How to achieve informed consent for research from Spanish-speaking individuals with low literacy: a qualitative report.

Posted: Oct 27, 2010
J Health Commun. 15 Suppl 2. 172-82.
KEYWORDS: Knowledge/Attitudes/Beliefs, Language or Cultural Barriers, Low Literacy, Non-English Speaking, Level of Clinical Trials Knowledge or Awareness, Consent, Minority Groups, Hispanic or Latino, Verbal Communications, Print Media


Improvements to both informed consent documents and processes are needed for Spanish speakers with low-literacy.

Why this item may be useful

People who do not understand the informed consent document are less likely to agree to participate in a research study. Lowering the reading level of the document and/or improving the accuracy of its translation into Spanish are insufficient to ensure comprehension of the document; research staff should take additional measures to address this problem.


  • Even when they can read the consent document well, people who are unfamiliar with research and/or consent documents have difficulty understanding research purposes, risks, and privacy protection.
  • Lowering the reading level of the document by using plain language, increasing margins, and shortening sentences and the entire document is helpful but not sufficient to ensure comprehension of the document.
  • People need space and time to read the document carefully, it helps to be able take the document home to discuss with family and have research staff available to go over the document with them.
  • This study shows that additional effort must be invested in obtaining consent from non-English speakers, as translating documents from one language to another is not enough to ensure comprehension.
  • When targeting either low-literacy people or foreign language speakers, it is helpful to conduct a pilot test to assess the comprehension of the document.
  • It may be helpful to add an introductory statement to informed consent documents about the importance of knowing what is involved in a research study before agreeing to participate.