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Research Articles

Broad consent for biobank research in South Africa - Towards an enabling ethico-legal framework

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Article: 2288331 | Received 29 May 2023, Accepted 22 Nov 2023, Published online: 20 Dec 2023

References

  • Academy of Science of South Africa. POPIA Code of Conduct for Research. Retrieved March 10, 2023, from https://www.assaf.org.za/wp-content/uploads/2023/04/ASSAf-POPIA-Code-of-Conduct-for-Research.pdf.
  • Adams, R., Adeleke, F., Anderson, D., Bawa, A., Branson, N., Christoffels, A., de Vries, J., Etheredge, H., Flack-Davison, E., Gaffley, M., Marks, M., Mdhluli, M., Mahomed, S., Molefe, M., Muthivhi, T., Ncube, C., Olckers, A., Papathanasopoulos, M., Pillay, J., … Ramsay, M. (2021). Popia code of conduct for research. Discussions on POPIA, 117, 1–12.
  • Borgman, C. L. (2018). Open data, grey data, and stewardship: Universities at the privacy frontier. Berkeley Technology Law Journal, 33, 365–412.
  • Budimir, D., Polašek, O., Marušić, A., Kolčić, I., Zemunik, T., Boraska, V., Jerončić, A., Boban, M., Campbell, H., & Rudan, I. (2011). Ethical aspects of human biobanks: A systematic review. Croatian Medical Journal, 52(3), 262–279.
  • Caplan, A. L. (2009). What no one knows cannot hurt You: The limits of informed consent in the emerging world of biobanking. In J. H. Solbakk, S. Holm, & B. Hofmann (Eds.), The ethics of research biobanking (pp. 25–32). Springer Science.
  • Coppola, L., Cianfone, A., Grimaldi, A. M., et al. (2019). Biobanking in health care: Evolution and future directions. Journal of Translational Medicine, 17, 1–18.
  • Council for International Organizations of Medical Sciences. (2016). International Ethical Guidelines for Health Related Research Involving Humans. Retrieved March 10, 2023, from https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.
  • Dove, E. S., & Chen, J. (2020). Should consent for data processing be privileged in health research? A comparative legal analysis. International Data Privacy Law, 10(2), 117–131. https://doi.org/10.1093/idpl/ipz023
  • Eisenhauer, E. R., Tait, A. R., & Rieh, S. Y. (2019). Participants’ understanding of informed consent for biobanking: A systematic review. Clinical Nursing Research, 28(1), 30–51. https://doi.org/10.1177/1054773817722690
  • Eriksson, S., & Helgesson, G. (2005). Potential harms, anonymization, and the right to withdraw consent to biobank research. European Journal of Human Genetics, 13, 1071–1076. https://doi.org/10.1038/sj.ejhg.5201458
  • Fisher, C. B., & Layman, D. M. (2018). Genomics, big data, and broad consent: A new ethics frontier for prevention science. Prevention Science, 14, 1–9.
  • Hallinan, D. (2020). Broad consent under the GDPR: An optimistic perspective on a bright future. Life Sciences, Society and Policy, 16(1), 1–18. https://doi.org/10.1186/s40504-019-0096-3
  • Hansson, M. G., Dillner, J., Bartram, C. R., et al. (2006). Should donors be allowed to give broad consent to future biobank research? Lancet Oncology, 7, 266–269. https://doi.org/10.1016/S1470-2045(06)70618-0
  • Horowitz, A. (2000). Legal interpretation, morality, and semantic fetishism. American Philosophical Quarterly, 37, 335–357.
  • Kaye, J., Whitley, E. A., Lund, D., et al. (2015). Dynamic consent: A patient interface for twenty-first century research networks. European Journal of Human Genetics, 23, 141–146. https://doi.org/10.1038/ejhg.2014.71
  • Laurie, G. (2011). Reflexive governance in biobanking: On the value of policy led approaches and the need to recognise the limits of law. Human Genetics, 130, 347–356. https://doi.org/10.1007/s00439-011-1066-x
  • Laurie, G. (2016). Liminality and the limits of law in health research regulation: What are we missing in the spaces in-between? Medical Law Review, 25(1), 47–72. https://doi.org/10.1093/medlaw/fww029
  • Lexis Nexis. (2023). Ex ante definition. Retrieved March 15, 2023, from https://www.lexisnexis.co.uk/legal/glossary/exante#:~:text=What%20does%20Ex%20ante%20mean,post%20(after%20the%20fact).
  • Mahomed, S. (2020). Human biobanking in developed and developing countries: An ethico-legal comparative analysis of the frameworks in the United Kingdom, Australia, Uganda, and South Africa. Bioethics Beyond Borders, 30, 146–160.
  • Mahomed, S., & Labuschaigne, M. (2019). The role of research ethics committees in South Africa when human biological materials are transferred between institutions. South African Journal of Bioethics and Law, 12(2), 79–83. https://doi.org/10.7196/SAJBL.2019.v12i2.685
  • Mahomed, S., & Staunton, C. (2021). Ethico-legal analysis of international sample and data sharing for genomic research during COVID-19: A South African perspective. BioLaw Journal – Rivista di BioDiritto, Special Issue 1/2021, 261–276.
  • Martin, R. (2008). Law, and public health policy. International Encyclopedia of Public Health, 30–38. https://doi.org/10.1016/B978-012373960-5.00236-7
  • Massey, A. K., Rutledge, R. L., Antón, A. I., & Swire, P. P. (2009). Identifying and classifying ambiguity for regulatory requirements. pdfs.semanticscholar.org.
  • Master, Z., Nelson, E., Murdoch, B., et al. (2012). Biobanks, consent and claims of consensus. Nature Methods, 9(9), 885–888. https://doi.org/10.1038/nmeth.2142
  • Melham, K., Moraia, L. B., Mitchell, C., et al. (2014). The evolution of withdrawal: Negotiating research relationships in biobanking. Society and Policy, 10, 1–13.
  • Mikkelsen, R. B., Gjerris, M., Waldemar, G., & Sandøe, P. (2019). Broad consent for biobanks is best – provided it is also deep. BMC Medical Ethics, 20, 1–12.
  • Moodley, K., & Kleinsmidt, A. (2020). Allegations of misuse of African DNA in the UK: Will data protection legislation in South Africa be sufficient to prevent a recurrence? Developing World Bioethics, 2020, 1–6.
  • Moodley, K., & Singh, S. (2016). “It’s all about trust”: Reflections of researchers on the complexity and controversy surrounding biobanking in South Africa. BMC Medical Ethics, 17, 1–9.
  • Mwaka, E., & Horn, L. (2019). Researchers’ perspectives on informed consent and ethical review of biobank research in South Africa: A cross-sectional study. Journal of Empirical Research on Human Research Ethics, 1–11.
  • National Cancer Institute. (2016). Informed consent. Retrieved April 9, 2023, from https://biospecimens.cancer.gov/bestpractices/elp/ic.asp.
  • National Health Act No. 61 of 2003 Material Transfer Agreement of Human Biological Materials (SA MTA). (2018). Government Gazette 41781 of 20 July 2018.
  • Nembaware, V., Johnston, K., & Diallo, A. A. (2019). A framework for tiered informed consent for health genomic research in Africa. Nature Genetics, 1–11.
  • Nienaber, A. (2011). Consent to and authorisation of the export and use of human biological specimens for future research - perspectives from three African countries. CILSA, 225–254.
  • Peloquin, D., DiMaio, M., Bierer, B., & Barnes, M. (2020). Disruptive and avoidable: GDPR challenges to secondary research uses of data. European Journal of Human Genetics, 28, 697–705. https://doi.org/10.1038/s41431-020-0596-x
  • Petersen, A. (2005). Securing our genetic health: Engendering trust in UK biobank. Sociology of Health and Illness, 27(2), 271–292. https://doi.org/10.1111/j.1467-9566.2005.00442.x
  • Ploug, T., & Hols, S. (2017). Eliciting meta consent for future secondary research use of health data using a smartphone application - a proof of concept study in the Danish population. BMC Medical Ethics, 18, 1–8.
  • Protection of Personal Information Act No. 4 of 2013. (37067 of 26 November 2013). (2013). Government Gazette.
  • Ram, N. (2008). Tiered consent and the tyranny of choice. Faculty Scholarship, 253–284.
  • Rothstein, M. A. (2005). Expanding the ethical analysis of biobanks. Regulation of Biobanks, Spring 2005, 89–101.
  • Shabani, M., Chassang, G., & Marelli, L. (2021). The impact of the GDPR on the Governance of Biobank Research. GDPR and Biobanking, Law, Governance and Technology, Series, 43, 45–60. https://doi.org/10.1007/978-3-030-49388-2_4
  • Singh, S., & Moodley, K. (2021). Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa. BMC Medical Ethics, 22, 84. https://doi.org/10.1186/s12910-021-00645-z
  • South African Department of Health. (2015). Ethics in Health Research: Principles Processes and Structures. Retrieved from http://nhrec.health.gov.za/index.php/grids-preview
  • Staunton, C., Adams, R., Botes, M., et al. (2019). Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013. South African Medical Journal, 109(7), 468–470. https://doi.org/10.7196/SAMJ.2019.v109i7.14148
  • Staunton, C., Adams, R., Botes, M., et al. (2020). Privacy rights of human research participants in South Africa must be taken seriously. South African Medical Journal, 110(3), 175–176. https://doi.org/10.7196/SAMJ.2020.v110i3.14450
  • Staunton, C., & De Vries, J. (2020). The governance of genomic biobank research in Africa: Reframing the regulatory tilt. Journal of Law and the Biosciences, 1–20. http://doi.org/10.1093/jlb/lsz018
  • Steinsbekk, K. S., Myskja, B. K., & Solberg, B. (2013). Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem? European Journal of Human Genetics, 21, 897–902. https://doi.org/10.1038/ejhg.2012.282
  • Strech, D., Bein, S., Brumhard, M., et al. (2016). A template for broad consent in biobank research. Results and explanation of an evidence and consensus-based development process. European Journal of Medical Genetics, 59, 295–309. https://doi.org/10.1016/j.ejmg.2016.04.002
  • Thaldar, D., & Townsend, B. (2021). Exempting health research from the consent provisions of POPIA. Pioneer in peer-reviewed, open access online law publications, 24, 1–31.
  • Thompson, R., & McNamee, M. J. (2017). Consent, ethics and genetic biobanks: The case of the Athlome project. BMC Genomics, 18(Suppl 8, 830), 49–58. https://doi.org/10.1186/s12864-017-4189-1
  • Thorogood, A., Dalpé, G., & Knoppers, B. M. (2019). Return of individual genomic research results: Are laws and policies keeping step? European Journal of Human Genetics, 27, 535–546. https://doi.org/10.1038/s41431-018-0311-3
  • Tindana, P., Depuur, C., de Vries, J., Seeley, J., & Parker, M. (2020). Informed consent in genomic research and biobanking: Taking feedback of findings seriously. Global Bioethics, 1–16.
  • Wolf, S. M., Lawrenz, F. P., Nelson, C. A., et al. (2008). Managing incidental findings in human subjects research: Analysis and recommendations. Journal of Law Med Ethics, 36(2), 219–211. https://doi.org/10.1111/j.1748-720X.2008.00266.x
  • World Medical Association. (2016). Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks. Retrieved March 26, 2023, from https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/.