When applying for Exempt Review, you are only required to provide specific information, in which the entire submission does not need to be completed (details provided below). To see if your study qualifies for Exempt Review, please use our Submission Decision Tree tool . An Example of this type of submission can be found on our Submission Examples and Guidance page.
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.
Please note that what is required is subject to change depending on the specifics of your study. Additionally, all other requirements that may apply to your study (e.g., required training, certified translation of documents, PI eligibility, etc.) still apply to your Exempt research.
Sections in IRB Wise to be Completed for Exempt Research
- Section I. General Information
- Please be sure to complete all of the questions in this section and fully describe what you are doing in your study in response to question C of this section. Additionally, you will need to complete the Exempt Research sub-section (question E), as this section asks specific questions in regards to your research.
- Section II. Research Design and Methodology
- If your study is funded, then you will need to answer question N of this section and add the funding source. The rest of this section can be skipped.
- Section III. Subject Information, Consent and Types of Studies
- If you are obtaining identifiable human specimen for your research, you will need to answer question E of this section. The rest of this section can be skipped.
- Section IV. Studies involving Department of Defense, Radiation, or Nanotechnology
- This is a required section and must be completed.
- Section V. Key Words that Describe this Protocol
- Please select the Key Words that reflect your study.
- Section VI. Attach Documents
- All study documents must be uploaded to your submission. This includes funding proposals, consent, recruitment, data collection instruments (e.g., surveys, interview guides, etc.). For Exempt research that involves interaction with subjects, there usually should be a process to ask subjects to participate and confirm their agreement. However, signed consent is not required for most exempt research, and the consent process and documents can be much simpler than those required for non-exempt research.
- Conflict of Interest
- This is a required section and must be completed.