Formative Research Findings from the National Cancer Institute on the Development of a Clinical Trial Informed Consent Template for Spanish Speakers

Latinos are disproportionately under-represented in clinical trials. Although they represent 14% of the United States population, only 3% participate in cancer clinical trials. In order for Latinos to benefit from advances in the prevention, detection and treatment of diseases such as cancer and to reduce health disparities, increasing participation in clinical trials is crucial. Few studies have examined the role informed consent plays in the clinical trial enrollment process for this population and how to increase comprehension of consent documents. For the past year, the National Cancer Institute has conducted formative research to develop a culturally and linguistically appropriate informed consent template for Spanish-speaking Latino populations who quality for cancer prevention trials. Research methods include a literature review; semi-structured in-depth interviews (N=9) with health care professionals with experience in providing informed consent to Spanish speakers; and pilot testing with Latinos who qualify for cancer chemoprevention trials. Findings include plain language recommendations to increase comprehension, how to incorporate linguistic practices and health beliefs, and presenting basic clinical trial concepts such as randomization, placebo, and risk that are consistent with Latino cultural values.