1932

Abstract

Genomic research and biobanking are increasingly being conducted in the context of collaborations between researchers in high-income countries and those in low- and middle-income countries. Although these scientific advancements have presented unique opportunities for researchers to contribute to cutting-edge scientific projects and address important health problems, they have also challenged existing ethical and regulatory frameworks, particularly in sub-Saharan Africa. Broad consent is a model that allows the use of human biological samples and associated data in future research that may be unrelated to the original study. Drawing on emerging perspectives in low- and middle-income countries, we argue that broad consent is equivalent to consent to governance and that a robust governance framework for genomics and biobanking should seek to promote global health and research equity and take into account five key elements: respect, authentic community engagement and trust building, the preservation of privacy and confidentiality, feedback of results, and capacity strengthening.

Loading

Article metrics loading...

/content/journals/10.1146/annurev-genom-083115-022456
2016-08-31
2024-10-07
Loading full text...

Full text loading...

/deliver/fulltext/genom/17/1/annurev-genom-083115-022456.html?itemId=/content/journals/10.1146/annurev-genom-083115-022456&mimeType=html&fmt=ahah

Literature Cited

  1. Abou-Zeid A, Silverman H, Shehata M, Shams M, Elshabrawy M. 1.  et al. 2010. Collection, storage and use of blood samples for future research: views of Egyptian patients expressed in a cross-sectional survey. J. Med. Ethics 36:539–47 [Google Scholar]
  2. Andanda PA. 2.  2008. Human-tissue-related inventions: ownership and intellectual property rights in international collaborative research in developing countries. J. Med. Ethics 34:171–79 [Google Scholar]
  3. Anderson N, Edwards K. 3.  2010. Building a chain of trust: using policy and practice to enhance trustworthy clinical data discovery and sharing. Proceedings of the 2010 Workshop on Governance of Technology, Information and Policies15–20 New York: ACM [Google Scholar]
  4. Appiah-Poku J, Newton SAM, Kass N. 4.  2011. Participants’ perceptions of research benefits in an African genetic epidemiology study. Dev. World Bioeth. 11:128–35 [Google Scholar]
  5. Árnason V. 5.  2004. Coding and consent: moral challenges of the database project in Iceland. Bioethics 18:27–49 [Google Scholar]
  6. Barchi F, Matlhagela K, Jones N, Kebaabetswe PM, Merz JF. 6.  2015. “The keeping is the problem”: a qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research. BMC Med. Ethics 16:54 [Google Scholar]
  7. Bull S, Cheah PY, Denny S, Jao I, Marsh V. 7.  et al. 2015. Best practices for ethical sharing of individual-level health research data from low- and middle-income settings. J. Empir. Res. Hum. Res. Ethics 10:302–13 [Google Scholar]
  8. Bull S, Roberts N, Parker M. 8.  2015. Views of ethical best practices in sharing individual-level data from medical and public health research: a systematic scoping review. J. Empir. Res. Hum. Res. Ethics 10:225–38 [Google Scholar]
  9. Caulfield T, Upshur RE, Daar A. 9.  2003. DNA databanks and consent: a suggested policy option involving an authorization model. BMC Med. Ethics 4:E1 [Google Scholar]
  10. Charo RA. 10.  2006. Body of research—ownership and use of human tissue. N. Engl. J. Med. 355:1517–19 [Google Scholar]
  11. Cheah PY, Tangseefa D, Somsaman A, Chunsuttiwat T, Nosten F. 11.  et al. 2015. Perceived benefits, harms, and views about how to share data responsibly: a qualitative study of experiences with and attitudes toward data sharing among research staff and community representatives in Thailand. J. Empir. Res. Hum. Res. Ethics 10:278–89 [Google Scholar]
  12. Christenhusz GM, Devriendt K, Dierickx K. 12.  2013. To tell or not to tell? A systematic review of ethical reflections on incidental findings arising in genetics contexts. Eur. J. Hum. Genet. 21:248–55 [Google Scholar]
  13. Chu KM, Jayaraman S, Kyamanywa P, Ntakiyiruta G. 13.  2014. Building research capacity in Africa: equity and global health collaborations. PLOS Med. 11:e1001612 [Google Scholar]
  14. de Vries J, Abayomi A, Littler K, Madden E, McCurdy S. 14.  et al. 2015. Addressing ethical issues in H3Africa research—the views of research ethics committee members. HUGO J. 9:1 [Google Scholar]
  15. de Vries J, Bull S, Doumbo O, Ibrahim M, Mercereau-Puijalon O. 15.  et al. 2011. Ethical issues in human genomics research in developing countries. BMC Med. Ethics 12:5 [Google Scholar]
  16. de Vries J, Jallow M, Williams TN, Kwiatkowski D, Parker M, Fitzpatrick R. 16.  2012. Investigating the potential for ethnic group harm in collaborative genomics research in Africa: Is ethnic stigmatisation likely?. Soc. Sci. Med. 75:1400–7 [Google Scholar]
  17. de Vries J, Littler K, Matimba A, McCurdy S, Ouwe Missi Oukem-Boyer O. 17.  et al. 2016. Evolving perspectives on broad consent for genomics research and biobanking in Africa. Report of the Second H3Africa Ethics Consultation Meeting, 11th May 2015. Glob. Health Epidemiol. Genom. In press [Google Scholar]
  18. de Vries J, Tindana P, Littler K, Ramsay M, Rotimi C. 18.  et al. 2015. The H3Africa policy framework: negotiating fairness in genomics. Trends Genet. 31:117–19 [Google Scholar]
  19. de Vries J, Williams T, Bojang K, Kwiatkowski D, Fitzpatrick R, Parker M. 19.  2014. Knowing who to trust: exploring the role of “ethical metadata” in mediating risk of harm in collaborative genomics research in Africa. BMC Med. Ethics 15:62 [Google Scholar]
  20. Denny SG, Silaigwana B, Wassenaar D, Bull S, Parker M. 20.  2015. Developing ethical practices for public health research data sharing in South Africa: the views and experiences from a diverse sample of research stakeholders. J. Empir. Res. Hum. Res. Ethics 10:290–301 [Google Scholar]
  21. Emerson CI, Singer PA, Upshur RE. 21.  2011. Access and use of human tissues from the developing world: ethical challenges and a way forward using a tissue trust. BMC Med. Ethics 12:2 [Google Scholar]
  22. Fairhead J, Leach M, Small M. 22.  2006. Where techno-science meets poverty: medical research and the economy of blood in The Gambia, West Africa. Soc. Sci. Med. 63:1109–20 [Google Scholar]
  23. Garrett SB, Dohan D, Koenig BA. 23.  2015. Linking broad consent to biobank governance: support from a deliberative public engagement in California. Am. J. Bioeth. 15:56–57 [Google Scholar]
  24. Geissler PW. 24.  2005. “Kachinja are coming!” Encounters around medical research work in a Kenyan village. Africa 75:173–202 [Google Scholar]
  25. Gibbons S, Kaye J, Smart A, Heeney C, Parker M. 25.  2007. Governing genetic databases: challenges facing research regulation and practice. J. Law Soc. 34:163–89 [Google Scholar]
  26. Grady C, Eckstein L, Berkman B, Brock D, Cook-Deegan R. 26.  et al. 2015. Broad consent for research with biological samples: workshop conclusions. Am. J. Bioeth. 15:34–42 [Google Scholar]
  27. 27. H3Africa Consort 2014. Enabling the genomic revolution in Africa. Science 344:1346–48 [Google Scholar]
  28. Hansson M. 28.  2006. Should donors be allowed to give broad consent to future biobank research?. Lancet Oncol. 7:266–69 [Google Scholar]
  29. Hate K, Meherally S, Shah More N, Jayaraman A, Bull S. 29.  et al. 2015. Sweat, skepticism, and uncharted territory: a qualitative study of opinions on data sharing among public health researchers and research participants in Mumbai, India. J. Empir. Res. Hum. Res. Ethics 10:239–50 [Google Scholar]
  30. Hudson KL, Collins FS. 30.  2015. Bringing the Common Rule into the 21st century. N. Engl. J. Med. 373:2293–96 [Google Scholar]
  31. Igbe MA, Adebamowo CA. 31.  2012. Qualitative study of knowledge and attitudes to biobanking among lay persons in Nigeria. BMC Med. Ethics 13:27 [Google Scholar]
  32. Jao I, Kombe F, Mwalukore S, Bull S, Parker M. 32.  et al. 2015. Involving research stakeholders in developing policy on sharing public health research data in Kenya: views on fair process for informed consent, access oversight, and community engagement. J. Empir. Res. Hum. Res. Ethics 10:264–77 [Google Scholar]
  33. Jao I, Kombe F, Mwalukore S, Bull S, Parker M. 33.  et al. 2015. Research stakeholders’ views on benefits and challenges for public health research data sharing in Kenya: the importance of trust and social relations. PLOS ONE 10:e0135545 [Google Scholar]
  34. Karlsen JR, Solbakk JH, Holm S. 34.  2011. Ethical endgames: broad consent for narrow interests; open consent for closed minds. Camb. Q. Healthc. Ethics 20:572–83 [Google Scholar]
  35. Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. 35.  2013. The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Cent. Rep. 43:S4–15 [Google Scholar]
  36. Kaye J, Whitley EA, Lund D, Morrison M, Teare H, Melham K. 36.  2014. Dynamic consent: a patient interface for twenty-first century research networks. Eur. J. Hum. Genet. 23:141–46 [Google Scholar]
  37. Leach M, Fairhead J. 37.  2011. Being “with the Medical Research Council”: infant care and the social meanings of cohort membership in Gambia's plural therapeutic landscapes. Evidence, Ethos and Experiment: The Anthropology and History of Medical Research in Africa PW Geissler, C Molyneux 77–97 New York: Berghahn [Google Scholar]
  38. Ma Y, Dai H, Wang L, Zhu L, Zou H, Kong X. 38.  2012. Consent for use of clinical leftover biosample: a survey among Chinese patients and the general public. PLOS ONE 7:e36050 [Google Scholar]
  39. Marsh V, Kamuya D, Rowa Y, Gikonyo C, Molyneux S. 39.  2008. Beginning community engagement at a busy biomedical research programme: experiences from the KEMRI CGMRC-Wellcome Trust Research Programme, Kilifi, Kenya. Soc. Sci. Med. 67:721–33 [Google Scholar]
  40. Marshall PA, Adebamowo CA, Adeyemo AA, Ogundiran TA, Vekich M. 40.  et al. 2006. Voluntary participation and informed consent to international genetic research. Am. J. Public Health 96:1989–95 [Google Scholar]
  41. Merson L, Phong TV, Nhan LNT, Dung NT, Ngan TT. 41.  et al. 2015. Trust, respect, and reciprocity: informing culturally appropriate data-sharing practice in Vietnam. J. Empir. Res. Hum. Res. Ethics 10:251–63 [Google Scholar]
  42. Molyneux CS, Peshu N, Marsh K. 42.  2004. Understanding of informed consent in a low-income setting: three case studies from the Kenyan coast. Soc. Sci. Med. 59:2547–59 [Google Scholar]
  43. Moodley K, Sibanda N, February K, Rossouw T. 43.  2014. “It's my blood”: ethical complexities in the use, storage and export of biological samples: perspectives from South African research participants. BMC Med. Ethics 15:4 [Google Scholar]
  44. Munung NS, Marshall P, Campbell M, Littler K, Masiye K. 44.  et al. 2016. Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents. J. Med. Ethics 42:132–37 [Google Scholar]
  45. Nobile H, Vermeulen E, Thys K, Bergmann MM, Borry P. 45.  2013. Why do participants enroll in population biobank studies? A systematic literature review. Expert Rev. Mol. Diagn. 13:35–47 [Google Scholar]
  46. Pantelic M, Shenderovich Y, Cluver L, Boyes M. 46.  2015. Predictors of internalised HIV-related stigma: a systematic review of studies in sub-Saharan Africa. Health Psychol. Rev. 9:469–90 [Google Scholar]
  47. Parker M, Bull S. 47.  2015. Sharing public health research data: toward the development of ethical data-sharing practice in low- and middle-income settings. J. Empir. Res. Hum. Res. Ethics 10:217–24 [Google Scholar]
  48. Parker M, Bull S, de Vries J, Agbenyega T, Doumbo OK, Kwiatkowski DP. 48.  2009. Ethical data release in genome-wide association studies in developing countries. PLOS Med. 6:e1000143 [Google Scholar]
  49. Petrini C. 49.  2010. “Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Soc. Sci. Med. 70:217–20 [Google Scholar]
  50. Ramsay M, de Vries J, Soodyall H, Norris SA, Sankoh O. 50.  2014. Ethical issues in genomic research on the African continent: experiences and challenges to ethics review committees. Hum. Genom. 8:15 [Google Scholar]
  51. Sheehan M. 51.  2011. Broad consent is informed consent. BMJ 343:d6900 [Google Scholar]
  52. Sheehan M. 52.  2011. Can broad consent be informed consent?. Public Health Ethics 4:226–35 [Google Scholar]
  53. Stadler J, Saethre E. 53.  2010. Rumours about blood and reimbursements in a microbicide gel trial. Afr. J. AIDS Res. 9:345–53 [Google Scholar]
  54. Staunton C, Moodley K. 54.  2013. Challenges in biobank governance in Sub-Saharan Africa. BMC Med. Ethics 14:35 [Google Scholar]
  55. Stein DT, Terry SF. 55.  2013. Reforming biobank consent policy: a necessary move away from broad consent toward dynamic consent. Genet. Test. Mol. Biomark. 17:855–56 [Google Scholar]
  56. Steinsbekk KS, Kare Myskja B, Solberg B. 56.  2013. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?. Eur. J. Hum. Genet. 21:897–902 [Google Scholar]
  57. Strech D. 57.  2015. Ethical review of biobank research: Should RECs review each release of material from biobanks operating under an already-approved broad consent and data protection model?. Eur. J. Med. Genet. 58:545–49 [Google Scholar]
  58. Tekola F, Bull S, Farsides B, Newport M, Adeyemo A. 58.  et al. 2009. Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study. BMC Med. Ethics 10:13 [Google Scholar]
  59. Tekola F, Bull S, Farsides B, Newport M, Adeyemo A. 59.  et al. 2009. Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting. PLOS Negl. Trop. Dis. 3:e482 [Google Scholar]
  60. Tindana P, Bull S, Amenga-Etego L, de Vries J, Aborigo R. 60.  et al. 2012. Seeking consent to genetic and genomic research in a rural Ghanaian setting: a qualitative study of the MalariaGEN experience. BMC Med. Ethics 13:15 [Google Scholar]
  61. Tindana P, Kass N, Akweongo P. 61.  2006. The informed consent process in a rural African setting: a case study of the Kassena-Nankana district of northern Ghana. IRB 28:1–6 [Google Scholar]
  62. Tindana P, Molyneux CS, Bull S, Parker M. 62.  2014. Ethical issues in the export, storage and reuse of human biological samples in biomedical research: perspectives of key stakeholders in Ghana and Kenya. BMC Med. Ethics 15:76 [Google Scholar]
  63. Tindana P, Rozmovits L, Boulanger RF, Bandewar SV, Aborigo RA. 63.  et al. 2011. Aligning community engagement with traditional authority structures in global health research: a case study from northern Ghana. Am. J. Public Health 101:1857–67 [Google Scholar]
  64. Traore K, Bull S, Niare A, Konate S, Thera M. 64.  et al. 2015. Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali. BMC Med. Ethics 16:42 [Google Scholar]
  65. Upshur R, Lavery J, Tindana P. 65.  2007. Taking tissues seriously means taking communities seriously. BMC Med. Ethics 26:8–11 [Google Scholar]
  66. van Schalkwyk G, de Vries J, Moodley K. 66.  2012. “It's for a good cause, isn't it?”—exploring views of South African TB research participants on sample storage and re-use. BMC Med. Ethics 13:19 [Google Scholar]
  67. Vaz M, Srinivasan K. 67.  2014. Ethical challenges in biobanking: moving the agenda forward in India. Indian J. Med. Ethics 11:79–88 [Google Scholar]
  68. Wendler D, Emanuel E. 68.  2002. The debate over research on stored biological samples: What do the sources think?. Arch. Intern. Med. 162:1457–62 [Google Scholar]
  69. Wendler D, Pace C, Talisuna AO, Maiso F, Grady C, Emanuel E. 69.  2005. Research on stored biological samples: the views of Ugandans. IRB 27:1–5 [Google Scholar]
  70. White L. 70.  2000. Speaking with Vampires: Rumor and History in Colonial Africa Berkeley: Univ. Calif. Press [Google Scholar]
  71. Winickoff DE, Winickoff RN. 71.  2003. The charitable trust as a model for genomic biobanks. N. Engl. J. Med. 349:1180–84 [Google Scholar]
/content/journals/10.1146/annurev-genom-083115-022456
Loading
/content/journals/10.1146/annurev-genom-083115-022456
Loading

Data & Media loading...

  • Article Type: Review Article
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error