Encounters Online Magazine
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By ROBERTO TORRES, DHA (c), MANAGER OF OPERATIONS, PROJECT MANAGEMENT, DAC PATIENT RECRUITMENT
A
qualitative research, conducted at a North Texas Research facility,
studied how clinical trials’ participants administered and managed
informed consent procedures when language represented a
communication barrier to the clinical trial processes.
The barriers of communication between providers and research participants
are affecting the informed consent process during clinical trials. The
problem of barriers in communication has been identified and has resulted
in alternatives to improve the quality of the medical processes. Scientific
research is important to the improvement of treatments and understanding
of illnesses. The communications process during the informed consent
manifests how well participants understand the clinical trials procedures.
Communication barriers may be a possible cause of not understanding
procedures, benefits, and possible risks. Miscommunication during the
informed consent process may result in adverse events, delay treatments or
initiate treatment errors. Misunderstanding of informed consent processes
may increase, hospitalization, early withdraw from treatments, incomplete
data, financial losses for sponsors, and ethical concerns.
Informed consent provides the patient explanations about the interventions,
consequences, nature of the study, and available alternative treatments.
The presentation and signing of the informed consent prior to the start of a
research study is paramount to the patient-doctor relationship.
Data analysis involved reviewing the emerging themes from Principal
Investigators (PI), Interpreters, and LEPs responses. The forms of data
collection included interviews, questionnaires, document analysis, and
behavioral observations.
The conclusion included multiple descriptions and emerging themes:
Principal Investigators as authority figures, cultural sensitivity, and
educational level.
Other factors included deficiency of resources, such as trained interpreters
in specific therapeutic areas, documents written in primary language of
the LEP, and accessibility to care. The studied groups described how the
process could alter experiences, if the right resources were allocated
during the informed consent process. Removing communication barriers
is imperative for LEP participants to exercise the autonomy of self-
determination and ethics regarding research participation.
With the continued growth of immigrants, LEP Americans, and emerging
clinical trials, there is need for research to explore how communication
barriers affect clinical trial outcomes. Further research is necessary using
a larger sample size and diverse organizations to develop parallels to
perceived communication barriers in the development of clinical trials.
Communication Methods with Limited
English Proficiency Research Participants
