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University of Wisconsin–Madison

Welcome to the New IEP and IRBs Newsletter

September 2020

Welcome to our new newsletter for the IRB Efficiency Project (IEP) and IRBs! The purpose of this combined newsletter is to provide the research community with important IEP and IRB updates in one place. This will be a monthly newsletter that will be distributed through both the HS/MR and ED/SBS IRBs’ listservs as well as being posted on the IEP website.

IEP

Our project is well underway and key developments include:

  • The IEP website is now live and features a project timeline as well as an organizational chart.
  • An IEP researcher survey is live and will remain open until October 1st. Although the research community has been previously surveyed about the IRB review process, the results of this survey will be used to measure the impact of the IEP over time. Your help in completing the survey will ensure we have a good baseline from which to work moving forward.
  • Smaller project groups as well as the Advisory Working Group are currently focused on issues including:
    • Adapting the Huron Toolkit documents (e.g., SOPs, checklists, worksheets) for use at the UW. This includes consolidation and streamlining of current IRB policies and guidance.
    • Development of protocol templates specific to different types of research studies as well as revisions to consent templates.
    • Initial planning for possible changes to board structure and meeting schedules. We encourage researchers to contact the IEP program managers with any questions they may have about the project (Thomas Bechert and Carol Pech)

ED/SBS IRB Updates

  • Revamped Consent Form Wizard Now Live: As many ED/SBS researchers know, the Consent Form Wizard is a tool to help ensure all federally required elements of consent are included. The ED/SBS IRB Office worked with IT to update the Wizard to be more user friendly and incorporate Revised Common Rule requirements. The new Wizard can be found here. Researchers now have to log-in with their NetID to access the Wizard. This provides more security and allows more features to be available in the Wizard. Please note, the Wizard should only be used by researchers submitting to the ED/SBS IRB. If researchers are submitting to the Health Sciences IRB or Minimal Risk IRB, their consent templates, available on their website, need to be used.
  • Workshops and Outreach Sessions: The ED/SBS IRB office offers workshops throughout the year that are open to all faculty, staff and students. The following virtual workshops are planned for the Fall 2020 semester:
    • How to Avoid Delays in the IRB Approval Process, October 21, 2020 @ 10-11am: This session will address the most frequent errors seen by IRB Staff when reviewing protocol submissions and how to avoid them. Also, a checklist of items that can slow the approval process of a protocol submission will be reviewed.Because this session is being offered via Cisco WebEx, registration is required. Registrants will receive a WebEx invitation the day before the event. Please register by October 19.Register HERE
    • Consent Considerations, November 17, 2020 @ 10-11am: This session will review, in detail, each of the consent processes that may be used when conducting research. Also, the most frequent errors seen by IRB Staff when reviewing consent forms and documents and how to avoid those errors will be discussed.Because this session is being offered via Cisco WebEx, registration is required. Registrants will receive a WebEx invitation the day before the event. Please register by November 15.Register HERE

HS/MR IRB Updates

    • Public Health Surveillance Projects: Our QI/program evaluation decision tool has been updated to clarify that it cannot be used to assess whether a project qualifies as public health surveillance under the Common Rule. Study teams planning to conduct such projects should contact the IRB director for assistance.
    • Coming Soon – RELIANT Office Hour: As a pilot outreach project, RELIANT will be holding an open office hour on Zoom. Study teams are welcome to drop by to get assistance with any single IRB or collaborative research questions they may have. We will announce the date and time in the October newsletter.
    • JSPR Update: The Joint Security and Privacy Review process is using a new tool for review requests called OneTrust. This tool is secure and users should log in using their netID.