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1、InformedConsentSomeQuestions知情同意的几个问题TheICModelCentraltoresearchethics–guidelinesandpractice2KeyClaims:MustgaininformedconsentSupportedbyappealtoautonomyCanasksomequestionsaboutthis1.Whatistherequirement?Provisionorcomprehension?‘Beforerequestinganindividual’sconsentt
2、oparticipateinresearch,theinvestigatormustprovidethefollowinginformation,inlanguageoranotherformofcommunicationthattheindividualcanunderstand…anexplanationoffeaturesoftheresearchdesign(e.g.,randomization,double-blinding)…’.(CIOMS,Guideline5)(myitalics)‘mustbeadequatel
3、yinformedoftheaims,methods,sourcesoffunding,anypossibleconflictsofinterest,institutionalaffiliationsoftheresearcher,theanticipatedbenefitsandpotentialrisksofthestudyandthediscomfortitmayentail…..Afterensuringthatthesubjecthasunderstoodtheinformation,thephysicianshould
4、thenobtainthesubject’sfreely-giveninformedconsent,preferablyinwriting’.(Helsinki,paragraph.22)(myitalics)5.HowdoesICfitwithothermorallyimportantfactors?Harm/benefit.RoleofREC.Protection.Paternalism.MethodologicalbenefitsofnotobtainingIC(e.g.certainCRTs;costofseekingre
5、trospectiveIC–financialorharmetc)6.DoestheICmodelassumeaplausibleviewofagency?PerfectrationalassessoranddeliberatorBut:TherapeuticmisconceptionFramingeffectsThe‘musttryharder’response7.DopatientsevenwantIC?EvidencesuggeststhatpatientswanttoknowwhatwillhappenMajoritydo
6、notwantmassesofinformation(thoughlawyersandphilosophersmight)SuspectpatientswouldpreferacaringprofessionalAdifferentviewMostpeoplearehappytocontributetoresearchAcceptrealityofbeingapatient(anxiety,pain,lackofsleepetc).Fromidealagent.Acceptrealityofbeingahumanbeing.Cog
7、nitivelimitsandsocialreality.SevenQuestionsWhatistherequirement?WhatjustifiedIC?WhatisthemoralstatusofIC?WhatisthepurposeofIC?HowdoesICfitwithothermorallyimportantfactors?DoestheICmodelassumeaplausiblemodelofagency?DopatientsevenwantIC?外貌nice-looking,great-looking,whi
8、te-haired,short/far-sighted,beingoodhealth,charming,attractive，elegant，neat性格气质warm-hearted,bad-tempered,naughty,diligent,hu
