title: Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali.
abstract: 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.
authors.affiliation: Malaria Research and Training Center, DEAP/FMPOS, UMI3189, Université des Sciences, des Techniques et des Technologies de Bamako, BP 1805, Bamako, Mali. karim@icermali.org.
authors.forename: Karim
authors.initials: K
authors.lastname: Traore
authors.affiliation: The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK. susan.bull@ethox.ox.ac.uk.
authors.forename: Susan
authors.initials: S
authors.lastname: Bull
authors.affiliation: Malaria Research and Training Center, DEAP/FMPOS, UMI3189, Université des Sciences, des Techniques et des Technologies de Bamako, BP 1805, Bamako, Mali. flanyalass@yahoo.fr.
authors.forename: Alassane
authors.initials: A
authors.lastname: Niare
authors.affiliation: Malaria Research and Training Center, DEAP/FMPOS, UMI3189, Université des Sciences, des Techniques et des Technologies de Bamako, BP 1805, Bamako, Mali. sakonate@icermali.org.
authors.forename: Salimata
authors.initials: S
authors.lastname: Konate
authors.affiliation: Malaria Research and Training Center, DEAP/FMPOS, UMI3189, Université des Sciences, des Techniques et des Technologies de Bamako, BP 1805, Bamako, Mali. mthera@icermali.org.
authors.forename: Mahamadou A
authors.initials: MA
authors.lastname: Thera
authors.affiliation: Wellcome Trust Centre for Human Genetics, Oxford, OX3 7BN, UK. dominic@well.ox.ac.uk.
authors.forename: Dominic
authors.initials: D
authors.lastname: Kwiatkowski
authors.affiliation: The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, OX3 7LF, UK. Michael.parker@ethox.ox.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Parker
authors.affiliation: Malaria Research and Training Center, DEAP/FMPOS, UMI3189, Université des Sciences, des Techniques et des Technologies de Bamako, BP 1805, Bamako, Mali. okd@icermali.org.
authors.forename: Ogobara K
authors.initials: OK
authors.lastname: Doumbo
mesh_terms: D000328:Adult; D035843:Biomedical Research / Q000941:ethics; D002675:Child, Preschool; D032882:Comprehension; D003906:Developing Countries; D032984:Ethics, Research; D005260:Female; D017144:Focus Groups; D016678:Genome; D055106:Genome-Wide Association Study; D023281:Genomics / Q000941:ethics; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007258:Informed Consent; D008288:Malaria / Q000235:genetics*; D008297:Male; D008302:Mali; D010290:Parents; D011203:Poverty; D036301:Qualitative Research; D012107:Research Design; D055990:Therapeutic Misconception