title: Seeking consent to genetic and genomic research in a rural Ghanaian setting: a qualitative study of the MalariaGEN experience.
abstract: BACKGROUND
  Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrollment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study.
  
  
  METHODS
  The study used a rapid assessment incorporating multiple qualitative methods including in depth interviews, focus group discussions and observations of consent processes. Differences between verbal information provided during community engagement processes, and consent processes during the enrollment of cases and controls were identified, as well as the factors influencing the tailoring of such information.
  
  
  RESULTS
  MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria. Some genetic aspects of the study were also well understood. Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research.Moreover, trust in and previous experience with the Navrongo Health Research Centre which was conducting the research influenced beliefs about the benefits of participating in the MalariaGEN study and subsequent decision-making about research participation.
  
  
  CONCLUSIONS
  It is important to recognise that some aspects of complex genomic research may be of less interest to and less well understood by research participants and that such gaps in understanding may not be entirely addressed by best practice in the design and conduct of consent processes. In such circumstances consideration needs to be given to additional protections for participants that may need to be implemented in such research, and how best to provide such protections.Capacity building for research ethics committees with limited familiarity with genetic and genomic research, and appropriate engagement with communities to elicit opinions of the ethical issues arising and acceptability of downstream uses of genome wide association data are likely to be important.
authors: The Ethox Centre, Department of Public Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, United Kingdom.
authors: Paulina
authors: P
authors: Tindana
authors: Susan
authors: S
authors: Bull
authors: Lucas
authors: L
authors: Amenga-Etego
authors: Jantina
authors: J
authors: de Vries
authors: Raymond
authors: R
authors: Aborigo
authors: Kwadwo
authors: K
authors: Koram
authors: Dominic
authors: D
authors: Kwiatkowski
authors: Michael
authors: M
authors: Parker
mesh_terms: D016022:Case-Control Studies; D015986:Confounding Factors, Epidemiologic; D017144:Focus Groups; D036281:Genetic Research / Q000941:ethics*; D055106:Genome-Wide Association Study; D005869:Ghana; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008288:Malaria / Q000235:genetics* / Q000276:immunology; D056186:Metagenomics; D033262:Narration; D036301:Qualitative Research; D012424:Rural Population