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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. Developed by: U-MIC

Flexibility initiatives: Exemption 7 and two-year approval Developed by: U-MIC University of Michigan IRB Collaborative

Exemption 7 and two-year approval 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 Developed by: U-MIC

Exemption 7 and two-year approval 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. Developed by: U-MIC

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

Exemption 7 and two-year approval 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 Developed by: U-MIC

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

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

Thank you. Brian Seabolt IRBMED Developed by: U-MIC

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