Stakeholder input fuels progress on planned SBER IRB

With input from researchers and other stakeholders, Vanderbilt University is making steady progress toward launching the new Vanderbilt University Social, Behavioral and Educational Research IRB in calendar year 2025.

Phased transition approach

Currently all human research at Vanderbilt University is overseen by the Vanderbilt University Medical Center IRB even though the vast majority of VU studies involving human participants focus on social, behavioral and education research, with fewer than 2 percent being health expedited or standard studies.

The new VU SBER IRB will oversee social, behavioral and educational research involving human participants at Vanderbilt University. The existing VUMC IRB will continue to oversee biomedical and clinical research studies involving human participants.

"This new VU Social, Behavioral and Educational IRB enables VU and VUMC to refine our respective IRB processes to best fit our research communities," said Vice Provost for Research and Innovation Padma Raghavan. "My thanks go out to VUMC, Assistant Provost Liane Moneta-Koehler, IRB Director Mila Tahai, Associate Provost Liz Zechmeister, and all our faculty and staff partners across campus for collaborating with us on this transition."

To ensure a smooth and eliminate unnecessary extra work for faculty, staff and other stakeholders, the VU SBER IRB will launch in three phases beginning in early 2025. The first two phases redirect new SBER human participants studies to the VU SBER IRB, while the third phase moves active, ongoing SBER human participants studies from the VUMC IRB to the VU SBER IRB.

• Phase : Soft launch will include new expedited, standard and international SBER studies:
  • New expedited studies, new standard (i.e., full committee or greater-than-minimal-risk) studies, and new and ongoing international studies involving human participants will be submitted to the VU SBER IRB rather than the VUMC IRB.
  • New biomedical and clinical studies, as well as modifications and continuing reviews of active studies with human participants, continue to be submitted to the VUMC IRB.
• Phase Two: Full launch will include new exempt SBER studies:
  • New exempt studies will be submitted to the VU SBER IRB rather than the VUMC IRB.
  • Phase One process continues for new expedited studies, new standard studies, and new and ongoing international studies submitted to the VU SBER IRB.
  • Biomedical and clinical studies continue to be submitted to the VUMC IRB, as well as modifications and continuing reviews of studies previously approved by VUMC IRB.
• Phase Three: Long-term maintenance will transition active SBER studies:
  • All active, ongoing SBER studies already approved by the VUMC IRB will transition to the VU SBER IRB at their natural IRB review or reevaluation points, such as annual continuing review.

This three-step approach will support a seamless handover of preexisting studies from the VUMC IRB to the new VU SBER IRB and minimize redundancy. At the start of the phased launch, the VU SBER IRB will provide tools to help researchers determine if their study needs IRB review and, if so, which IRB to use.

Current progress and next steps

After announcing the new IRB earlier this year, Vanderbilt formed the VU SBER IRB Advisory Committee and hired Liudmila Tahai as the inaugural director of the VU Human Research Protections Program, within the Office of the Vice Provost for Research and Innovation. Official IRB members will be appointed later this year.

The VU SBER IRB is currently in the design phase, with the Research Integrity and Compliance team actively incorporating insights from faculty leaders and IRB users across campus to map out tailored processes for the new IRB.

The team is also preparing additional resources to support researchers throughout the transition, including a dedicated VERA module and an investigator manual. Streamlined training will guide researchers step-by-step through the phased launch.

"We're deeply grateful to the advisory committee members and the VUMC HRPP team for their guidance and collaboration, as well as to Vice Provost Raghavan and Provost Raver for their commitment to establishing an IRB tailored to our research community's unique needs," said. "We are dedicated to ensuring a smooth transition for our researchers."

In the coming months, the team will continue testing and refining these new systems with input from faculty, staff and other stakeholders in the social, behavioral and educational research community. As transition resources are finalized, start dates for each phase of the launch will be announced well in advance, allowing community members ample time to prepare for this change.

How to get involved and prepare for the transition

Vanderbilt encourages all researchers to join monthly VU SBER IRB update and Q&A sessions where they can learn more about the new IRB's progress, ask questions and provide input.

Upcoming sessions:

• 20, 10 to 11 a.m. CT
• 18, 10 to 11 a.m. CT

Future sessions will be offered before, during and after each phase of the launch in calendar year 2025.

As progress continues, future updates will include announcements about:

• new on-demand tools, such as a quick-and-easy decision tree to help researchers decide whether their study falls under the purview of the VUMC IRB or the new VU SBER IRB
• additional office hours
• training resources
• advance notice and guidance for each phase of the launch

The university remains committed to launching the SBER IRB with comprehensive support to ensure a smooth, well-supported transition for all involved. For more information, visit the Human Subjects Research webpage or email [email protected].

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