams! Staff from both the Health Sciences and Minimal Risk Research IRBs will be available.   

Please join us the first Thursday of every month from 12PM-1PM. Please click here for the Zoom link.  

To make best use of everyone’s time, please bring focused questions. Examples of focused questions include:   

• What information do we need to provide the IRB to share data between two studies?  
• We have X study in mind and were wondering what type of application we should submit?  
• Would XYZ changes to recruitment methods or participant population be allowable to improve recruitment?  

If you have questions about a submission currently undergoing IRB review, please contact your assigned staff reviewer. As always, the IRB website has plenty of resources that can assist with submitting a study to the IRB.