HRPP Newsletter March 2021
IRB Efficiency Project (IEP): Next Steps
The IEP is moving from the planning to implementation phase, with the following changes rolling out in the next couple of months:
- ARROW update March 27th includes new protocol-based application (PBA). Researchers will be able to use the PBA starting March 28.
- The new HRPP website will also go-live at the end of March and will include new documents including:
- Protocol and consent templates
- Toolkit worksheets, checklists, and SOPs
- Draft investigator and reliance manuals
- Consolidation of the IRB offices and staff reorganization, including changes to IRB office leadership (see details below).
Work on implementing additional IEP projects will continue throughout 2021 and will be announced in future editions of this newsletter.
Website Re-Launch
As part of the restructuring of the IRBs, we’ll be launching a new combined website for all UW-Madison IRBs at the end of this month. The current Health Sciences IRBs and Educational and Social/Behavioral IRB KnowledgeBase sites will remain active for the next couple months. We’ll eventually retire that content, relying solely on the new IRBs website: irb.wisc.edu.
In addition to the Toolkit documents, protocol and consent templates, the new Investigator Manual, and Reliant Manual can be accessed from this site. Additional information on the site will include news items, upcoming educational outreach events, and resources for IRB submission.
Upcoming Toolkit Orientation Session
The UW-Madison IRBs are hosting two, identical information sessions to cover the following topics:
- Understanding the Toolkit
- Introduction to the Investigator Manual
- New and existing investigator resources
- Q&A
Register for these sessions via the OHRD catalog:
A recording will be made available on the IEP webpage, where you can also view the recording from the previous information session on Protocol-Based Application and Templates.
RELIANT Update
- RELIANT has created a new draft reliance manual for researchers that will be posted on the new IRB website.
- This manual is being posted as a draft, and we welcome your feedback. The new website will include links to an HRPP Toolkit Feedback Form. Please use that form to provide any thoughts or feedback on this manual and other Toolkit documents.
- Along with other Toolkit documents, the reliance manual will be updated this June.
- RELIANT will be offering a workshop on March 30th on Ceding IRB Review and Introduction of the Ancillary Review Matrix. The matrix is a new tool to assist researchers in navigating institutional requirements for human research apart from the IRB approval process. Registration is required and available here.
Navigating and Using the Investigator Manual
The Investigator Manual (IM) is designed to guide you through policies and procedures related to the conduct of Human Research that are specific to this institution. There are several key features of the IM to note:
- You will notice many topics that are covered extensively in our current guidance, but only briefly mentioned in the IM. For now, our current guidance will remain, but eventually, the IM will become the sole guidance document.
- The IM refers to Toolkit (TK) documents throughout.
- To limit redundancy, where a TK document covers a topic, limited information is provided in the IM. It will be important to become familiar with the TK document as these are what IRB staff and members will use to review applications and make relevant regulatory determinations.
The IM will be accessible as a pdf document via the Toolkit Library tab on the new website, under Manuals. The IM is organized by topic in the table of contents, with anchors and links throughout. The IM is a living document and will be revised over time based on stakeholder feedback. As mentioned above, the HRPP Toolkit Feedback Form found on the new webpage can be used to provide your feedback on the IM.
Office of Research Compliance- Human Research Protection Program restructuring
April 1, 2021, the re-organization of the human research protection program compliance under the auspices of the Office of Research Compliance (ORC) within the OVCRGE will be completed. This began with the transition of the ED/SBS IRB office to the ORC in 2017, RELIANT and the HSIRBs in 2019 and culminates with the creation of a single IRB office in 2021.
RELIANT:
- The reliance and navigation team (RELIANT), led by Carol Pech, Associate Director of the ORC, support investigators engaged in multi-site and collaborative human research, including working with other sites on single IRB arrangements. RELIANT will also be assisting researchers in navigating institutional requirements for human research that stand apart from the IRB approval process.
- The RELIANT team: Michael Bingham, Kendall Holley and Brandy Stoffel. Contact at irbreliance@wisc.edu.
IRB office re-organization:
- Gretchen Anding will oversee all IRB operations as the new IRB Director.
- MRR Team
- To provide more uniform support to all the minimal risk research, staff from the current ED/SBS IRB office will join with some staff from the current HSIRBs office to form a new minimal risk research (MRR) team. This team will review and support committee review of all minimal risk research, including educational, social, behavioral, medical records review, and minimal biomedical interventional research.
- Leadership- Assistant Director, Casey Pellien and team lead, Monica Esquibel.
- Team members: Laura Conger, Sherry Holcomb, Olyvia Kuchta, Jackie Lee, Anna Martin, Stephanie Wilson
- To provide more uniform support to all the minimal risk research, staff from the current ED/SBS IRB office will join with some staff from the current HSIRBs office to form a new minimal risk research (MRR) team. This team will review and support committee review of all minimal risk research, including educational, social, behavioral, medical records review, and minimal biomedical interventional research.
- HS Team
- The HSIRB team will provide support for all the more than minimal risk biomedical research, including all clinical trials and research, FDA regulated research, and emergency use applications. This team will also review all VA research, regardless of risk level.
- Leadership- Assistant Director, Catherine Rogers and team lead, Becky Hoffman.
- Team members: John Cejka, Jennifer Fenne, Kendall Holley, Jessie Johnson, Steph Metzger, and Joscelyn Stangel
- The HSIRB team will provide support for all the more than minimal risk biomedical research, including all clinical trials and research, FDA regulated research, and emergency use applications. This team will also review all VA research, regardless of risk level.
- General Office Support:
- Rob Whitehead: IRB submissions and office IT support
- Hannah Rickey: IRB office manager- committee, financial, HR operational support
Contact information will remain the same during the transition. Please direct leadership questions to IRBDIRECTOR@hsirb.wisc.edu, protocol specific questions to the staff reviewer assigned to your study, and general IRB questions to asktheirb@hsirb.wisc.edu.