Regulation of Biobanks in South Africa

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).

Id. (Staunton and Moodley).

H3Africa- Human Heredity & Health in Africa, supra note 1.

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.

Consisting of local, provincial, and national governments.

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).

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).

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).

National Department of Health, Health Research Policy in South Africa, 2001.

National Department of Health, General Notice 667 of 1997.

Id., at Preface.

See National Department of Health, supra note 12.

National Department of Health, Strategic Plan 2010/11–2012/13.

Id., at 22.

Act No. 37 of 2000.

Id., at § 4(b).

Id., at § 5(2) (b) (emphasis added).

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.

Abayomi A. Christoffels A. Grewal R. , “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.

For a comprehensive list of known biobanks, see Abayomi , id., at 348, table 1.

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).

See Dhai , supra note 21, at 38.

National Health Act, § 72 (6)(a).

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).

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).

Cancer Epidemiology Research Group, available at <http://www.nioh.ac.za/?page=cancer_epidemiology_research_group&id=179> (last visited November 11, 2015).

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).

Mahomed S. Behrens K. Slabbert M. , “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).

Constitution of the Republic of South Africa Act 106 of 1998, § 14.

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.

Id., at 97.

See Constitution of the Republic of South Africa, supra note 34, at § 39(3).

Act No. 61 of 2003, §§ 53–68.

GN R.182 GG 35099 of March 2, 2012.

GN R.181 GG 35099 of March 2, 2012.

GN R.177 GG 35099 of March 2, 2012.

GN R.183 GG 35099 of March 2, 2012.

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.

Paragraph (a).

GN R.177 GG 35099 of March 2, 2012.

Supra note 43.

The national Health Act, supra note 27.

Supra note 47, reg. 21.

Act 4 of 2013.

Id. at § 2.

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.

Id., articles 25 and 26.

South African Law Reform Commission Report (Project 124), Report on Privacy and Data Protection (2009), at 392.

Id., at 9.

Supra note 50, chapter 1.

South African Law Reform Commission Report, supra note 54, at 110.

Supra note 50 at § 57(1) (d).

Id., at § 2(a) (ii).

Id., at § 2(b).

Staunton and Moodley; H3Africa- Human Heredity & Health in Africa, supra note 1.

Supra note 39.

Id., at s 72.

Id., at s 73(2).

GN R. 719 GG 38000 of Sept. 19, 2014.

Id., regs 2(g); 3(a); 6.

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).

GN R. 719 GG 38000 of Sept. 19, 2014. Reg. 6(b).

National Department of Health, supra note 69.

Id., at clause 8.7.

Dhai , supra note 21, at 38; see also Abayomi , supra note 22, at 350.

GN R.182 GG 35099 of 2 March 2012.

National Department of Health, supra note 69, at clause 9.2

UNESCO, International Declaration on Human Genetic Data, 2003 Article 14.

Lunshof J. Chadwick R. Vorhaus D. , “From Genetic Privacy to Open Consent,” Nature Reviews Genetics 9, no. 5 (2008): 406–411.

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.

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.

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).

See supra note 43, reg. 10.

Supra note 69, clause 9.2.

Supra note 82, clause 13.3.

Supra note 69, clause 9.3

GN R. 719 GG 38000 of Sept. 19, 2014, reg. 2(a).

H3Africa- Human Heredity & Health in Africa, supra note 1.

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.

Staunton Moodley , supra note 1.

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.

Kirchhoffer Dierickx , supra note 89, at 76.

GN R. 719 GG 38000 of Sept. 19. 2014.

Id., reg. 2(h).

South African Medical Research Council, Guidelines on Ethics in Reproductive Biology and Genetic Research (2000).

Supra note 82.

Constitution of the Republic of South Africa, supra note 34.

Supra note 69.

Supra note 96.

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).

General Ethical Guidelines for Health Researchers, supra note 82, clause 6.4.

Id., clause 9.2.6.

Id., clause 2.2.

Dhai , supra note 21, at 38.

Abayomi , 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.

Knoppers , supra note 81, at 12.

The Human Research Ethics Committee Medical (HREC) Principles and Policy on Biobanks, supra note 24.

See Secko D. Preto N. Niemeyer S. , “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.

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.

The Human Research Ethics Committee Medical (HREC) Principles and Policy on Biobanks, supra note 24.

Dhai , supra note 21.