

TexasA&M UniversitySystemResearchComplianceWorkshop
ErinShermanMacc,CRA,CIP
ResearchComplianceOfficer
TexasA&M University‐CorpusChristi
 42CFRPart50SubpartF(grantsandcooperative
agreements)
 45CFRPart94(contracts)
InitialRegulationeffective10‐1‐95
http://grants.nih.gov/grants/compliance/42_CFR_50_Sub
part_F.htm
RevisedFinalRulepublishedon8‐25‐11
http://www.gpo.gov/fdsys/pkg/FR‐2011‐08‐
25/pdf/2011‐21633.pdf
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
RevisedregulationsonResponsibilityofApplicantsfor
PromotingObjectivityinResearchforwhichPublicHealth
ServiceFundingisSoughtand
ResponsibleProspectiveContractors

PublishedinFederalRegisteronAugust25,2011

ImplementationbyAugust24,2012

AppliestoeachNoticeofAwardissuedsubsequentto
compliancedatesoffinalrule
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 Intheinterim,Institutionsshould:
o
o
o
o
o
Complywith1995regulations;
Revisepolicies;
Establishproceduresforcompliance;
TrainInvestigators;and
ContinuetoreportFCOIstoNIH.
 Institutionsthatimplementtheregulationpriorto
August24,2012signifytheircomplianceby
makingtheinstitutionalFCOIpolicypublicly
accessible.
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Promotesobjectivityinresearchbyestablishing
standardsthatprovideareasonableexpectation
thatthedesign,conduct,andreportingofresearch
fundedunderNIHgrantsorcooperative
agreementswillbefreefrombiasresultingfrom
Investigatorfinancialconflictsofinterest.
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
EachInstitutionthatappliesfororreceivesPHS/NIH
grantsorcooperativeagreementsforresearch
o Domestic,foreign,public,private(notFederal)

AnyInvestigator,asdefinedbytheregulation,planningto
participateinorparticipatingintheresearch

PhaseISmallBusinessInnovativeResearchorSmall
BusinessTechnologyTransferapplicationsareexempt
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KeyDefinitions
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TheprojectdirectororprincipalInvestigatorand
anyotherperson,regardlessoftitleorposition,
whoisresponsibleforthedesign,conduct,or
reportingofresearchfundedbytheNIH,or
proposedforsuchfunding,whichmayinclude,for
example,collaboratorsorconsultants.
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AnInvestigator'sprofessionalresponsibilitieson
behalfoftheInstitution,andasdefinedbythe
Institution initspolicyonfinancialconflictsof
interest,whichmayincludeforexample:activities
suchasresearch,researchconsultation,teaching,
professionalpractice,institutionalcommittee
memberships,andserviceonpanelssuchas
InstitutionalReviewBoardsorDataandSafety
MonitoringBoards.
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(1)Afinancialinterestconsistingofoneormoreofthefollowinginterestsof
theInvestigator(andthoseoftheInvestigator’sspouseanddependent
children)thatreasonablyappearstoberelatedtotheInvestigator’s
institutionalresponsibilities:
(i)Withregardtoanypubliclytradedentity,asignificantfinancialinterest
existsifthevalueofanyremunerationreceivedfromtheentityinthe
twelvemonthsprecedingthedisclosureandthevalueofanyequity
interestintheentityasofthedateofdisclosure,whenaggregated,
exceeds$5,000.Forpurposesofthisdefinition,remunerationincludes
salaryandanypaymentforservicesnototherwiseidentifiedassalary
(e.g.,consultingfees,honoraria,paidauthorship);equityinterestincludes
anystock,stockoption,orotherownershipinterest,asdetermined
throughreferencetopublicpricesorotherreasonablemeasuresoffair
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marketvalue;
(ii)Withregardtoanynon‐publiclytradedentity,asignificantfinancial
interestexistsifthevalueofanyremunerationreceivedfromtheentity
inthetwelvemonthsprecedingthedisclosure,whenaggregated,
exceeds$5,000,orwhentheInvestigator(ortheInvestigator’sspouse
ordependentchildren)holdsanyequityinterest(e.g.,stock,stock
option,orotherownershipinterest);or
(iii)Intellectualpropertyrightsandinterests(e.g.,patents,copyrights),
uponreceiptofincomerelatedtosuchrightsandinterests.
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(2)Investigatorsalsomustdisclosetheoccurrenceofany
reimbursedorsponsoredtravel(i.e.,thatwhichispaidon
behalfoftheInvestigatorandnotreimbursedtothe
Investigatorsothattheexactmonetaryvaluemaynotbe
readilyavailable),relatedtotheirInstitutional
responsibilities,provided,however,thatthisdisclosure
requirementdoesnotapplytotravelthatisreimbursedor
sponsoredbyexcludedsourcesprovidedinregulation.
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
Salaryroyalties,orotherremunerationpaidbythe
InstitutiontotheInvestigatoriftheInvestigatoriscurrently
employedorotherwiseappointedbytheInstitution;

IntellectualPropertyRightsassignedtotheInstitutionand
agreementstoshareinroyaltiesrelatedtosuchrights;

AnyownershipinterestintheInstitutionheldbythe
Investigator,iftheInstitutionisacommercialorfor‐profit
organization;

Incomefrominvestmentvehicles,suchasmutualfundsand
retirementaccounts,aslongastheInvestigatordoesnotdirectly
controltheinvestmentdecisionsmadeinthesevehicles;

Incomefromseminars,lectures,orteachingengagementssponsored
byafederal,stateorlocalgovernmentagency,anInstitutionof
highereducationasdefinedat20U.S.C.1001(a),anacademic
teachinghospital,amedicalcenter,oraresearchinstitutethatis
affiliatedwithanInstitutionofhighereducation;or

Incomefromserviceonadvisorycommitteesorreviewpanelsfora
federal,stateorlocalgovernmentagency,Institutionofhigher
educationasdefiedat20U.S.C.1001(a),anacademicteaching
hospital,amedicalcenter,oraresearchinstitutethatisaffiliated
withanInstitutionofhighereducation.
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AnSFIthatcoulddirectlyandsignificantlyaffect
thedesign,conduct,orreportingofNIH‐funded
research.
15
Senior/keypersonnelmeansthePD/PIandanyotherperson
identifiedassenior/keypersonnelbytheInstitutioninthe
grantapplication,progressreport,oranyotherreport
submittedtothePHSbytheInstitutionundertheregulation.
Note:DifferentdefinitionthantheNIH
GrantsPolicyStatement
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GranteeInstitution
Responsibilities
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
Institutionsmustestablishstandardsthatprovidea
reasonableexpectationthatthedesign,conduct,and
reportingofNIH‐fundedresearchwillbefreefrombias
resultingfromInvestigatorfinancialconflictsofinterest.

Maintainanup‐to‐date,written,enforcedpolicythatcomplies
withtheFCOIregulationandmakepolicypubliclyaccessible.
MaintenanceofRecords
 MaintainrecordsofallInvestigatordisclosuresoffinancial
interestsandtheInstitution’sreviewof,andresponseto,
suchdisclosures(whetherornotadisclosureresultedinthe
Institution’sdeterminationofFCOI)andallactionsunderthe
Institution’spolicyorretrospectivereview,ifapplicable
o foratleastthreeyearsfromthedateofsubmissionofthefinal
expendituresreportor,whereapplicable,
o fromotherdatesspecifiedin45C.F.R.74.53(b)and
92.42(b)fordifferentsituations.
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 Certifyineachapplicationforfundingthatthe
Institution:
o Hasineffectanup‐to‐datewritten,andenforced
administrativeprocesstoidentifyandmanageFCOIs
relatedtoallPHSresearchprojects.
o ShallpromoteandenforceInvestigatorcompliancewith
theregulationpertainingtodisclosureofSFIs.
o ShallmanageFCOIsandprovideinitialandongoingFCOI
reportstoPHS/NIH.
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 Certifyineachapplicationforfundingthatthe
Institution:
o Agreestomakeinformationavailableuponrequest
relatingtoanyInvestigatordisclosureoffinancialinterest
andtheInstitution’sreviewof,andresponseto,such
disclosure,whetherornotthedisclosureresultedinthe
Institution’sdeterminationofanFCOI.
o Fullycomplywiththerequirementsoftheregulation.
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
DesignateanInstitutionalOfficial(s)tosolicit&review
disclosurestatementsfromeachInvestigatorplanningto
participatein,orisparticipatingin,PHS/NIH‐fundedresearch

Provideguidelinestoidentifyconflictinginterestsrelatedto
proposedorPHS/NIH‐fundedresearch

Developmanagementplansthatspecifytheactionsthathave
been,andshallbe,takentomanageFCOI
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 MustinformeachInvestigatorofthe:
o
Regulation;
o
Institution’spolicyonFCOI;and
o
Investigator’sresponsibilitiesregarding
disclosureofSFIs
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InstitutionsmustrequirethateachInvestigatorcomplete
FCOItraining:
o PriortoengaginginresearchrelatedtoanyNIHfunded
project;
o Atleasteveryfouryears,and
o Immediatelywhenanyofthefollowingcircumstancesapply:
i.
Institutionrevisesitspolicyinamannerthataffectsthe
investigator;
ii. WhenaninvestigatorisnewtotheInstitution;or
iii. WhentheInstitutionfindsanInvestigatorisnotincompliancewith
theInstitution’spolicyormanagementplan.
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
SFIsincludefinancialintereststhatarerelatedtoan
Investigator’sinstitutionalresponsibilities.

InstitutionsareresponsiblefordeterminingwhetherSFI
relatestoNIH‐fundedresearchandifitisanFCOI.
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 AttimeofApplication:RequirethateachInvestigator,including
subrecipientInvestigators,ifapplicable,planningtoparticipatein
PHS/NIH‐fundedresearchtodisclosetothedesignatedofficial(s)at
timeofapplication.
 Annually:RequireeachInvestigator,includingsubrecipientInvestigator,
ifapplicable,tosubmitanupdateddisclosureofSFIatleastannually,in
accordancewiththespecifictimeperiodprescribedbytheInstitution,
duringtheperiodoftheaward.
 Within30days:RequireeachInvestigator,includingsubrecipient
Investigator,ifapplicable,whoisparticipatingintheNIH‐funded
researchtosubmitanupdateddisclosureofSFIwithinthirtydaysof
discoveringoracquiring(e.g.,throughpurchase,marriage,or
inheritance)anewSFI.
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



TakenecessaryactionstomanageFCOIsofits
Investigators,includingthoseofsubrecipient Investigators.
Developamanagementplan(s)andmonitorcompliance.
IfanInstitutionidentifiesanSFIthatwasnotdisclosedor
reviewedinatimelymanner,thedesignatedofficial(s)
shallwithinsixty(60)daysreviewtheSFI,determineifan
FCOIexistsandimplementaninterimmanagementplan,if
needed.
Incasesofnoncompliance,completearetrospective
reviewandsubmitmitigationreportifbiasisfound.
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ProvideinitialandongoingFCOIreportstoNIH:
o Priortotheexpenditureoffunds
o Duringtheperiodofaward

Within60daysofidentifyinganewFCOI
o Annually


ReportonthestatusofFCOIandanychangesin
managementplan
Dueatthesametimeaswhengranteeisrequiredto
submittheannualprogressreport,includingmulti‐year
progressreport,orattimeofextension
AllFCOIreportsaresubmittedtoNIHthroughtheeRA
CommonsFCOIModule
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
Incorporateaspartofawrittenagreementtermsthat
establishwhethertheFCOIpolicyoftheawardee
Institutionorthatofthesubrecipientwillapplyto
subrecipientInvestigatorsandincludetimeperiodstomeet
SFIdisclosure,ifapplicable,andFCOIreporting
requirements.

SubrecipientInstitutionswhorelyontheirFCOIpolicy
mustreportidentifiedFCOIstotheawardeeInstitutionin
sufficienttimetoallowtheawardeeInstitutiontoreport
theFCOItothePHS/NIHAwardingComponent(i.e.,toNIH
throughtheeRACommonsFCOIModule)tomeetFCOI
reportingobligations.
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 MakeFCOIpolicyavailableviaapublically
accessibleWebsite.
 Makewrittenpolicyavailabletoanyrequestor
withinfivebusinessdaysofarequestonly when
InstitutiondoesnothaveapubliclyaccessibleWeb
site.
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• Priortoexpenditureoffunds,makecertain
informationconcerningFCOIsheldbysenior/key
personnelpubliclyaccessibleviaaWebsiteor
providewrittenresponsewithinfivebusinessdays
ofarequest.
oUpdatethewebsiteannuallyandwithin60daysof
identifyinganynewFCOIswhenpostingFCOIsto
Website
oRetaininformationforthreeyears
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Noncompliance
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WheneveranFCOIisnotidentifiedormanagedinatimely
manner,includingfailurebytheInvestigatortodisclosean
SFI,failurebytheInstitutiontoreviewormanagean
FCOI,orfailuretocomplywiththemanagementplan,the
institutionshallwithin120daysofthedeterminationof
noncompliance,completearetrospectivereviewofthe
Investigator’sactivitiesandtheprojecttodeterminebias
inthedesign,conductorreportingofsuchresearch.
NotifyNIHpromptlyandsubmitamitigationreportwhen
biasisfound.
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Establishadequateenforcementmechanismsand
provideforemployeesanctionsorother
administrativeactionstoensureInvestigator
compliance.
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Mailboxforinquiries
FCOICompliance@mail.nih.gov
OERFCOIWebSite
http://grants.nih.gov/grants/policy/coi/
Webcast:WhatNIHGranteesNeedtoKnowAboutthe2011
RevisedFinancialConflictofInterest(FCOI)Regulations
http://videocast.nih.gov/Summary.asp?file=16994
Adaptedfrompresentationby:DavidCurren– AssistantGrantsPolicyOfficer
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