Patient-Related Issues

Guest Expert Silvia Inez' Salazar, MPA: Developing Spanish Language Consent Documents

Last Updated: May 27, 2014

Please join me in welcoming this month's guest expert, Silvia Inez' Salazar, MPA, of the National Cancer Institute's Office of Communications and Education. Silvia is the Informatics Research Laboratory Manager and throughout her NIH career, she has conducted social science research to identify the cancer education needs of people affected by cancer and those who serve them. 

From Silvia:

According to the Census Bureau, the Spanish speaking population in the US has continuously increased, and the number is projected to reach 43 million by 2020. [1]  Given the rapid growth of this ethnic group, the research community has an opportunity to better understand the public health needs of Hispanics/Latinos. Two questions that arise from this changing demographic are:  how does one identify methods to increase clinical trials participation, and how does one address challenges and attitudes resulting from cases of previous unethical research? [2],[3] In the past, the translation of clinical trial informed consent documents (ICDs) has been the responsibility of clinical trial sites, often resulting in inconsistencies in the quality of the translation and in the lack of use of standard terminology. Each time I was asked to review ICDs that had been translated into Spanish, I noticed these inconsistencies. Even the use of the term clinical trial varied because in Spanish there is more than one translation, e.g., “estudio clínico” and “ensayo clínico.” Which was the correct or most appropriate term? Instead of repeating the same review process each time, would it be possible to create a new resource that could benefit all clinical sites?  Since the NCI Division of Cancer Prevention had developed an existing ICD template in English for prevention trials, perhaps translating this template into Spanish could provide a solution.

Before translating the consent document into Spanish the following was considered:

  • Determine the translation method to be used.
  • Identify the cultural and linguistic practices of bi and monolingual Spanish-speaking populations that should be included in the ICD.
  • Recognize Limited English Proficiency (LEP) needs.
  • Validate the translation by conducting research with end users and healthcare professionals.
  • Ascertain whether Spanish-speaking populations were affected by unethical research practices and how such issues should be addressed in the ICD.

Since I had previously conducted a needs assessment about the cancer communication needs of Spanish-speakers living in the US, a basis for the cultural and linguistic requirements of the population and LEP needs had been established.[4] Best practices and lessons learned were collected by conducting in-depth interviews with healthcare professionals fluent in Spanish (n=9) that had extensive experience conducting consents without the use of an interpreter.  Furthermore, pilot testing with Spanish speakers that were eligible to participate in prevention trials (n=30) was conducted.  All research participants represented different levels of education, acculturation, income, and language proficiency.  Participants from Puerto Rico2 and Guatemala3 were intentionally included because of the history of unethical research trials that took place in those communities. 

The best practices learned include allowing more time for the informed consent process with Spanish-speakers, recognizing that consenting does not involve only the potential study participant, but their family as well, and the fact that specific cultural values4 should be incorporated into consent documents including:

  • Personalismo (building personal rapport)
  • Familismo      (including family)
  • Confianza       (establishing trust)
  • Fatalismo       (overcoming attitudes of fatalism)

Pilot testing allowed the project team to:

·         Refine specific areas of the ICD such as randomization, placebo, and risk.

·         Explore ways to reflect the needs of bi and monolingual Spanish speakers.

·         Identify the use of technology in the consenting process (i.e., reading the consent on a mobile device or as a printed version).

·         Learn that using translation programs and software are not an effective approach in that there is no opportunity to incorporate linguistic practices and cultural values into the ICD.

These research findings were then incorporated into the Spanish language consent template and provided background information about how the template was developed and translated. The template includes a bilingual glossary that defines basic clinical trial terms in Spanish and English, as well as providing examples of tests, procedures, and side effects in both languages so that LEP study participants can better understand and communicate with the research staff.  Vertical and horizontal illustrations of randomization were compared and participants preferred the vertical design. Furthermore, examples that consenters can use to build cultural and linguistic rapport have been included. As a result of conducting this research, it became apparent that what was learned can benefit many types of clinical trials across different diseases and cancer types and that has generated interest in pursuing opportunities to disseminate these findings across the spectrum of cancer care providers.

[1] Ortman, J.M., & Shin, H.B. (2011, August). Language Projections: 2010 to 2020. Population Projections Branch, Population Division, U.S. Census Bureau, Washington, DC.

[2] Seaman, B. (2003).  The greatest experiment ever performed on women. Exploding the estrogen myth ( 2nd ed.). New York, NY: Hyperion Books.

[3] Cuerda-Galindo, E., Sierra-Valenti, X., González-López, E., & López-Muñoz, F.  (2014, January). Syphilis and Human Experimentation From World War II to the Present: A Historical Perspective and Reflections on Ethics. Actas Dermo-Sifiliográficas. Advance online publication. doi: 10.1016/  [Article in English & Spanish]

[4] Buki, P., Salazar, S.I., & Pitton, V. (2009, October).  Design Elements for the Development of Cancer Education Print Materials for a Latina/o Audience.  Health Promotion Practice, 10(4), 564-572.


Please Login or Register to post comments.