irb regulatory determinations
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1Developed by:U-MICTo 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.
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