1. Ample literature acknowledges language barriers in standard care of practice. However, there is an acute shortage of research on communication barriers during the informed consent process in clinical trials. To contribute to the growing need to address Limited English Proficiency (LEP) in health care, a qualitative case study was used to explore communication methods and the understanding of LEP guardians of pediatric patients while participating in the informed consent process during clinical trials. Five principal investigators with diverse medical backgrounds, nine LEP Spanish speaking guardians, and five interpreters from the Language Assistance Program at a North Texas Research Institution (NTRI) participated in the study. Four major themes impacting decision making emerged: (a) the influence of physician and principal investigator as authority figure, (b) communication challenges including emotional involvement and verbal and non-verbal language, (c) cultural awareness and sensitivity including religious or spiritual beliefs and country of origin, and (d) level of education. A significant finding of the study was the importance of the inclusion of LEP participants’ country of origin and recognition of various dialects to mitigate communication barriers; the ability to speak Spanish was not enough. In addition, LEP guardians’ pervious knowledge and/or experiences with clinical trials in their country of origin influenced their understanding of participation. The findings of this study support the literature on communication and language barriers in the healthcare system. Scientific research is important to the continuous innovation of treatments and understanding of illnesses. Significant numbers of patients participate in clinical trials every year. The communications process during clinical trials manifests how well participants understand the aims and protocol procedures of a study during the informed consent process. Possible miscommunication during the informed consent process may result in adverse events including of hospitalization, early withdrawal from study treatments, incomplete data, financial losses for sponsors, and ethical concerns of research participation (Woods, Ashcroft, Jackson, Tobin, Kivits, Burton, and Samani, 2007). Communication challenges can be intensified when patients present with Limited English Proficiency (LEP) defined “as a limited ability or inability to speak, read, write, or understand the English language” (Jacobs, Chen, Karliner, Agger-Gupta, & Mutha 2003, p. 60; cf., DHHS, 2013). The recruitment of diverse ethnic groups and cultures in clinical trials is imperative for the development of new alternatives of treatment (Kao, Hsu, & Clark, 2004). Maintaining mutually beneficial, clear, and efficient communication during the informed consent process facilitates research study outcomes (Helgesson, Ludvigsson, & Gustafsson, 2005) and promotes the clinical trials industry. The purpose of the present qualitative case study was to explore if communication barriers affect the understanding of LEP research participants while participating in the informed consent process during clinical trials. Results of the current study may inform leaders of the medical research industry to promote clear communication environments increasing research participation, clear data, and scientific improvements. Limited English Proficiency, Informed Consent, and Clinical Trials University of Phoenix School of Advance Studies Roberto Torres, DHA and Joann Kovacich, PhD. Introduction Methods Abstract Results Conclusion A qualitative exploratory case study was used to explore communication methods and the understanding of LEP guardians of pediatric patients while participating in the informed consent process during clinical trials. A convenience sample of five principal investigators with diverse medical backgrounds, nine LEP Spanish speaking guardians, and five interpreters from the Language Assistance Program at a North Texas Research Institution (NTRI) participated in the study. A pilot test was conducted to determine clarity and appropriateness of interview questions for each group of participants. Data collection was conducted by face-to-face interviews, phone interviews, observation, and a retrospective review of electronic medical records of LEP participants to validate eligibility criteria. Interviews lasted between 30 to 45 minutes. Each session opened with a brief explanation of the purpose of the study and interview procedures. The interviews with PIs were conducted in English because the primary language of the PI sample was English. Interviews with the interpreters were conducted in English. LEP interviews were conducted in Spanish. PI and interpreter interviews took place on site at the research facility. The interviews of the LEP participants took place over the phone in a private office using an audio recording device. The reasons for not coming to the facility for a face-to –face interview varied: work, had to pick up siblings from school, and could not schedule Medicaid transportation for non-medical arrangements, no appointments in the near future, and lack of transportation. Data was reviewed, organized and coded, using the qualitative software package NVivio9 to discover and explore emerging themes. Reviews of the transcribed data occurred several times to capture details, ideas, and similarities among the groups before breaking the data into different parts; this occurred by writing memos, notes, and delineating important information. NVivo 9 assisted in the review of procedures by groups and subthemes. Acknowle Participants Principal Investigators Principal investigators in the current study were medical doctors who (a) worked at the study site, (b) worked as principal investigators in clinical trials, or (c) worked as sub investigators with clinical trial experience. All participating PIs worked at the research site for over five years and have overseen two or more clinical trials. All PIs self- reported as Caucasians, MDs, and listed English as their primary language. Four PIs reported poor proficiency in Spanish although they attempted to speak Spanish occasionally. Interpreters Four interpreters self-reported as Hispanic or Latino, and one as Caucasian. Four of the interpreters self-reported Spanish as their primary language and English as their second language. One interpreter reported a first language of English and second language of Spanish. Four out of the five interpreters were born in Mexico and one in the United States. One interpreter reported to speak Italian and “a little” Portuguese. LEP Participants Twenty LEP Participants were contacted to take part in the research; nine were interviewed. The other 11 LEP participants declined participation because of lack of time or not remembering their participation in a clinical trial. The LEP participants self-reported as Spanish speakers only; not able to read or speak English. All LEP Participants reported Mexico as their country of origin. Two of the LEP participants reported to have a “Secundaria” (secondary) level of education comprising of grades seventh through ninth in the Mexican educational system. Four participants reported a level of “Primaria” (primary) comprising of grades first through sixth in the Mexican educational system. Two participants reported a level of “preparatoria” (high school) or “bachillerato” (Bachelor’s Degree), consisting of grades tenth through twelfth. LEP participants were all mothers of patients with clinical trial experience; two fathers approached by first contact referred the call to the patient’s mother. None of the participants reported any other languages than Spanish. Emerged Themes and Subthemes Major Theme Subtheme 1Subtheme 2Subtheme 3 Authority Figure Presented no other alternatives for treatment by PIs/Providers -- Barriers of CommunicationInterpreters emotional involvement Origin of Language Body language Cultural SensitivityReligious and superstitious beliefs-- EducationInterpreter clinical education-- Table 1 Communication barriers during the informed consent process are an example of a continuing issue studied in response to a neglected ethical standard in the health care system. The results demonstrated that LEP research participants had signed and participated in clinical trials not knowing or understanding the parameters involved. The results showed that a communication gap between leadership, PIs, and interpreters exist. To ensure the informed consent process during clinical trials is performed clearly and with the ethical principles of good clinical practice when the patient has LEP, PIs and interpreters need to overcome communication barriers as well as cultural barriers. The findings supported the need for more cultural education for PIs and interpreters. Other findings indicated the need for investigators to mentor interpreters as well as apply resources to comply with a high LEP population and the translation of documents in the patient’s first language. Clinical trial education for patients, who visit educational facilities, providing them with interpreters who have a research background, is also needed. Clearly communication in the field of health care is complex. The PIs and interpreters of this current study shared a sense of responsibility among the patients, evoking a personal accountability to the quality of care provided to LEP patients. The identified emergent themes as a result of this study are entwined, indicating the need for a more holistic view of communication barriers in the informed consent process necessary for clinical trials.