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Assessing children’s competence to consent in research by a standardized tool a validity study.doc

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Assessing children’s competence to consent in research by a standardized tool a validity study

Assessingchildren’scompetencetoconsentin researchbyastandardizedtool:avaliditystudy Heinetal. Heinetal.BMCPediatrics2012,12:156 /1471-2431/12/156 Heinetal.BMCPediatrics2012,12:156 /1471-2431/12/156 STUDY PROTOCOL OpenAccess Assessingchildren’scompetencetoconsentin researchbyastandardizedtool:avaliditystudy IrmaMHein1*,PieterWTroost1,RobertLindeboom2,MartineCdeVries3,CMichelZwaan4and RamónJLLindauer1 Abstract Background:Currentlyover50%ofdrugsprescribedtochildrenhavenotbeenevaluatedproperlyforuseintheir agegroup.Onekeyreasonwhychildrenhavebeenexcludedfromclinicaltrialsisthattheyarenotconsidered abletoexercisemeaningfulautonomyoverthedecisiontoparticipate.Dutchlawstatesthatcompetenceto consentcanbepresumedpresentattheageof12andabove;however,inpediatricpracticechildren’s competenceisnotthatclearlypresentedandthetransitionfromassenttoactiveconsentisgradual.Agold standardforcompetenceassessmentinchildrendoesnotexist.Inthisarticlewedescribeastudyprotocolonthe developmentofastandardizedtoolforassessingcompetencetoconsentinresearchinchildrenandadolescents. Methods/design:InthisstudywemodifiedtheMacCAT-CR,thebestevaluatedcompetenceassessmenttoolfor adults,foruseinchildrenandadolescents.Wewilladministerthetoolprospectivelytoacohortofpediatric patientsfrom6to18yearsduringtheselectionstagesofongoingclinicaltrials.TheoutcomesoftheMacCAT-CR interviewswillbecomparedtoareferencestandard,establishedbythejudgmentsofclinicalinvestigators,andan expertpanelconsistingofchildpsychiatrists,childpsychologistsandmedicalethicists.Thereliability, criterion-relatedvalidityandreproducibilityofthetoolwillbedetermined.AsMacCAT-CRisamulti-itemscale consistingof13items,powerwasjustifiedat130–190subjects,providingaminimumof10–15observationsper item.MacCAT-CRoutcomeswillbecorrelatedwithage,lifeexperience,IQ,ethnicity,socio-economicstatusand competencejudgmentoftheparent(s).Itisanticipatedthat160participantswillberecruitedover2yearsto completeenrollment. Discussion:Avaliditystudyonanassessmenttool