Background Latinxs are vastly underrepresented in mental health research; one of many contributing factors may be complexities in the research consent process, including language preferences. We examined determinants of comprehension of research consent procedures and tested the effects of a preconsent research schema condition among 180 adults with schizophrenia (60 Latinx-English and 60 Latinx-Spanish preference, and 60 non-Latinx White). Study Design Participants were randomly assigned (equal allocation) to an educational session regarding clinical research concepts and processes (schema condition) or to an attention control. Following a subsequent simulated consent procedure for a hypothetical drug trail, comprehension of consent disclosures was measured with 2 standard measures. Study Results One-way ANOVAs showed significant medium effect size differences between ethnicity/language groups on both measures of comprehension (η2s = 0.066–0.070). The Latinx-Spanish group showed lower comprehension than non-Latinx White participants; differences between the 2 Latinx groups did not reach statistical significance. Group differences were not statistically significant after adjusting for differences in education, or on scores from structured measures of acculturation, health literacy, or research literacy. Two-way ANOVAs showed no significant main effects for consent procedure on either comprehension measure (Ps > .369; partial η2s < 0.006) and no significant group-by-consent interactions (Ps > .554; partial η2s < 0.008). Conclusions Although the preconsent procedure was not effective, the results suggest health and research literacy may be targets for reducing disparities in consent comprehension. The onus is on researchers to improve communication of consent information as an important step to addressing health care disparities.

中文翻译：

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同意涉及西班牙语和英语拉丁裔精神分裂症成年人的研究

背景 拉丁裔在心理健康研究中的代表性严重不足；许多影响因素之一可能是研究同意过程的复杂性，包括语言偏好。我们检查了理解研究同意程序的决定因素，并测试了 180 名精神分裂症成年人（60 名拉丁裔英国人、60 名拉丁裔西班牙人、60 名非拉丁裔白人）中事先同意的研究图式条件的影响。研究设计 参与者被随机分配（平等分配）参加有关临床研究概念和过程（图式条件）的教育课程或注意力控制。在随后对假设的药物试验进行模拟同意程序后，通过两种标准措施来衡量对同意披露的理解。研究结果 单向方差分析显示，种族/语言组之间对两种理解能力的中等效应大小存在显着差异 (η2s = 0.066–0.070)。拉丁裔西班牙裔群体的理解力低于非拉丁裔白人参与者；两个拉丁裔群体之间的差异没有达到统计学显着性。在调整教育差异或文化适应、健康素养或研究素养的结构化测量分数后，组间差异不具有统计学意义。双向方差分析显示，同意程序对任一理解测量均没有显着的主效应（Ps > .369；部分 η2s < 0.006），并且没有显着的逐组同意交互作用（Ps > .554；部分 η2s < 0.008） ）。结论 尽管预先同意程序并不有效，但结果表明健康和研究素养可能是减少同意理解差异的目标。研究人员有责任改善同意信息的沟通，作为解决医疗保健差异的重要一步。