CONFLICTOFINTERESTMANAGEMENTPLAN(COIMP)

PursuanttoAppalachianStateUniversity’s ConflictofInterestandCommitmentPolicy(ASUPolicyManual604.6), anactual or apotential Conflict ofInterest(COI) hasbeen identified thatmustbemitigatedthroughaConflictofInterestManagementPlan(COIMP).Thisdocument,developedin accordance with Policy604.6, Section4.8, setsforththestepsagreed uponby thesignatories below inorder tomanage the conflict(s).Inparticular,theCoveredPerson(s)agree(s)tocooperatewithofficialsofASUinmanagingactualorpotentialCOIsidentifiedinthisdocument.

1.NAMEOF COVERED PERSON(S):

2.SPONSOR/ENTITYORINDIVIDUALWITHWHOMCOIEXISTS:

3.UNIVERSITYAND/OREXTERNALPROJECTIDENTIFIERS

AIR Disclosure #

/

AGrants Project #

/

Award#

/ ProjectName

Other,ifapplicable(e.g.,InternalReviewBoard,NSFAwardNumber,etc.):

4.TITLEANDBRIEFDESCRIPTIONOFFUNDEDPROJECT(S)(ifapplicable):

5.PRINCIPALINVESTIGATOR(S)(ifapplicable):

6.PROJECTDIRECTOR(S)(ifapplicable):

7.NATUREOFCONFLICTOFINTEREST(checkallthatapply):

Equityinterest_

Relationship(e.g.,colleague,familymember,etc.)

Consultingfee

Travelreimbursement

Honorarium

Other(pleasedescribe):

8.VALUEOFFINANCIALINTEREST(checkone):

Notapplicabletothisproject/disclosure.

$0-$4,999

$20,000-$100,000

$5,000-9,999(indicateincrementof$20,000)

_

$10,000-$19,999

Over$100,000 (indicateincrementof$50,000)

Thevalueofthisfinancialinterestcannotbereadilydeterminedthroughreasonable measuresoffairmarketvalue.

9.RELATIONSHIPOFFINANCIALINTERESTTOANYFUNDEDPROJECT(S)AND BASISFORDETERMINATIONTHATCOIEXISTS(ifapplicable):

10.ROLEANDPRINCIPALDUTIESOFCOVEREDPERSON(S)INEACHFUNDED PROJECT(ifapplicable):

ThefollowingitemsindicateelementsthatmaybeappropriatefortheCOIMP.Foreachitem,indicatespecificrequirements,iftheitemapplies;orindicatethattheitemdoesnotapply.[Seeattachedguidancedocumentforexamplesofpossibleprovisions.]

1.PUBLICDISCLOSUREOFFINANCIALINTERESTS.

_

ThisitemisnotapplicabletothisCOIMP.

Requirements:

2.MONITORINGOFRESEARCHOROTHERACTIVITYBYNEUTRAL, INDEPENDENTREVIEWER(S).

____ This item is not applicable to this COIMP.

Requirements:

3.MODIFICATIONOFRESEARCHPLANORWORKPLAN.

_

ThisitemisnotapplicabletothisCOIMP.

Requirements:

4.DISQUALIFICATIONOFCOVEREDPERSONFROMPARTICIPATIONINPROJECTORACTIVITY,ORPARTSTHEREOF.

_

ThisitemisnotapplicabletothisCOIMP.

Requirements:

5.DIVESTITUREORSEVERANCEOFSIGNIFICANTFINANCIALOROTHER INTERESTSWHICHCREATEACOIWITHUNIVERSITYEMPLOYMENTRESPONSIBILITIES(seePolicyManual604.6,Section3.19)ORPHSRESPONSIBILITIES.

_

ThisitemisnotapplicabletothisCOIMP.

Requirements:

6. RELATIONSHIPMANAGEMENT(SPOUSE,PARTNER,COLLEAGUE,ETC.)

_____ ThisitemisnotapplicabletothisCOIMP.

Requirements:

7. OTHER.(Ifapplicable,insertanyotherconditionsnecessarytomanagethe conflictsidentifiedinconnectionwiththisproject.)

1.PolicyCompliance,IncludingHuman/AnimalSubjectsProtections

AllresearchactivitymustcomplywithallapplicableUniversitypolicies,includingbutnotlimitedto:

  • ReviewofResearchInvolvingHumanSubjects(ASUPolicy209)
  • PaymentstoHumanSubjects(ASUPolicy210)
  • HumanSubjectResearchRecruitment(ASUPolicy216)
  • CareandUseofAnimalsforResearchTeachingorDemonstration(ASUPolicy213)
  • UseofRecombinantDNAinResearchandTeachingLaboratories(ASU Policy212)
  • IntegrityinScholarshipandScientificResearch(ASUPolicy211)
  • ExportControlManagementPlan(ASUPolicy208)

SpecificconditionsmaybeindicatedaboveunderManagementPlanRequirements.FullIRBapprovalmustbesoughtandobtainedpriortoconductinganyresearchinvolvinghumansubjects.

2.LegalandRegulatoryCompliance

Allresearchactivitymustcomplywithallapplicablelawsandregulations,includingbutnotlimitedtothosegoverningresearchfundedbythePublicHealthService.

3.IntellectualProperty

Inventorshipandownershipofanynewintellectualpropertyarisingfromtheproject(s)describedinthisCOIMPwillbedeterminedinaccordancewiththeUniversity’sPolicy onIntellectualPropertyTransfer(ASUPolicy207),subjecttothirdpartyrights;orpertheresearchagreementbetweenASUandSPONSOR(onrecordattheOfficeofResearchandSponsoredProgramsandAGrants).Financialarrangementsrelatedtonewinventionsordiscoverieswillbenegotiatedatfairmarketvalue.

4.Personnel

Allpersonneldirectlyinvolvedintheconductof projectssupportedbySPONSOR willbemadeawareoftheassociatedpotentialoractualconflictsofinterestandthemannerinwhichtheywillbemanaged.Withrespecttotheproject(s)andCOIsidentifiedinthisdocument,personnelwhohaveconcernsorquestionsrelatedtopossibleCOIsmay speakwith______,whoisnotaffiliatedwiththeproject(s)andcanprovideobjectiveguidance.

5.Publications

ScholarlypublicationswillbesubmittedinaccordancewithAppalachianandUNCpolicies,andinaccordancewithsponsoringresearchagreement(s).(SeerespectiveAGrantsfiles listed on page 1).

6.ReportingandReviewofConflictofInterestManagement

COVEREDPERSON(S)willprepareanannualreportupdatingallinformationrelevanttothismanagementplan,whichwillbereviewedandapprovedby______andforwardedtothedeanofthe______foradministrativereviewandapprovalonatleastanannualbasis.AdditionalprojectssubmittedtoSPONSOR(S)willbeattachedandsubjecttothismanagementplanpriortosubmissiontoSPONSOR(S)ormanagedseparatelyunderanewplanapprovedpriortoproposalsubmission.

7.UseofUniversityResources

NoUniversityfacilities,equipment,orstaffwillbeutilizedforthedirectbenefitoftheSPONSORunlesssuchworkiscoveredbyaResearchAgreementorotherappropriate agreement.AllusesofUniversityresourcesbyoronbehalfofSPONSORwillbeappropriatelyreimbursed(assummarizedinthepreviouslylistedagreements).ShouldASUfacilities,equipment,orstaffbeused,ASUmustbecompensatedfullyfordirectandindirectexpensesincurredbyASUinsupportof theseprojects.UseofASUresourcesinsuchprojectsmustbewelldocumentedandchargedtotheSPONSOR.

[Endoftext.Seenextpageforsignatures.]

Management Plan Committee:

Role / Name/Title (Print) / Signature / Date

Submit the approved plan and a copy of the most recent Conflict of Interest Disclosure form to all relevant individuals and offices – e.g., Management Plan Committee members, Officer of Research, and Sponsored Programs, Institutional Review Board, department chair, dean, etc.

______

Institutional Conflict of Interest Management Plan Approval:

______

COI Coordinator (or Designee)

Date: ______

CONFLICTOFINTERESTMANAGEMENTPLAN(COIMP) GUIDANCEFORCOMPLETION

GeneralInformation

ThisdocumentprovidesatemplateforpreparingaConflictofInterestManagementPlan (COIMP)whenaConflictofInterest(COI)hasbeenidentifiedthatrequiresmanagementunder thetermsoftheUniversity’sPolicyonConflictofInterestand Commitment,ASUPolicyManual604.6(“Policy 604.6”).AmongthekeydefinitionsinthatPolicy arethefollowing:

ConflictofInterestCoordinator:GeneralCounselortheGeneralCounsel’sdesignee.

CoveredPerson(orCoveredIndividual):seePolicy 604.6, Section3.5.Forpresentpurposes,statedbriefly,anindividualforwhomaconflicthasbeenidentified.

DesignatedUniversityOfficial(DUO):Deanoftheindividual’scollegeorother appropriateunit head.

ConflictofInterestandCommitmentCouncil:Astandingcommittee,withmembership andresponsibilitiesasdescribedinPolicy604.6,Section4.5.Amongotherthings,the CouncilwillreviewCOImanagementplansupontherequestofany dean,vicechancellor,orchancellorandmakerecommendationstothereferringofficial.

UnderthePolicy,whenapotentialCOIisidentified,theConflictofInterestCoordinatoris requiredtoconferwiththeCoveredPersonandtheCoveredPerson’sdepartmentchairor supervisor,dean,vicechancellor,orchancellorasappropriate.Ultimately, theDesignatedUniversityOfficialisresponsiblefordeterminingwhetheraCOIexists.Policy604.6,Section 4.7.

OnceitisdeterminedthataCOIexists,theDesignatedUniversityOfficial(inconsultationwiththeConflictofInterestandCommitmentCouncil,ifapplicable)isresponsiblefordrafting,approving,andimplementingaConflictofInterestManagementPlan.Policy 604.6,Section

4.8.4.TheCOICoordinatorapprovesallsuchplansataninstitutionallevelandreportsallidentifiedCOIsandCOIMPstotheProvost.Policy604.6,Section4.8.7.

ThetemplatesetforthaboveisbasedontherequirementsandguidelinessetforthinPolicy 604.6,Sections4.7and4.8,andisintendedtoprovideastartingpointforDesignated UniversityOfficialswhoareresponsiblefordevelopingCOIMPs.Additionalguidanceappears below.TheCOICoordinator(OfficeofUniversityCounsel,262-2751)andtheOfficeofResearch(262-2130)areavailableforassistance.

ManagementPlanRequirements

Theitemssetforthinthesectionlabeled“ManagementPlanRequirements”aredrawnfrom Policy604.6,Section4.8.5.Examplesoftextthatcouldberelevantinaparticularsituationappearbelow.Iftheitem isnotapplicableinagivensituation,simply checkthestatementto thateffectsothatitwillbecleartheitemhasbeenconsidered.

Notethatforexternallyfundedresearch,provisionsaddressingcertainoftheseitemsmay be thesubjectofnegationbetweentheOfficeofResearchandtheFUNDERandincorporatedintheresearchagreement.

1.PUBLICDISCLOSUREOFFINANCIALINTERESTS

Examplescouldinclude,butarenotlimitedto:

  • DisclosureinIRBdocumentationprovidedtohumansubjects.
  • Annotationstopublicationssubmittedtojournals.
  • Othermeasuresasappropriate.

2.MONITORINGOFRESEARCHOROTHERACTIVITYBYNEUTRAL,INDEPENDENTREVIEWER(S)

Examplescouldinclude,butarenotlimitedto:

  • Monitoringbyacolleague(withinthedepartmentor in another departmentorunitoncampus)withappropriateexpertise.
  • Monitoringby animpartialexternalthirdparty.
  • Monitoringby asmalladhoccommitteeformedspecificallyforthispurpose.
  • Othermeasuresasappropriate.

3.MODIFICATIONOFRESEARCHPLANORWORKPLAN

Examplescouldinclude,butarenotlimitedto:

  • Requiringthatrandom samplesofbiomaterialsbesenttoanalternative lab tosupportfindings.
  • Requiringsupplementstobepurchasedfrom anon-conflictedvendor.
  • Mandatingachangeinproceduresorstatisticalanalysis.
  • Assigningan objectivethirdpartytomanageorreviewfinancesonaregularschedule.
  • Othermeasuresasappropriate.

4.DISQUALIFICATIONOFCOVEREDPERSONFROMPARTICIPATIONINPROJECTORACTIVITY,ORPARTSTHEREOF

Mayberelevantespeciallyforsmallbusinesstechnologydevelopmentandsmall businessinnovationawards,wherePrincipalInvestigatorsareboththecampusPIand theownerofaspinoffcompany.

Examplescouldinclude,butarenotlimitedto:

  • Conflictedindividual is disqualifiedasservingasthecampusPIandacampuscollaboratorappointedtothatrole.
  • PIdivestsher-orhimselfoftheadministrativeroleintheexternalbusiness.
  • Othermeasuresasappropriate.

5.DIVESTITUREORSEVERANCEOFSIGNIFICANTFINANCIALOROTHER INTERESTSWHICHCREATEACOIWITHUNIVERSITYEMPLOYMENTRESPONSIBILITIES(seePolicyManual604.6,Section3.19)ORPHSRESPONSIBILITIES

Examplescouldinclude,butarenotlimitedto:

  • Serviceonboardofdirectorsorscientificadvisory boardofenterprisethatprovidesfinancialsupportforUniversityresearch,whereCoveredPersonor ImmediateFamilymemberreceivessuchfinancialsupport:COIMPcouldrequiredisclosure,recusal,orresignation.
  • DepartmentalandFinancialOversight:Toensurethataconflictedinvestigator doesnothavesolecontroloffinances,itmay beappropriatetodesignatean individualwhohasnorelationshiptotheSPONSORtoapproveannualprojectbudgets,anybudgetamendments,humansubjectspayments,etc.

6.RELATIONSHIPMANAGEMENT(SPOUSE,PARTNER,COLLEAGUE,ETC.)

Examplescouldinclude,butarenotlimitedto:

  • Measurestoensureneutral decision-makingaboutformulationandpassageofrecommendations(e.g.,ensuringthattherearesafeguardsinplacetoeliminate anychanceofbiastowardoutcomesthatfavoreither orbothofyourdisciplines).
  • Budgetarycontrols(e.g.,designatingwhoapprovesmoneyforanyactivitiestoensurenofavoritismtowardyouortherelated person).
  • Othermeasuresasappropriate.

PleasecontacttheCOICoordinator(OfficeofUniversityCounsel,262-2751)ortheOfficeofResearchandSponsoredPrograms(262-2130)ifyouhavequestions,comments,andneedassistance.

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