IBC KEY DEFINITIONS AND ACRONYMS

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IBCKEYDEFINITIONSANDACRONYMS
BiosafetyLevel(BL):Adescriptionofthedegreeofphysicalcontainmentbeingemployedto
confineorganismscontainingrecombinantDNAmoleculesandtoreducethepotentialforexposure
oflaboratoryworkers,personsoutsideofthelaboratory,andtheenvironment.InAppendixGofthe
NIHGuidelines,thesearegradedfromBL‐1(theleaststringent)toBL‐4(themoststringent).
BiologicalSafetyOfficer(BSO):Anindividualappointedbyaninstitutiontooverseemanagement
ofbiosafetyrisks.TheNIHGuidelinesrequirethataBSObeappointedwhentheinstitutionis
engagedinlarge‐scaleresearchorproductionactivities,orinresearchrequiringcontainmentat
BL‐3orBL‐4.ThedutiesoftheBSOaredescribedinsectionIV‐B‐3oftheNIHGuidelines.
Institution:InthecontextoftheNIHGuidelines,aninstitutionisanypublicorprivateentity,
includingfederal,state,andlocalgovernments.
InstitutionalBiosafetyCommittee(IBC):AninstitutionalcommitteecreatedundertheNIH
GuidelinestoreviewresearchinvolvingrecombinantDNA.TheroleofIBCshasevolvedovertime,
andmanycommitteesalsoreviewotherformsofresearchthatentailbiohazardousrisksaspartof
theirinstitutionallyassignedresponsibilities.
NationalInstitutesofHealth(NIH):Oneoftheworld'sforemostmedicalresearchinstitutionsand
thepreeminentfederalfunderofmedicalresearchintheU.S.TheNIH,comprisedof27separate
InstitutesandCenters,isoneofeighthealthagencieswithinthePublicHealthService,whichisan
agencywithintheU.S.DepartmentofHealthandHumanServices.ThegoalofNIHresearchisto
acquireknowledgetohelpprevent,detect,diagnose,andtreatdiseaseanddisability.TheNIH
missionistouncoverknowledgethatwillleadtobetterhealthforeveryone.
NIHGuidelinesforResearchInvolvingRecombinantDNAMolecules(NIHGuidelines):A
documentcreatedin1976thatoutlinesprinciplesforthesafeconductofresearchemploying
recombinantDNAtechnology.TheNIHGuidelinesdetailpracticesandproceduresforthe
containmentofvariousformsofrecombinantDNAresearch,fortheproperconductofresearch
involvinggeneticallymodifiedplantsandanimals,andforthesafeconductofhumangenetransfer
research.Asa�living�document,itisperiodicallyrevisedtokeeppacewiththechangingstate
ofscience.
OfficeofBiotechnologyActivities(OBA):TheNIHofficeresponsiblefordeveloping,implementing,
andmonitoringNIHpoliciesandproceduresforthesafeconductofrecombinantDNAactivities,
includinghumangenetransfer.
RecombinantDNAAdvisoryCommittee(RAC):AnNIHadvisorycommitteewhoseprincipalroleis
toprovideadviceandrecommendationstotheNIHDirectoron(1)theconductandoversightof
researchinvolvingrecombinantDNA,includingthecontentandimplementationoftheNIH
Guidelines,and(2)otherNIHactivitiespertinenttorecombinantDNAtechnology.Amajorelement
ofthisroleistoexaminethescience,safety,andethicsofclinicaltrialsthatinvolvethetransferof
recombinantDNAtohumans.MoredetailsaboutRACmembershipandresponsibilitiescanbe
foundontheRACpageoftheOBAWebsite,aswellasinitsCharter.
RecombinantDNAMolecules:UnderthecurrentNIHGuidelines,thesearemoleculesconstructed
outsideoflivingcellsbyjoiningnaturalorsyntheticDNAsegmentstoDNAmoleculesthatcan
replicateinalivingcell,ormoleculesthatresultfromtheirreplication.
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