Enrollers’ perceptions of communication during informed consent at a South African tuberculosis research site
Date
2018
Authors
Nolle, Samantha
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Abstract
The informed consent process (ICP) in clinical trials is an interaction of communication: one in which important information should be adequately conveyed by the enroller and sufficiently understood by the potential participant. However, barriers to effective communication are often encountered during the process and result in participants’ comprehension of information being compromised. This study aimed to use qualitative methods to explore the reported experiences of thirteen enrollers involved in the ICP pre- and post- the implementation of a communication training programme in a Human Immunodeficiency Virus (HIV) and tuberculosis (TB) research study in Rustenburg, South Africa. The communication training programme aimed to improve communication processes during the ICP and enhance participant comprehension of information. This study used journaling and FGDs as data collection methods. Inductive thematic analysis was used to explore the reported experiences of enrollers during the ICP, and to identify perceived barriers and facilitators to communication during these interactions. Findings revealed language-, procedure- and participant-related facilitators and barriers. Furthermore, communication and language strategies employed by enrollers to overcome reported barriers were discussed. Several strategies paralleled the communication and language skills taught during the communication skills training. Many of these strategies were found to facilitate communication processes within the enroller-participant interaction, improve understandings of the informed consent form (ICF) and obtain proper informed consent. These findings confirm that enrolment is a complex process impacted by many variables.
Keywords: informed consent, communication, enrollers, clinical research
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Nolle, Samantha (2018) Enrollers’ perceptions of communication during informed consent at a South African tuberculosis research site, University of the Witwatersrand, Johannesburg, <http://hdl.handle.net/10539/26324>