Blog
About

  • Record: found
  • Abstract: found
  • Article: found
Is Open Access

Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

Read this article at

Bookmark
      There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

      Abstract

      BackgroundThe 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.MethodsA 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.ResultsInformed 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.ConclusionH3Africa 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.

      Related collections

      Most cited references 30

      • Record: found
      • Abstract: found
      • Article: not found

      Genome-wide association studies in diverse populations.

      Genome-wide association (GWA) studies have identified a large number of SNPs associated with disease phenotypes. As most GWA studies have been performed in populations of European descent, this Review examines the issues involved in extending the consideration of GWA studies to diverse worldwide populations. Although challenges exist with issues such as imputation, admixture and replication, investigation of a greater diversity of populations could make substantial contributions to the goal of mapping the genetic determinants of complex diseases for the human population as a whole.
        Bookmark
        • Record: found
        • Abstract: not found
        • Article: not found

        Research capacity. Enabling the genomic revolution in Africa.

          Bookmark
          • Record: found
          • Abstract: found
          • Article: found
          Is Open Access

          Dynamic consent: a patient interface for twenty-first century research networks

          Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a specific project and a wider concept that offers a new approach to consent; one designed to meet the needs of the twenty-first century research landscape. At the heart of DC is a personalised, digital communication interface that connects researchers and participants, placing participants at the heart of decision making. The interface facilitates two-way communication to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient participant recontact. DC has mainly been developed in biobanking contexts, but it also has potential application in other domains for a variety of purposes.
            Bookmark

            Author and article information

            Affiliations
            [1 ]Department of Medicine, University of Cape Town , Cape Town, South Africa
            [2 ]Center for Genetic Research Ethics and Law Department of Bioethics, School of Medicine, Case Western Reserve University , Cleaveland, Ohio, USA
            [3 ]Department of Psychiatry and Mental Health, University of Cape Town , Cape Town, South Africa
            [4 ]Wellcome Trust , London, UK
            [5 ]Centre de Recherche Médicale et Sanitaire (CERMES) , Niamey, Niger
            [6 ]Cameroon Bioethics Initiative (CAMBIN) , Yaounde, Cameroon
            [7 ]MRC/UVRI Uganda Research Unit on AIDS , Entebbe, Uganda
            [8 ]MRC Unit on Anxiety & Stress Disorders Department of Psychiatry and Mental Health, University of Cape Town , Cape Town, South Africa
            [9 ]Navrongo Health Research Centre, Ghana Health Service , Navrongo, Ghana
            Author notes
            [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@ 123456uct.ac.za , jantina1304@ 123456gmail.com
            Journal
            J Med Ethics
            J Med Ethics
            medethics
            jme
            Journal of Medical Ethics
            BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
            0306-6800
            1473-4257
            February 2016
            7 December 2015
            : 42
            : 2
            : 132-137
            26644426
            4752624
            medethics-2015-102796
            10.1136/medethics-2015-102796
            Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

            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/

            Product
            Categories
            1506
            Research Ethics
            Paper
            Custom metadata
            unlocked

            Ethics

            informed consent

            Comments

            Comment on this article