Hostname: page-component-586b7cd67f-t7fkt Total loading time: 0 Render date: 2024-11-24T02:25:23.377Z Has data issue: false hasContentIssue false
  • English
  • Français

Regulation of Biobanks in South Africa

Published online by Cambridge University Press:  01 January 2021

Pamela Andanda  and
Sandra Govender
Get access Rights & Permissions [Opens in a new window]

Extract

The ongoing efforts to establish biobanks in Africa envisage the availability of biological samples and data in accordance with relevant national legislation and ethical principles. Current literature has established that many African countries “do not have national legislation or guidelines on the use of stored biological samples” or if such guidelines are in place, then “disparities exist in relation to informed consent and export and import requirements.” In this regard, this article considers the extent to which the available legal and ethical regulatory frameworks in South Africa are capable of governing the use of stored biological samples in a manner that facilitates health research while at the same time protecting the interests of sample donors.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 43 , Issue 4 , Winter 2015 , pp. 787 - 800
Copyright
Copyright © American Society of Law, Medicine and Ethics 2015

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Staunton, C. Moodley, K., “Challenges in Biobank Governance in Sub-Saharan Africa,” BMC Medical Ethics 14, no. 35 (2013): 1–8, available at <http://www.biomedcentral.com/1472–6939/14/35> (last visited November 11, 2015); see also H3Africa- Human Heredity & Health in Africa, High-Level Principles on Ethics, Governance and Resource Sharing, available at <http://h3africa.org/about/ethics-and-governance> (last visited November 11, 2015).Google Scholar
Id. (Staunton and Moodley).Google Scholar
Id.Google Scholar
H3Africa- Human Heredity & Health in Africa, supra note 1.Google Scholar
Id.Google Scholar
Id.Google Scholar
Gottweis, H. Petersen, A., “Biobanks and Governance: An Introduction,” in Gottweis, H. Petersen, A., eds., Biobanks: Governance in Comparative Perspective (New York: Routledge, 2008): At 5.CrossRefGoogle Scholar
Consisting of local, provincial, and national governments.Google Scholar
South African Government website, “South Africa at a Glance,” available at <http://www.gov.za/about-sa/south-africa-glance> (last visited November 11, 2015).+(last+visited+November+11,+2015).>Google Scholar
Statistics South Africa, Mid-Year Population Estimates 2015, at 7, available at <http://www.statssa.gov.za/publications/P0302/P03022015.pdf> (last visited November 22, 2015).+(last+visited+November+22,+2015).>Google Scholar
The Republic of South Africa (Department of communications), South Africa Yearbook 2013/14, available at <http://www.gcis.gov.za/sites/www.gcis.gov.za/files/docs/resourcecentre/yearbook/2013–4Health.pdf> (last visited November 11, 2015).+(last+visited+November+11,+2015).>Google Scholar
National Department of Health, Health Research Policy in South Africa, 2001.Google Scholar
National Department of Health, General Notice 667 of 1997.Google Scholar
Id., at Preface.Google Scholar
See National Department of Health, supra note 12.Google Scholar
National Department of Health, Strategic Plan 2010/11–2012/13.Google Scholar
Id., at 22.Google Scholar
Act No. 37 of 2000.Google Scholar
Id., at § 4(b).Google Scholar
Id., at § 5(2) (b) (emphasis added).Google Scholar
Dhai, A., “Establishing National Biobanks in South Africa: The Urgent Need for an Ethico-Regulatory Framework,” South African Journal of Bioethics and Law 6, no. 2 (2013): 38–39, at 38.Google Scholar
Abayomi, A. Christoffels, A. Grewal, R. et al. , “Challenges of Biobanking in South Africa to Facilitate Indigenous Research in an Environment Burdened with Human Immunodeficiency Virus, Tuberculosis, and Emerging Noncommunicable Diseases,” Biopreservation and Biobanking 11, no. 6 (2013): 347–354 at 349.Google Scholar
For a comprehensive list of known biobanks, see Abayomi, et al. , id., at 348, table 1.Google Scholar
The Human Research Ethics Committee Medical (HREC) Principles and Policy on Biobanks University of the Witwatersrand, Johannesburg, available at <http://www.wits.ac.za/files/ge41p_501401001375950888.pdf> (last visited November 11, 2015).+(last+visited+November+11,+2015).>Google Scholar
See Dhai, , supra note 21, at 38.Google Scholar
Id.Google Scholar
National Health Act, § 72 (6)(a).Google Scholar
University of the Western Cape, the Biomedical Research Ethics Committee (BMREC) Principles and Policy on Biobanks, available at <http://www.uwc.ac.za/Research/Pages/Biomedical-Research-Ethics-Committee.aspx> last visited November 11, 2015).+last+visited+November+11,+2015).>Google Scholar
The African Centre for Health and Population Studies, available at <http://www.southern-africa.cnrs.ird.fr/partnerships/partners-in-southern-africa/africa-centre-for-health-and-population-studies> (last visited November 23, 2015).+(last+visited+November+23,+2015).>Google Scholar
Id.Google Scholar
Cancer Epidemiology Research Group, available at <http://www.nioh.ac.za/?page=cancer_epidemiology_research_group&id=179> (last visited November 11, 2015).+(last+visited+November+11,+2015).>Google Scholar
Development of H3 Africa Biorepositories to Facilitate Studies on Biodiversity, Disease & Pharmacogenomics of African Populations, available at <http://h3africa.org/consortium/projects/16-projects/62-development-of-h3-africa-biorepositories-to-facilitate-studies-on-biodiversity-disease-pharmacogenomics-of-african-populations> (last visited November 11, 2015).+(last+visited+November+11,+2015).>Google Scholar
Mahomed, S. Behrens, K. Slabbert, M. et al. , “Managing Human Tissue Transfer across National Boundaries – An Approach from an Institution in South Africa,” Developing World Bioethics (e-pub ahead of print; forthcoming 2015).Google Scholar
Constitution of the Republic of South Africa Act 106 of 1998, § 14.Google Scholar
Id.Google Scholar
Govender, S., “The Protection of Genetic Privacy in South Africa: Towards a Legislative Response Based on a Cross-jurisdictional Review of Legal Developments” (2012), Unpublished Ph.D. Thesis University of the Witwatersrand, at 11.Google Scholar
Id., at 97.Google Scholar
See Constitution of the Republic of South Africa, supra note 34, at § 39(3).Google Scholar
Act No. 61 of 2003, §§ 53–68.Google Scholar
GN R.182 GG 35099 of March 2, 2012.Google Scholar
GN R.181 GG 35099 of March 2, 2012.Google Scholar
GN R.177 GG 35099 of March 2, 2012.Google Scholar
GN R.183 GG 35099 of March 2, 2012.Google Scholar
These are activities related to removal, acquisition or importation of human tissues from any living or deceased person; preservation, screening, testing, processing, storage, separation, production, labelling, packing, supplying or distributing or exporting or in any other manner disposing of human tissues whether in its original form or in any altered form; releasing any human tissue products for transplantation in the body of a person.Google Scholar
Paragraph (a).Google Scholar
GN R.177 GG 35099 of March 2, 2012.Google Scholar
Supra note 43.Google Scholar
The national Health Act, supra note 27.Google Scholar
Supra note 47, reg. 21.Google Scholar
Act 4 of 2013.Google Scholar
Id. at § 2.Google Scholar
EU Directive 1995/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data.Google Scholar
Id., articles 25 and 26.Google Scholar
South African Law Reform Commission Report (Project 124), Report on Privacy and Data Protection (2009), at 392.Google Scholar
Id.Google Scholar
Id., at 9.Google Scholar
Supra note 50, chapter 1.Google Scholar
South African Law Reform Commission Report, supra note 54, at 110.Google Scholar
Supra note 50 at § 57(1) (d).Google Scholar
Id., at § 2(a) (ii).Google Scholar
Id., at § 2(b).Google Scholar
Staunton and Moodley; H3Africa- Human Heredity & Health in Africa, supra note 1.Google Scholar
Supra note 39.Google Scholar
Id., at s 72.Google Scholar
Id.Google Scholar
Id., at s 73(2).Google Scholar
GN R. 719 GG 38000 of Sept. 19, 2014.Google Scholar
Id., regs 2(g); 3(a); 6.Google Scholar
National Department of Health, Ethics in Health Research: Principles, Structures and Processes (2004), available at <http://www.mrc.ac.za/ethics/DOHEthics.pdf> (last visited November 11, 2015).+(last+visited+November+11,+2015).>Google Scholar
GN R. 719 GG 38000 of Sept. 19, 2014. Reg. 6(b).Google Scholar
National Department of Health, supra note 69.Google Scholar
Id., at clause 8.7.Google Scholar
Dhai, , supra note 21, at 38; see also Abayomi, et al. , supra note 22, at 350.Google Scholar
GN R.182 GG 35099 of 2 March 2012.Google Scholar
National Department of Health, supra note 69, at clause 9.2Google Scholar
Id.Google Scholar
Id.Google Scholar
UNESCO, International Declaration on Human Genetic Data, 2003 Article 14.Google Scholar
Lunshof, J. Chadwick, R. Vorhaus, D. et al. , “From Genetic Privacy to Open Consent,” Nature Reviews Genetics 9, no. 5 (2008): 406–411.CrossRefGoogle Scholar
Malin, B. Sweeney, L., “How (Not) to Protect Genomic Data Privacy in a Distributed Network: Using Trail Re-identification to Evaluate and Design Anonymity Protection Systems,” Journal of Biomedical Informatics 37, no. 3 (2004): 179–192.CrossRefGoogle Scholar
Knoppers, B., “Biobanking: International Norms,” Journal of Law, Medicine and Ethics 33 (2005): 7–14; see also Knoppers, B. Zawati, M. Kirby, E., “Sampling Populations of Humans across the World: ELSI Issues,” Annual Review of Genomics and Human Genetics 13 (2012): 395–413, at 401.Google Scholar
General Ethical Guidelines for Health Researchers, Guidelines for Good Practice in the Health Care Professions (May 2008) clause 13.3, available at <http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_1_guidelines_good_prac.pdf> (last visited November 11, 2015).+(last+visited+November+11,+2015).>Google Scholar
See supra note 43, reg. 10.Google Scholar
Supra note 69, clause 9.2.Google Scholar
Supra note 82, clause 13.3.Google Scholar
Supra note 69, clause 9.3Google Scholar
Id.Google Scholar
GN R. 719 GG 38000 of Sept. 19, 2014, reg. 2(a).Google Scholar
H3Africa- Human Heredity & Health in Africa, supra note 1.Google Scholar
Kirchhoffer, D. G. Dierickx, K., “Human Dignity and Consent in Research Biobanking,” South African Journal of Bioethics and Law 5, no. 2 (2012): 74–77 at 75.CrossRefGoogle Scholar
Staunton, Moodley, , supra note 1.Google Scholar
Id.Google Scholar
Mello, M. Wolf, L., “The Havasupai Indian Tribe Case–Lessons for Research Involving Stored Biologic Samples,” New England Journal of Medicine 363, no. 3 (2010): 204–207, at 206.CrossRefGoogle Scholar
Kirchhoffer, Dierickx, , supra note 89, at 76.Google Scholar
GN R. 719 GG 38000 of Sept. 19. 2014.Google Scholar
Id., reg. 2(h).Google Scholar
South African Medical Research Council, Guidelines on Ethics in Reproductive Biology and Genetic Research (2000).Google Scholar
Supra note 82.Google Scholar
Constitution of the Republic of South Africa, supra note 34.Google Scholar
Supra note 69.Google Scholar
Supra note 96.Google Scholar
World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and last amended by the 59th WMA General Assembly, Seoul, Korea, October 2008, available at <http://www.wma.net/en/30publications/10policies/b3/> (last visited November 11, 2015).+(last+visited+November+11,+2015).>Google Scholar
General Ethical Guidelines for Health Researchers, supra note 82, clause 6.4.Google Scholar
Id., clause 9.2.6.Google Scholar
Id., clause 2.2.Google Scholar
Dhai, , supra note 21, at 38.Google Scholar
Abayomi, et al. , supra note 22; see also Pepper, M. S., “Enactment of Chapter 8 of the National Health Act and Regulations Thereto,” South African Journal of Bioethics & Law 5, no. 1 (2012): 60.Google Scholar
Knoppers, , supra note 81, at 12.Google Scholar
The Human Research Ethics Committee Medical (HREC) Principles and Policy on Biobanks, supra note 24.Google Scholar
See Secko, D. Preto, N. Niemeyer, S. et al. , “Informed Consent in Biobank Research: A Deliberative Approach to the Debate,” Social Science & Medicine 68, no. 4 (2009): 781–779; World Health Organization, Guideline for Obtaining Informed Consent for the Procurement and Use of Human Tissues, Cells, and Fluids in Research (2003), Geneva, Switzerland; Master, Z. Resnik, D. B., “Incorporating Exclusion Clauses in Informed Consent for Biobanking,” Cambridge Quarterly of Healthcare Ethics 22, no. 2 (2013): 203–212.CrossRefGoogle Scholar
Knoppers, supra, note 81, at 401; see also Hoffman, B., “Broadening Consent and Diluting Ethics?” Journal of Medical Ethics 35, no. 2 (2009): 125–129.CrossRefGoogle Scholar
The Human Research Ethics Committee Medical (HREC) Principles and Policy on Biobanks, supra note 24.Google Scholar
Dhai, supra note 21.Google Scholar