title: Knowing who to trust: exploring the role of 'ethical metadata' in mediating risk of harm in collaborative genomics research in Africa.
abstract: BACKGROUND
  The practice of making datasets publicly available for use by the wider scientific community has become firmly integrated in genomic science. One significant gap in literature around data sharing concerns how it impacts on scientists' ability to preserve values and ethical standards that form an essential component of scientific collaborations. We conducted a qualitative sociological study examining the potential for harm to ethnic groups, and implications of such ethical concerns for data sharing. We focused our empirical work on the MalariaGEN Consortium, one of the first international collaborative genomics research projects in Africa.
  
  
  METHODS
  We conducted a study in three MalariaGEN project sites in Kenya, the Gambia, and the United Kingdom. The study entailed analysis of project documents and 49 semi-structured interviews with fieldworkers, researchers and ethics committee members.
  
  
  RESULTS
  Concerns about how best to address the potential for harm to ethnic groups in MalariaGEN crystallised in discussions about the development of a data sharing policy. Particularly concerning for researchers was how best to manage the sharing of genomic data outside of the original collaboration. Within MalariaGEN, genomic data is accompanied by information about the locations of sample collection, the limitations of consent and ethics approval, and the values and relations that accompanied sample collection. For interviewees, this information and context were of important ethical value in safeguarding against harmful uses of data, but is not customarily shared with secondary data users. This challenged the ability of primary researchers to protect against harmful uses of 'their' data.
  
  
  CONCLUSIONS
  We identified three protective mechanisms--trust, the existence of a shared morality, and detailed contextual understanding--which together might play an important role in preventing the use of genomic data in ways that could harm the ethnic groups included in the study. We suggest that the current practice of sharing of datasets as isolated objects rather than as embedded within a particular scientific culture, without regard for the normative context within which samples were collected, may cause ethical tensions to emerge that could have been prevented or addressed had the 'ethical metadata' that accompanies genomic data also been shared.
authors.affiliation: Department of Medicine, University of Cape Town, Anzio Road Observatory, Cape Town 7925, South Africa. Jantina.devries@uct.ac.za.
authors.forename: Jantina
authors.initials: J
authors.lastname: de Vries
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Williams
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
authors.forename: Dominic P
authors.initials: DP
authors.lastname: Kwiatkowski
authors.forename: Raymond
authors.initials: R
authors.lastname: Fitzpatrick
authors.forename: Michael
authors.initials: M
authors.lastname: Parker
mesh_terms: D044383:Black People / Q000235:genetics*; D003299:Cooperative Behavior; D032984:Ethics, Research; D005006:Ethnicity; D005714:Gambia; D036281:Genetic Research / Q000941:ethics*; D023281:Genomics / Q000941:ethics*; D006801:Humans; D033181:Information Dissemination / Q000941:ethics*; D007258:Informed Consent; D007630:Kenya; D008288:Malaria / Q000235:genetics*; D028681:Moral Obligations; D036301:Qualitative Research; D012108:Research Personnel; D012306:Risk; D035502:Trust; D006113:United Kingdom