Managing Human Tissue Transfer Across National Boundaries - An Approach from an Institution in South Africa

Developing World Bioethics

Volumn 16, Issue 1, 2016, Pages 29-35

  Mahomed, Safia ^a   Behrens, Kevin ^b   Slabbert, Melodie ^b   Sanne, Ian ^b  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^b NONE

Author keywords

Benefit sharing; Biobanks; Human Biological Materials; Informed consent; Intellectual Property rights; Material Transfer Agreements; Ownership

Indexed keywords

ETHICS; HUMAN; INFORMED CONSENT; INTERNATIONAL COOPERATION; MEDICAL RESEARCH; ORGANIZATION AND MANAGEMENT; PATENT; SOUTH AFRICA; SPECIMEN HANDLING; TISSUE BANK;

BIOMEDICAL RESEARCH; HUMANS; INFORMED CONSENT; INTELLECTUAL PROPERTY; INTERNATIONAL COOPERATION; OWNERSHIP; SOUTH AFRICA; SPECIMEN HANDLING; TISSUE BANKS;

EID: 84959507199     PISSN: 14718731     EISSN: 14718847     Source Type: Journal    
DOI: 10.1111/dewb.12080     Document Type: Article

References (34)

1. A. Dhai . Establishing National Biobanks in South Africa: The Urgent need for an Ethico-Regulatory framework. SAJBL 2013; 6: 38-39.
2. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html [Accessed 15 Jan 2015].
3. 64th World Medical Association General Assembly, Fortaleza, Brazil, October 2013.
4. Available at: http://www.wits.ac.za/academic/researchsupport/19112/ethics_application_forms_guidance:notesand_policy_documents.html [Accessed 15 Jan 2015].
5. S. Mahomed & A. Dhai . Biobank Research - Implications for Africa? Science in Africa, Science magazine for Africa CC. Available at: http://www.scienceinafrica.com/biotechnology/people/biobank-research-%E2%80%93-implications-africa [Accessed 15 Jan 2015]. See also: A. Dhai & S. Mahomed . Biobank Research: Time for Discussion and Debate. SAMJ 2013;103;4: 225-227.
6. A. Dhai . Practical Ethics Guide for Researchers and Research Ethics Committee Members. Steve Biko Centre for Bioethics Resource Manual 2012.
7. S. Mahomed & A. Dhai . op. cit. note .
8. The Human Research Ethics Committee Medical: Principles and Policy on Biobanks, University of the Witwatersrand, Johannesburg, South Africa. Compiled by the Biobanks Ethics Committee of the WITS HREC; 2013. Available at: http://www.wits.ac.za/files/ge41p_501401001375950888.pdf [Accessed 15 Jan 2015] (This definition was adapted from the Organisation for Economic Co-operation and Development Guidelines on Human Biobanks and Genetic Research Data bases 2009)
9. A. Sathar etal. Collaborative International Research: Ethical and Regulatory Issues Pertaining to Human Biological Materials at a South African Institutional Research Ethics Committee DWB 2013: 1471-8847.
10. GN R 378 in South African Government Gazette 36508 of 29 May 2013.
11. The Human Research Ethics Committee Medical: Material Transfer Agreement for Human Biological Materials, University of the Witwatersrand, Johannesburg, South Africa. 2014. Compiled by the Biobanks Ethics Committee of the WITS HREC.
12. K.S. Steinsbekk, B.K. Myskja & B. Solberg . Broad ConsentversusDynamic Consent in Biobank Research: Is Passive Participation an Ethical Problem? European Journal of Human Genetics 2013; 21: 897-902. Available at: http://www.nature.com/ejhg/journal/v21/n9/full/ejhg2012282a.html [Accessed 15 Jan 2015].
13. M. Otlowski . Developing an Appropriate Consent Model for Biobanks: in Defence of 'Broad' Consent; in: Kaye J, Stranger M (eds.) Principles and Practise in Biobank Governance. Burlington: Aschgate Publishing Company 2009; 79-92; K.S. Steinsbekk & B. Solberg . Biobanks - When is Re-Consent Necessary? Public Health Ethics 2011; 4: 236-250
14. G. Helgesson . In Defense of Broad Consent. Camb Q Healthc Ethics 2012; 21: 40-50. M.G. Hansson etal. Should Donors be allowed to give Broad Consent to Future Biobank Research? Lancet Oncol 2006; 7: 266-269.
15. K.S. Steinsbekk, B.K. Myskja & B. Solberg . Broad Consent versus Dynamic Consent in Biobank Research: Is Passive Participation an Ethical Problem? European Journal of Human Genetics 2013; 21: 897-902.
16. K.S. Steinsbekk, B.K. Myskja & B. Solberg . op. cit. note .
17. G. Foe . Biobanks and Informed Consent Voices in Bioethics, Columbia University, 26 March 2014. Available at: http://voicesinbioethics.org/2014/03/26/biobanks-and-informed-consent/ [Accessed 15 Jan 2015].
18. The Human Research Ethics Committee Medical: Material Transfer Agreement for Human Biological Materials, University of the Witwatersrand, Johannesburg, South Africa. Compiled by the Biobanks Ethics Committee of the WITS HREC 2014.
19. Legal opinion by Norton Rose Fulbright titled: Biobank- Opinion 5 February 2014.
20. Section 11 of the Protection of Personal Information Act 4 of 2013 & Legal opinion by Norton Rose Fulbright titled: Biobank- Opinion 5 February 2014.
21. A. Cambon-Thomsen, E. Rial-Sebbag & B.M. Knoppers . Trends in Ethical and Legal Frameworks for the use of Human Biobanks. European Respiratory Journal 2007; 30 373-382.
22. Chennells R.S, The Action Group on Erosion, Technology and Concentration, 2005, Group web site, Available at: http://www.etcgroup.org/text/txt_key_defs.asp [Accessed 15 Jan 2015]; Report on Biopiracy by the Edmonds Institute in cooperation with the African Centre for Biosafety, Available at: http://www.edmonds-institute.org/outofafrica.pdf. [Accessed 25 June 2014];
23. R.S. Chennells . Equitable Access to Human Biological Resources in Developing Countries: Benefit Sharing without Undue Inducement. School of Health: University of Central Lancashire, PhD theses, April 2014
24. P.A. Andanda . Human Tissue related Invention; Ownership and Intellectual property rights in International Collaborative Research in Developing Countries. J Med Ethics 2008; 34: 171-179.
25. A.S. Muula & J.M. Mfutso-Bengo . Responsibilities and Obligations of using Human Research Specimens Transported across National Boundaries. J. Med. Ethics 2007; 33: 35-38
26. Sathar etal. Collaborative International Research: Ethical and Regulatory Issues Pertaining to Human Biological Materials at a South African Institutional Research Ethics Committee DWB 2013: 1471-8847.
27. The Human Research Ethics Committee Medical: Material Transfer Agreement for Human Biological Materials, University of the Witwatersrand, Johannesburg, South Africa 2014. Compiled by the Biobanks Ethics Committee of the WITS HREC.
28. S. Mahomed, M. Nöthling-Slabbert & M.S. Pepper . The Legal Position on the Classification of Human Tissue in South Africa: Can Tissues be Owned? SAJBL 2013; 6: 16-20. Available at: http://www.sajbl.org.za/index.php/sajbl/article/view/258/275 [Accessed 15 Jan 2015].
29. http://www.telegraph.co.uk/news/worldnews/africaandindianocean/southafrica/8124710/South-African-hospital-pleads-guilty-to-organ-trafficking-case.html [Accessed 14 November 2014]
30. S.F. Gibson . The Washington University v Catalona: Determining Ownership of Genetic Samples. Jurimetrics J 2008; 48: 167-191.
31. L.M. Ivey . Moore v Regents of the University of California: Insufficient Protection of Patients' Rights in the Biotechnological Market. Georgia Law Review 1990-1992; 25: 490
32. J. Lavoie . Ownership of Human Tissue: Life after Moore v. Regents of the University of California. Virginia Law Review 1989; 75(7): 1363-1396.
33. S.F. Gibson . The Washington University v Catalona: Determining Ownership of Genetic Samples. Jurimetrics J 2008; 48: 167-191.
34. The Human Research Ethics Committee Medical: Material Transfer Agreement for Human Biological Materials, University of the Witwatersrand, Johannesburg, South Africa. 2014. Compiled by the Biobanks Ethics Committee of the WITS HREC.