Justice.docx

1、JusticeJusticeWhat This Module Covers:Fair distribution of the benefits and burdens of research公平分配利益和负担的研Inclusion of Women, Minorities, andChildrenin Research包含的女性、少数族裔、和孩子的研究Issues to consider in international research在国际研究中需要考虑的问题The Objectives For This Module Are:To understand the concept of fa

2、ir and equitable sharing of the benefits and burdens of research理解公平的概念和公平分享利益和负担的研究To learn about NIH policies on inclusion of women, minorities, and children in research了解国家政策的妇女,少数民族,和孩子的研究The definition of justice has two parts:正义的定义有两个部分: Fair procedures and outcomes are used toselectresearch p

3、articipants,公平的程序和结果用于选择研究参与者 There is a fair distribution of benefits and burdens to populations whoparticipatein research 公平分配利益和负担人群参与研究Individual Justice and Social JusticeThe Belmont Report distinguishes social justice and individual justice in the selection of subjects:贝尔蒙特报告区分社会正义和个人正义的选择主题:I

4、ndividual justicerequires thatinvestigators“should not offer potentially beneficial research only to some patients who are in their favor or select only undesirable persons for risky research.”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。”Social justice“requires that distinction be drawn between

5、 classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons.”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

6、一步的负担已经负担的人。”More on Social Justice“The choice of participants in research needs to be considered carefully to ensure that groups (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are not selected for inclusion mainly because of easy availability,

7、 compromised position, or manipulability.”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。”Selection should depend on reasons directly related to the research questions. When research leads to the development of new treatments, procedures, or devices, justice demands both

8、 that: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,These advancements are provided to those who can benefit from them,这些进步都是提供给那些可以受益于他们,The research should involve persons from groups who are likely to benefit from subsequent applications of the research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Equity vs. Equality

9、 in Human Subjects ResearchThe meanings of equity and equality are similar, but not the same. The difference between equity and equality has important implications for justice in research.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。To treat“equitably”means to treat fairly;To treat“equally”means to tr

10、eat in exactly the same way.Research should strive for equitable distribution of the risks and potential benefits of the research.This means that investigatorsare treating the groups involved in the research fairly and justly. It does not necessarily mean that all groups are equally represented, but

11、 that their representation is fair and just based on the risks and potential benefits associated with the research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Equitable Distribution公平分配 公平分配制 资源的公平分配 In order to achieve an equitable distribution of the r

12、isks and potential benefits of the research,investigatorsmust determine the distribution of different groups (men and women, racial or ethnic groups, adults andchildren, age, etc.) in the populations that: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. May be affected by the disea

13、se or condition under study, and2. That are anticipated to benefit from the knowledge gained through the researchChallenges to Achieving an Equitable Distribution of Benefits and BurdensInvestigatorsmust ensure that the participants recruited for the research will not beunduly burdenedand that recru

14、itment reflects the diversity of the population that may benefit from the knowledge generated from the study.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。Individuals with the advantages of wealth and education may have an unfair advantage in terms of reaping the benefits of research because they

15、 may be able to afford new and costly treatments more easily than individuals in resource-poor settings.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NIH Inclusion Policies: Women and MinoritiesOne way the justice principle is applied is through the inclusion of women and minorities as

16、participants in human subjects research. Because knowledge gained from clinical research may define health policy and shape standards of care for all patients, it is important to consider whether the intervention or therapy under scrutiny “affects women or men or members of minority groups and their

17、 subpopulations differently.”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。”TheNIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Researchdescribes the Agencys requirements for the inclusion of wom

18、en and minorities in NIH-supported biomedical and behavioral research involving human subjects.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。Case Study: Migraine Intervention TrialA researcher seeks to improve treatment for severe migraines that are partially responsiv

19、e to oral medication. He proposes to test whether acupuncture, in addition to a sufferers oral medication, is more effective treatment than oral medication alone. Becausewomen are three times more likely to experience migraines than men, he proposes to enroll three times as many women as men. They w

20、ill be recruited from racially and ethnically diverse communities.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。Does this study design fulfill the principle of justice?Yes, this study design does fulfill the principle of justiceCorre

21、ct!The research includes women and men in proportion to the rates of severe migraines experienced by each sex, and is designed to have racial and ethnic diversity. The study provides both sexes and racial/ethnic communities with the opportunity for benefits from theclinical trials, and does not unfa

22、irly burden any single group with the risks of research. Its design is fair.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, this study design does not fulfill the principle of justiceThe correct answer is Yes.The study includes women and men in propor

23、tion to the rates of severe migraines experienced by each sex, and is designed to have racial and ethnic diversity. The study provides both sexes and racial/ethnic communities with the opportunity for benefits from theclinical trials, and does not unfairly burden any single group with the risks of r

24、esearch. Its design isCase Study: Esophageal CancerA group ofinvestigatorsproposes to investigate genetic factors that may increase risks for esophageal cancer. Genetic factors in esophageal cancer are not well understood and esophageal cancer occurs in many racial and ethnic populations. The invest

25、igators propose to collect DNA from cheek swabs and administer a risk factor questionnaire. Both cancer patients and age-matched controls will be included.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。The investigators have access to a predomina

26、ntly Caucasian sample, and have no plans to recruit participants outside of their available pool.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。Is this an acceptable strategy?Yes, this is an acceptable strategyThe correct answer is No.The NIH inclusion policies require that inclusion be generalizable to the p

27、opulation of the United States. Acceptable inclusion of women and/or minorities depends both upon the scientific question addressed by the study and the prevalence of the disease, disorder, or condition in these populations.In this case, it is scientifically appropriate to include a broad population

28、. Failure to include groups that would be affected by this condition could result in gaps in scientific knowledge.No, this is not an acceptable strategyCorrect!The NIH inclusion policies require that inclusion be generalizable to the population of the United States. Acceptable inclusion of women and

29、/or minorities depends both upon the scientific question addressed by the study and the prevalence of the disease, disorder, or condition in these populations.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。In this case, it is scientifically appropriate to include a broad populati

30、on. Failure to include groups that would be affected by this condition could result in gaps in scientific knowledge.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。Inclusion of Children in ResearchNIH also applies the principle of justice through theNIH Policy and Guidelines on the Inclusion of C

31、hildren as Participants in Research Involving Human Subjects.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。The policy emerged from the observation that children have often received treatments that have only been tested in adults, and that there is insufficient data on safe and effective uses for

32、many treatments provided tochildren. Although the past practice of excluding children may have stemmed from good motives, “protecting” children in this way has resulted in: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. Denying children the benefits of participation in research, and2. Preventing the collection of sufficient data about the effects of agents in children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Excluding Children from ResearchTheNIH Policy and Guidelines on th