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

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          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.

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          Most cited references25

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          Data sharing in genomics--re-shaping scientific practice.

          Funding bodies have recently introduced a requirement that data sharing must be a consideration of all funding applications in genomics. As with all new developments this condition has had an impact on scientific practice, particularly in the area of publishing and in the conduct of research. We discuss the challenges that must be addressed if the full benefits of data sharing, as envisaged by funders, are to be realized.
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            Sharing research data to improve public health.

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              Seeking consent to genetic and genomic research in a rural Ghanaian setting: A qualitative study of the MalariaGEN experience

              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 enrolment 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 enrolment 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.
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                Author and article information

                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
                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
                Article
                medethics-2015-102796
                10.1136/medethics-2015-102796
                4752624
                26644426
                f88d6bce-508a-4a00-a6bc-4c3dab84128c
                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/

                History
                : 20 March 2015
                : 7 September 2015
                : 15 September 2015
                Categories
                1506
                Research Ethics
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                Ethics
                informed consent
                Ethics
                informed consent

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