CostingandProcurementUpdates

JimLuther,DukeUniversityEdwinBemmel,UniversityofMiami

DougBackman,UniversityofSouthFloridaSaraBible,StanfordUniversity

January8,2018

Agenda• Update(Costing&AdminBurden)

• SingleIRBcostingupdate• Costingforpublicdataaccessrequirements

• ProcurementRequirementsandUpdateonMicro-purchaseThreshold

• NIHUpdate• RecentNotices

• EnforcementofCloseoutPolicies• NIHnoticeonStandardsofDocumentationofPersonnelExpenses

• NIHClinicalTrialDefinition2

sIRB Implementation Date

• ExtendedtoJanuary25,2018 (NOT-OD-17-076)• GrantapplicationsreceivedbyNIHonorafter1/25/2018requiretheuseofansIRBfordomesticsitesofamulti-sitestudyusingthesameprotocolfornon-exemptresearch

• Extendedfrompreviouseffectivedateof5/25/17

• DatenowcoincideswiththeeffectivedatefortheNIHpolicyrequiringallapplicationsinvolvingoneormoreclinicaltrialstobesubmittedthroughanFOAspecificallydesignedforclinicaltrials

• sIRBcostscanbeincludedinanapplicant’sbudget(evenpriortoJanuary25thifsIRBtobeused)

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ManagingsIRBCosts

• NIHprovidesguidanceonchargingprimaryandsecondarycosts(FAQs)https://osp.od.nih.gov/clinical-research/irb-review/

• MultipleoptionsforrecoveringthecostofsIRBactivitiesareavailablebutitisuptotheinstitutiontodecidewhatapproachtheytake.

• Incrementalorincreasedcostsbeyondwhatiscapturedinaninstitutionsindirectcostpoolcanbedirectlycharged

• AllIRBcostscanberemovedfromtheindirectcostpoolandshiftedtodirectcharging(includingsIRB)

• AfterestablishingstandardfeesforsIRBactivities,arechargecentercanbeusedtorecovercosts(45CFR75.468requirementsapplyrelativetotheoperationofarechargecenter)

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“PollingQuestions”

• sIRB• IsyourinstitutiongoingtobeasIRBorgoingcommercial?

• IfleadforsIRB,areyoudevelopingratestodirectcharge?Ordoyouplantojustabsorbtheincrementalcostsinternally?

• Whathasyourfacultyreactionbeen?

• Areyouready?• Technology?Infrastructure?FacultyandResearchadminstaff?

• Anyconcerns?

PublicAccesstoDataResultingfromFederallyFundedResearch

• Areport bytheAAU-APLUPublicAccessWorkingGroupoffersasetofgoals,recommendations,andguidancetoagencies,universities,andresearchcommunities

• Summarystatementsextractedfromthereport:• Althoughthereisgeneralagreementaboutthevalueofincreasedpublicaccesstodata,ensuring

suchexpandedaccesswillrequireasignificantcultureshiftatuniversitiesandamongtheirfaculty,thoughtfulandcarefullycraftednewgovernmentpoliciesandpractices,andinvestmentintheinfrastructurerequiredtomakedatapubliclyaccessible.

• Universitieswillneedtocreatetheinfrastructure requiredbythepublicaccessmandatesofthefederalagenciesfundingtheirresearchsothatdatacollectedtosupportfederallyfundedresearchcanbeshared,totheextentpossible,withthepublic.

• Facultywillhavetocometounderstandthatthedatatheycreatewithfederallyfundedresearchisnot“their”dataalone,andthereforetheywillneedtoadapttheirviewsconcerningdatasharing.

• Atthesametime,federalagencieswillneedtofundthecostsassociatedwithmakingthesedatawidelyavailable andprovideconsistentandclearpolicies,complianceguidelines,anddefinitionsacrossagenciestominimizetheburdenonresearchersandinstitutions.

• Bycommittingtoasetofsharedprinciplesandminimallevelsofstandardizationacrossinstitutionsandagencies,wecanhelpminimizecosts,enhanceinteroperabilitybetweeninstitutionsanddisciplines,andmaximizethecontrolinstitutionscanexertoverhowtheyensureaccesstopubliclyfundedscholarship.

“PollingQuestions”

• PublicAccess• Howaware/preparedisyourinstitutionforthe2013OSTPrequirement?

• Areyouseeingtherequirementinproposals?• UsingDataManagementPlanstodocumentrequirements?• Plantodirectorindirectcharge?

• Developingratestodirectcharge?Ordoyouplantojustabsorbtheincrementalcostsinternally?

• Areyouready?• Technology?Infrastructure?FacultyandResearchadminstaff?

• Whathasyourfacultyreactionbeen?• Anyotherconcerns?

Procurement

• TopicsforDiscussion

• Micro-PurchaseThreshold

• Readinessfornewrequirements(bid,etc.)

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Procurement:Micro-PurchaseThreshold(MPT)

• Anadditionaloneyearextensionhasbeengranted;forIHEswithafiscalyearendofJune30th implementationisrequiredbyJuly1,2018

• Micro-purchasethreshold(MPT)• Originallysetat$3,000,wasrevisedto$3,500intheFAR(48CFR,subpart2.1)

• Insteadofabenefit,wouldthisbecomeanewaudittargetforsmallvalueitems(p-cardtransactions)?

• Whenapurchase>MPT,morethanonebidorquoteisrequired

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NationalDefenseAuthorizationAct- ImplicationsonMPT

• NDAA12/23/16• RaisedMPTto$10,000orhigher– appliestoGrants,CooperativeAgreementsandContractsforallfederalagencies

• PertheNDAA:$10,000orhigherthresholdasdeterminedbytheheadoftherelevantexecutiveagencyandconsistentwithcleanauditfindings,institutionalriskassessment,orStatelaw.

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Procurement:Micro-purchaseThreshold

• Data:• Numberoftransactionsanddollarvalue:

• lessthan$3,500,...$10,000,….$25,000,…• Reviewandanalyzethedata• Whereistherisk?

• Highdollarvaluepurchases• Cleanaudits/reviews

• A-133/SingleAudits• ONRContractingPurchasingSystemReviews• Other?

• JustifytheincreaseintheMPT11

“Polling”

• Procurement• Whatthresholddoyouplantouse?If>$10k,haveyouhaddiscussionsabouthowtocoordinatethis?

• WhenisyourFYstartdate?AreyoureadyforUGprocurementrequirements?

• Whatchangeshaveyoumade?Haveyoureviewedyourprocurementpolicies&procedures?Whatisyourprocesstodocumentbids?Otherchanges?

• Doyouhaveadifferentdocumentprocessforservicesasopposedtocommodities?

• DidyourSingleAuditauditorfocusonprocurementthisyear?Didtheydiscusstheirplansfornextyear?

• Whatisyourinterpretationontheimportanceof41USCpar1902?

• DoesthatreallysettheMPTat$10k• Howareinstitutionspreparing?

RecentNIHNoticeontheEnforcementoftheAwardCloseoutPolicy(Nov30,2017)

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RecentNIHNoticeontheEnforcementoftheAwardCloseoutPolicy- Highlights

• Strictenforcementofthe120daydeadlineforcloseouts• FailuretosubmittimelyreportswilltriggerunilateralcloseoutbyNIH

• “Failuretocorrectrecurringreportingproblemsmaycause…withholdingoffurtherawards,suspensionortermination.”

• Priorapprovalforadelayincloseoutmustbejustifiedandapprovedbytheawardinginstituteorcenter

• NIHcompliancewiththeGONEActisoneofthedriversforthestrengthenedenforcement

• Basicrecipientrequirements(see:NIHGrantsPolicyStatementsec8.6)• SubmissionofafinalFederalFinancialReport(FFR),FinalResearchPerformanceProgressReport(F-RPPR),FinalInventionStatementandCertification(FIS)

• ReconciliationofcashtransactionsreportssubmittedtoPMSwithexpenditurereportssubmittedtoNIH

“PollingQuestions”

• Closeout(inresponsetoNovember2017NIHNoticeNOT-OD-18-107)

• Hasyourinstitutionbeenlargelysuccessfulinclosing-outtimely?Forfinancialandprogrammatic?

• HowmanyofyourprojectshasNIHinitiatedunilateralcloseout?Weretheyfinancialorprogrammatic?

• Whathasyourfacultyreactionbeen?

• Anyconcerns?

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NIHIssuesaRemindertoRecipientsofthe“StandardsforDocumentationofPersonnelExpenses”

NIHIssuesaRemindertoRecipientsofthe“StandardsforDocumentationofPersonnelExpenses”

• NOT-OD-18-108,issuedlateinNovember,remindsrecipientsofNIHawardsoftherequirementsfordocumentingpersonnelexpenseschargedtograntsandcooperativeagreements

• Includeslanguagefrom45CFR75.430(i)thatprovidesthedetailedguidanceonapproachestodocumentingpersonnelexpensesonfederalawards

• Keyissues:• Compliancewithcurrenteffortpoliciesandprocesses&needforappropriateinternal

controls

• Costsharedsalaryissubjecttothesamelevelofdocumentation

• Chargesfor…nonexemptemployees…mustalsobesupportedbyrecordsindicatingthetotalnumberofhoursworkedeachday.

“PollingQuestions”

• “StandardsforDocumentationofPersonnelExpenses”(NIHNoticeNOT-OD-18-108)

• Haveyouchangedyoureffortsystem?• Stillrequiringcertification?Ifyes,areyouconsideringchangingthisinthenearfuture?

• ConvwithCognizant?DS-2changes?• Addedflexibility?Ideastoreduceburden?• Whathasyourfacultyreactionbeen?• Anyconcerns?

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NewClinicalTrialDefinition

UpdateonNIH’sModificationstoTheirDefinitionof“ClinicalTrial”

• NIHmodifiedtheirdefinitionofclinicaltrialinlate2014.

• Manyresearchersbelievethatitinappropriatelyclassifiesbasicresearchasclinicaltrials

• Primaryconcernsoftheresearchcommunity:

• ThecasestudytoolusedtohelpinstitutionsdeterminewhetherproposedresearchmeetstheNIHdefinitionofclinicaltrialinandofitselfmodifiesthedefinitiontoincludefundamentalandbasichealth-relatedresearch

• InconsistenciesandclarityissueswithinthetoolwillleadtodifferentconclusionsfrominstitutiontoinstitutionregardingtheapplicationoftheNIHdefinitionofclinicaltrial

• Theimpactonaninvestigatorandresearchstudyoftheexpandedapplicationofthedefinitionismoresignificantthanhasbeenacknowledged

• ImpactofthenewdefinitioncoupledwiththerecentNIHclinicaltrialsFOApolicy• BasicresearchstudieswillbecomesubjecttotheclinicaltrialsFOApolicy

• RegistrationandresultsreportinginClinicalTrials.govwillberequiredforbasicresearchstudies

• GoodClinicalPracticetrainingwillberequiredforbasicresearchstudies

• IneligibilityforTrainingAwardsduetotheuseoftheClinicalTrialsFOApolicywillnegativelyimpactthetechnicaldevelopmentofresearchscientists

• Basicresearchwouldbesubjecttoadditionalrestrictionsandoversight(sIRBreview,etc.)

NIHAnnouncesAdditionalReviewCriteriaforClinicalTrialApplications

• Theseadditionalcriteriawillbeaddedtotheexistingreviewquestionsforclinicaltrialapplications(grantsandcooperativeagreements)submittedonorafter1/25/18

• ApplicationofthisadditionalrigorinreviewingCTapplicationsispartofNIH’s“multi-facetedapproachtostrengtheningpoliciesacrossthelifecycleofaclinicaltrial”

• Theadditionalquestionswillprobethefollowingareas;significance,capabilitiesofinvestigator(s),innovation,studydesign,datamanagementandstatisticalanalysis,environment,andstudytimeline

• TheannouncementNOT-OD-17-118containsthedetailedquestionsandadditionalinformation

“PollingQuestions”

• ClinicalTrialDefinition• Areyouawareofthis?

• Isitadverselyimpactingyourinstitution?Particularlyinthenon-Medicineareas?

• Whathasyourfacultyreactionbeen?

• Anyconcerns?

DiscussionandQuestions

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FYI- sessiondescription

• Monday,January8,20181:00– 2:15pm• CostingandProcurementUpdate• Topic:ThissessionwillreviewseveraltopicsincludingSingleIRBcostingandreadiness,directchargingofpublicdataaccessrequirementsincludingarecentcommunicationfromPAWG,newNIHnoticesfocusedonEnforcementofCloseoutPoliciesandNIHStandardsforDocumentationofPersonnelExpenses.UGProcurementrequirementswillalsobediscussed,includingobtainingapprovalforamicro-purchasethresholdover$10,000consistentwiththeNationalDefenseAuthorizationAct(NDAA)forFY17andreadinessforyourinstitutionsimplementation.PleasesendquestionsfromyourinstitutiontoSaraBibleatsbible@stanford.edu.

• Speakers: JimLuther,DukeUniversity,EdwinBemmel,UniversityofMiami,DougBackman,UniversityofCentralFloridaandSaraBible,StanfordUniversity

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