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Anca Miron, PhD IRB Chair, UW Oshkosh Kelly Schill, BS, CIP

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Changes to the Common Rule and Single IRB (sIRB)

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

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

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.

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

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

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.

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

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