ArticleTherapeutic innovation & regulatory science2026
Improving Informed Consent for English and Spanish Speakers in Clinical Trials.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
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Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients often have suboptimal understanding of informed consent in clinical trials, impeding their ability to make informed decisions about participation. Additionally, translating complex informed consent information from English into other languages can introduce new areas of misunderstanding for patients. This qualitative study examined how English- and Spanish-speakers understood and perceived a complex clinical informed consent form.
methodsWe tested an informed consent form for a clinical trial on a gynecological medication with women who represented the study population. We conducted 18 semi-structured interviews with English- (n = 9) and Spanish-speaking (n = 9) participants to explore areas of misunderstanding, concerns, and preferences. With Spanish-speakers, we tested two professionally translated versions of the informed consent form-one generated by general translators and the second by translators with medical and scientific expertise. We used thematic analysis to explore patterns in the data.
resultsFive themes were common across both English- and Spanish-speakers: difficulty with medical jargon; unfamiliarity with the drug development and testing process; desire for understandable numeric information; aversion to uncertain or conflicting evidence; and affective reactions to information. Spanish-speakers generally preferred language from the medical translation over the general version, though this preference was not consistent.
conclusionsFindings underscore the importance of pretesting informed consent materials to ensure that they are understandable, avoid difficult language, and do not evoke negative emotions or reactions, particularly when communicating about risk and uncertainty. Findings also suggest using a combination of translation approaches, when resources allow, and reinforce the value of using plain language familiar to audiences.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.