Informed Consent Process When Conducting Genomic Research in Populations Characterized to Have Low Literacy Levels
Loading...
Date
2017
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Journal of Empirical Research on Human Research Ethics
Abstract
Background
Conducting genomic research in low- and middle-income countries cannot be underestimated because of the high disease burden found in these countries and because genomic approaches can be a powerful tool in improving population health. However, conducting genomic research in populations with low literacy presents specific challenges in obtaining quality informed consent.
Method
This study was designed to explore the challenges associated with obtaining a valid informed consent when conducting genomic research with populations characterized as having low literacy levels. Qualitative methodologies were used to collect information including focus group discussions, in-depth interviews, and participant observations. This study was embedded in a genomic study on sickle cell disease conducted at a hospital. Participants were recruited using purposeful sampling. In total, there were 47 participants. Five focus group discussions were conducted with at least six participants in each, and 17 in-depth interviews were conducted. All the interviews were recorded using digital recorders and also captured in the field notes. All
data were analyzed using thematic content analysis.
Findings
The findings indicated that literacy level was not a key factor influencing participants’ understanding. However, adequacy of the information provided to the participants and the methods used to communicate the information were important contributing factors to help participants’ understanding. The preferred mode of the provision of information was through group sessions in the presence of nurses or doctors. The benefits of the research and returning results were considered by the participants to be important sections of the consenting process.
Discussion
As a qualitative approach was utilized, the results cannot be generalized to the population. This study was also a hospital based study and that, in some ways, might have an influence on the results. The relevance of the findings to other types of studies (non-genomics) requires further investigation. Gaining informed consent in populations with low literacy levels requires novel approaches to ensure that the information is fully comprehended. Our research indicates that individuals with low literacy levels require special consideration
in the method for delivering materials and information. Group sessions with trusted medical personnel present are desirable for the target population. Using group sessions requires careful consideration to protect the identity of potential participants. The findings from this study will be used to develop a tool and strategies to guide researchers in the context of genomic research.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Description
Keywords
Genome wide association studies (GWAS), Sickle cell disease, Human Hereditary and Health in Africa (H3Africa)
Citation
Daima Bukini, Julie Makani, Columba Mbekenga, Lisa A. Purvis, and Sheryl McCurdy (2017). Informed Consent Process When Conducting Genomic Research in Populations Characterized to Have Low Literacy Levels. Journal of Empirical Research on Human Research Ethics