Collaborative International Research: Ethical and Regulatory Issues Pertaining to Human Biological Materials at a South African Institutional Research Ethics Committee

Developing World Bioethics

Volumn 14, Issue 3, 2014, Pages 150-157

  Sathar, Aslam ^a   Dhai, Amaboo ^b   van der Linde, Stephan ^c  

^a UNIVERSITY OF KWAZULU NATAL   (South Africa)

^b UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^c University of KwaZulu Natal Faculty of Health Sciences   (South Africa)

Author keywords

Collaborative research; Developed and Developing Countries; Human Biological Materials

Indexed keywords

CONFIDENTIALITY; CROSS-SECTIONAL STUDY; ETHICS; HEALTH CARE FACILITY; HUMAN; INFORMED CONSENT; INTERNATIONAL COOPERATION; LABORATORY DIAGNOSIS; LEGISLATION AND JURISPRUDENCE; MEDICAL RESEARCH; METHODOLOGY; PERSONNEL; PROFESSIONAL STANDARD; RESEARCH ETHICS; RESEARCH SUBJECT; RETROSPECTIVE STUDY; SOUTH AFRICA; STANDARDS;

BIOMEDICAL RESEARCH; CONFIDENTIALITY; CROSS-SECTIONAL STUDIES; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; INTERNATIONAL COOPERATION; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RETROSPECTIVE STUDIES; SOUTH AFRICA; SPECIMEN HANDLING; TISSUE BANKS;

EID: 84939270517     PISSN: 14718731     EISSN: 14718847     Source Type: Journal    
DOI: 10.1111/dewb.12018     Document Type: Article

References (40)

1. F.A. Theirs, A.J. Sinskey & R. Berndt. Trends in the globalization of clinical trials. Nature Reviews Drug Discovery 2008; 7: 13-14.
2. A. Dhai. Research ethics review-protecting participants in research. SAMJ 2005; 95: 595-597.
3. R.E.G. Upshur, J.V. Lavery & P. Tindana. Taking tissue seriously means taking communities seriously. BMC Medical Ethics 2007; 8: 11 doi: 10.1186/1472-6939-8-11. Available at http://www.biomedcentral.com/1472-6939/8/11 [Accessed 28 Sept 2012].
4. 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.
5. G. Mudur. Indian scientists object to export of human biological material for research. BMJ 2002; 325: 990.
6. M.M. Mello & L.E. Wolf. The Havasupai Indian Tribe case-Lessons for research involving stored biological samples. NEJM. 2002; 363: 204-207
7. D. Schopper, R. Upshur, F. Matthys, J.A. Singh. etal. Research ethics review in Humanitarian contexts: The experience of the Independent Ethics Review Board of Medicins Sans Frontieres. Plos Med 2009; 6: 1-6.
8. C.I. Emerson, P.A. Singer & R.E. Upshur. Access and use of human tissues from the developing world; ethical challenges and a way forward using a tissue trust. BMC Medical Ethics 2011; 12: 2-5.
9. X. Zhang, K. Matsui, B. Krohmai. etal. 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. Available at http://www.biomedicalcentral.com/14726939/11/16. doi:10.1186/1472-6939-11-6 [Accessed 28 Sept 2012].
10. E.J. Emmanuel, D. Wendler, J. Killen & C. Grady. What makes clinical research in Developing countries ethical? The benchmarks of ethical research. J Infect Dis 2004; 189: 930-937.
11. T.J. Tucker & M.W. Makgoba. Public-Private partnerships and scientific imperialism. Science 2008; 320(23 May): 1016-1017.
12. P. Ndebele. Material Transfer Agreement are a "must" when transferring specimens across national boundaries. J Med Ethics 2007; 33: 35-38. Available at http://jme.bmj.Com/content/33/1/35reply (this is a letter in response to op.cit. note 33.) [Accessed 19 Dec 2012].
13. B.J. Hardy, B. Seguin, R. Ramesar, P.A. Singer & A.S. Daar. South Africa: from species cradle to genomic applications. Nature Reviews Genetics-Genomic medicine in developing countries 2008; October: S19-S23.
14. R.C. Altman. The Great Crash. A Geopolitical setback for the West, January/February Foreign Affairs 2008; Available at http://www.Foreignaffairs.com/print/63714 [Accessed 28 Sept 2012].
15. S.K. Langat. Reuse of samples; Ethical issues encountered by two institutional ethics review committees in Kenya. Bioethics 2005; 19: 538-549.
16. C. Agulanna. 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.
17. M.A. Hansson. Ethics and Biobanks. Br J Cancer 2009; 100: 8-12
18. J. Murphy, J. Scott, D. Kaufman, G. Geller etal. Public perspectives on informed consent for biobanking. Am J Pub Health 2009; 99: 1-7
19. A. Abou-Zeid, H. Silverman, M. Shehata Shams. etal. 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
20. M.M. Al-Qadire, M.M. Hammami, H.M. Abdulhameed & E.A. Al Gaai. Saudi views on consenting for research on medical records and leftover tissue samples. BMC Medical Ethics. 2010; 11: 18. Doi: 10.1186/1472-6939-11-18 http://www.biomedcentral.com/1472-6939/11/18 [Accessed 19 Dec 2012].
21. Department of Health. Republic of South Africa. Ethics in Health Research: Principles, Structures and Processes. 2004. Available from http://www.doh.gov.za/show.php?id=1492. [Accessed 19 Dec 2012].
22. B. Godard, J. Scmidtke, J.J. Cassiman & S. Ayme. Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective. Europ J Human Gent 11: S88-S122
23. Royal College of Pathologists (RCP). The Retention storage of pathological records and specimens. 2009. Available at http://www.rcpath.org/NR/rdonlyres/16790462-7978-434D-B3BB-A29E427059F9/o/go3/retentionstoragea [Accessed 28 Sept 2012].
24. World Health Organisation (WHO). Proposed international guidelines on ethical issues in medical genetics and genetic services. Geneva. 2009. Available at http://www.who.int/genomics/publications/en/ethicalissues_medgenetics%20report.pdf [Accessed 28 Sept 2012].
25. rd July 2004; 469 (26595). Available at http://www.info.gov.za/view/DownloadFileAction?id=68039. [Accessed 28 Sept 2012].
26. D. Wendler, C. Pace, A.O. Talisuna etal. Research on stored biological samples; The views of Ugandans. IRB Ethics and Human Research 2005; 27: 1-5.
27. South African Human Tissue Act (Act 65 of 1983). Available at http://www.ncbi.nlm.nih.gov/pubmed/12289616 [Accessed 28 Sept 2012].
28. 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. 97-124. Available at http://www.greengazette.co.za/notices/national-health-act-no-61-of-2003-regulations-import-and-export-of-human-tissue-blood-blood-products-cultured-cells-stem-cells-embryos-foetal-tissue-zygotes-and-gametes_20120302-GGR-35099-00181 [Accessed 19 Dec 2012].
29. OBBR. Symposium-Workshop on Custodianship and Ownership Issues in Biospecimen Research 2008. Available at http:/biospecimens.cancer.gov/resources/publications/workshop/cow.asp; [Accessed 19 Dec 2012]
30. 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.
31. SAMRC. Guidelines on Ethics for Medical Research. Book 1. General principles including research on children, vulnerable group, international collaboration and epidemiology 2002. Available at http://www.Sahealthinfo.org/ethics/book1.htm. [Accessed 28 Sept 2012].
32. HPCSA. Guidelines for Good Practice in Health Care Professions. General Ethical Guidelines for Health Researchers. 2008a; Booklet 6. Available at http://www.hpcsa.co.za/downloads/conduct_ethics/rules/generic_ethical_rules/booklet_6.pdf [Accessed 19 Dec 2012]
33. HPCSA. Guidelines for Good Practice in Health Care Professions General Guidelines for Biotechnology Research. 2008b; Booklet7. Available at http://www.hpcsa.co.za/downloads/conduct_ethics/rules/generic_ethical_rules/ [Accessed 19 Dec 2012].
34. FDA. Institutional Review Boards frequently asked questions-Information Sheet. Guidance to Institutional Review Boards and Clinical Investigators. 1998. Available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm#Informed%20Consent%20Process [Accessed 26 Oct 2012].
35. OHRP. Exculpatory language in informed consent documents. 1996; Available at http://www.hhs.gov/ohrp/policy/exculp.html. [Accessed 26 Oct 2012].
36. IPRAct. Intellectual Property Rights from Publicly Financed Research and Development Act 51 of 2008: Regulations. Government Gazette No. 33433 RSA. Regulation 675. 2010. Available at http://www.greengazette.co.za/acts/intellectual-property-rights-from-publicly-financed-research-and-development-act_2008-051 [Accessed 19 Dec 2012].
37. R. Steinbrook. Online disclosure of Physician-industry relationships. NEJM 2009; 360: 325-327
38. R. Steinbrook. Disclosure of Industry payments to physicians. NEJM 2008; 359: 559-561.
39. Department of Health. Republic of South Africa. Ethics in Health Research: Principles, Structures and Processes. 2004. op.cit. note 22. s 2.11:6 and 7.10:36, respectively.
40. D. McQuoid-Mason. UKZN Anniversary symposium on the medico-legal and ethical implications of human tissue use. SAJBL 2011; 4: 13-14.