Dataset Information

Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks.

ABSTRACT: A growing proportion of prospective research participants in the United States speak limited or no English. We conducted cognitive interviews with native Spanish speakers to test Spanish-language translations of simplified and traditional biobank consent forms. Comprehension was generally high and did not differ by form. Most of those who received the simplified form felt it contained the right amount of information, compared with fewer than half of those who received the traditional form. Qualitative results allowed us to identify overarching issues related to tone, formality, and voice that may affect prospective participants' trust and willingness to participate. Certain characteristics of written Spanish are seemingly at odds with recommended actions to simplify consent forms; thus, even when significant empirical effort has been expended to develop simplified consent materials in English, additional work is needed to ensure the accuracy, comprehensibility, and cultural-congruence of Spanish-language translations.

SUBMITTER: Brelsford KM

PROVIDER: S-EPMC6856797 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks.

Brelsford Kathleen M KM Ruiz Ernesto E Hammack Catherine M CM Beskow Laura M LM

Ethics & human research 20190901 5

A growing proportion of prospective research participants in the United States speak limited or no English. We conducted cognitive interviews with native Spanish speakers to test Spanish-language translations of simplified and traditional biobank consent forms. Comprehension was generally high and did not differ by form. Most of those who received the simplified form felt it contained the right amount of information, compared with fewer than half of those who received the traditional form. Quali ...[more]

PMID: 31541540

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Project description:BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged "appropriate"; 19 were judged "uncertain"; and none was judged "inappropriate". After the second round, 9 "uncertains" changed to "appropriate". All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = "extremely inappropriate", 5 = "uncertain", 9 = "extremely appropriate"). The sections "General recommendations" and "Gender perspective during the consent process for clinical studies" showed the highest "uncertainty" rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators' communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant's possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged "appropriate" by all stakeholders involved in the informed consent process.

Dataset Information

Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks.

Publications

Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks.

Similar Datasets

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