NSABBWorkingGroupProposal
Whoiscovered?
Researchinstitutions gettingUSGfunding
Whichpathogens?
Thosethatmeetthreestatedcriteriaontransmissibility,virulence,and
spreadinhumanpopulations
Whichactivities?
Thosereasonablyanticipatedtogenerateapathogenmeetingallthree
criteria
Whatisrequired?
Sevenprinciplesmustbesatisfiedbeforeprojectcanbefunded
ResearchmustundergoappropriateFederalandinstitutionaloversight
3/10/2016
ExistingPolicyContext:
StatuteandRegulation
USBioweaponsStatutes(18USC175)
Prohibitworkwithbiologicalagentsforuseasaweaponorin
typesandquantitiesnotreasonablyjustifiedforlegitimate
purpose
SelectAgentRegulations
Comprehensivesetofsafetyandsecurityrequirements
governingtheuseofspecificSelectAgentsorToxins
ExportControls
AffectexportofcertainpathogensfromtheUnitedStatesor
communicationofcertainnonpublicinformation
3/10/2016
ExistingPolicyContext:
USGFundingRequirements
PolicyforOversightofLifeSciencesDURC
Coversresearchthatstartswithcertainagents,includinghighly
pathogenicH5N1 influenzaand1918influenza
PolicyforInstitutionalOversightofLifeSciencesDURC
Same
HHSFrameworkforcertainH5N1andN7N9influenza
LarryKerrtodiscussingreaterdetail
BiosafetyGuidance
BiosafetyinMicrobiologicalandBiomedicalLaboratories
GuidelinesforResearchInvolvingRecombinantorSyntheticNucleic
AcidMolecules
3/10/2016
ExistingPolicyContext:
Other
TortLawandLiability
3/10/2016
ExistingPolicyContext:
Parameters
Whoiscovered?
Whichpathogensarecovered?
Whattypesofexperimentsoractivitiesarecovered?
Whatconditionsmustbemet?
Howaredecisionsmade,andwhoseapprovalsare
required?
Whatpotentialgainoffunctionresearchofconcernis
notcovered?
3/10/2016
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