2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. FLEXIBILITY INITIATIVES: EXEMPTION 7 AND TWO-YEAR APPROVAL Developed by: U-MIC University of Michigan IRB Collaborative Comprehensive Gender Services Program

4. Exemption 7 and two-year approval 3 Developed by: U-MIC Federal regulations’ existing flexibility non-federally-funded non-FDA-regulated Exemption 7 two-year approval within IRB’s discretion IRB staff asks researcher to verify that study meets criteria

5. Exemption 7 and two-year approval 4 Developed by: U-MIC Exemption 7 analysis of single dataset containing identifiable data no need for researchers to submit annual SCR Eligible studies must pose no more than minimal risk undertake only analysis of a single data set containing identifiable data include none of the following:  federal funding/federal training grants  FDA-regulated components  sponsor or other contractual restrictions  clinical research interventions (including behavioral)  previous restrictions on data use (e.g., data use agreements, previous IC restrictions)  NIH Certificate of Confidentiality Studies intended to support future proposals for federal funding should not be granted Exemption 7. Initial applications are not eligible for Exemption 7.

6. Exemption 7 and two-year approval 5 Developed by: U-MIC Two-year approval period for certain studies that comply with federal regulations no need for researchers to submit SCR annually all other requirements unchanged o amendments o adverse event reports o ORIO reports

7. Exemption 7 and two-year approval 6 Developed by: U-MIC Two-year approval period Eligible studies must pose no more than minimal risk include none of the following:  federal funding/federal training grants  FDA-regulated components  sponsor or other contractual restrictions  clinical research interventions (including behavioral)  prisoners as subjects  NIH Certificate of Confidentiality IRBMED may issue two-year approval for initial applications. Examples: secondary use of identifiable data/specimens (prospective/retrospective) not otherwise exempt survey, focus group, interview projects not otherwise exempt

8. Exemption 7 and two-year approval 7 Developed by: U-MIC IRB may choose not to issue Exempt 7/two-year approval, even if a study meets the criteria.

9. Exemption 7 and two-year approval 8 Developed by: U-MIC Flexibility initiatives: Exemption 7 and two-year approval

10. THANK YOU. Brian Seabolt IRBMED 9 Developed by: U-MIC