Abstract
BackgroundAdvances in genetic and genomic research have introduced challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for an H3Africa genomic study on Rheumatic Heart Disease (RHDGen) at the University of Cape Town in South Africa. The main aim of the study was to understand ethical challenges in obtaining informed consent in the RHDGen study.MethodsWe used a qualitative study methodology involving in-depth interviews and participant observations. Our study participants were RHDGen cases (patients), healthy controls and research staff involved in the recruitment of RHDGen cases and controls. In total, we conducted 32 in-depth interviews with RHDGen cases and controls, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen cases and controls. The interviews were conducted in English, audio-recorded and transcribed verbatim. Data were analyzed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa.ResultsMost healthy controls joined the RHDGen study in order to be screened for rheumatic heart disease (diagnostic misconception). A majority of RHDGen cases decided to join the RHDGen study because of therapeutic misconception.ConclusionThe ethical challenges that impacted on obtaining informed consent in the RHDGen study were complex. In this study, the main challenges were diagnostic misconception among RHDGen controls and therapeutic misconception among RHDGen cases.
Highlights
Advances in genetic and genomic research have introduced challenges in obtaining informed consent for research in low and middle-income settings
Specific ethical challenges in informed consent that have been previously identified in African genomic research include the difficulty in explaining scientific methods and concepts such as “gene”, “genetics”, “genomics”, “Deoxyribo-nucleic acid (DNA)”, “genetic database” and “data release” in local languages during the consent process; the conduct of research in emergency situations which make standard consent processes impracticable especially where patients or their guardians are under stress; therapeutic misconception among research participants who are recruited in clinical settings and who have the widespread conception that research studies result in clinical benefit; the trust that research participants have in medical doctors who are researchers [15,16,17,18,19]; and the possible risk of stigma or exploitation of study communities
Diagnostic misconception as a motivation for study participation among Genomics of rheumatic heart disease (RHDGen) controls In this paper, we focus our analysis on the factors that motivated healthy people to participate in the genomics research project we were concerned with
Summary
Advances in genetic and genomic research have introduced challenges in obtaining informed consent for research in low and middle-income settings. Advances in genetic and genomic research have introduced new challenges in obtaining informed consent in research practice [12]. There are few studies that have explored challenges in obtaining informed consent for genetic and genomic research in Africa [12,13,14,15,16,17,18,19]. There is a regulatory gap and limited legal and ethical guidance available in Africa to support a transition from specific consent to broad consent models [23] These ethical challenges are frequently compounded by low literacy, poverty, socio-cultural barriers and ineffective regulatory mechanisms in low and middle income countries
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
