Transcript Document
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 1 IRB REGULATORY DETERMINATIONS Developed by: U-MIC University of Michigan IRB Collaborative 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 o o o waivers study-specific AE reporting plan significant and nonsignificant risk devices unanticipated problem involving risk to subjects or others (UPIRSO or UaP) Developed by: U-MIC 3 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 Developed by: U-MIC 4 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 Developed by: U-MIC 5 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 Developed by: U-MIC 6 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 Developed by: U-MIC 7 IRB determinations study-specific adverse event reporting plans IRB must determine that study team’s plan is acceptable. Developed by: U-MIC 8 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 Developed by: U-MIC 9 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 Developed by: U-MIC 10 IRB determinations IRB regulatory determinations Developed by: U-MIC 11 THANK YOU. Brian Seabolt Cheryl Jamnick IRBMED Developed by: U-MIC 12