Phased launch of new VU SBER IRB begins March 3

On March 3, Vanderbilt University will soft– launch its new Social, Behavioral and Educational Research Institutional Review Board, which will oversee more than 90 percent of the university’s human-based research once it’s fully operational later this year.  

To prepare for this transition, the Research Integrity and Compliance team is offering additional training, office hours and online tools for VU researchers conducting studies involving human participants. 

First announced in February 2023, the new IRB will be implemented in three phases, beginning with this soft launch . This phased approach will allow the VU SBER IRB to gradually replace the Vanderbilt University Medical Center IRB for most university-based social, behavioral and educational research involving human participants while VUMC IRB will continue overseeing biomedical and clinical research studies.  

“Preparing for the VU SBER IRB launch has been a tremendous team effort,” Vice Provost for Research and Innovation Padma Raghavan said. “My deepest thanks go to Associate Provost Liz Zechmeister and Assistant Provost Liane Moneta-Koehler for leading the charge, our VUMC colleagues and stellar faculty including the IRB Advisory Committee for partnering with our team throughout, Hilda McMackin and the VERA team for advancing the VERA VU SBER IRB module, our new VU SBER IRB director Mila Tahai for taking on this exciting and challenging new role, and, of course, Provost Raver for her support through Discovery Vanderbilt.” 

Phased transition approach 

The phased launch of the VU SBER IRB will ensure a smooth transition and eliminate unnecessary extra work for faculty, staff and other stakeholders. 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 at their natural next IRB review or reevaluation point. 

Phase One Soft Launch on March 3 includes new expedited, standard and international SBER studies: 

• New expedited, standard (greater-than-minimal-risk) and international SBER studies involving human participants will be submitted to the VU SBER IRB. 
• BRANY-approved international studies will transition to the VU SBER IRB at natural review or reevaluation points, such as annual continuing reviews. 
• Biomedical and clinical studies, along with modifications and continuing reviews of active studies, will continue to be submitted to the VUMC IRB. 

Phase Two Full Launch in mid-calendar year 2025: 

• New exempt, expedited and standard SBER studies will be submitted to the VU SBER IRB. BRANY-approved studies will transition to the VU SBER IRB at natural review or reevaluation points, such as annual continuing reviews. 
• Biomedical and clinical studies remain under the VUMC IRB, along with ongoing modifications and 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 or BRANY will transition to the VU SBER IRB at natural review or reevaluation points, such as annual continuing reviews. 
• Biomedical and clinical studies remain under the VUMC IRB. 
• This phase completes the transition and establishes the VU SBER IRB as the primary body for all social, behavioral and educational research studies. 

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. In addition to smoothing this transition for researchers, the phased launch will allow the new VU SBER IRB Committee and Research Integrity and Compliance team to gradually implement new processes as they work up to full operational capacity, enabling thorough testing and continuous improvement throughout.  

Latest progress 

With comprehensive stakeholder input from the IRB Advisory Committee, faculty, staff and leaders across campus as well as our partners at VUMC, the Research Integrity and Compliance team have completed the design phase of this planned transition. This included the creation of new streamlined processes and resources for researchers as well as the hiring of Liudmila Tahai as the inaugural director of the VU Human Research Protections Program along with two new service-oriented staff members with extensive IRB experience to support the community. 

The Office of the Vice Provost for Research and Innovation is also onboarding the new SBER IRB Committee, which will review and make determinations on VU’s SBER studies. The committee brings together leaders across disciplines to uphold ethical research standards while advancing Vanderbilt’s research mission. The members are: 

• Jeremy Neal, associate professor of nursing, SBER IRB Committee chair 
• Robert Bodenheimer, professor of computer science 
• Carwil Bjork-James, associate professor of anthropology 
• Laura Ferguson-Mimms, executive director of the Tennessee Higher Education Initiative 
• Jonathan Hiskey, professor of political science 
• Deborah Rowe, professor of education 

How to prepare for the transition 

Researchers must complete required CITI training before they can submit a protocol for review to the new VU SBER IRB on or after March 3. Researchers should check their required CITI training status and, if needed, complete the full or refresher required training by logging in to https://about.citiprogram.org. Refresher training takes as little as 20 minutes. Full training for first-time users takes longer but is effective for three years before refresher training is required. 

Researchers are encouraged to explore the new suite of VU SBER IRB web resources, including:  

• A newly launched decision-support tool that helps researchers determine whether their studies require IRB review and whether submissions should be directed to the SBER IRB or the VUMC IRB. 
• The new https://www.vanderbilt.edu/researchintegrityandcompliance/irb/ website that provides comprehensive guidance for Vanderbilt researchers, including submission procedures, timelines and policy updates. 
• As of Jan. 27, Vanderbilt’s Electronic Research Administration system will include a dedicated IRB module that researchers can log into and explore, which is designed to streamline the submission and review process. Note that researchers cannot submit protocols for review until March 3; VU SBER IRB reviews will not begin until the start of soft launch on that date.   

Finally, researchers are invited to join the VU SBER IRB team for interactive info sessions and office hours:   

• Monthly “Introduction to the VU Social, Behavioral and Educational Research (SBER) IRB” sessions held on the fourth Wednesday of each month, with the first session scheduled for Jan. 22, 10–11 a.m. 
• Daily office hours every weekday, Monday through Friday, from 1 to 2 p.m. starting Feb. 3. 

For more information about the SBER IRB, including submission guidelines, training opportunities and upcoming events, visit Vanderbilt’s SBER IRB website at https://www.vanderbilt.edu/researchintegrityandcompliance/irb/ or contact the team at irb@vanderbilt.edu.