HRPP Newsletter July 2021
June Toolkit Revisions Complete!
Since the launch of the HRPP Toolkit in late March, we have been collecting feedback on the Toolkit materials from the research community, IRB staff, and HRPP leadership. That feedback has driven many of the revisions that will go-live the week of July 12, 2021. The most significant changes were made to the Investigator Manual and Reliance Manual. Both manuals received extensive improvements to their functionality which should make navigating the manuals and the external resources they reference much easier. Many of the remaining revisions involve changes to the Toolkit checklists and worksheets that IRB Staff have been using to conduct reviews for the past several months. However, one new addition to the Toolkit is an international research worksheet (HRP-336), which researchers may find helpful. As a reminder, we welcome feedback via the Toolkit Feedback Form that is linked throughout the IRB website or by email (toolkit@research.wisc.edu).
Research and the Return to Campus
As research continues to ramp up and students/staff return to campus, researchers should be aware that any research of patients with COVID or with COVID samples still requires review and approval from the SMPH COVID review committee prior to submission to the IRB.
While OVCGRE is no longer requiring formal approval for face-to-face research, other schools/departments/units may still have an expected evaluation/approval process for face-to-face research interactions. This process is separate from IRB review and approval. Researchers who are unclear about the required approval process should consult with their Associate Dean for Research.
Recent IRB Training Sessions
The IRB recently gave two training sessions on available protocol templates, choosing the right template for your study, and some tips and tricks on using the templates to ensure all necessary information is included. Recordings of these sessions are posted here.
Reliance and Navigation Team (RELIANT) Updates
- June Toolkit revisions included changes to our reliance manual which we encourage you to take a look at when planning your next request to cede IRB review or request the UW to serve as the reviewing IRB.
- Recordings of our recent training sessions on the new ancillary review matrix and reliance-related Toolkit documents are posted here.
- If your study requires that you obtain individual investigator agreements (IIAs) for external collaborators, please allow one week for processing to allow sufficient time to obtain the necessary signatures.
- Reminder: single IRB requirements do not apply to exempt and/or non-federally funded studies. Please contact us (irbreliance@wisc.edu) if you have questions about conducting exempt and/or non-federally funded studies involving external sites or personnel. We are happy to help identify the best IRB review options for your study.
FDA Begins Enforcing Rules for Sharing Clinical Trial Results
On April 28, the FDA issued its first notice of non-compliance to Acceleron Pharma, Inc. for failing to submit required results information to ClinicalTrials.gov. If Acceleron does not submit the required results within 30 days, the FDA may seek civil monetary penalties. FDA encourages voluntary compliance with ClinicalTrials.gov reporting requirements, but has shown now it will take action to ensure information is available to the public when necessary. Notices of non-compliance are preceded by a “pre-notice” and both are delivered in writing. If you receive a pre-notice or notice from the FDA regarding ClinicalTrials.gov, contact the Office of Research Compliance for assistance. For more information about ClinicalTrials.gov visit our KnowledgeBase page.