HRPP Newsletter – July 2025
HRPP Toolkit Updates
As part of our semi-annual updates, a number of toolkit documents were recently revised (tracked versions of the revised documents can be viewed here). As a reminder, revisions are initiated by changes to regulations as well as feedback from HRPP staff and the research community.
Many revisions made during this cycle were related to regulatory changes, including those related to updated VA Directives, DOE Orders, and ICH GCP E6 (R3). Highlighted changes to the Investigator Manual include improved guidance for temporary PI changes and situations where PIs are leaving the institution, statistical data analysis center applications, and email recruitment.
Just In Time Requests (JITs)
Help us to help you with JIT requirements! We need sufficient time to review your proposals. If a Principal Investigator (PI) receives an automated JIT request, it is recommended that they check their score/percentile through eRA Commons to determine whether it is within or near the published paylines for the granting agency (for that year or the prior year). If so, the PI and their department can start gathering the necessary information and completing (but not necessarily submitting) any necessary IRB materials. This could be an application for Protocol Development Activities (PDA) for funding only, a change to an existing IRB-approved study, or an application for a new study. If a grant is likely to be funded, a formal request for additional information from agency staff will be sent from the NIH Grants Management System (GMS). When the NIH GMS issues a JIT request, follow the instructions from RSP found in this guidance under the Requests for Additional Information and JIT tab. When you submit materials to the IRB, let us know of your urgent funding deadlines.
MyChart Recruitment Invitations
Studies that use MyChart Research Recruitment Invitations should contact the Clinical Research Program Specialist Team before submitting the invitation text to the Institutional Review Board (IRB). The team will ensure that the invitation conforms with the template approved by UW–Madison and UW Health, preventing additional study team work and the need for re-review by the IRB.
Please note that while IRB approval is required to recruit via MyChart, study teams must also comply with UW Health requirements for this type of MyChart use.
For more information, please access the following resources:
- The Pulse
- MyChart Research Studies Page and MyChart for Recruitment FAQ - See Appendices C and D for templates.
- HRPP Investigator Manual
Questions may be directed to the Clinical Research Program Specialist Team: crps@uwhealth.org.