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Human Biobanking in Developed and Developing Countries: An Ethico-Legal Comparative Analysis of the Frameworks in the United Kingdom, Australia, Uganda, and South Africa

Published online by Cambridge University Press:  29 December 2020

SAFIA MAHOMED
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Abstract

Although the concept of biobanking is not new, the open and evolving nature of biobanks has created profound ethical, legal, and social implications, including issues around informed consent, community engagement, secondary uses of materials over time, ownership of materials, data sharing, and privacy. Complexities also emerge because of increasing international collaborations and differing national positions. In addition, the degrees and topics of concern vary as legislative, ethical, and social frameworks differ across developed and developing countries. Implementing national laws in an internationally consistent manner is also problematic. However, these concerns should not cause countries, especially developing countries, to lag behind as this novel wave of research gains momentum, particularly while several biobank initiatives are already underway in the developing world. As the law has always struggled to keep up with the fast-evolving scientific arena, this article seeks to identify the ethico-legal frameworks in place in the United Kingdom, Australia, Uganda, and South Africa, for human biobank research, in an attempt to compare and contextualize the approaches to human biobanking in specific developed and developing countries.

Keywords

human biobankingdeveloping and developed countriessecondary uses of materialsownershipprivacycommunity engagementinformed consentbroad consentethico-legal framework
Type
Bioethics Beyond Borders
Information
Cambridge Quarterly of Healthcare Ethics , Volume 30 , Issue 1 , January 2021 , pp. 146 - 160
Copyright
© The Author(s), 2020. Published by Cambridge University Press

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Footnotes

Acknowledgment: This work is part of my Ph.D. thesis. I would like to acknowledge my doctoral supervisors, Prof. K. G. Behrens (Steve Biko Centre for Bioethics, University of the Witwatersrand, South Africa), Prof. M. Labuschaigne (formerly Nöthling-Slabbert) (University of South Africa) and Prof. I. M. Sanne (University of the Witwatersrand, South Africa). I acknowledge the grant support I received from the NIAID to the ACTG (UM1 AI068636). I acknowledge the financial support received by UNISAs College Research and Innovation Committee and absolve UNISA from any responsibility for any opinions or conclusions contained in this publication.

References

Notes

1. Organisation for Economic Co-operation and Development (OECD) Guidelines on Human Biobanks and Genetic Research Databases, 2009; available at http://www.oecd.org/sti/biotech/44054609.pdf (last accessed 07 Nov 2017).

2. Dhai, A, Mahomed, S. Biobank research: Time for discussion and debate. South African Medical Journal 2013;103(4):225–7.CrossRefGoogle ScholarPubMed

3. Supreme Court of Appeal of South Africa, History and background; available at http://www.justice.gov.za/sca/historysca.htm (last accessed 12 Dec 2017).

4. Human genome: UK to become world number 1 in DNA testing; available at https://www.gov.uk/government/news/human-genome-uk-to-become-world-number-1-in-dna-testing (last accessed 12 Dec 2017).

5. UK Biobank: The foundation for the establishment of UK Biocenter; available at http://www.ukbiocentre.com/media/5475/case%20study%201%20-%20uk%20biobank%20uk%20biocentre.pdf (last accessed 12 Dec 2017). See also Kaye, J, Bell, J, Briceno, L, Michell, C. Biobank report: United Kingdom. Journal of Law Medicine and Ethics 2016;44(1):96–105.CrossRefGoogle ScholarPubMed

6. Kaye, J, Bell, J, Briceno, L, Michell, C. Biobank report: United Kingdom. Journal of Law Medicine and Ethics 2016;44(1):96–105 at 97.CrossRefGoogle ScholarPubMed

7. London’s Global University, the Constitution Unit. What is the UK Constitution? 2015 Sept; available at https://www.ucl.ac.uk/constitution-unit/whatis/uk-constitution (last accessed 13 Dec 2017).

8. Kaye, J, Gibbons, S, Heeney, C, Smart, A. Governing Biobanks: Understanding the Interplay between Law and Practice. Parker, M, ed. Oxford: Hart Publishing; 2012 at 52.Google Scholar

9. See note 8, Kaye J 2012, at 52.

10. Brexit–UK and EU legal framework, Norton Rose Fulbright June 2016; available at http://www.nortonrosefulbright.com/knowledge/publications/136975/brexit-uk-and-eu-legal-framework (last accessed 13 Dec 2017).

11. See note 6, Kaye J 2016, at 98.

12. NHS Health Research Authority: HRA Approval; available at http://www.hra.nhs.uk/ (last accessed 13 Dec 2017).

13. NHS, Health Research Authority: Standard Operating Procedures version 7.2 in effect, January 2017, section 12.4; available at http://www.hra.nhs.uk/documents/2017/01/standard-operating-procedures-version-7-2.pdf (last accessed 13 Dec 2017).

14. See note 13, NHS Health Research Authority Standard Operating Procedures 2017, at section 11.4.

15. See note 13, NHS Health Research Authority Standard Operating Procedures 2017, at section 11.5.

16. See note 13, NHS Health Research Authority Standard Operating Procedures 2017, at section 11.7.

17. See note 13, NHS Health Research Authority Standard Operating Procedures 2017, at section 11.22.

18. See note 6, Kaye J 2016, at 98.

19. Australia’s health system, available http://www.aihw.gov.au/australias-health/2014/health-system/ (last accessed 19 Jan 2017).

20. According to Chalmers, D. Biobanking and Privacy laws in Australia. Journal of Law Medicine and Ethics 2015;43(4):703–13 at 705Google ScholarPubMed: “For many years Australia has enjoyed a fine record in scientific and medical research, which has led to innovations in medical devices (electronic heart pacemaker, bionic ear, Begg orthodontics, humidicrib, spray-on-skin, ultrasound scanner, solar scan, first bionic eye implantation) and new drugs (penicillin, lithium, aspro, relenza, cervical cancer vaccine, and folate). There have also been advances in medical procedures, particularly in physiotherapy and microsurgery.”

21. Australian Government NHMRC, Research and funding statistics and data, available at https://www.nhmrc.gov.au/grants-funding/research-funding-statistics-and-data (last accessed 19 Jan 2017).

22. The Australasian Biospecimen Network provides a list of Australian Biobanks, available at http://abrn.net/contact/links/ (last accessed 20 Jan 2017).

23. See note 20, Chalmers D 2015, at 705.

24. The National Health Act 1953, Federal Register of Legislation, available at https://www.legislation.gov.au/Details/C2014C00353 (last accessed 21 Jan 2017).

25. Australian Government, NHMRC, Australian Research Council, Australian Code for the Responsible Conduct of Research, available at https://www.nhmrc.gov.au/_files_nhmrc/file/publications/r39_australian_code_responsible_conduct_research_150811.pdf (last accessed 23 Jan 2017).

26. Australian Government, NHMRC, National Statement on Ethical Conduct in Human Research, 2007 (Updated May 2015); available at https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_statement_may_2015_150514_a.pdf (last accessed 21 Jan 2017). According to chapter 3.4, section 3.4.4 of the National Statement: “For human biospecimens collected for research purposes (including biobanks), there should be ethical review and approval by an HREC of the proposed consent, collection, processing, storage and distribution or disposal,” at 38.

27. See note 26, Australian Government, NHMRC, National Statement on Ethical Conduct in Human Research 2007, at 38.

28. Australian Government, NHMRC, Biobanks Information Paper, 2010; available at https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e110_biobanks_information_paper_140520.pdf (last accessed 21 Jan 2017).

29. The Department of Industry, Innovation, Science and Research, Strategic Roadmap for Australian Research Infrastructure, 2011 Sept; available at https://docs.education.gov.au/system/files/doc/other/national_collaborative_research_infrastructure_strategic_roadmap_2011.pdf (last accessed 25 Jan 2017). Chalmers, D, Nicol, D, Kaye, J, Bell, J, Campbell, AV, Ho, CW, et al. Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era. BioMed Central Medical Ethics 2016;17:39.CrossRefGoogle ScholarPubMed

30. Australian Government, NHMRC, National Biobanking Strategy, available at https://www.nhmrc.gov.au/_files_nhmrc/file/research/nhmrc_national_biobanking_strategy_130628.pdf (last accessed 21 Jan 2017).

31. The Australasian Biospecimens Network Biorepository Protocols, 2007 Mar; available http://www.iss.it/binary/ribo/cont/ABN_SOPs_Review_Mar07_final.pdf (last accessed 25 Jan 2017).

32. See note 26, Australian Government, NHMRC, National Statement on Ethical Conduct in Human Research 2007, at 15.

33. See note 26, Australian Government, NHMRC, National Statement on Ethical Conduct in Human Research 2007, at paragraph 5.1.22.

34. Nnamuchi, O. Biobank and genomic research in Uganda: Are extant privacy and confidentiality regimes adequate? Journal of Law Medicine and Ethics 2016;44(1):85–95.CrossRefGoogle ScholarPubMed

35. Whitworth, JAG, Kokwaro, G, Kinyanjui, S, Snewin, VA, Tanner, M, Walport, M, et al. Strengthening capacity for health research in Africa. Lancet 2008;372(9649):1590–3CrossRefGoogle ScholarPubMed.

36. Nienaber, A. Consent to and authorisation of the export and use of human biological specimens for future research-perspectives from three African countries. XLIV Cilsa 2011;44:225–54.Google Scholar

37. See note 34, Nnamuchi O 2016, at 87: “HIV/AIDS prevalence in the country, although declining remains unacceptably high. Uganda leads the rest of East African countries in prevalence rate, and in 2013 accounted for 10 percent of all new infections in sub-Saharan Africa.” See also: Chan BT, Weiser SD, Boum Y II, Siedner MJ et al. Persistent HIV-related stigma in rural Uganda during a period of increasing HIV incidence despite treatment expansion. AIDS (London, England) 2015;29(1):83–90.

38. The H3Africa, Human, Heredity & Health in Africa website, available at http://www.h3africa.org/ (last accessed 26 Jan 2017).

39. A partnership between Makerere University and the Uganda Virus Research Institute and funded by the UK Medical Research Council and the Wellcome Trust. See note 34, Nnamuchi 2016, at 85.

40. Sathar MA, Dhai A. Laws regulations and guidelines of developed countries, developing countries in Africa, and BRICS regions pertaining to the use of human biological material (HBM) in research. SAJBL 2012;5(1):51–4.

41. The Constitution of the Republic of Uganda, 1995; available at http://www.usig.org/countryinfo/laws/Uganda/CONSTITUTION%20OF%20THE%20REPUBLIC%20OF%20UGANDA%201995.pdf (last accessed 26 Jan 2017).

42. The Public Health Act 1935; available at http://www.ulii.org/ug/legislation/consolidated-act/281 (last accessed 26 Jan 2017).

43. Uganda’s National Council for Science and Technology, National Guidelines for Research Involving Humans as Research Participants, 2014 July; available at https://www.swarthmore.edu/sites/default/files/assets/documents/institutional-review-board/Human_Subjects_Protection_Guidelines_July_2014.pdf (last accessed 26 Jan 2017).

44. In accordance with Research Ethics policies: “The Ugandan National Council for Science and Technology (UNCST) has a mandate to facilitate and coordinate the development and implementation of policies and strategies for integrating Science and Technology (S&T) into the national development process. The UNCST is also tasked with overseeing the appropriate application of research ethics policies and practices within Uganda”; available at http://www.ccghr.ca/resources/harmonization/uganda/uganda-research-ethics/ (last accessed 26 Jan 2017).

45. See note 43, National Guidelines for Research Involving Humans as Research Participants 2014, at 1.

46. See note 34, Nnamuchi 2016, at 88.

47. See note 43, National Guidelines for Research Involving Humans as Research Participants 2014, at 2 which states that:

  • “Human Research Participants have a right to, inter alia:

    1. a.

      a. Participate in research or not or withdraw at any time without penalty;

    2. b.

      b. Be respected, including the right of their autonomy, culture, beliefs, and values;

    3. c.

      c. Information about the research (it is important to ensure that information is communicated in understandable language, format, and in a conducive environment at all stages of the research);

    4. d.

      d. Protection against research related injuries, harm, exploitation, and any other forms of abuse;

    5. e.

      e. Privacy and confidentiality of their participation, during and after the research;

    6. f.

      f. The standard of healthcare that is established nationally;

    7. g.

      g. Treatment and management of research-related injuries; and

    8. h.

      h. Reimbursement for costs associated with their participation in the research.” at 2.

48. See note 43, National Guidelines for Research Involving Humans as Research Participants 2014, at 2.

49. Andanda, P, Govendor, S. Regulation of Biobanks in South Africa. Journal of Law, Medicine and Ethics 2015;43(4):787–800.Google ScholarPubMed

50. Supreme Court of Appeal of South Africa, History and background; available at http://www.justice.gov.za/sca/historysca.htm (last accessed 12 Dec 2017).

51. The Constitution of the Republic of South Africa. South African Government; available at http://www.gov.za/documents/constitution/constitution-republic-south-africa-1996-1 (last accessed 7 Nov 2017).

52. National Department of Health Ethics in Health Research: Principles, Processes and Structures. 2nd ed. 2015.

53. The International ethical guidelines for health-related research involving humans prepared by the Council for International Organizations of Medical Sciences in collaboration with the World Health Organization prepared by the Council for International Organizations of Medical Sciences in collaboration with the World Health Organization Geneva (CIOMS Guidelines) 2016; available at https://cioms.ch/shop/product/international-ethical-guidelines-for-health-related-research-involving-humans/ (last accessed 08 Nov 2017).

54. See note 53, CIOMS Guidelines 2016, at 43.

55. See note 52, National Department of Health Ethics in Health Research: Principles, Processes and Structures, at 30.

56. The NHS, Health Research Authority, Questions and Answers—The Human Tissue Act 2004. Code of Practice on the import and export of human bodies, body parts and Tissue; available at http://www.hra.nhs.uk/resources/research-legislation-and-governance/questions-and-answers-the-human-tissue-act-2004/ (last accessed 13 Dec 2017).

57. See note 26, Australian Government, NHMRC, National Statement on Ethical Conduct in Human Research 2007, at 40.

58. See note 43, National Guidelines for Research Involving Humans as Research Participants 2014, at 28–9.

59. De Vries, J, Munung, SN, Matimba, A, McCurdy, S, Staunton, O, Yakubu, C et al. Regulation of genomic and biobanking research in Africa: A content analysis of ethics guidelines, policies and procedures from 22 African countries. BMC Medical Ethics 2017;18(8): 1–9.CrossRefGoogle ScholarPubMed

60. GN R 182 in Government Gazette 35099 of 2 March 2012.

61. See note 26, Australian Government, NHMRC, National Statement on Ethical Conduct in Human Research 2007, at 44 which states that:

  • “Consent should be sought from appropriate community representatives as well as from the individuals concerned where:

    1. (a)

      (a) researchers propose to collect genetic material and information from individuals who are chosen because of their membership of a particular community;

    2. (b)

      (b) the research involves sensitivities for that community; and

    3. (c)

      (c) there is known to be a culturally relevant community structure involved in such matters.”

62. See note 43, National Guidelines for Research Involving Humans as Research Participants 2014, at section 12.

63. See note 20, Chalmers D, 2015 at 703–13. See also, Knoppers, BM, Saginur, M. The Babel of genetic data terminology, Nature Biotechnology 2005;23:925–7CrossRefGoogle ScholarPubMed, where the precision of the use of the term “reidentifiable” is questioned.

64. The International Ethical Guidelines for Health-related Research Involving Humans prepared by the Council for International Organizations of Medical Sciences in collaboration with the World Health Organization prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) Geneva 2016; available at https://cioms.ch/shop/product/international-ethical-guidelines-for-health-related-research-involving-humans/ (last accessed 08 Nov 2017); WMA Declaration of Taipei on Ethical considerations regarding Health Databases and Biobanks adopted by the 53rd WMA General Assembly, Washington, DC, USA, October 2002 and revised by the 67th WMA General Assembly, Taipei, Taiwan, 2016 Oct; available at https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/ (last accessed 08 Nov 2017).

65. WHO Human Genomics in Global Health, Bioethics Advisory Committee, 2002. Report: Human Tissue Research. Singapore (Singapore Report); available at http://www.who.int/genomics/elsi/regulatory_data/region/wpro/096/en/ (last accessed 29 Jan 2017).

66. See note 65, Singapore Report at 32.

67. See note 65, Singapore Report at 32.