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如何使英语水平有限的受试者在临床试验中的代表性更加公平?

How Should Representation of Subjects With LEP Become More Equitable in Clinical Trials?

机构信息

Fourth-year medical student at the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

Fourth-year medical student the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

出版信息

AMA J Ethics. 2022 Apr 1;24(4):E319-325. doi: 10.1001/amajethics.2022.319.

Abstract

Underrepresentation of individuals with limited English proficiency (LEP) who speak Spanish is ongoing in phase 3 biomedical clinical trials and exacerbates health inequity. This article suggests strategies for increasing representation of Spanish speakers in clinical rials by emphasizing the importance of early engagement with Spanish language communities, inclusive participant recruitment, and collaborative trial design and implementation. Although investigators and institutions administering government-funded research must meet federal requirements for language assistance, journal editors, peer reviewers, institutional review board members, academic health centers, and all beneficiaries of the biomedical and behavioral research enterprise in the United States must motivate linguistic inclusion.

摘要

在 3 期生物医学临床试验中,讲西班牙语的英语水平有限(LEP)个体的代表性不足仍在持续,这加剧了健康不平等。本文提出了通过强调早期与西班牙语社区的接触、包容性的参与者招募以及协作的试验设计和实施来增加临床试验中西班牙语参与者代表性的策略。尽管进行政府资助研究的研究人员和机构必须符合语言援助的联邦要求,但期刊编辑、同行评审员、机构审查委员会成员、学术医疗中心以及美国生物医学和行为研究企业的所有受益者都必须激励语言包容性。

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