Latinos are the largest ethnic minority group in the U.S., yet remain vastly underrepresented in NIMH and FDA-associated mental health research. One of the most salient barriers to enrollment for some Latinos may be language barriers in the informed consent process. It is important to avoid stereotyping Latinos as being characterized by a monolithic background, preferences, or skills;key factors likely relevant to the informed consent process (such as language, acculturation, education, and health literacy) vary widely, yet also tend to be intertwined among Latino subgroups. Although valuable empirical data on decisional capacity and the informed consent process in neuropsychiatric populations has amassed over the past 15 years, there has been a dearth of such research focused on informed consent in the Latino Community. This project will serve to fill this vital empirical information gap.
Specific aims i nclude identifying the degree to which language, acculturation, education, health, and research literacy affect participants'initial comprehension and 1-month retention of information. In addition, grounded in a conceptual model highlighting the role of a research schema in the consent process, we will also test the effects of a pre-consent educational intervention (teaching participants about clinical research and the consent process prior to discussing a specific protocol) on initial comprehension and 1-month retention. Participants will include 180 people with schizophrenia or schizoaffective disorder [60 Latinos with Spanish language preference, 60 Latinos with English preference, and 60 (English speaking) non-Latino whites]. Participants will be randomized to a routine or educationally enhanced consent procedure for a hypothetical phase 3 clinical trial. Measures will include standard rating scales of acculturation, health literacy, and comprehension of information disclosed during consent procedures. In addition, qualitative interviews will be conducted with a subsample of 30 participants to ascertain their impressions of the consent procedures, as well as their preferences regarding informed consent and decision making about research participation. All procedures, interviews, and assessments will be conducted in each participant's preferred language (Spanish or English) by bilingual- bicultural research staff. By providing information to foster effective and linguistically and culturally appropriate consent procedures, the work proposed will facilitate pursuit of Objective 3 in the NIMH Strategic Plan, i.e., to "Develop New and Better Interventions for Mental Disorders that Incorporate the Diverse Needs and Circumstances of People with Mental Illness."

Public Health Relevance

Latinos are the largest ethnic minority group in the U.S., yet are vastly underrepresented in mental health research. The proposed study will provide data essential to ensuring that investigators are able to enroll a diverse range of Latinos with schizophrenia using linguistically, culturally appropriate, and effective procedures for obtaining informed consent for participation.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Research Project (R01)
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Special Emphasis Panel (ZRG1-HDM-T (90))
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Rudorfer, Matthew V
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University of California San Diego
Schools of Medicine
La Jolla
United States
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