HRPP Newsletter – October 2025
Helpful Reminders for Submitting Changes of Protocol
1. Accept all previously approved tracked changes in study documents (e.g., consent, protocol, recruitment material) and resolve any outstanding comments before making updates for the current change submission. Only the changes relevant to the current submission should be tracked.
2. Clearly describe how the study is changing. For example, write, “We are increasing enrollment from 50 to 100 participants” instead of simply, “Increasing enrollment.” Rather than, “Adding a new study aim”, include a description of the new aim in the change form.
3. If you have several changes, number them. Use consistent numbering in other responses on the change form.
4. Provide a complete response when asked about any changes to the study’s overall risk/benefit ratio. Indicate whether the ratio will change, and if not, explain why it remains unchanged. A response of “No change” is not sufficient.
5. Do not repeat changes that have already been described when completing the “Revised Documents” and “Other Changes” pages.
6. Upload revised documents to the modified application, not the change application.
7. Use the “Upload Revision” feature in ARROW to replace existing documents in the modified application (this is found by clicking the 3-dot ellipsis icon next to the uploaded document). Do not use “remove” and “add”. For more tips, review the pre-recorded presentation on submitting changes of protocol .
UW Health/SMPH Research Operations Committee (UROC) Review Reminder
All prospective, non-oncology studies involving human research participants that use UW Health facilities, staff, equipment, procedures, or occur in any SMPH space must be reviewed and endorsed by UROC. This includes studies only involving interviews, surveys, or focus groups (visit the UROC KB Page for more information). This requirement is outside of the IRB approval process and is needed before IRB review begins. Final UROC endorsement letters must be uploaded to the ARROW application before the application can be submitted to the IRB. Questions about the UROC process can be directed to UROCAdmin@med.wisc.edu.
Considerations for Industry Funded Studies Reviewed Locally
While fully industry sponsored studies are generally ceded to independent IRBs (e.g. WCG or Advarra), there are some exceptions to this requirement, including when the UW serves as a statistical or data analysis center or when industry support is limited to provision of the drug or device under study.
Another scenario is when an investigator applies for an Industry Grant, whereby a company provides support for a project or program that was developed by a university researcher (i.e. investigator-initiated), and the company agrees to fund it, usually after a formal application and review process.
The UW-Madison IRB can review Investigator-Initiated trials (IIT) funded by industry grants and because these are similar to other external grants, there is no IRB review fee charged.
These are different than industry authored sponsorships, which are typically industry-initiated multi-site trials, where UW investigators are invited to participate in the trial. These are ceded to independent IRB, but if an exception has been made for this type of study to be reviewed by the UW-IRB, IRB fees will be applied (see IRB fee schedule); if ceded to an independent IRB, reliance review fees will be applied.