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
Department of General Medicine, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban
Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg
Human biological material (HBM) is an invaluable resource in biomedical research. Although research ethics committees (RECs) are guided by international guidelines and frameworks, some RECs might not be fully informed about local ethical and regulatory requirements regarding the use, collection, storage, ownership, transfer and benefit-sharing of HBM in collaborative research.
S Afr J BL 2012;5(1);51-54.
Analysis of human biological material (HBM) is quite lucrative.1 Developing countries’ ethical and regulatory frameworks are influenced by debates between Europe and the USA, and their regulations. Hence, traditional cultural values placed on HBM by communities in developing countries might not be considered. The frameworks of selected developed countries2 (Australia, Canada, the UK and USA), selected developing countries in Africa2 (Kenya, Malawi, Nigeria Tanzania, Uganda and Zimbabwe) and the BRICS countries2 (Brazil, Russia, India, China and South Africa) were reviewed and compared for robustness of ethical protection of HBM in research.
Key organisations, laws, regulations and guidelines
All research on humans in Australia and Canada is guided respectively by The National Statement3 and The Australian Code,4 and also the Interagency Advisory Panel on Research (PRE) Tri-Council Policy Statement (TCPS2).5 In the UK, the Human Tissue Act of 2004 (UKHTAct)6 applies in full in England, Wales and Northern Ireland, but not in full in Scotland. The Act established the Human Tissue Authority (HTA)7 as the overseeing body corporate which deals with issues about the use of HBM for research. In the USA, the Department of Health and Human Science’s (DHHS) Code of Federal Regulations (CFR) (title 45 part 46) [54CFR46]8 (also referred to as the Common Rule) governs human subject research. Oversight of these federal regulations is delegated to the Office of Human Protection Research (OHRP) which monitors compliance.
In the selected developing countries in Africa (Kenya,9 Malawi,10 , 11 Nigeria,12 Tanzania,13 Uganda14 and Zimbabwe),15 their respective national research ethics committees or councils are responsible for developing regulations, guidelines and co-ordinating all human subject research.
In the RSA, the national ethics regulations are governed by the National Health Act (NHA) [Act No 61 of 2003].16 Legal aspects of using HBMs are governed by Chapter 8 of the Act. The Department of Health (DoH) has promulgated complementary guidelines.17 , 18 The Health Professions Council of South Africa (HPCSA),19 , 20 and the Medical Research Council of South Africa (SAMRC),21 , 22 have independently published research ethics guidelines. The South African Intellectual Property Rights from Publicly Financed Research and Development Act (IPR Act)23 regulates intellectual property rights, patents and benefits that may be applicable to HBMs.
In Brazil, the Comissao Nacional de Ethica em Pesquisa (National Commission for Research Ethics) (CONEP) is responsible for assessing ethical issues arising from all research involving human participants. Resolution 196 (the standard guidelines for participant protections) is used. HBM research is regulated in complementary resolutions that include the need for a memorandum of co-operation for foreign research, special protections for indigenous peoples, and information on storage or use of HBM.24
The Indian Council of Medical Research (ICMR) formulates, co-ordinates and promotes biomedical research in India28 and collaboration between India and other foreign agencies through the Indo-Foreign Cell (IFC).
Definitions of HBM
In the UK’s UKHT Act,6 ‘tissue’ refers to ‘any, and all, constituent part(s) of the human body formed by cells’ and is divided into ‘relevant and bodily material’. When a sample contains even a single human cell, it is classified as ‘relevant material.’ The USA’s policy and guideline documents of the OHRP and the National Bioethics Advisory Committee (NBAC) use interchangeably ‘biological materials, human biological specimens, human tissue materials and biological specimens’ without providing any definitions,29 although the National Cancer Institute of the National Institute of Health (NIH) provides comprehensive definitions for ‘biospecimens’ and ‘specimens’.32 TCPS25 in Canada and The Australian Code4 refer to ‘biological materials’, the latter without providing a definition.
The Ugandan national guideline is the only one in Africa (excluding BRICS) that refers to HBM and includes ‘microorganisms’ in its definition.14 ‘Human tissue’ is defined in the Kenyan9 and Tanzanian13 national guidelines. The Malawian guidelines refer to ‘genetic resources’ in the context of ‘agricultural/forestry/fisheries/parks and wildlife resources’ and not HBM.10 , 11 The Nigerian national guidelines refer to ‘samples and biological materials’ that include ‘herbs and plants’ without defining what constitutes ‘samples’ or ‘biological materials.’12 The Zimbabwean national guidelines provide no definitions15 except guidelines for the collection of blood samples.33
Of the BRICS countries, only India provides a comprehensive definition of HBMs.28 The RSA national ethics guidelines defines the constituents of ‘human tissue’,17 while the National Health Act (NHA) defines ‘biological materials’34 and ‘tissues’,35 where ‘tissues’ is used collectively to indicate cells and tissues, including stem cells. In Brazil, Resolution 196/96 refers to ‘scientific material, tissue, organs, other parts of the human body and biological materials’ without providing a definition of what constitutes these materials.24
Indentifiability of HBM
The various frameworks have no consistency in the level of identifiably used for HBM. Europe36 and Canada5 use 5 levels of identifiablity. The Indian28 and American37 frameworks distinguish between samples that are stored in repositories and samples that are collected for research. The RSA17 and Australia3 define 3 categories, while Kenya9 and Tanzania13 guidelines refer to 2 categories. None of the frameworks of the developing countries in Africa provides for nor defines the levels of identifiability for HBM.
Informed consent (IC)
Developed countries favour either broad consent or multilayered consent3 , 5 , 6 , 7 , 37 , 38 for the use of their HBM. Developing countries in Africa9-15 and the BRICS17 , 22 , 27 , 28 favour specific and multilayered consent. Broad consent allows investigators and other secondary users access to HBM in current and all unspecified future research anytime and anywhere. Multilayered consent provides research participants with several options, while specific consent allows use of HBM only in current research, and research participants must obtain consent for new use of their HBM that is outside the scope of the original consent.
Material transfer agreements (MTAs) and export permits (EPs)
Material transfer agreements (MTAs) are legally binding contracts that govern the transfer of HBM between collaborating researchers and institutions. The frameworks of developed countries, developing countries in Africa and BRICS countries require MTAs and permits for the import and export of HBM. In the RSA, the NHA16 is silent on the requirement of an MTA or an intellectual property right (IPR) for the transfer and use of HBM in international collaborative research. However, the IPR Act (Act No 51 of 2008) may apply to HBM.23 Of the national guidelines, only the HPCSA19 makes an MTA mandatory before tissues leave the country.
The absence of a globally acceptable uniform definition of HBM causes confusion, ambiguities and difficulties. The extent to which the identity of HBM can be linked with the identity of its source is important in assessing the potential risks and benefits to the provider of the material. The use of many terms to describe different levels of identifiability and their differing interpretations has been problematic in defining confidentiality.39 As a step towards harmonisation, the International Conference on Harmonisation of Technical Requirements (ICH)40 adopted 4 levels of identifiability, i.e. identified, coded, anonymised and anonymous. When research is conducted with HBM that is not identifiable and cannot be linked through a system of codes, the OHRP’s Common Rule (45CFR 46)8 considers such research as ‘non human.’ The Common Rule allows researchers unlimited use of leftover clinical specimens for any type of unspecified future research without IC or REC approval. Some individuals and communities object to certain uses of their HBM to the extent of instigating lawsuits.41 In the wake of the Tuskegee Syphilis and Guatemala scandals and the Havasupai Indian Tribe Case, President Obama issued an executive order to re-examine the Common Rule and all federal regulations, to consider consistency of regulations across the federal government and to extend federal oversight over all research in the USA.42
Defining IC requirements for collecting, storing and using HBM for research remains a controversial international issue.43 While most developed countries support broad consent, studies suggest that broad consent has not been convincingly embraced by all research communities,44 and they question the appropriateness of applying the IC formats of highly industrialised, individualist countries such as the USA and UK to manage HBM in cross-cultural settings and communitarian societies in developing countries, including those in Africa.50
Permits to export and import HMB are a legal requirement in most jurisdictions. In the UK, the HTA recommends that, whenever possible, the import and export of tissues be conducted via the HTA licensing regime under the supervision of a ‘designated individual (DI)’ named on the license.7 In the RSA, anecdotal evidence suggests that HBM and data might be regularly leaving the country, undocumented and unaccounted for at a national level51 without explicit consent, and the fate of the HBM is unknown.52 The NHA makes it a criminal offence punishable by a fine or imprisonment to export HBM without an export permit.53
It has been recommended that benefits derived from using HBMs are best addressed through MTAs and IPR agreements.54 Developing countries in Africa and BRICS regions require an MTA when using HBM in collaborative research with developed countries. The latter require MTAs for collaborations intra-nationally and between developed countries and take the position ‘that MTAs should not contain legally binding benefit sharing arrangements and restrictions on IP rights and that reference should be made only to guidelines’,55 perhaps because guideline documents are not legally binding.
In landmark cases in the UK and USA,41 the courts ruled, with reference to their national case laws, state health and safety laws, that research participants who ‘donate’ their HBM for research, make an irrevocable gift. The courts implied that research participants waived their rights to their HBM in accordance with properly obtained IC. These rulings were based solely on ownership and property rights. The Nuffield Council on Bioethics (NCB) proposed that HBM removed from patients during their treatment should be considered as ‘abandoned’,38 effectively denying rights to tissue providers over their removed tissues. Under such circumstances, benefits accrue only to the institutions in possession of HBM. In the Havasupai case, the US Appeal Court ruled that researchers from the University of Arizona return HBM to the Havasupai native Americans.48 Thus, the court respected the traditional customs of the Havasupai native Americans and recognised their right of custody and ownership of their HBM. Ownership of HBM has not been tested in South African Courts.
The lack of uniformity extends to the duration of storage of HBM obtained for research. Several policy statements recommend that HBM is stored for limited periods and not beyond the end date of a specific research project56 unless the original IC did not prohibit ‘unlimited time’ for the storage of HBM. The Royal College of Pathologists (UK) specify storage periods from 24 hours up to ‘at least 30 years’, depending on donor consent and on the type of HBM.57 The WHO recommends that genetic material (DNA) should be stored for as long as it can be of benefit to living or future relatives.58 The RSA national ethics guidelines place the responsibility on institutions to develop policies regulating the conduct of research using HBM.16 In Brazil, Resolution 347 in the guidelines on biobanks, authorises storage of HBM for 5 years.27
Differing definitions of what constitutes HBMs terms to describe identifiability and confidentiality, models of IC, and ambiguous regulatory language, are confusing and make comparisons of laws, regulations and guidelines of the different countries difficult and highly complex. There is also no general consensus as to how long HBM can and should be stored for research. These are serious impediments to ethical conduct of biomedical research involving HBM, and there is an urgent need to harmonise laws and regulations globally. This must reflect and embrace the interests and opinions of communities who altruistically provide HBM, as legitimate stakeholders, to advance medical knowledge and improve healthcare without compromising or hindering collaborative research. There must also be a paradigm shift from viewing HBM not only as a proprietary good, but also as a national resource for the common good.
With the troubled history of vulnerable populations in developing countries being exploited for their HBM, local national guidelines and laws require urgent amendment to include the need for MTAs when HBM is used in collaborative research. This could go a long way to end opportunities for the proliferation of undesirable and unethical practices.
1. Upshur REG, Lavery JV, Tindana P. Taking tissue seriously means taking communities seriously BMC Medical Ethics 2007; 8:11 [http://dx.doi.org/10.1186/1472-6939-8-11] http://www.biocentral.com/1472-6939/8/11 (accessed 30 October 2011).
2. International Compilation of Human Research Protections (CHRP).2011 edition compiled by OHRP. U.S. DHHS. http://www.hhs.gov/ohrp/international /HSPCCompilation.pdf (accessed 26 September 2011).
3. The Australian National Statement. National Statement on Ethical Conduct in Human Research. 2007. Joint statement of the Australian National Health Medical Research Council, Australian Research Council and Universities Australia. http://www.nhmrc.gov.au/files_nhmrc/file/publications/synopses/e72-jul09.pdf (accessed 29 April 2011).
4. The Australian Code for the Responsible Conduct of Research. 2007. Joint statement of the Australian National Health Medical Research Council, Australian Research Council and Universities Australia. http://www.unisa.edu.au/res /australiancode .asp (accessed 29 April 2011).
5. Tri Council Policy Statement (TCPS2). Ethical Conduct of Research Involving Humans. 2010. http:// www.pre.ethics.gc.ca/end/policy - politique/initiatives/revised-revisee/Default/ (accessed 20 Jan 2011).
6. United Kingdom Human Tissue Act (UKHTAct of 2004). Chapter 30. http://www.opsi.gov.uk/acts/acts2004/ ukpa_20040030_en_1 (accessed 2 January 2011).
7. Human Tissue Authority (HTA). Codes of Practices. 2009. http://www.hta.gov.UK/legislationpoliciesandcodesofpractice/codesofpractice.cfm (accessed 12 July 2011).
8. Code of Federal Regulations Title 45 Public Welfare. Department of Health and Human Services Part 46 (54CRF46). Protection of human subjects. 2009. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html (accessed 2 January 2011).
9. National Council for Science and Technology (NCST). No 45. Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya, 2004. http://webapps.sph.harvard.Edu/live/gremap/files/ke_NCST_guidelines. pdf (accessed 15 March 2010).
10. National Research Council of Malawi (NRCM) .Procedures and Guidelines for the conduct of Research in Malawi 2003. http://www.sdnp.org.mw/ NRCM/policies/guidline3.htm (accessed 15 March 2010).
11. National Research Council of Malawi (NRCM). Proceedings and guidelines for access and collection of genetic resources in Malawi. 2002. http://www.sdnp.org.mw/NRCM/policies/guideline 4.htm (accessed 15 March 2010).
12. National Health Research Ethics Committee of Nigeria (NHRECN). Federal Ministry of Health, Department of Health Planning and Research. National Code of Health Research Ethics. 2007. http://www.nhrec.net (accessed 15 March 2010).
13. National Health Research Ethics Committee of Tanzania (NHRECT) United Republic of Tanzania. 2001. TNHRF. Guidelines on Ethics for Health Research in Tanzania. http//:www.sph.havard.edu/live/gremap/files/guidelines-2001-TZ-full.pdf (accessed 15 March 2010).
14. Ugandan National Council of Science and Technology (UNCST). National Guidelines for Research Involving Humans as Research Participants. 2007. http://www.UNCST.go.ug/site/document/rihpguide.pdf (accessed 20 August 2010).
15. Medical Research Council of Zimbabwe (MRCZ). Conducting Health Research in Zimbabwe: What researchers need to know. Aug 2004 (accessed 15 March 2010).
16. National Health Act (Act No 61 of 2003). Government Gazette, RSA; Vol 469, No 26595; 23rd July 2004. http://www.info.gov.za/view/Download File Action?id=68039 (accessed 19 January 2010).
17. Department of Health. Ethics in Health Research: Principles, Structures and Processes. 2004. http://www.doh.gov.za /documents/factsheets/ guidelines/ research ethicsguidelines (accessed 15 September 2011).
18. Department of Health. Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa Department of Health: 2006. Pretoria, South Africa. http://www.kznhealth.gov.za/research/ guidelines2.pdf. (Accessed 20 March 2012).
19. Health Professions Council of South Africa (HPCSA). 2008. Guidelines for Good Practice in Health Care Professions. General Ethical Guidelines for Health Researchers. Booklet 6. http://www.hpcsa.co.za/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_6.pdf (accessed 20 October 2010).
20. Health Professions Council of South Africa (HPCSA). Guidelines for Good Practice in Health Care Professions General Guidelines for Biotechnology Research. Booklet 7. 2008. http://www.hpcsa.co.za/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_7_medical_biotechnologyresearch.pdf9 (accessed 20 October 2010).
21. South African Medical Research Council (SAMRC) Guidelines on Ethics for Medical Research. Book 1. General principles including research on children, vulnerable group, international collaboration and epidemiology. 2002. http://www. sahealthinfo.org/ethics/book1.htm (accessed 16 June 2010).
22. South African Medical Research Council (SAMRC). Guidelines on Ethics for Medical Research. Book 2. Reproductive Biology and Genetic Research 2002. http://www.sahealthinfo.org/ethics/ book2. Htm (accessed 16 June 2010).
23. Intellectual Property Rights from Publicly Financed Research and Development Act (IPR Act) (Act No 51 of 2008). Government Gazette. No 3174 RSA. Vol 522. 22nd December 2008. http://www.polity.org.za/article /intellectual-property-rights-from-publicly-financed-research-and-development-act-act-no-51-of-2008-2009-01-22 (accessed 20 November 2010).
24. Consello Nacional de Saude (National Health Council) (CNS) Resolution No 196. 1996. Rules on Research involving Human Subjects. http://www. conselho.saude.gov.br/docs/Resolucoes/ reso_196 english. doc (accessed 6 January 20109).
25. Consello Nacional de Saude (National Health Council) CNS. (Resolution No 292. Research with Foreign co-operation. 1999. http://www.conselho.saude.gov.br/web_comissoes/.../regulation_res_ 292_ english.doc (accessed 6 January 2010).
26. Consello Nacional de Saude (National Health Council) CNS (Resolution 304) Research Involving Human Subjects - Indigenous Area. 2000. http://conselho.saude.gov.br/docs/Reso304.doc (accessed 6 January 2010).
27. Consello Nacional de Saude (National Health Council) CNS Resolution No 347. Approval guidelines for ethical analysis of research projects involving storage of materials or use of materials stored by previous research. 2005. http://conselho.saude.gov.br/docs/Reso347.doc (accessed 6 January 2010)
28. Indian Council of Medical Research (ICMR). Ethical Guidelines for Biomedical Research on human Participants. 2006. New Delhi. http://www.icmr.nic.in/ethical_guidlines.pdf (accessed 20 January 2010).
29. Office for the Protection of Human Research Protections (OHRP). Guidance on Research Involving Coded Private Information or Biological Specimens. October 16, 2008. http://www.hhs.gov/ohrp/humansubjects/guidance /codebiol.htm (accessed 10 January 2010).
30. Office for the Protection of Human Research Protections (OHRP). Issues to consider in the Research Use of stored data or tissues. Guidance Topic; Office for Protection from Research Risks. Department of Health and Human Services. November 7, 1997. http://www.hhs.gov/OHRP/policy/ index.html (accessed 10 January 2011).
31. National Bioethics Advisory Commission (NBAC). Ethical and Policy issues in research involving human participants, Vol 1, Report and Recommendations of the NBAC. August 2001. Bethesda, Maryland. http://bioethics.georgetown.edu/nbac/human/overvol1.pdf (accessed 15 August 2010).
32. National Cancer Institute (NCI). Office of Biorepositories and Biospecimen Research. Best Practices for biospecimen resources. June 2007. http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.PDF (accessed 27 June 2010).
33. Medical Research Council of Zimbabwe (MRCZ). Ethical Guidelines on the Collection of Blood Samples for Research purposes, Article No.1. 29TH July 1999. http://www.MRCZ.org.zw/doc/blood (accessed 15 March 2010).
34. National Health Act (Act No 61 of 2003). Regulations relating to the use of Human Biological Material 20110401 – Regulation No.9699, Government Gazette No 35099, Notice No.177 of 02-March--2012. pages 31-38. http://discover.sabinet. co.za/document/GGD120926 (accessed 19 March 2012).
35. National Health Act (Act No 61 of 2003). Regulations relating to Tissue Banks. Regulation No.9699, Government Gazette No 35099, Notice No.182of 02-March-2012. Pages 125-141. http://discover.sabinet.co.za/document / GGD120931 (accessed 19 March 2012).
36. Council of Europe (CoE). Bioethics Division Recommendation of the Committee of Ministers to member states on research on biological materials of human origin. Strasbourg, France: Council of Europe. 2006. http://conventions.coe.int/t/dg3/ healthbioethic (accessed 5 January 2011).
37. National Bioethics Advisory Commission (NBAC). Ethical and Policy issues in International Research; Clinical trials in developing countries Vol 1, Report and Recommendations of the NBAC. Bethesda, Maryland. April 2001. http:/www.bioethics.georgetown.edu/nbac/ clinical/vol1.pdf (accessed 15 August 2011).
38. Nuffield Council of Bioethics (NCB). Human Tissue. Ethical and Legal Issues. 1995. http://www.nuffieldbioethics.org/sites/default/files/Human% 20tissue .pdf. (Accessed 15 February 2011).
39. Knoppers BM, Saginur M. The babel of genetic data terminology. Nat Biotech 2005;23:925-927.
40. International Conference on Harmonisation (ICH). Harmonised tripartite guideline definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories, E15. vol. 73. The US Federal Register 2007;19074-19076. http:// www. ich.org /LOB /media / MEDIA 3383. pdf.(accessed 20 March 2012).
41. Wolf LE. Advancing research on stored biological materials. Reconciling law, ethics and practice. Minn JL Sci Tech 2010;11:99-156.
42. Emmanuel EJ, Menikoff J. Reforming the regulations governing research with human subjects N Engl J Med 2011;365:1145-1150.
43. Hofmann B. Broadening consent and diluting ethics? J Med Ethics 2009;35:125-129.
44. Hanson MG. Ethics and biobanks.Br J Cancer 2009;100:8-12.
45. Murphy SJ, Kaufman D, Geller G, LeRoy L, Hudson K. Public perspectives on informed consent for biobanking. Am J Pub Health 2009;99:1-7.
46. Abou-Zeid A, Silverman H, Shehata SM, et al. Collection, storage and use of blood samples for future research: views of Egyptian patients expressed in a cross-sectional survey. J Med Ethics 2010;36:539-547.
47. Al-Qadire MM, Hammami MM, Abdulhameed HM, Al Gaai EA. Saudi views on consenting for research on medical records and leftover tissue samples. BMC Medical Ethics 2010; 11:18 [http://dx.doi.org/10.1186/1472-6939-11-18 (accessed 15 December 2011).
48. Mello MM, Wolf LE. The Havasupai Indian Tribe case – Lessons for research involving stored biological samples. N Engl J Med 2010;363(3):204-207.
49. Agulanna C.The requirement of informed consent in research ethics: Procedure for implementing a crucial ethical norm in African communal culture. Euro J Sci Res 2010;44:204-219.
50. Hardy B-J, Seguin B, Ramesar R, Singer PA, Daar AS. South Africa: from species cradle to genomic applications. Nature Reviews Genetics 2008;October:S19-S23.
51. Schoppe, D, Upshur R, Matthys F, et al. Research ethics review in humanitarian contexts: The experience of the Independent Ethics Review Board of Medicins Sans Frontieres. Plos Med 2009;6:1-6.
52. MacQueen KM, Alleman P. International perspectives on the collection, storage, and testing of human biospecimens in HIV research. IRB Ethics and Human Research 2008;30:9-14.
53. National Health Act (Act No 61 of 2003). Regulations relating to the import and export of human tissue, blood, blood products, cultured cells, stem cells, embryos, zygotes and gametes. Regulation No.9699, Government Gazette No 35099, Notice No.181of 02-March-2012. Pages97-124. http://discover.sabinet.co.za/ document /GGD120930 (accessed 19 March 2012).
54. Andanda PA. Human tissue related invention; ownership and intellectual property rights in international collaborative research in developing countries. J Med Ethics 2008;34:171-179.
55. Zhang X, Matsui K, Krohmai B, et al. Attitudes towards transfers of human tissue samples across borders: An international survey of researchers and policy makers in five countries. BMC Medical Ethics 2010;11:16. htpp:// www. biomedicalcentral.com/1472-6939/11/16.Doi:10.1186/1472-6939-11-6 (accessed 20 October 2011).
56. Godard B, Scmidtke J, Cassiman JJ, Ayme S. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective. Europ J Human Genet 2003;11:S88-S122.
57. Royal College of Pathologists (RCP). The retention storage of pathological records and specimens. 2009. http://www.rcpath.org/NR/rdonlyres /16790462-7978-434D-B3BB-A29E427059F9/o/go3/retentionstoragea (accessed 20 October 2011).
58. World Health Organization (WHO). Proposed international guidelines on ethical issues in medical genetics and genetic services. Geneva. 2009. http:// www.who.int /genomics/publications/en/ethical_issues_medgenetics%20report.pdf (accessed 2 March 2012).
This paper forms part of a research report for the MSc Med (Bioethics & Health Law) completed by the first author at the Steve Biko Centre for Bioethics.
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