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IRB regulatory determinations

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IRB regulatory determinations

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  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. Developed by: U-MIC

  2. IRB regulatory determinations Developed by: U-MIC University of Michigan IRB Collaborative

  3. 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 • 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

  4. 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

  5. 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

  6. 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

  7. 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

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

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

  10. 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

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

  12. Brian Seabolt Cheryl Jamnick IRBMED thank you. Developed by: U-MIC

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