Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali

Abstract

BackgroundObtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data. This study investigated researchers’ and participants’ parents’ experiences of a consent process and understandings of a genome-wide association study of malaria involving children aged five and under in Mali. It aimed to inform best practices in recruiting participants into genomic research.MethodsA qualitative rapid ethical assessment was undertaken. Fifty-five semi-structured interviews were conducted with the parents of research participants. An additional nine semi-structured interviews were conducted with senior research scientists, research assistants and with a member of an ethics committee. A focus group with five parents of research participants and direct observations of four consent processes were also conducted. French and translated English transcripts were descriptively and thematically coded using OpenCode software.ResultsParticipants’ parents in the MalariaGEN study had differing understandings of the causes of malaria, the rationale for collecting blood samples, the purposes of the study and the kinds of information the study would generate. Genomic aspects of the research, including the gene/environment interaction underlying susceptibility or resistance to severe malaria, proved particularly challenging to explain and understand.ConclusionsThis study identifies a number of areas to be addressed in the design of consent processes for genomic research, some of which require careful ethical analysis. These include determining how much information should be provided about differing aspects of the research and how best to promote understandings of genomic research. We conclude that it is important to build capacity in the design and conduct of effective and appropriate consent processes for genomic research in low and middle-income settings. Additionally, consideration should be given to the role of review committees and community consultation activities in protecting the interests of participants in genomic research.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-015-0035-7) contains supplementary material, which is available to authorized users.

What constitutes good ethical practice in genomic research in Africa? Perspectives of participants in a genomic research study in Uganda

“…Findings from this study point to the need to de-emphasise the role of experts (doctors and other health workers) and institutions (health facilities), and to instead principally engage community members and spaces as a means of obtaining adequately informed consent for research participation. Indeed, our findings suggest that, on reflection, our interviewees felt that they had consented to participate without adequate information about the study, which echoes findings from several previous studies (Robinson, Slashinski, Wang, Hilsenbeck, & McGuire, 2013;Traore et al, 2015).…”

Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

“…Investigators examining consent to genomic research in African settings have identified a number of challenges in communicating study goals, methods and procedures. 12–14 40 This is compounded by difficulties in finding equivalent terminology to explain pertinent concepts in local languages. 12 In our examination of consent documents, we found that researchers sought to find layperson explanations of some of the difficult concepts in genomics.…”

Challenges arising when seeking broad consent for health research data sharing: a qualitative study of perspectives in Thailand

“…This may be particularly challenging in rural populations, where greater efforts and more time are likely to be needed to effectively explain data sharing. In practice, research participants may not feel that information about data sharing is a priority to engage with and understand, in comparison with the information they receive about potential benefits, harms and burdens of the biomedical study from which data will be shared [ 42 , 43 ]. In such circumstances, concerns arise that too much information about data sharing may ‘crowd out’ information about the biomedical study from which data are to be shared, and adversely impact participants’ understandings of the study [ 26 ].…”