A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya

BMC Medical Ethics

Volumn 13, Issue 1, 2012, Pages

  Vreeman, Rachel ^a,b,c,f   Kamaara, Eunice ^d   Kamanda, Allan ^e   Ayuku, David ^d   Nyandiko, Winstone ^b,d   Atwoli, Lukoye ^b,d   Ayaya, Samuel ^b,d   Gisore, Peter ^b,d   Scanlon, Michael ^a   Braitstein, Paula ^a,b,c  

^a INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ACADEMIC MODEL PROVIDING ACCESS TO HEALTHCARE AMPATH   (Kenya)

^c REGENSTRIEF INSTITUTE   (United States)

^d MOI UNIVERSITY   (Kenya)

^e MOI TEACHING AND REFERRAL HOSPITAL   (Kenya)

^f Children's Health Services Research   (United States)

Author keywords

Community based research; Ethics; Informed consent; Kenya; Sub Saharan Africa

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); COMPREHENSION; DEMOGRAPHY; ETHICS; HUMAN; HUMAN EXPERIMENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMED CONSENT; KENYA; MEDICAL RESEARCH; METHODOLOGY; PATIENT SELECTION; QUALITATIVE RESEARCH; RESEARCH ETHICS; RESEARCH SUBJECT;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; COMPREHENSION; ETHICS, RESEARCH; HIV INFECTIONS; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; KENYA; PATIENT SELECTION; QUALITATIVE RESEARCH; RESEARCH DESIGN; RESEARCH SUBJECTS; RESIDENCE CHARACTERISTICS; THIRD-PARTY CONSENT;

EID: 84866558023     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/1472-6939-13-23     Document Type: Article

References (55)

1. Ethical complexities of conducting research in developing countries. Varmus H, Satcher D, N Engl J Med 1997 337 14 1003 1005 10.1056/ NEJM199710023371411 9309109 (Pubitemid 27425960)
2. Ethical issues in the design and conduct of clinical trials in developing countries. Shapiro HT, Meslin EM, N Engl J Med 2001 345 2 139 142 10.1056/NEJM200107123450212 11450665 (Pubitemid 32634575)
3. A new look at international research ethics. Benatar SR, Singer PA, BMJ 2000 321 7264 824 826 10.1136/bmj.321.7264.824 11009528
4. Ethics of medical research in developing countries: the role of international codes of conduct. Hutton JL, Stat Methods Med Res 2000 9 3 185 206 11084704
5. After Helsinki: unresolved issues in international research. Macklin R, Kennedy Inst Ethics J 2001 11 1 17 36 10.1353/ken.2001.0005 12166444
6. Implication of socio-cultural contexts for the ethics of clinical trials. Ashcroft RE, Chadwick DW, Clark SRL, Edwards RHT, Frith L, Hutton JL, Health Services Research Methods: A guide to best practice. edn British Medical Journal, London, Black N, Brazier J, Fitzpatrick R, Reeves B, 1998
7. The ethics of clinical research in the Third World. Angell M, N Engl J Med 1997 337 12 847 849 10.1056/NEJM199709183371209 9295243 (Pubitemid 27391637)
8. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. Lurie P, Wolfe SM, N Engl J Med 1997 337 12 853 856 10.1056/NEJM199709183371212 9295246 (Pubitemid 27391640)
9. Research in developing countries: taking "benefit" seriously. Glantz LH, Annas GJ, Grodin MA, Mariner WK, Hastings Cent Rep 1998 28 6 38 42 10.2307/3528268 9868610 (Pubitemid 128746716)
10. Scientific imperialism. Wilmshurst P, BMJ 1997 314 7084 840 841 10.1136/bmj.314.7084.840 9093085 (Pubitemid 27182013)
11. Beyond informed consent. Bhutta ZA, Bull World Health Organ 2004 82 10 771 777 15643799 (Pubitemid 39457828)
12. UNAIDS, Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS Guidance Document Joint United Nations Programme on HIV/AIDS, Geneva, Switzerland 2000
13. What makes clinical research in developing countries ethical? The benchmarks of ethical research. Emanuel EJ, Wendler D, Killen J, Grady C, J Infect Dis 2004 189 5 930 937 10.1086/381709 14976611 (Pubitemid 38328195)
14. Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelines. Tangwa GB, J Med Ethics 2004 30 1 63 67 10.1136/jme.2003.003194 14872078 (Pubitemid 38262811)
15. Protecting communities in pharmacogenetic and pharmacogenomic research. Weijer C, Miller PB, Pharmacogenomics J 2004 4 1 9 16 14647406 (Pubitemid 38256599)
16. Involving study populations in the review of genetic research. Sharp RR, Foster MW, J Law Med Ethics 2000 28 1 41 51 43 10.1111/j.1748-720X.2000.tb00315. x 11067631
17. Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Gikonyo C, Bejon P, Marsh V, Molyneux S, Soc Sci Med 2008 67 5 708 720 10.1016/j.socscimed.2008.02. 003 18362046 (Pubitemid 352004086)
18. Community permission for medical research in developing countries. Diallo DA, Doumbo OK, Plowe CV, Wellems TE, Emanuel EJ, Hurst SA, Clin Infect Dis 2005 41 2 255 259 10.1086/430707 15983925 (Pubitemid 40962509)
19. International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of Medical Sciences, Geneva 2002
20. Are distinctive ethical principles required for cluster randomized controlled trials? Hutton JL, Stat Med 2001 20 3 473 488 10.1002/1097- 0258(20010215)20:3<473::AID-SIM805>3.0.CO;2-D 11180314 (Pubitemid 32125134)
21. Comprehension during informed consent in a less-developed country. Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW, Lancet 2002 360 9342 1301 1302 10.1016/S0140-6736(02)11338-9 12414207 (Pubitemid 35284623)
22. Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Krosin MT, Klitzman R, Levin B, Cheng J, Ranney ML, Clin Trials 2006 3 3 306 313 10.1191/1740774506cn150oa 16895047 (Pubitemid 44098068)
23. Research and informed consent in Africa - another look. IJsselmuiden C, Faden RR, N Engl J Med 1992 326 12 830 833 10.1056/NEJM199203193261212 1538731
24. Some popular versions of uninformed consent. Hutton JL, Ashcroft RE, Health Care Anal 2000 8 1 41 53 10.1023/A:1009421824028 10977160 (Pubitemid 30324138)
25. 'Even if they ask you to stand by a tree all day, you will have to do it (laughter)!': community voices on the notion and practice of informed consent for biomedical research in developing countries. Molyneux CS, Wassenaar DR, Peshu N, Marsh K, Soc Sci Med 2005 61 2 443 454 10.1016/j.socscimed.2004.12.003 15893058 (Pubitemid 40703936)
26. Experiences with community engagement and informed consent in a genetic cohort study of severe childhood diseases in Kenya. Marsh VM, Kamuya DM, Mlamba AM, Williams TN, Molyneux SS, BMC Med Ethics 2010 11 13 10.1186/1472-6939-11-13 20633282
27. The therapeutic misconception: informed consent in psychiatric research. Appelbaum PS, Roth LH, Lidz C, Int J Law Psychiatry 1982 5 3-4 319 329 6135666
28. Obtaining voluntary consent for research in desperately ill patients. Bosk CL, Med Care 2002 40 9 Suppl 2264 V68 12226587
29. Understanding informed consent for participation in international health research. Jegede AS, Dev World Bioeth 2009 9 2 81 87 10.1111/j.1471-8847.2008. 00238.x 18637943
30. Community based trials and informed consent in rural north India. DeCosta A, D'Souza N, Krishnan S, Chhabra MS, Shihaam I, Goswami K, J Med Ethics 2004 30 3 318 323 10.1136/jme.2002.001065 15173372 (Pubitemid 38868087)
31. Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Hutton JL, Eccles MP, Grimshaw JM, Implement Sci 2008 3 52 10.1186/1748-5908-3-52 19091100
32. Informed consent and collaborative research: perspectives from the developing world. Hyder AA, Wali SA, Dev World Bioeth 2006 6 1 33 40 10.1111/j.1471-8847.2006.00134.x 16436172
33. The role of community advisory boards: involving communities in the informed consent process. Strauss RP, Sengupta S, Quinn SC, Goeppinger J, Spaulding C, Kegeles SM, Millett G, Am J Public Health 2001 91 12 1938 1943 10.2105/AJPH.91.12.1938 11726369 (Pubitemid 33114396)
34. Nuffield Council on Bioethics, The ethics of research related to healthcare in developing countries; Follow-up discussion Nuffield Council on Bioethics, London 2005 22906683
35. Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of Medical Sciences, Geneva 2002
36. Grand challenges in global health: community engagement in research in developing countries. Tindana PO, Singh JA, Tracy CS, Upshur RE, Daar AS, Singer PA, Frohlich J, Lavery JV, PLoS Med 2007 4 9 273 10.1371/journal.pmed.0040273 17850178 (Pubitemid 47503036)
37. Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast. Molyneux CS, Peshu N, Marsh K, Soc Sci Med 2004 59 12 2547 2559 10.1016/j.socscimed.2004.03.037 15474208 (Pubitemid 39345760)
38. An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa. Leach A, Hilton S, Greenwood BM, Manneh E, Dibba B, Wilkins A, Mulholland EK, Soc Sci Med 1999 48 2 139 148 10.1016/S0277-9536(98)00317-7 10048773 (Pubitemid 29017825)
39. Obtaining informed consent in Bangladesh. Lynoe N, Hyder Z, Chowdhury M, Ekstrom L, N Engl J Med 2001 344 6 460 461 11221611
40. Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. Preziosi MP, Yam A, Ndiaye M, Simaga A, Simondon F, Wassilak SG, N Engl J Med 1997 336 5 370 373 10.1056/NEJM199701303360511 9011793 (Pubitemid 27057191)
41. A needs assessment to build international research ethics capacity. Sidle JE, Were E, Wools-Kaloustian K, Chuani C, Salmon K, Tierney WM, Meslin EM, J Empir Res Hum Res Ethics 2006 1 2 23 38 10.1525/jer.2006.1.2.23 19385876
42. Rooting inquiry in tradition: the health baraza as a tool for social research in Kenya. Naanyu V, Sidle JE, Frankel RM, Ayuku D, Nyandiko WM, Inui TS, Qual Health Res 2011 21 1 14 26 10.1177/1049732310367498 20435788
43. Aligning community engagement with traditional authority structures in global health research: a case study from northern Ghana. Tindana PO, Rozmovits L, Boulanger RF, Bandewar SV, Aborigo RA, Hodgson AV, Kolopack P, Lavery JV, Am J Public Health 2011 101 10 1857 1867 10.2105/AJPH.2011.300203 21852635
44. AMPATH: living proof that no one has to die from HIV. Inui TS, Nyandiko WM, Kimaiyo SN, Frankel RM, Muriuki T, Mamlin JJ, Einterz RM, Sidle JE, J Gen Intern Med 2007 22 12 1745 1750 10.1007/s11606-007-0437-4 17972138 (Pubitemid 50000146)
45. Responding to the HIV pandemic: the power of an academic medical partnership. Einterz RM, Kimaiyo S, Mengech HN, Khwa-Otsyula BO, Esamai F, Quigley F, Mamlin JJ, Acad Med 2007 82 8 812 818 10.1097/ACM.0b013e3180cc29f1 17762264 (Pubitemid 47356397)
46. Partnerships in international health. The Indiana University-Moi University experience. Einterz RM, Kelley CR, Mamlin JJ, Van Reken DE, Infect Dis Clin North Am 1995 9 2 453 455 7673682
47. Strauss A, Corbin J, Basics of qualitative research: Grounded theory procedures and techniques SAGE Publications, Newbury Park, CA 1990
48. Ethical goals of community consultation in research. Dickert N, Sugarman J, Am J Public Health 2005 95 7 1123 1127 10.2105/AJPH.2004.058933 15983268 (Pubitemid 40880859)
49. Ethics in public health research: protecting human subjects: the role of community advisory boards. Quinn SC, Am J Public Health 2004 94 6 918 922 10.2105/AJPH.94.6.918 15249289 (Pubitemid 38691533)
50. Community advisory boards: their role in AIDS clinical trials. Terry Beirn Community Programs for Clinical Research on AIDS. Cox LE, Rouff JR, Svendsen KH, Markowitz M, Abrams DI, Health Soc Work 1998 23 4 290 297 10.1093/hsw/23.4.290 9834882 (Pubitemid 128457794)
51. Community consultation in HIV prevention research: a study of community advisory boards at 6 research sites. Morin SF, Maiorana A, Koester KA, Sheon NM, Richards TA, J Acquir Immune Defic Syndr 2003 33 4 513 520 10.1097/00126334- 200308010-00013 12869841 (Pubitemid 36886081)
52. Mbiti J, African Religions and Philosophy Heinemann, Nairobi 1969
53. Ethics. Protecting communities in biomedical research. Weijer C, Emanuel EJ, Science 2000 289 5482 1142 1144 10.1126/science.289.5482.1142 10970227 (Pubitemid 30650717)
54. Informed consent in international health research. Marshall PA, J Empir Res Hum Res Ethics 2006 1 1 25 42 10.1525/jer.2006.1.1.25 19385865
55. Working with Concepts: The Role of Community in International Collaborative Biomedical Research. Marsh VM, Kamuya DK, Parker MJ, Molyneux CS, Public Health Ethics 2011 4 1 26 39 10.1093/phe/phr007 21416064