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

BMC Medical Ethics

Ogobara K. Doumbo²  Michael Parker¹  Dominic Kwiatkowski³  Mahamadou A. Thera²  Salimata Konate²  Alassane Niare²  Susan Bull¹  Karim Traore² 

[1] The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK;Malaria Research and Training Center, DEAP/FMPOS, UMI3189, Université des Sciences, des Techniques et des Technologies de Bamako, Bamako, BP 1805, Mali;Wellcome Trust Centre for Human Genetics, Oxford OX3 7BN, UK

关键词: Qualitative research;    Malaria;    Mali;    Genomic research;    Children;    Bioethics;    Research ethics;    Consent;   

Others  :  1218616
DOI  :  10.1186/s12910-015-0035-7

 received in 2014-10-22, accepted in 2015-05-29,  发布年份 2015

【 摘 要 】

Background

Obtaining 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.

Methods

A 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.

Results

Participants’ 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.

Conclusions

This 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.

【 授权许可】

   
2015 Traore et al.

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