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Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents
  1. Nchangwi Syntia Munung1,
  2. Patricia Marshall2,
  3. Megan Campbell3,
  4. Katherine Littler4,
  5. Francis Masiye1,
  6. Odile Ouwe-Missi-Oukem-Boyer5,6,
  7. Janet Seeley7,
  8. D J Stein8,
  9. Paulina Tindana9,
  10. Jantina de Vries1
  1. 1Department of Medicine, University of Cape Town, Cape Town, South Africa
  2. 2Center for Genetic Research Ethics and Law Department of Bioethics, School of Medicine, Case Western Reserve University, Cleaveland, Ohio, USA
  3. 3Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa
  4. 4Wellcome Trust, London, UK
  5. 5Centre de Recherche Médicale et Sanitaire (CERMES), Niamey, Niger
  6. 6Cameroon Bioethics Initiative (CAMBIN), Yaounde, Cameroon
  7. 7MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda
  8. 8MRC Unit on Anxiety & Stress Disorders Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa
  9. 9Navrongo Health Research Centre, Ghana Health Service, Navrongo, Ghana
  1. Correspondence to Dr Jantina de Vries, Division Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town 7925, South Africa; jantina.devries{at}uct.ac.za, jantina1304{at}gmail.com

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.

Conclusion 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.

  • Informed Consent

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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