- About IRB
- Launch IRB Wise Protocol Portal
- Important News and Updates
- Submitting a Protocol
- Policies, Regulations and Resources
- IRB Committee Members
- Contact Us
Updated: January 19, 2024
The Georgia Tech IRB has added two new categories in which Exempt research can be reviewed under; FLEX 2 and FLEX 3. These categories can only be used in very specific scenarios (listed below). For FLEX 2, the definition is the same as Exempt 2 with the addition of allowing minors who are enrolled GT students as participants. For FLEX 3, the differences between this new category and Exempt 3 are that minors who are enrolled as GT students can be added as participants and non-invasive commercially available sensors can be used during the study to collect data, excluding MRI, fMRI, and TMS. More information about these categories can be found in our Policies and Procedures.
Exempt research under FLEX 2 and FLEX 3 must meet the following criteria in addition to all specifications of the exemption category:
- Research is not subject to FDA regulations.
- Research is not federally funded.
- Research is not contractually or otherwise subject to federal research requirements, including but not limited to research conducted under the Department of Veterans Affairs or under an NIH Certificate of Confidentiality.
- Research does not involve prisoners as participants.
- Research meets Georgia Tech’s ethical standards governing the conduct of the research, including appropriate provisions for the protection of privacy and confidentiality when identifiable and coded information are used.
The EU GDPR documents that are to be used when collecting identifiable sensitive data from individuals who are located in the EU have been revised to include data from individuals who are in the United Kingdom (UK) and the European Economic Area (EEA) territories. More information can be found on our policy page and on our forms page.