Voluntary participation and comprehension of informed consent in a genetic epidemiological study of breast cancer in Nigeria

BMC Medical Ethics

Volumn 15, Issue 1, 2014, Pages

  Marshall, Patricia A ^a   Adebamowo, Clement A ^b   Adeyemo, Adebowale A ^c   Ogundiran, Temidayo O ^d   Strenski, Teri ^e   Zhou, Jie ^c   Rotimi, Charles N ^c  

^a CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^c NATIONAL INSTITUTES OF HEALTH   (United States)

^d UNIVERSITY OF IBADAN   (Nigeria)

^e NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Breast cancer; Genetic epidemiological research; Informed consent; Nigeria

Indexed keywords

ADULT; ARTICLE; ATTITUDE TO HEALTH; BLACK PERSON; BREAST TUMOR; COMPREHENSION; ETHICS; ETHNOLOGY; FEMALE; GENETIC PREDISPOSITION; GENETICS; HUMAN; INFORMED CONSENT; MALE; MOLECULAR EPIDEMIOLOGY; NIGERIA; PATIENT SELECTION; PSYCHOLOGICAL ASPECT; QUESTIONNAIRE; REFUSAL TO PARTICIPATE; STATISTICS;

ADULT; AFRICAN CONTINENTAL ANCESTRY GROUP; BREAST NEOPLASMS; COMPREHENSION; FEMALE; GENETIC PREDISPOSITION TO DISEASE; GENETIC RESEARCH; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INFORMED CONSENT; MALE; MOLECULAR EPIDEMIOLOGY; NIGERIA; PATIENT SELECTION; QUESTIONNAIRES; REFUSAL TO PARTICIPATE; THIRD-PARTY CONSENT;

EID: 84901625794     PISSN: None     EISSN: 14726939     Source Type: Journal    
DOI: 10.1186/1472-6939-15-38     Document Type: Article

References (65)

1. A global network for investigating the genomic epidemiology of malaria. Malaria Genomic Epidemiology Network, Nature 2008 11 456 732 737
2. Ethical challenges of genomic epidemiology in developing countries. Chokshi DA, Kwiatkowski DP, Genomics Soc Policy 2005 1 1 15 10.1186/1746-5354-1- 1-1
3. '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 61 443 454 10.1016/j.socscimed.2004.12.003 15893058 (Pubitemid 40703936)
4. Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana. Chaisson LH, Kass NE, Chengeta B, Mathebula U, Samandari T, PLoS One 2011 6 10 22696 10.1371/journal.pone.0022696 22046230
5. Informed consent: practices and views of investigators in a multinational clinical trial. Sabik L, Pace CA, Forster-Gertner HP, Wendler D, Bebchuk JD, Tavel JA, McNay LA, Killen J, Emanuel EJ, Grady C, IRB: Ethics & Hum Res 2005 27 5 13 18 10.2307/3564530 (Pubitemid 41680193)
6. The quality of informed consent for a clinical research study in Thailand. Pace C, Emanuel E, Chuenyam T, Duncombe C, Bebhuk JD, Wendler D, Tavel JA, McNay LA, Phanuphak P, Forster HP, Grady C, IRB: Ethics and Hum Res 2005 27 Suppl 1 9 17 (Pubitemid 41674176)
7. Quality of parental consent in a Ugandan malaria study. Pace C, Talisuma A, Wendler D, Faustin M, Wabwire-Mangen F, Bakyaita N, Okira E, Garrett-Mayer ES, Emanuel E, Grady C, Am J Public Health 2005 95 Suppl 7 1184 1189 15933235 (Pubitemid 40880866)
8. Informed consent and collaborative research: perspectives from the developing world. Hyder AA, Wali SA, Dev World Bioeth 2006 1 33 40
9. Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya. Okello G, Jones C, Bonareri M, Ndegwa SN, Mcharo C, Kengo J, Kinyua K, Dubeck MM, Halliday K, Jukes MCH, Molyneux S, Brooker SJ, BioMed Centeral Trials 2013 14 142
10. 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 10.1016/j.socscimed.2004.03.037 15474208 (Pubitemid 39345760)
11. Trust and informed consent: insights from community members on the Kenyan coast. Molyneux CS, Peshu N, Marsh K, Soc Sci Med 2005 61 7 1463 1473 10.1016/j.socscimed.2004.11.073 16005781 (Pubitemid 40991271)
12. 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)
13. Incorporating a quiz into informed consent processes: qualitative study of participants' reactions. Molyneux S, Gikonyo C, Marsh V, Bejon P, Malar J 2007 6 145 10.1186/1475-2875-6-145 17996116
14. The challenge of cross-cultural clinical trials research: case report from the Tibetan Autonomous Region, People's Republic of China. Adams V, Miller S, Craig S, Samen A, Nyima S, Droyoung L, Varner M, Med Anthropol Q 2005 19 3 267 289 10.1525/maq.2005.19.3.267 16222962 (Pubitemid 41426771)
15. Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme Experience. Boga M, Davies A, Kamuya D, Kinyanjui SM, Kivaya E, Kombe F, Lang T, Marsh V, Mbete B, Mlamba A, Molyneux S, Mulupi S, Mwalukore S, PLoS Med 2011 8 9 1001089 10.1371/journal.pmed.1001089 21931539
16. Decision-making and motivation to participate in biomedical research in southwest Nigeria. Osamor PE, Kass N, Dev World Bioeth 2012 12 2 87 95 10.1111/j.1471-8847.2012.00326.x 22708614
17. Working with Community Health Workers as 'volunteers' in a vaccine trial: practical and ethical experiences and implications. Angwenyi V, Kamuya D, Mwachiro D, Marsh V, Njuguna P, Molyneux S, Dev World Bioeth 2013 13 1 38 47 10.1111/dewb.12015 23521823
18. Participants' perceptions of research benefits in an African genetic epidemiology study. Appiah-Poku J, Newton S, Kass N, Dev World Bioeth 2011 11 3 128 135 10.1111/j.1471-8847.2011.00309.x 22103636
19. Impact of social stigma on the process of obtaining informed consent for genetic research on podoconiosis: a qualitative study. Tekola F, Bull S, Farsides B, Newport MJ, Adeyemo A, Rotimi CN, Davey G, BMC Med Ethics 2009 10 13 10.1186/1472-6939-10-13 19698115
20. Tailoring consent to context: designing an appropriate consent process of a biomedical study in a low income setting. Tekola R, Bull SJ, Farsides B, Newport MJ, Adeyemo A, Rotimi CN, Davey G, PLoS Negl Trop Dis 2009 21 482
21. Tailoring information provision and consent process to research contexts: the value of rapid assessments. Bull S, Farsides B, Tekola AF, J Empir Res Hum Res Ethics 2012 7 37 52
22. Voluntary participation and informed consent to international genetic research. Marshall PA, Adebamowo CA, Adeyemo AA, Ogundiran TO, Vekich M, Strenski T, Zhou J, Prewitt TE, Cooper RS, Rotimi CN, Am J Public Health 2006 96 11 1989 1995 10.2105/AJPH.2005.076232 17018820 (Pubitemid 44655924)
23. Issues of consent and feedback in a genetic epidemiological study of women with breast cancer. Richards MPM, Ponder M, Pharoah P, Everest S, Mackay J, J Med Ethics 2003 29 2 93 96 10.1136/jme.29.2.93 12672889 (Pubitemid 36504104)
24. 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 Ethic 2010 15 11 13
25. Seeking consent to genetic and genomic research in a rural Ghanaian setting: a qualitative study of the MalariaGEN experience. Tindana P, Bull S, Amenga-Etego L, De Vries J, Aborigo R, Koram K, Kwiatkowski D, Parker M, BMC Med Ethic 2012 2 13 15
26. Ethical issues in human genomics research in developing countries. De Vries J, Bull SJ, Doumbo O, Ibrahim M, Mercereau-Puijalon O, Kwiatkowski D, Parker M, BMC Med Ethics 2011 18 12 15
27. Tailoring the process of informed consent in genetic and genomic research. Rotimi CN, Marshall PA, Genome Med 2010 24 20
28. What makes clinical research in developing countries ethical? The benchmarks of ethical research. Emanuel E, Wendler D, Killen J, Grady C, J Infect Dis 2004 189 932 937
29. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association, Amended by the WMA General Assembly 2013
30. Nuffield Council on Bioethic, The Ethics of Research Related to Healthcare in Developing Countries London: Nuffield Council on Bioethics 2002
31. Nuffield Council on Bioethics, he Ethics of Research Related to Healthcare in Developing Countries; Follow-Up Discussion London: Nuffield Council Bioethics 2005
32. Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects Geneva, Switzerland: Council for International Organizations of Medical Sciences 2002
33. Council for International Organizations of Medical Sciences (CIOMS), International Guidelines for Ethical Review of Epidemiological Studies Geneva: Council for International Organizations of Medical Sciences; 1991, draft rev 2006
34. Informed consent in human subject research: a comparison of current international and Nigerian guidelines. Fadare JO, Porteri C, J Empir Res Hum Res Ethics 2010 5 1 67 73 10.1525/jer.2010.5.1.67
35. Marshall P, Ethical Issues in Research Design and Informed Consent to Biomedical and Social Research in Resource Poor Settings Geneva: World Health Organization, Special Topics in Social, Economic, and Behavioral Research Series of Programme for Research and Training in Tropical Diseases (TDR) 2007
36. Beyond informed consent. Bhutta Z, Bull World Org 2004 82 10 771 777 (Pubitemid 39457828)
37. Motivations, understanding and voluntariness in international randomized trials. Kass N, Maman S, Atkinson J, IRB: Ethics and Hum Res 2005 27 6 1 8 10.2307/3563534 (Pubitemid 41771804)
38. Community based trials and informed consent in rural north India. DeCosta A, D'Souza N, Krishnan S, Chhabra MS, Shihaam I, Goswami K, J of Med Ethics 2004 30 318 323 10.1136/jme.2002.001065 (Pubitemid 38868087)
39. 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
40. Ensuring consent to research is voluntary: how far do we need to go? Bull S, Lindegger GC, Am J Bioeth 2011 11 8 27 29 10.1080/15265161.2011.585272
41. An international researchers' perspective. Rivera R, Borasky D, Rivera R, Borasky D, Rice R, Carayon F, Wong E, Am J Public Health 2007 97 1 25 29 10.2105/AJPH.2005.081604 17138913 (Pubitemid 46067679)
42. A model designed to enhance informed consent: experiences from the HIV Prevention Trials Network. Woodsong C, Karim QA, Am J Public Health 2005 95 412 419 10.2105/AJPH.2004.041624 15727968 (Pubitemid 40315114)
43. Length and complexity of US and international HIV consent forms from federal HIV network trials. Kass NE, Chaisson L, Taylor HA, Lohse J, J Gen Intern Med 2011 26 11 1324 1328 10.1007/s11606-011-1778-6 21748435
44. Ethical challenges in international HIV prevention research. MacQueen KM, Shapiro K, Karim QA, Sugarman J, Account Res 2004 11 48 61
45. Communication and miscommunication in informed consent to research. Sankar P, Med Anthro Quarterly 2004 18 4 429 446 10.1525/maq.2004.18.4.429 (Pubitemid 41277778)
46. Views of US researchers about informed consent in international collaborative research. Dawson L, Kass NE, Soc Sci Med 2005 61 1211 1222 10.1016/j.socscimed.2005.02.004 15970232 (Pubitemid 40828566)
47. Informed consent in international health research. Marshall P, J Empir Res Hum Res Ethics 2006 1 25 41 10.1525/jer.2006.1.1.25 19385865
48. Human rights research and ethics review: protecting individuals or protecting the state? Amon JJ, Baral SD, Beyrer C, Kass N, PLoS Med 2012 9 10 1001325 10.1371/journal.pmed.1001325 23091422
49. Human rights, cultural pluralism, and international health research. Marshall P, Theor Med Bioeth 2005 6 529 557 (Pubitemid 41684733)
50. The individual and the community in international genetic research. Marshall PA, J Clinical Ethics 2004 15 1 76 86 (Pubitemid 38949807)
51. Informed consent practices in Nigeria. Ezeome ER, Marshall PA, Dev World Bioeth 2009 9 3 138 148 10.1111/j.1471-8847.2008.00234.x 18452553
52. International HapMap Consortium: Community engagement and informed consent in the International HapMap project. Rotimi C, Leppert M, Matsuda I, Zeng C, Zhang H, Adebamowo C, Ajayi I, Aniagwu T, Dixon M, Fukushima Y, Macer D, Marshall P, Nkwodimmah C, Peiffer A, Royal C, Suda E, Zhao H, Wang VO, McEwen J, Community Genet 2007 10 3 186 198 10.1159/000101761 17575464 (Pubitemid 46944295)
53. Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelines. Tangwa G, J Med Ethics 2004 30 1 63 67 10.1136/jme.2003.003194 14872078 (Pubitemid 38262811)
54. The relevance of culture for informed consent in U.S.-funded international health research. Marshall PA, Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Vol II Bethesda, MD: National Bioethics Advisory Commission; C-1-C38 2001
55. Denizen NK, Lincoln YS, The SAGE Handbook of Qualitatiive Research Thousand Oaks, Californnia: Sage Publications 4 2011
56. Green J, Thorogood: Qualitative Methods for Health Research Thousand Oaks, California: Sage Publications 2013
57. Strauss A, Corbin JM, Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory Thousand Oaks, California: Sage Publications 1998
58. Friese S, Qualitative Data Analysis with ATLAS.ti Thousand Oaks, CA: Sage Publications 2012
59. Denizen NK, Lincoln YS, Collecting and Interpreting Qualitative Materials Thousand Oaks, CA: Sage Publications 4 2012
60. Boeije H, Analysis in Qualitative Research London: Sage Publications 2010
61. Genetic research on rare familial disorders: consent and the blurred boundaries between clinical service and research. Ponder M, Statham H, Hallowell N, Moon JA, Richards M, Raymond FL, J Med Ethics 2008 34 690 694 10.1136/jme.2006.018564 18757643
62. Lay and Professional Understandings of Research and Clinical Activities in Cancer Genetics and Their Implications for Informed Consent. Hallowell N, Parry S, Cooke S, Crawford G, Lucassen A, Parker M, AJOB Primary Res 2010 1 2 25 34 10.1080/21507716.2010.492717
63. How do index patients participating in genetic screening programmes for familial hypercholesterolemia (FH) interpret their DNA results? Jenkins N, Lawton J, Douglas M, Walker S, Finnie R, Porteous M, Hallowell N, Patient Educ Couns 2013 90 372 377 10.1016/j.pec.2011.09.002 21962872
64. Integrating science and ethics in the International HapMap Project. International HapMap Consortium, Nat Rev Genet 2004 5 467 475 10.1038/nrg1351 15153999 (Pubitemid 38915413)
65. H3Africa, Human Heredity and Health in Africa http://www.h3africa.org/