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Limited English Proficiency, Informed Consent, and Clinical Trials
University of Phoenix School of Advance Studies
Roberto Torres, DHA and Joann Kovacich, PhD.
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.
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.
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.
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 selfreported as Caucasians, MDs, and listed English as their primary language. Four PIs reported poor proficiency in Spanish although they attempted to speak Spanish
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.
Table 1
Emerged Themes and Subthemes
Major Theme
Subtheme 1
Authority Figure
Presented no other alternatives for treatment by -PIs/Providers
Barriers of Communication
Interpreters emotional involvement
Origin of
Body language
Cultural Sensitivity
Religious and superstitious beliefs
Subtheme 2
Interpreter clinical education
Subtheme 3