title: Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.
abstract: BACKGROUND
  The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium.
  
  
  METHODS
  A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results.
  
  
  RESULTS
  Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results.
  
  
  CONCLUSIONS
  H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa.
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Nchangwi Syntia
authors.initials: NS
authors.lastname: Munung
authors.affiliation: Center for Genetic Research Ethics and Law Department of Bioethics, School of Medicine, Case Western Reserve University, Cleaveland, Ohio, USA.
authors.forename: Patricia
authors.initials: P
authors.lastname: Marshall
authors.affiliation: Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
authors.forename: Megan
authors.initials: M
authors.lastname: Campbell
authors.affiliation: Wellcome Trust, London, UK.
authors.forename: Katherine
authors.initials: K
authors.lastname: Littler
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Francis
authors.initials: F
authors.lastname: Masiye
authors.affiliation: Centre de Recherche Médicale et Sanitaire (CERMES), Niamey, Niger Cameroon Bioethics Initiative (CAMBIN), Yaounde, Cameroon.
authors.forename: Odile
authors.initials: O
authors.lastname: Ouwe-Missi-Oukem-Boyer
authors.affiliation: MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda.
authors.forename: Janet
authors.initials: J
authors.lastname: Seeley
authors.affiliation: MRC Unit on Anxiety & Stress Disorders Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
authors.forename: D J
authors.initials: DJ
authors.lastname: Stein
authors.affiliation: Navrongo Health Research Centre, Ghana Health Service, Navrongo, Ghana.
authors.forename: Paulina
authors.initials: P
authors.lastname: Tindana
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Jantina
authors.initials: J
authors.lastname: de Vries
mesh_terms: D000349:Africa; D018070:Biological Specimen Banks / Q000941:ethics*; D044383:Black People / Q000235:genetics*; D055812:Community-Based Participatory Research / Q000941:ethics*; D032962:Consent Forms / Q000941:ethics; D036281:Genetic Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D033181:Information Dissemination / Q000941:ethics* / Q000331:legislation & jurisprudence; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence
keywords: Informed Consent