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IRB regulatory determinationsDeveloped by:U-MICUniversity of Michigan IRB Collaborative

IRB determinations

regulatory determinationsconvened board meetingrecorded in minutesCFR citationsexpedited review

compliance with federal regulations for human subject protectionsvulnerable populationsrisk/benefit assessmentother determinations, as applicablewaiversstudy-specific AE reporting plansignificant and nonsignificant risk devicesunanticipated problem involving risk to subjects or others (UPIRSO or UaP)3Developed by:U-MICIRB determinations

most applicationsnew studiesamendmentsscheduled continuationsadverse events (AE)/other reportable information or occurrence (ORIO)

compliance with human subject protections regulationsHHS: 45 CFR 46.111FDA: 21 CFR 56.111other federal regulationsDepartment of Defense: 32 CFR 219.111Department of Justice: 28 CFR 46.111OCR HIPAA Privacy Rule: 45 CFR 160 and 1644Developed by:U-MICIRB determinations

vulnerable subject populationsfederally definedwomen of childbearing potentialpregnant women, fetuses, and neonatesprisonerschildrenparent signatures

per U-Mpatients of the study teameducationally disadvantaged individualseconomically disadvantaged individualscognitively impaired adultsother special populations5Developed by:U-MICIRB determinations

risk/benefit assessmentIRB mayconfirm study teams assessmentdetermine thatrisk level should be higher or lowerno more than minimal riskminor increase over minimal riskmoderate riskhigh riskbenefit type should be changedpotential direct benefitindirect benefit6Developed by:U-MICIRB determinations

waiversinformed consentdocumentation of informed consentassentHIPAA Authorization

may befullall subjects and study activitypartialonly a portion of the studyonly certain subjects

study must meet criteria for waiverHHSFDAOCR7Developed by:U-MICIRB determinations

study-specific adverse event reporting plans

IRB must determine that study teams plan is acceptable.8Developed by:U-MICIRB determinations

investigational medical devicessignificant risknonsignificant risk

IRB mayagree with sponsors determinationdisagreemodifies determinationinstructs sponsor to notify FDA of IRB determination9Developed by:U-MICIRB determinations

unanticipated problems involving risk to subjects or othersUPIRSO / UaP

unexpectedrelated or possibly related to researchsuggests study presents greater risk than previously recognized10Developed by:U-MICIRB determinations

11Developed by:U-MICIRB regulatory determinationsthank you.Brian SeaboltCheryl JamnickIRBMED12Developed by:U-MIC