1. 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.
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U-MIC

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

3. 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
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U-MIC

4. 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.
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U-MIC

5. 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
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U-MIC

6. 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
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U-MIC

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

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

9. Thank you.
Brian Seabolt
IRBMED
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U-MIC