贝尔蒙特报告

贝尔蒙特报告保护人体研究受试者的道德伦理准则与指导方针(美国)国家生物医学与行为研究人体受试者保护委员会1979年4月18日陈为真、范思陆译刘祖祥校2004年1月6日北京磁共振脑成像中心thanimmediatebenefittotheindividualreceivinganintervention,however,shouldnotconfusethegeneraldestinationbetweenresearchandpractice.Evenwhenaprocedureappliedinpracticemaybenefitsomeotherperson,itremainsaninterventiondesignedtoenhancethewell-beingofaparticularindividualorgroupsofindividuals;thus,itispracticeandneednotbereviewedasresearch.(3)Becausetheproblemsrelatedtosocialexperimentationmaydiffersubstantiallyfromthoseofbiomedicalandbehavioralresearch,theCommissionspecificallydeclinestomakeanypolicydeterminationregardingsuchresearchatthistime.Rather,theCommissionbelievesthattheproblemoughttobeaddressedbyoneofitssuccessorbodies.贝尔蒙特报告保护人体研究受试者的道德伦理准则与指导方针(美国)国家生物医学与行为研究人体受试者保护委员会1979年4月18日机构：卫生、教育与福利部目的：征求公众意见通告摘要：1974年7月12日，国家研究法案(Pub.L.93-348)正式立法，并成立了国家生物医学与行为研究人体受试者保护委员会。委员会的职责之一是，确定用以规范涉及人体受试者的生物医学与行为研究应当遵循的基本伦理道德准则，并制定出指导方针来确保这样的研究遵守这些准则。为此，委员会受权考虑以下问题：（i）生物医学与行为研究同已被认可的、常规的医学处置（practice）之间的界限；（ii）在确定涉及人体受试者研究的适宜性时，风险—收益评价标准所具有的作用；（iii）用于对人体受试者进行选择的、恰当的指导方针；（iv）适用于各种研究项目的人体受试者协议（InformedConsent）的性质与定义。该报告试图总结委员会在商议过程中所制定的基本道德准则。1976年2月在斯密斯桑尼研究所的贝尔蒙特会议中心举行了长达4天的热烈讨论，并且在近四年的时间里委员会还每月召开一次例会进行补充与完善，其结果就是这份报告。这份报告陈述的基本道德伦理准则与指导方针，有助于解决通过人体受试者进行研究时所遇到的有关道德问题。通过在“联邦注册（FederalRegister）”上公开发表，以及通过抽印本方式，委员会秘书为科学家、学会评审委员会成员、以及联邦雇员提供这份报告。另外，由协助委员会工作的专家们完成的长达两卷的附录，也作为No.(OS)78-0013和No.(OS)78-0014的DHEW（DepartmentofHealth,Education,andWelfare，卫生、教育与福利部）出版物，可以从美国政府出版署的档案管理处（TheSuperintendentofDocuments,U.S.GovernmentPrintingOffice,Washington,D.C.20402）购买到。和委员会大多数其它报告不同的是，该报告并不是作为卫生、教育与福利部部长的行政措施来专门推荐给大家的。委员会认为，该报告是在整体上作为部门政策的阐述而被采用的，并需要公众的意见。(2)Althoughpracticeusuallyinvolvesinterventionsdesignedsolelytoenhancethewell-beingofaparticularindividual,interventionsaresometimesappliedtooneindividualfortheenhancementofthewell-beingofanother(e.g.,blooddonation,skingrafts,organtransplants)oraninterventionmayhavethedualpurposeofenhancingthewell-beingofaparticularindividual,and,atthesametime,providingsomebenefittoothers(e.g.,vaccination,whichprotectsboththepersonwhoisvaccinatedandsocietygenerally).Thefactthatsomeformsofpracticehaveelementsotherbasedontheabilityofmembersofthatclasstobearburdensandontheappropriatenessofplacingfurtherburdensonalreadyburdenedpersons.Thus,itcanbeconsideredamatterofsocialjusticethatthereisanorderofpreferenceintheselectionofclassesofsubjects(e.g.,adultsbeforechildren)andthatsomeclassesofpotentialsubjects(e.g.,theinstitutionalizedmentallyinfirmorprisoners)maybeinvolvedasresearchsubjects,ifatall,onlyoncertainconditions.Injusticemayappearintheselectionofsubjects,evenifindividualsubjectsareselectedfairlybyinvestigatorsandtreatedfairlyinthecourseofresearch.Thusinjusticearisesfromsocial,racial,sexualandculturalbiasesinstitutionalizedinsociety.Thus,evenifindividualresearchersaretreatingtheirresearchsubjectsfairly,andevenifIRBsaretakingcaretoassurethatsubjectsareselectedfairlywithinaparticularinstitution,unjustsocialpatternsmayneverthelessappearintheoveralldistributionoftheburdensandbenefitsofresearch.Althoughindividualinstitutionsorinvestigatorsmaynotbeabletoresolveaproblemthatispervasiveintheirsocialsetting,theycanconsiderdistributivejusticeinselectingresearchsubjects.Somepopulations,especiallyinstitutionalizedones,arealreadyburdenedinmaywaysbytheirinfirmitiesandenvironments.Whenresearchisproposedthatinvolvesrisksanddoesnotincludeatherapeuticcomponent,otherlessburdenedclassesofpersonsshouldbecalleduponfirsttoaccepttheserisksofresearch,exceptwheretheresearchisdirectlyrelatedtothespecificconditionsoftheclassinvolved.Also,eventhoughpublicfundsforresearchmayoftenflowinthesamedirectionsaspublicfundsforhealthcare,itseemsunfairthatpopulationsdependentonpublichealthcareconstituteapoolofpreferredresearchsubjectsifmoreadvantagedpopulationsarelikelytobetherecipientsofthebenefits.Onespecialinstanceofinjusticeresultsfromtheinvolvementofvulnerablesubjects.Certaingroups,sucharacialminorities,theeconomicallydisadvantaged,theverysick,andtheinstitutionalizedmaycontinuallybesoughtasresearchsubjects,owingtotheirreadyavailabilityinsettingswhereresearchisconducted.Giventheirdependentstatusandtheirfrequentlycompromisedcapacityforfreeconsent,theyshouldbeprotectedagainstthedangerofbeinginvolvedinresearchsolelyforadministrativeconvenience,orbecausetheyareeasytomanipulateasaresultoftheirillnessorsocioeconomiccondition.(1)Since1945,variouscodesfortheproperandresponsibleconductofhumanexperimentationinmedicalresearchhavebeenadoptedbydifferentorganizations.ThebestknownofthesecodesaretheNurembergCodeof1947,theHelsinkiDeclarationof1964(revisedin1975),andthe1971Guidelines(codifiedintoFederalRegulationsin1974)issuedbyetheU.S.DepartmentofHealth,Education,andWelfareCodesfortheconductofsocialandbehavioralresearchhavealsobeenadopted,thebestknownbeingthattheAmericanPsychologicalAssociation,publishedin1973.(美国)国家生物医学与行为研究人体受试者保护委员会委员名单肯尼思·约翰·赖安，医学博士，主席波士顿妇女医院主任医师约瑟夫·V·布瑞德，博士约翰霍布金斯大学行为生物学教授罗伯特·E·库克，医学博士宾夕法尼亚医学院院长桃乐茜·I·海特，会长国家黑人妇女协会艾伯特·R·卓森，博士旧金山的加利福尼亚大学生物伦理学副教