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首页> 外文期刊>Journal of empirical research on human research ethics : >When the subject is more than just the subject: two case studies of family involvement in human subjects research.
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When the subject is more than just the subject: two case studies of family involvement in human subjects research.

机译：当主题不仅仅是主题时：家庭参与人类主题研究的两个案例研究。

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摘要

Institutional review boards (IRBs) protect human research subjects by reviewing research to ensure compliance with federal regulations and institutional policies. One of the most important functions of IRBs is to ensure that investigators anticipate, plan for, and minimize risks to subjects. Under certain circumstances, however, participation in research may pose risks to nonsubject family members or other members of a subject's social network. In the context of a research protocol designed to test an intervention to prevent depression among a population of culturally diverse, urban mothers, we present two case studies of unanticipated problems, which demonstrate how nonsubject family members can either impact, or be impacted by, an individual's participation in research. The case studies illustrate the incongruence between federal regulations addressing IRB approval of research-which focus specifically on risks to subjects-and regulations on reporting incidents that occur during the conduct of the research, which extend to risks involving "others" as well. The cases also illustrate how risks to "others" can be accentuated in certain cultures where codependent family structures may increase the role that family members play in an individual's decision to participate in research. The question is raised as to whether this incongruence can inadvertently result in investigators and IRBs under-appreciating the risks that participation in research can pose to nonsubjects.
机译：机构审查委员会（IRB）通过审查研究以确保符合联邦法规和机构政策来保护人类研究对象。 IRB的最重要功能之一是确保研究人员预测，计划和最大程度降低受试者的风险。但是，在某些情况下，参与研究可能会给非主题的家庭成员或受试者社交网络的其他成员带来风险。在旨在测试一项干预措施以预防在文化上各异的城市母亲群体中进行预防的研究协议的背景下，我们针对未曾预料到的问题进行了两个案例研究，这些案例研究说明了非主题家庭成员如何影响或受到家庭成员的影响。个人参与研究。案例研究表明，针对IRB批准研究的联邦法规（特别侧重于受试者的风险）与报告在研究过程中发生的事件的法规之间存在不一致的情况，该法规还扩展到涉及“其他”风险。这些案例还说明了在某些文化中如何强调“他人”的风险，在这些文化中，相互依存的家庭结构可能会增加家庭成员在个人参与研究决策中的作用。提出了一个问题，即这种不一致是否会导致研究人员和IRB误认为参与研究可能给非受试者带来的风险。

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