ࡱ> TVS bjbjupup 40,80<l.:f$;..0.0.0.0.0.0.,0K3T\.OOO\.eq.eeeOd..eO..ee*B,ИJ$+..0.+3e3,B,eB,V,OOO\.\.eOOO.3OOOOOOOOO :   A Summarized Resource of NIH Guidelines for Research Involving Recombinant DNA Molecules Compliance with the NIH Guidelines for Research Involving Recombinant DNA ( HYPERLINK "http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines" http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines) is mandatory for every institution that receives NIH funding for research involving recombinant DNA (rDNA) or synthetic nucleic acids. It is the responsibility of each investigator to make sure that his/her laboratory is in compliance. If your experiments require registration, go to  HYPERLINK "http://www.research.usf.edu/dric/biosafety/forms.asp" http://www.research.usf.edu/dric/biosafety/forms.asp register.This outline is intended only to serve as a summarized resource to the NIH Guidelines. If you are unsure in which category your experiments fall, please contact us at  HYPERLINK "mailto:biosafety@research.usf.edu" biosafety@research.usf.edu or via telephone at 974-0954 Section III-A & B & C Experiments that require registration and NIHOBA and Vlog IBC approval Prior to initiation: Deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally if such acquisition could compromise the use of the drug to control disease. (Section III-A-1-a) Cloning of toxin molecules with LD50 of less than 100 ng / kilogram body weight. (Section III-B-1) Experiments that involve the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into one or more human research participant. (Section III-C-1) Section III-D - Experiments that require registration & Vlog IBC approval Prior to initiation: Experiments using Risk Group 2, 3, or 4 agents as host-vector systems. (Section III-D-1) Experiments in which DNA from Risk Group 2, 3, or 4 agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems. (Section III-D-2-a) Experiments in which DNA from restricted agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems. (Section III-D-2-b) Experiments involving the use of infectious DNA or RNA viruses from Risk Group 2, 3 or 4 in tissue culture systems; or defective recombinant viruses in the presence of helper virus or packaging cells in tissue culture systems (this includes all eukaryotic viruses). (Section III-D-3) Experiments that generate transgenic animals, including insects. (Section III-D-4-b) Experiments involving viable rDNA-modified microorganisms tested on whole animals.(Section III-D-4-b) Experiments involving whole plants that require BSL3 or BSL4 containment. (Section III-D-5) Experiments involving more than 10 liters of culture.(Section III-D-6) Experiments involving human influenza strains H2N2, 1918 H1N1, and/or highly pathogenic H5N1.(Section III-D-7) Section III-E - Experiments that require registration simultaneous with initiation :(Vlog Expedited review) Introduction into cultured cells of any rDNA containing greater than half but less than 2/3 of a eukaryotic viral genome (with the exception of Risk Group 3 or 4 agents). (Section III-E-1) Experiments involving whole plants that require BSL1 or BSL2 containment.(Section III-E-2) Cloning in non-pathogenic prokaryotes and non-pathogenic lower eukaryotes.(Section III-E) Experiments involving breeding of transgenic rodents that contain more than 50 percent of the genome of an exogenous eukaryotic virus from a single family, in order to prevent inadvertent reconstitution of an exogenous virus in the resultant transgenic rodent. (Section III-E-3) Experiments involving breeding of transgenic rodents in which the transgenic rodent's transgene is under the control of a gammaretroviral long terminal repeat (LTR), in order to address the small risk of recombination with endogenous retroviruses which could potentially result in mobilization of the transgene via a replication-competent mouse retrovirus. (Section III-E-3,Appendix C-VIII (2)) Cloning of all other DNA in E. coli K12, S. cerevisiae, and B. subtilis host-vector systems (with the exception of DNA from Risk Group 3 or 4 pathogens). (Appendix C-II, C-III, C-IV) Section III-F - Experiments that are exempt and do not require Vlog IBC registration: Use of rDNA that is not in organisms or viruses. (Section III-F-1) Purchase or transfer of transgenic rodents that may be maintained at BL1 containment.(Appendix C-VI) Introduction into cultured cells of any recombinant DNA containing less than half of a eukaryotic viral genome (with the exception of Risk Group 3 or 4 pathogens). (Appendix C-I) Breeding 2 different transgenic strains of rodents to generate novel transgenic strains requiring BL1 containment. (Appendix C-VII)     RCDC#049.2 Revised 08/25/2015 ?@LYZ\jo  R S T U W b p s t Ͷ͢{shYNYh.Rh.RCJaJjh.Rh.RCJUaJh.Rh}hNCJaJh VHCJaJjh0JCJUaJh?h VH0JCJaJhjhUh VHh}hNCJaJh}hN6CJaJhrbh}hN6CJaJh>=h}hNCJaJh}hNCJaJh}hN56\]h&2 h}hN56\]h&2 h}hN5\]h}hN5\]@Z[  S fgVr & Fdd[$\$gd}hN & Fgd.R & F 8^`gd&m  & F 8gdPT & F 8^`gd}hN)$$d%d&d'dNOPQa$gd}hN $ 7 8 ? M P  ! 0 Q T Y ] ͹űŊ{sf\fRHfHhL56\]h}hN56\]hn,56\]hyih}hN56\]h}hN5\]h>=h}hN5CJ\]aJh.RCJaJjh0JCJUaJhcih Z0JCJaJhjhUh1h}hN6CJaJh ZCJaJh>=h}hNCJaJh}hNCJaJh.Rjh.Rh.RCJUaJh.Rh.R0JCJaJ] j k o p ~  > ? 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