Do I need IRB Review?
This HRPP Determination tool is designed to identify whether your study requires review by an Institutional Review Board (IRB). If a review is needed, the questionnaire will guide you on whether to submit your study to the Vanderbilt University (VU) IRB or the Vanderbilt University Medical Center (VUMC) IRB based on its specific criteria.
Complete Required SBER Human Research Protection Training
To meet IRB submission requirements, all researchers must complete Social Behavioral Educational Research (SBER) Human Research Protection Training through the CITI Program. Be sure to affiliate your CITI account with Vanderbilt University.
- Visit the CITI Program Website to complete one of these full or refresher courses.
Group 2: Social Behavioral Investigators and Key Personnel
Group 1: Biomedical Research Investigators and Key Personnel - A step-by-step CITI guide is coming soon.
- Please use your Vanderbilt.edu email address in your CITI profile
Research Study Materials
Develop protocol and other materials such as informed consent documents, recruitment materials, translations, etc. Please use the protocol and informed consent templates.
VERA: Electronic Admin System for IRB
All submissions to the VU IRB must be completed through VERA, Vanderbilt's electronic research administration system. VU Faculty, staff, postdocs, and PhD students who have Oracle accounts can serve as the PI of a study. Other students will need their faculty advisors to serve as the PI on a study and should be included as key study personnel. Researchers are required to:
- Complete the VERA Smart Form: Provide a detailed study summary as requested by the system. See VERA Guides for step-by-step instructions.
- Attach Research Study Materials: Upload all relevant documents, preferably in Word format when possible. PhD students must obtain a completed Faculty Advisor Responsibilities form and include it with the study materials.
- Request Department Chair approval: Submit an ancillary review to the department chair.
- Don't forget to press "Submit"
Using VERA is required and ensures efficient and secure submission, review, and tracking of research studies.
Multi-Site Research
For multi-site research requiring Single IRB, please email irb@vanderbilt.edu prior to submitting a grant proposal or as soon as possible.
IRB Submission Types
Researchers may need to submit different types of IRB requests based on the status and progress of their study:
- Initial (New Study): Submit a new research study for IRB review and approval.
- Modification: Request approval for changes to an existing approved study.
- Continuing Review: Submit periodic updates for ongoing studies requiring continued IRB approval.
- Reporting New Information: Report protocol deviations, unanticipated problems, or adverse events that may affect participant safety or study integrity.
- Closure: Notify the IRB when a study is completed, terminated, or no longer requires oversight. This is done as a Continuing Review in VERA.
These submission types help maintain compliance and ensure proper oversight throughout the research lifecycle. Please see the Investigator Manual for more detailed explanations and instructions.
IRB Review Levels
Research studies undergo different levels of IRB review based on their risk, complexity, and regulatory requirements:
- JIT/118 Determination: A certification that an research awards has an a human research component, but the plans for participants are not yet defined or ready for IRB approval.
- Exempt: Research involving minimal risk that meets specific federal criteria, exempting it from full IRB review.
- Exempt Limited Review: Studies qualifying for exemption but requiring a limited IRB review to ensure participant protections.
- Expedited: Research involving no more than minimal risk that falls into federally defined categories for quicker IRB review.
- Greater Than Minimal Risk: Studies involving more significant risk to participants, requiring full IRB committee review.
These review levels ensure appropriate oversight while balancing efficiency and participant protection.