"The keeping is the problem": A qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research

BMC Medical Ethics

Volumn 16, Issue 1, 2015, Pages

  Barchi, Francis ^a   Matlhagela, Keikantse ^b   Jones, Nicola ^c   Kebaabetswe, Poloko M ^b   Merz, Jon F ^d  

^a RUTGERS UNIVERSITY   (United States)

^b UNIVERSITY OF BOTSWANA   (Botswana)

^c BOTSWANA UPENN PARTNERSHIP   (Botswana)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOBANK; BOTSWANA; CAPACITY BUILDING; DECISION MAKING; ETHICS; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD; QUALITATIVE RESEARCH; RESEARCH ETHICS;

BIOLOGICAL SPECIMEN BANKS; BIOMEDICAL RESEARCH; BOTSWANA; CAPACITY BUILDING; DECISION MAKING; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; OWNERSHIP; QUALITATIVE RESEARCH;

EID: 84939422073     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/s12910-015-0047-3     Document Type: Article

References (47)

1. International HapMapProject [http://hapmap.ncbi.nlm.nih.gov]
2. The 1000 Genomes Project [www.1000genomes.org]
3. Malaria Genomic Epidemiology Network [www.malariaGEN.net]
4. Sirugo G, van der Loeff S, Sam O, Nyan O, Pinder M, Hill AV, et al. A national DNA bank in the Gambia, West Africa, and genomic research in developing countries. Nat Genet. 2004;36:785-6. doi: 10.1038/ng0804-785.
5. Matimba A, Oluka MN, Ebeshi BU, Sayi J, Bolaji OO, Guantai AI, et al. Establishment of a biobank and pharmacogenetics database of African populations. Eur J Hum Genet. 2008;16:780-3. doi: 10.1038/ejhg.2008.49.
6. University of Kwazulu-Natal African Center for Health and Population Studies [www.africacentre.ac.za/Default.aspx?tabid=460]
7. Human Heredity and health in Africa (H3Africa) [http://www.h3africa.org/]
8. Bruinenberg M, Frey M, Napier M, Summers A. Comparing the hub-and-spoke model practices of the LifeLines study in the Netherlands and the H3Africa Initiative. Biopreserv Biobank. 2014;12:13-6. doi: 10.1089/bio.2013.0057.
9. Abayomi A. Experience of the NHLS Stellenbosch Biobank-H3Africa and the H3Africa Consortium biobanking working group. [Powerpoint presentation at the ESBB 2013 Conference, Verona, Italy: 8 - 11 October 2013] [www.esbb.org/verona/download/14.abayomi%20.pdf]
10. De Vries J, Bull SJ, Doumbo O, Ibrahim M, Mercereau-Puijalon O, Kwiatkowski D, et al. Ethical issues in human genomics research in developing countries. BMC Med Ethics 2011, 12:5 [http://www.biomedcentral.com/1472-6939/12/5]
11. Nykia A. Ethical and practical challenges surrounding genetic and genomic research in developing countries. Acta Trop. 2009;112(S):S21-31. doi: 10.1016/j.actatropica.2009.07.034.
12. Staunton C, Moodley K. Challenges in biobank governance in Sub-Saharan Africa. BMC Med Ethics 2013, 14:35. [http://www.biomedcentral.com/1472-6939/14/35]
13. Christakis NA. Ethics are local: engaging cross-cultural variation in the ethics for clinical research. Soc Sci Med. 1992;35:1079-91. doi: 10.1016/0277-9536(92)90220-K.
14. Baylor International Pediatric AIDS Initiative [www.bipai.org/botswana]
15. Botswana Harvard AIDS Institute Partnership (BHP) [aids.harvard.edu/reserch/bhp/]
16. Botswana-UPenn Partnership [www.med.upenn.edu/botswana]
17. BOTUSA Project [www.cdc.gov/tb/topic/globaltb/botswana.htm]
18. I-TECH Botswana [www.go2itech.org/where-we-work/botswana/]
19. University of Botswana. A strategy for excellence: University of Botswana Strategic Plan to 2016 and Beyond 2008. [www.ub.bw/content/id/2167/read-more/]
20. BHP. Mochudi Prevention Project [https://clinicaltrials.gov/ct2/show/NCT01583439]
21. University of Pennsylvania, Perelman School of Medicine. African Genomic and Phenotypic Diversity Project. [http://www.med.upenn.edu/tishkoff/Research/research.html#DiversityProject]
22. H3Africa. Collaborative African Genomics Network (CAfGEN) [www.H3africa.org/projects/16-projects/89 - cafgen]
23. Botswana Statute Law. The Anthropological Research Act 1967 [http://www.elaws.gov.bw/docs/statutes/Botswana%20Statute%20Law%201967.pdf]
24. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. [http://www.wma.net/en/30publications/10policies/b3/]
25. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research involving Human Subjects [http://www.cioms.ch/publications/layout-guide2002.pdf]
26. Botswana Drugs Advisory Board. Guidelines on drug registration applications in Botswana [4th rev. version]. 2014. [www.moh.gov.bw/Publications/drug-regulation/Guidelines%20on%20Drug%20Registration%20Applications%20in%20Botswana%202014.pdf]
27. Republic of Botswana, Ministry of Health. Standard operating procedures for review of biomedical and bio-behavioural research in Botswana. 2011.
28. Sithole J. Botswana: Killing two birds with one stone. Exchange on HIV/AIDS, Sexuality, and Gender 2009. [www.bibalex.org/Search4Dev/document/315738]
29. Kayira K, Bwanais L, Njobvu A, Malenga G, Talor T. What It Means to Offer an Autopsy in Malaw. In: Lavery JV, Grady C, Wahl ER, Emanuel EJ, editors. Ethical Issues in International Biomedical Research: A Casebook. New York: Oxford University Press; 2007. p. 285-6.
30. Marshall PA, Adebamowo CA, Adeyemo AA, Ogundiran TO, Vekich M, Strenski T, et al. Voluntary participation and informed consent to international genetic research. Am J Public Health. 2006;96:1989-95. doi: 10.2105/AJPH.2005.076232.
31. Molyneux CS, Peshu N, Marsh K. Trust and informed consent: insights from community members on the Kenyan coast. Soc Sci Med. 2006;61:1463-73. doi: 10.1016/j.socscimed.2004.11.073.
32. Moodley K, Sibanda N, February K, Rossouw T. It's my blood: ethical complexities in the use, storage, and export of biological samples: perspectives from South African research participants. BMC Med Ethics 2014, 15:4. [http://www.biomedcentral.com/1472-6939/15/4]
33. Jenkins G, Sugarman J. The importance of cultural considerations in the promotion of ethical research with human biological material. J Lab Clin Med. 2005;145:118-24. doi: 10.1016/j.lab.2005.01.001.
34. Campbell CS. Religion and the body in medical research. Kennedy Inst Ethic J. 1996;8:c275-305.
35. Dukepoo F. Sensitivities and concerns of research in Native American communities. [Transcript of the meeting of the National Bioethics Commission held in Portland, Oregon, 14-15 July 1998.] Unpublished document. Bethesda, MD: The Commission. July 1998.
36. Geissler PW, Kelly A, Imoukhuede B, Pool R. 'He is now like a brother, I can even give him some blood' - Relational ethics and material exchanges in a malaria vaccine 'trial community' in The Gambia. Soc Sci Med. 2008;67:696-707. doi: 10.1016/j.socscimed.2008.02.004.
37. van Schalkwyk G, de Vries J, Moodley, K. "It's for a good cause, isn't it?" - exploring views of South African TB research participants on sample storage and re-use. BMC Med Ethics 2012, 13:19. [http://www.biomedcentral.com/1472-6939/13/19]
38. Emerson CI, Singer PA, Upshur REG. Access and use of human tissues from the developing world: Ethical challenges and a way forward using a tissue trust. BMC Med Ethics 2011, 12:2 [http://www.biomedcentral.com/1472-6939/12/2]
39. Wendler D, Pace C, Talisuna AO, Maiso F, Grady C, Emanuel EJ. Research on stored biological samples: The views of Ugandans. IRB. 2005;27:1-5.
40. Igbe MA, Adebamowo CA. Qualitative study of knowledge and attitudes to biobanking among lay persons in Nigeria. BMC Med Ethics 2012, 13:27. [http://www.biomedcentral.com/1472-6939/13/27]
41. Langat SK. Reuse of samples: Ethical issues encountered by two institutional ethics review committees in Kenya. Bioethics. 2005;19:537-49. doi: 10.1111/j.1467-8519.2005.00463.x.
42. Nykia A, Kilama W, Chilengi R, Tangwa G, Tindana P, Ndebele P, et al. Composition, training needs and independence of ethics review committees across Africa: are the gatekeepers rising to the emerging challenges? J Med Ethics. 2009;35:189-93. doi: 10.1136/jme.2008.025189.
43. Sathar MA, Dhai A. 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. S Afr J BL. 2012;5:51-4.
44. Tindana P, Bull S, Amenga-Etego L, deVries J, Aborigo R, Koram K, et al. Seeking consent to genetic and genomic research in a rural Ghanaian setting: a qualitative study of the MalariaGEN experience. BMC Med Ethics 2012, 13:15. [http://www.biomedcentral.com/1472-6939/13/15]
45. Abayomi A, Christoffels A, Grewal R, Karam LA, Rossouw C, Staunton C, 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. Biopreserv Biobank. 2013;11:347-54. doi: 10.1089/bio.2013.0049.
46. Knoppers BM. Biobanking: International norms. J Law Med Ethics. 2005;33:7-14. doi: 10.1111/j.1748-720x.2005.tb00205.x.
47. De Vries J, Abayomi A, Littler K, Madden E, McCurdy S, Oukem-Boyer OOM, et al. Addressing ethical issues in H3Africa research - the views of research ethics committee members. HUGO J. 2015;9:1. doi: 10.1186/s11568-015-0006-6.