April 18 2018 Full Committee Review FCR NIH Guidelines httpsospodnihgovwpcontentuploadsNIHGuidelineshtmlToc446948316 Designated Member Review DMR Biosafety Review Bio ID: 1040536
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1. IBC APPLICATION REQUIRED (April 18, 2018)Full Committee Review (FCR)NIH Guidelines: https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.html#_Toc446948316Designated Member Review (DMR)Biosafety Review (Bio)Administrative ReviewNewNIH Guidelines IIIA- IIIDRisk Group (RG)2 , RG3 and RG4 agents and materials potentially infected with RG2, RG3 and RG4Non human primate materials including fluids/tissues/organsAnimals/Arthropods that are natural reservoirs/vectors of zoonotic diseasesUse of Botulinum neurotoxin at any amountUse of Select toxin above permissible amountNIH Guidelines IIIE (with approval at IBC meeting) Use of Select Toxin, (except Botulinum neurotoxin) below permissible amount Primary human materials including tissues and organsNIH Guidelines IIIFHuman blood, bodily fluidEstablished human and non human primate cells onlyNon-rDNA at BSL1Addition/Removal of personnelChange in Faculty Sponsor Change in Funding Removal of location (Consult with Biosafety)Change in PI RenewalNIH Guidelines IIIA- IIIDRisk Group (RG)2 , RG3 and RG4 agents and materials potentially infected with RG2, RG3 and RG4Non human primate materials including fluids/tissues/organsAnimals/Arthropods that are natural reservoirs/vectors of zoonotic diseasesUse of Botulinum neurotoxin at any amountUse of Select toxin above permissible amountNIH Guidelines IIIE (with approval at IBC meeting) Use of exempt Select Toxin except Botulinum neurotoxinPrimary human materials including tissues and organsNIH Guidelines IIIFHuman blood, bodily fluidEstablished human and non human primate cells onlyNon-rDNA at BSL1ModificationAll applications above that fall under different NIH Guidelines (IIIA- IIID) All modifications (except changes in location, personnel, number of subjects enrolled, statistical analysis) in HGT application (IIIC)All modification involving RG 3 and RG4Change in procedures/materials/host/agent that result in higher risk ( eg. purchasing lentivirus from outside vendor versus growing lentivirus in the lab, using aerosol transmissible pathogen versus bloodborne pathogen, using modified agent that is amphotrophic versus ecotrophic, using sheep for heart transplant versus mice)IIIE (with approval at IBC meeting) that is different from approved applicationPrimary human materials that might have different risk from currently approved onesNIH Guidelines IIIFIIID that meets the following criteria 1) currently approved under the same applicable guideline 2) has the same risk (eg. Adding different reporter gene in Lentiviral vector, carrying out same experiments in mice versus rats, adding RG2s that have the same risk as currently approved ones) 3) has same NIH guidelines requirementsAddition of new location
2. Submission deadline, Day 1Full Committee Review (FCR)Full ApprovalSubcommittee review/ Administrative reviewIf no prereview comments* All days are business days
3. On-going (no submission deadline) Designated Member Review (DMR)If no prereview comments* All days are business days
4. On-going (no submission deadline) Biosafety Review If no prereview comments* All days are business days