The ethical challenges in the consenting process when conducting genomic research in low literacy settings

Abstract

Background: Genomic researches have proven to be valuable tools in identifying genetic variants that have a role in disease causation. The value of conducting these type of researches cannot be underestimated in developing countries where there is high disease burden. However, there is a need to identify, analyze and address specific ethical challenges arising when conducting genomic researches in populations with lower literacy level in order to protect the research participants and interest of scientists in these particular settings. Objective: The study explored challenges associated with obtaining a valid informed consent when conducting genomic research in individuals with low literacy level. Methodology: The methodology was based on qualitative data involving focus-group discussions, in-depth interviews as well as observation of the consent process. Research team and research participants involved in the Sickle cell Disease study at Muhimbili National Hospital were the target group. The data obtained from the FGDs and IDIs were transcribed into meaningful codes depending on the nature of the responses and were analyzed using thematic analysis. Results and Discussion: Findings indicated that literacy level was not a key factor influencing participant understandings, adequacy of the information provided to the participants and the methods used to communicate the information were the contributing factors. Preferred mode of provision of the information was through video or group sessions in the presence of nurses or doctors to ensure comprehension of the information. Benefits of the research and return of results were considered by participants to be more important sections during the consenting process than others. Recommendations: The findings from this study will be used to develop a tool to guide the researchers in eliciting informed consent in the context of genomic research. Regular sessions to remind and update the researchers and research participants are also recommended for good clinical practices and protection of the research participants.