AAOMS-Disclosure-Form

AmericanAssociationofOralandMaxillofacialSurgeonsDisclosureStatementRegardingDualCommitmentItisthepolicyoftheAmericanAssociationofOralandMaxillofacialSurgeonstoensurebalance,independence,objectivityandscientificrigorinscientific/educationalactivities.Thisrequirementincludesrelationshipswithpharmaceuticalcompanies,biomedicaldevicemanufacturersordistributors,orotherswhoseproductsorservicesmaybeconsideredtoberelatedtothesubjectmatterofthescientific/educationalactivity.Theprincipalintentofrequiringdisclosureisnottopreventanauthorwithdualcommitmentsfromsubmittingapublication.Disclosureisrequestedsothatthereadermayreasonablyformulatetheirownjudgmentsregardingthepaperinthelightoffulldisclosureofrelatedinformation.SUMMARYOFOPERATINGPRINCIPLESGOVERNINGDISCLOSUREOFDUALCOMMITMENT1.Theexpression“dualcommitment”describesthedilemmafacedbyauthorswhentheirresponsibilitytoremainunbiasedmaybecompromised,orperceivedtobecompromised,byasimultaneouscommitmenttocommercialinterestsrelatedtothesubjectofaspecificscientific/educationalactivity.“ConflictofInterest”referstoadegreeofdualcommitmentthatmaybestrongenoughtoproducereservationsregardingpotentiallossofobjectivity.2.DualcommitmentsgovernedbytheAAOMSPolicyonDualCommitmentincludebutarenotlimitedto:specialcustomerpreferences(materialdonations,clinicalmaterials,specialdiscounts,specialgifts,etc.)financialinterest(honorariaforlectureshipsorotherteachingactivities;stipends)consultantships(paidorunpaid)governance(corporateresponsibility,corporateallegiances,e.g.throughserviceongoverningboards)researchcontractsorothersupportforinvestigationownershipofpatentsorcompanies,royalties,stockoptions,equitybyvirtueofpastorpresentemploymentofimmediatefamilyorrelatives3.AAOMSrequiresdisclosureofdualcommitments.Indeterminingthesignificanceofadualcommitment,AAOMSconsidersthefollowing:scopeoftherelationshiporcommitmentfrequencyandtiming,i.e.whetherpastorrecent,occasionalorlong-standingnumber,i.e.asingle,exclusiverelationshipratherthanmultiple,competingrelationships4.Ifadualcommitmentisrelatedtothesubmission,itmustbedisclosedtothereaders,regardlessofscope,frequency,timing,ornumber.5.PenaltiesforfailuretodisclosewillbeconsideredatthediscretionoftheAAOMSCommissiononProfessionalConduct.DisclosureofUnlabeledand/orInvestigationalProductUsageTheAmericanAssociationofOralandMaxillofacialSurgeonsrequiresallauthorstodisclosewhetheranyproductdiscussedintheirsubmissionisunlabeledfortheusediscussedorisinvestigational.Definitions:Unlabeled:AnyuseofaproductordeviceforpurposesotherthanthosespecificallystatedbythemanufacturerandapprovedbytheFoodandDrugAdministration.Investigational:AnyproductordevicethathasnotyetreceivedapprovalforgeneralusebytheFoodandDrugAdministration.AmericanAssociationofOralandMaxillofacialSurgeonsDisclosureStatementPublication:JournalofOralandMaxillofacialSurgeryAuthor:___________________________________________________________ArticleTitle:___________________________________________________________DisclosureofDualCommitmentIhavereadtheoperatingprinciplesgoverningdualcommitmentandpotentialconflictofinterestandthepolicygoverningunlabeledandinvestigationalcommercialproductusage.Asitpertainstothearticlelistedabove,Ideclarethat(selectonebymarkingthespacewithan“X”):_____Ihavenodualcommitment(asdefinedonthereverseofthispage)._____ImayhaveanareaofdualcommitmentthatIaffirmwillnotinfluencemyobjectivity.TypeofCommitmentCompanyTypeofCommitmentCompanySpecialCustomerPreferencesGovernanceHonorariaConsultantship(paid)Consultantship(unpaid)StockOptions/HoldingsEquityResearchContracts/GrantsCompanyOwnershipFamilyEmploymentPatentOwnershipRoyaltiesOther(pleaseexplain):DisclosureofUnlabeledand/orInvestigationalProductUsage1.Inthecourseofyourarticle,doyouintendtodiscussanyunlabeledand/orinvestigationaluseofanycommercialproduct,asdefinedabove?(selectonebymarkingthespacewithan“X”):Yes_____No_____2.Ifyouhaveanswered“Yes”toitem1,pleaseidentifytheproductanddescribethespecificproductusageyouintendtodiscuss:ProductUsageFDAApprovalStatus(selectone)Unlabeled/InvestigationalUnlabeled/InvestigationalUnlabeled/InvestigationalUnlabeled/InvestigationalSignature_________________________________________Date____________________(typename)(enterdate)