Human Research Protections Program and IRB

Vanderbilt University soft-launched a new Human Research Protections Program with a Social, Behavioral, and Educational Research (SBER) Institutional Review Board (IRB) on March 3, 2025.

This new VU SBER IRB oversees the majority of human research conducted at the university, offering tailored support for SBER studies while enabling the Vanderbilt University Medical Center (VUMC) IRB to focus on biomedical and clinical research.

Research conducted in a classroom

Next Event

Which IRB reviews my research during the soft launch? (March 3, 2025 - June 30, 2025)

Flowchart titled 'VU or VUMC IRB?' outlining the decision process for Vanderbilt University researchers to determine whether to submit their study to the Vanderbilt University IRB or the Vanderbilt University Medical Center (VUMC) IRB. It begins with Vanderbilt University Principal Investigators starting with a REDCap questionnaire. If the study is defined as 'Not Human Subjects Research,' it directs researchers to obtain REDCap certification. Social, behavioral, and educational research without VUMC clinical resources or personnel is directed to the Vanderbilt University IRB, while studies involving VUMC clinical resources or biomedical research are directed to the VUMC IRB. Exempt and non-exempt studies involving VUMC study personnel are advised to consult the Vanderbilt University IRB. Each decision point is visually connected to guide researchers through the process clearly.

See descriptions of the flowchart categories. VU PIs submitting to the VUMC IRB must include the HRPP Determination with their study material.

Phased Transition

  • First Phase: Soft Launch on March 3, 2025

    New expedited, standard (greater-than-minimal-risk) and international SBER studies involving human participants should 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 activestudies, should continue to be submitted to the VUMC IRB.

  • Second Phase: Full Launch on July 1, 2025

    During this phase, the VU HRPP will begin to accept new Exempt research. Expedited and standard SBER studies should continue to 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. FAQs about exempt research are provided below.

    Biomedical and clinical studies remain under the VUMC IRB, along with ongoing modifications and reviews of studies previously approved by VUMC IRB. 

    Second Phase HRPP Determination Tool

  • Final Phase: Transition Active 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.

FAQs about Exempt Research

  • What is Exempt research? 

    Exempt research includes studies that fall under categories outlined in the federal regulations for minimal risk research, which are exempt from federal regulatory oversight and requirements. Research qualifying for exemption must still be submitted to and reviewed by the VU HRPP in VERA.

  • Does Exempt research need to be submitted to the VU HRPP for review?

    Yes. Exempt research studies must be reviewed by the IRB unless they are determined not to be human subjects research.

  • What Exempt categories does the VU HRPP apply?

    The VU HRPP reviews Exempt categories 1 - 6. The VU HRPP will not be applying broad consent under Exempt categories 7 and 8 at this time. Exempt categories, specific exceptions regarding protected populations within these categories, and Exempt Limited IRB Review information can be found in 45 CFR 46 (2018 Common Rule).  

  • When can I submit a new Exempt research study to the VU SBER IRB?

    The VU HRPP will be accepting new Exempt research submissions starting on July 1, 2025.  

  • Do I need to transfer my existing VUMC IRB or BRANY IRB approved Exempt research to the VU SBER IRB on July 1, 2025?

    No. VU researchers do not need to transfer existing Exempt research that has already been approved by the VUMC IRB or BRANY IRB on July 1, 2025 unless major amendments to the approved study are made that affect the risk and/or review level.   

  • Do I need to complete the VU HRPP protocol template?

    Yes. Complete the questions in green font within the VU HRPP Protocol Template only. This document is required for all studies submitted to the VU HRPP. 

  • Can a reliance agreement be executed for Exempt research?

    No. The VU HRPP does not execute reliance agreements for studies determined to be Exempt. 

  • Does an Exempt and Exempt Limited IRB Review study require Continuing Review?

    No.

  • Do I need to submit a modification for my approved Exempt research?

    Yes. For example, modifications for Exempt research that must be submitted may include the following. Please note, this is not an exhaustive list. 

    • a change to the scope of the research (e.g. new procedures to collect data) 
    • change to study risks or privacy and/or confidentiality (e.g. adding sensitive questions, rewording questions that may increase risks, collecting personal identifiers that were previously not collected) 
    • changes in the study population (e.g. adding protected populations, such as children and prisoners) 
    • adding study sites or research personnel (e.g. adding international sites, a new collaborating organization) 
    • changes in funding/regulatory requirements (e.g. adding study procedures that would make the study subject to FDA regulations, the study now is now federally funded).  
  • Are there any additional requirements for Exempt research conducted internationally?

    It depends.  

    • The VU HRPP International Research Consultant Form is not required for Exempt research, but may be requested at the discretion of the VU HRPP and IRB reviewers.   
    • Translated Materials. Members of the research team who are fully proficient (speak, read, write) in the local language(s) and English may translate study materials. This individual must provide a translation attestation statement in a separate document attached to the IRB submission (i.e., “I attest the research study materials translated from ______ to ______ are accurate and complete to the best of my knowledge.”)  
    • Additional Layers of Review/Considerations. Researchers should account for additional local reviews/considerations that may affect their international research (e.g., local ethics committee review, ancillary reviews, data privacy laws). This will vary on a case-by-case basis and typically conducted separate from the IRB review. 

     

  • How do I submit Exempt research to the VU HRPP for review?

    Exempt research must be submitted to the VU HRPP through VERA (VU IRB’s electronic admin system). Please review the VU HRPP “Getting Started – Submitting to VU IRB” webpage for details regarding requirements and instructions for submission. VU researchers must have up-to-date CITI training completed and are required to submit the VU HRPP Protocol Template (green questions), along with all study related materials for review. Templates, forms, and guidance documents can be found on the VU HRPP website.   

    Upon submitting to the VU HRPP, an Exempt research submission will (a) undergo an intake process for administrative checks, and (b) then be assigned to a Compliance Analyst for review and processing. Once an Exempt research study is assigned to a Compliance Analyst, VU researchers should work directly with that assigned individual.