Contraception Requirements in Clinical Research Consent Forms: Assessing and Supporting Gender Inclusive Practices.

IF 1.7 4区 哲学 Q2 ETHICS Journal of Empirical Research on Human Research Ethics Pub Date : 2024-07-01 Epub Date: 2024-03-11 DOI:10.1177/15562646241238301
Tara Coffin, Erin Brower, Sharad Adekar
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Abstract

Gender-diverse individuals are underserved in clinical research settings. Reliance on gendered language throughout the consent process for clinical research contributes to the marginalization of these populations. The research objective was to assess use of gender-inclusive language used to describe the contraception requirement in consent forms. We categorized and analyzed contraception language in 289 clinical trial consent forms using a deductive and summative content analysis approach. We found that 79% (n = 227) of consent forms contained gender-inclusive language, 80% (n = 231) used terms that fell under the biological sex language, and 91% (n = 264) used gendered language. No consent forms used exclusively gender-inclusive language and the majority 63% (n = 182) featuring a combination of all three language types. There were many consent forms which would have been entirely gender-inclusive language if section headings with references to biological-sex-specific contraceptives were excluded, suggesting that gender-inclusive language may be attainable with minor revisions.

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临床研究同意书中的避孕要求:评估和支持性别包容实践。
在临床研究环境中,不同性别的人得不到充分的服务。在临床研究的整个同意过程中,依赖于性别语言会导致这些人群被边缘化。我们的研究目标是评估在同意书中描述避孕要求的性别包容性语言的使用情况。我们采用演绎和总结性内容分析法对 289 份临床试验同意书中的避孕用语进行了分类和分析。我们发现,79%(n = 227)的同意书包含性别包容性语言,80%(n = 231)的同意书使用了属于生物性别语言的术语,91%(n = 264)的同意书使用了性别化语言。没有一份同意书只使用了性别包容性语言,大多数同意书的 63%(n = 182)使用了这三种语言的组合。有许多同意书如果不包括提及特定生物性别避孕药具的章节标题,就完全可以使用性别全纳语言,这表明只要稍加修改,就可以使用性别全纳语言。
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来源期刊
CiteScore
3.50
自引率
7.70%
发文量
30
审稿时长
>12 weeks
期刊介绍: The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.
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