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. IRB REGULATORY DETERMINATIONS Developed by: U-MIC University of Michigan IRB Collaborative

4. IRB determinations regulatory determinations convened board meeting  recorded in minutes  CFR citations expedited review  compliance with federal regulations for human subject protections  vulnerable populations  risk/benefit assessment  other determinations, as applicable o waivers o study-specific AE reporting plan o significant and nonsignificant risk devices o unanticipated problem involving risk to subjects or others (UPIRSO or UaP) 3 Developed by: U-MIC

5. IRB determinations most applications new studies amendments scheduled continuations adverse events (AE)/other reportable information or occurrence (ORIO) compliance with human subject protections regulations  HHS: 45 CFR 46.111  FDA: 21 CFR 56.111  other federal regulations  Department of Defense: 32 CFR 219.111  Department of Justice: 28 CFR 46.111  OCR — HIPAA Privacy Rule: 45 CFR 160 and 164 4 Developed by: U-MIC

6. IRB determinations vulnerable subject populations federally defined  women of childbearing potential  pregnant women, fetuses, and neonates  prisoners  children  parent signatures per U-M  patients of the study team  educationally disadvantaged individuals  economically disadvantaged individuals  cognitively impaired adults  other special populations 5 Developed by: U-MIC

7. IRB determinations risk/benefit assessment IRB may  confirm study team’s assessment  determine that  risk level should be higher or lower  no more than minimal risk  minor increase over minimal risk  moderate risk  high risk  benefit type should be changed  potential direct benefit  indirect benefit 6 Developed by: U-MIC

8. IRB determinations waivers  informed consent  documentation of informed consent  assent  HIPAA Authorization may be  full  all subjects and study activity  partial  only a portion of the study  only certain subjects study must meet criteria for waiver  HHS  FDA  OCR 7 Developed by: U-MIC

9. IRB determinations study-specific adverse event reporting plans IRB must determine that study team’s plan is acceptable. 8 Developed by: U-MIC

10. IRB determinations investigational medical devices  significant risk  nonsignificant risk IRB may  agree with sponsor’s determination  disagree o modifies determination o instructs sponsor to notify FDA of IRB determination 9 Developed by: U-MIC

11. IRB determinations unanticipated problems involving risk to subjects or others  UPIRSO / UaP unexpected related or possibly related to research suggests study presents greater risk than previously recognized 10 Developed by: U-MIC

12. IRB determinations 11 Developed by: U-MIC IRB regulatory determinations

13. THANK YOU. Brian Seabolt Cheryl Jamnick IRBMED 12 Developed by: U-MIC