Justice.docx
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Justice
Justice
WhatThisModuleCovers:
Fairdistributionofthebenefitsandburdensofresearch公平分配利益和负担的研
InclusionofWomen,Minorities,and Children inResearch包含的女性、少数族裔、和孩子的研究
Issuestoconsiderininternationalresearch在国际研究中需要考虑的问题
TheObjectivesForThisModuleAre:
Tounderstandtheconceptoffairandequitablesharingofthebenefitsandburdensofresearch理解公平的概念和公平分享利益和负担的研究
TolearnaboutNIHpoliciesoninclusionofwomen,minorities,andchildreninresearch了解国家政策的妇女,少数民族,和孩子的研究
Thedefinitionofjusticehastwoparts:
正义的定义有两个部分:
▪Fairproceduresandoutcomesareusedto select researchparticipants,公平的程序和结果用于选择研究参与者
▪Thereisafairdistributionofbenefitsandburdenstopopulationswho participate inresearch
公平分配利益和负担人群参与研究
IndividualJusticeandSocialJustice
TheBelmontReportdistinguishessocialjusticeandindividualjusticeintheselectionofsubjects:
贝尔蒙特报告区分社会正义和个人正义的选择主题:
Individualjustice requiresthat investigators “shouldnotofferpotentiallybeneficialresearchonlytosomepatientswhoareintheirfavororselectonly‘undesirable’personsforriskyresearch.”个人正义要求调查人员“不应该提供潜在有益的研究只对一些患者对自己有利或选择唯一的风险研究‘不良’的人。
”
Socialjustice “requiresthatdistinctionbedrawnbetweenclassesofsubjectsthatought,andoughtnot,toparticipateinanyparticularkindofresearch,basedontheabilityofmembersofthatclasstobearburdensandontheappropriatenessofplacingfurtherburdensonalreadyburdenedpersons.”社会正义”要求的对象类之间的区别是,应该和不应该参与任何特定类型的研究,基于该类的成员承担的能力负担和适当的将进一步的负担已经负担的人。
”
MoreonSocialJustice
“Thechoiceofparticipantsinresearchneedstobeconsideredcarefullytoensurethatgroups（e.g.,welfarepatients,particularracialandethnicminorities,orpersonsconfinedtoinstitutions）arenotselectedforinclusionmainlybecauseofeasyavailability,compromisedposition,ormanipulability.” 10“研究参与者的选择需要考虑仔细,确保组织（如、福利患者特定的种族和少数民族,或人局限于机构）不选择包含主要是因为简单的可用性、破坏位置,或可操纵性。
”
Selectionshoulddependonreasonsdirectlyrelatedtotheresearchquestions.Whenresearchleadstothedevelopmentofnewtreatments,procedures,ordevices,justicedemandsboththat:
选择应该取决于原因直接相关的研究问题。
当研究导致新的治疗方法的发展,程序,或设备,正义要求,
Theseadvancementsareprovidedtothosewhocanbenefitfromthem,这些进步都是提供给那些可以受益于他们,
Theresearchshouldinvolvepersonsfromgroupswhoarelikelytobenefitfromsubsequentapplicationsoftheresearch和研究应该从组织涉及的人可能会受益于后续的应用研究
Equityvs.EqualityinHumanSubjectsResearch
Themeaningsof�equity�and�equality�aresimilar,butnotthesame.Thedifferencebetweenequityandequalityhasimportantimplicationsforjusticeinresearch.股本��,��平等的含义是类似的,但不是相同的。
公平与平等之间的差异为正义研究有着重要的意义。
Totreat “equitably” meanstotreatfairly;
Totreat “equally” meanstotreatinexactlythesameway.
Researchshouldstriveforequitabledistributionoftherisksandpotentialbenefitsoftheresearch. Thismeansthatinvestigators aretreatingthegroupsinvolvedintheresearchfairlyandjustly.Itdoesnotnecessarilymeanthatallgroupsareequallyrepresented,butthattheirrepresentationisfairandjustbasedontherisksandpotentialbenefitsassociatedwiththeresearch研究应该争取公平的分配研究的风险和潜在的好处。
这意味着治疗组调查人员参与这项研究公平和公正。
它并不意味着所有组也同样表示,但是,他们表示是公平公正的基础上与研究相关的风险和潜在的好处
EquitableDistribution
公平分配公平分配制资源的公平分配
Inordertoachieveanequitabledistributionoftherisksandpotentialbenefitsoftheresearch, investigators mustdeterminethedistributionofdifferentgroups（menandwomen,racialorethnicgroups,adultsand children,age,etc.）inthepopulationsthat:
为了实现风险和潜在收益的公平分配的研究,调查人员必须确定的分布不同群体（男性和女性、种族或民族,成人和儿童,年龄,等等）的数量:
1.Maybeaffectedbythediseaseorconditionunderstudy,and
2.Thatareanticipatedtobenefitfromtheknowledgegainedthroughtheresearch
ChallengestoAchievinganEquitableDistributionofBenefitsandBurdens
Investigators mustensurethattheparticipantsrecruitedfortheresearchwillnotbe undulyburdened andthatrecruitmentreflectsthediversityofthepopulationthatmaybenefitfromtheknowledgegeneratedfromthestudy.调查人员必须确保参与者招募的研究不会过度负担和招聘反映人口的多样性可能会受益于这项研究产生的知识。
Individualswiththeadvantagesofwealthandeducationmayhaveanunfairadvantageintermsofreapingthebenefitsofresearchbecausetheymaybeabletoaffordnewandcostlytreatmentsmoreeasilythanindividualsinresource-poorsettings.人财富和教育的优势可能的获得不公平的优势研究的好处,因为他们可以负担得起的新和昂贵的治疗比个人更容易在资源贫乏的环境中
NIHInclusionPolicies:
WomenandMinorities
Onewaythejusticeprincipleisappliedisthroughtheinclusionofwomenandminoritiesasparticipantsinhumansubjectsresearch.Becauseknowledgegainedfromclinicalresearchmaydefinehealthpolicyandshapestandardsofcareforallpatients,itisimportanttoconsiderwhethertheinterventionortherapyunderscrutiny“affectswomenormenormembersofminoritygroupsandtheirsubpopulationsdifferently.”正义原则是应用的一种方法是通过将女性和少数族裔参与人体试验研究。
因为来自临床研究的知识可能定义形状和卫生政策标准的照顾所有的患者,重要的是要考虑是否干预或治疗下审查”影响的男性或女性或少数民族的成员和他们的亚种群不同。
”
The NIHPolicyandGuidelinesontheInclusionofWomenandMinoritiesasSubjectsinClinicalResearch describestheAgency’srequirementsfortheinclusionofwomenandminoritiesinNIH-supportedbiomedicalandbehavioralresearchinvolvinghumansubjects.美国国立卫生研究院政策和指导方针包含女性和少数族裔的临床研究描述了机构的要求把女性和少数族裔NIH-supported生物医学和行为涉及人体受试者的研究。
CaseStudy:
MigraineInterventionTrial
Aresearcherseekstoimprovetreatmentforseveremigrainesthatarepartiallyresponsivetooralmedication.Heproposestotestwhetheracupuncture,inadditiontoasufferer�soralmedication,ismoreeffectivetreatmentthanoralmedicationalone.Because womenarethreetimesmorelikelytoexperiencemigrainesthanmen,heproposestoenrollthreetimesasmanywomenasmen.Theywillberecruitedfromraciallyandethnicallydiversecommunities.研究人员寻求改善治疗严重的偏头痛,部分响应口服药物治疗。
他提出要测试是否针灸,除了患者�年代口服药物,仅比口服药物更有效的治疗。
因为女人是三倍经验比男性偏头痛,他提出招收女性患者是男性的三倍。
他们将招募从种族和种族多元化的社区。
Doesthisstudydesignfulfilltheprincipleofjustice?
Yes,thisstudydesigndoesfulfilltheprincipleofjustice
Correct!
Theresearchincludeswomenandmeninproportiontotheratesofseveremigrainesexperiencedbyeachsex,andisdesignedtohaveracialandethnicdiversity.Thestudyprovidesbothsexesandracial/ethniccommunitieswiththeopportunityforbenefitsfromthe clinicaltrials,anddoesnotunfairlyburdenanysinglegroupwiththerisksofresearch.Itsdesignisfair.研究包括女性和男性的比例严重的偏头痛的性,和设计有种族和民族的多样性。
这项研究提供了两种性别和种族/族裔社区受益于临床试验的机会,不公平,不负担任何单一组织的风险研究。
它的设计是公平的。
No,thisstudydesigndoesnotfulfilltheprincipleofjustice
ThecorrectanswerisYes.
Thestudyincludeswomenandmeninproportiontotheratesofseveremigrainesexperiencedbyeachsex,andisdesignedtohaveracialandethnicdiversity.Thestudyprovidesbothsexesandracial/ethniccommunitieswiththeopportunityforbenefitsfromthe clinicaltrials,anddoesnotunfairlyburdenanysinglegroupwiththerisksofresearch.Itsdesignis
CaseStudy:
EsophagealCancer
Agroupof investigators proposestoinvestigategeneticfactorsthatmayincreaserisksforesophagealcancer.Geneticfactorsinesophagealcancerarenotwellunderstoodandesophagealcanceroccursinmanyracialandethnicpopulations.TheinvestigatorsproposetocollectDNAfromcheekswabsandadministerariskfactorquestionnaire.Bothcancerpatientsandage-matchedcontrolswillbeincluded.一组调查人员提出探讨遗传因素可能增加食道癌的风险。
遗传因素在食道癌并不好理解和食道癌发生在许多种族和民族群体。
调查人员提出从脸颊棉签收集DNA和管理一个危险因素问卷调查。
癌症患者和年龄组都将被包括在内。
TheinvestigatorshaveaccesstoapredominantlyCaucasiansample,andhavenoplanstorecruitparticipantsoutsideoftheiravailablepool.调查人员已经进入一个以白人为主的样本,并没有计划招募参与者之外他们可用池。
Isthisanacceptablestrategy?
Yes,thisisanacceptablestrategy
ThecorrectanswerisNo.
TheNIHinclusionpoliciesrequirethatinclusionbegeneralizabletothepopulationoftheUnitedStates.Acceptableinclusionofwomenand/orminoritiesdependsbothuponthescientificquestionaddressedbythestudyandtheprevalenceofthedisease,disorder,orconditioninthesepopulations.
Inthiscase,itisscientificallyappropriatetoincludeabroadpopulation.Failuretoincludegroupsthatwouldbeaffectedbythisconditioncouldresultingapsinscientificknowledge.
No,thisisnotanacceptablestrategy
Correct!
TheNIHinclusionpoliciesrequirethatinclusionbegeneralizabletothepopulationoftheUnitedStates.Acceptableinclusionofwomenand/orminoritiesdependsbothuponthescientificquestionaddressedbythestudyandtheprevalenceofthedisease,disorder,orconditioninthesepopulations.NIH包容政策要求包含存在于美国的人口。
可接受的女性和/或少数族裔都取决于科学问题解决的研究和疾病的患病率,在这些群体的障碍,或条件。
Inthiscase,itisscientificallyappropriatetoincludeabroadpopulation.Failuretoincludegroupsthatwouldbeaffectedbythisconditioncouldresultingapsinscientificknowledge.在这种情况下,它是科学的适合包括一个广泛的人口。
未能包括团体将受到这种情况的影响可能导致科学知识缺口。
InclusionofChildreninResearch
NIHalsoappliestheprincipleofjusticethroughthe NIHPolicyandGuidelinesontheInclusionofChildrenasParticipantsinResearchInvolvingHumanSubjects.通过美国国立卫生研究院NIH的原则也同样适用司法政策和指导方针的孩子在涉及人体受试者的研究参与者。
Thepolicyemergedfromtheobservationthatchildrenhaveoftenreceivedtreatmentsthathaveonlybeentestedinadults,andthatthereisinsufficientdataonsafeandeffectiveusesformanytreatmentsprovidedto children.Althoughthepastpracticeofexcludingchildrenmayhavestemmedfromgoodmotives,“protecting”childreninthiswayhasresultedin:
观察的政策出现,孩子们常常得到治疗,只有在成人身上得到检验,安全有效,没有足够的数据使用了许多治疗方法提供给孩子们。
尽管过去的做法不包括孩子可能源于良好的动机,“保护”孩子们以这种方式导致:
1.Denyingchildrenthebenefitsofparticipationinresearch,and
2.Preventingthecollectionofsufficientdataabouttheeffectsofagentsinchildren
否认孩子参与研究的好处,以及防止收集足够的数据代理在儿童的影响
ExcludingChildrenfromResearch
The NIHPolicyandGuidelinesonth
升级会员 