Informed consent comprehension in African research settings

Tropical Medicine and International Health

Volumn 19, Issue 6, 2014, Pages 625-642

  Afolabi, Muhammed O ^a,b   Okebe, Joseph U ^a   Mcgrath, Nuala ^c   Larson, Heidi J ^b   Bojang, Kalifa ^a   Chandramohan, Daniel ^b  

^a MEDICAL RESEARCH COUNCIL LABORATORIES   (Gambia)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

Author keywords

Africa; Informed consent; Systematic review; Understanding; Vulnerable population

Indexed keywords

AFRICA; ARTICLE; BIOETHICS; COMPREHENSION; CONSENSUS; EMBASE; HEALTH; HUMAN; INFORMED CONSENT; MEDICAL INFORMATION; MEDICAL RESEARCH; MEDLINE; META ANALYSIS (TOPIC); QUESTIONNAIRE; RANDOMIZATION; READING; SYSTEMATIC REVIEW; THERAPEUTIC MISCONCEPTION;

EID: 84899985719     PISSN: 13602276     EISSN: 13653156     Source Type: Journal    
DOI: 10.1111/tmi.12288     Document Type: Article

References (53)

1. Abdool Karim Q, Abdool Karim SS, Coovadia HM & Susser M (1998) Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary? American Journal of Public Health 88, 637-640.
2. Angell M (1997) The ethics of clinical research in the Third World. New England Journal of Medicine 337, 847-849.
3. Annas GJ (2009) Globalized clinical trials and informed consent. New England Journal of Medicine 360, 2050-2053.
4. Appelbaum P, Roth L & Lidz C (1982) The therapeutic misconception: informed consent in psychiatric research. International Journal of Law and Psychiatry 5, 319-329.
5. Chaisson LH, Kass NE, Chengeta B, Mathebula U & Samandari T (2011) Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana. PLoS ONE 6, e22696.
6. Ciampa PJ, Vaz LM, Blevins M et al. (2012) The association among literacy, numeracy, HIV knowledge and health-seeking behavior: a population-based survey of women in rural Mozambique. PLoS ONE 7, e39391.
7. CIOMS (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects, 3rd edn. Prepared by the Council for International Organizations of Medical Sciences, Geneva, Switzerland. http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm (accessed 2 June 2012).
8. Collins F, Beaudet A, Draghia-Akli R et al. (2013) A database on global health research in Africa. The Lancet Global Health 1, e64-e65.
9. Coulibaly-Traore D, Msellati P, Vidal L, Ekra CW & Dabis F (2003) Essai clinique ditrame (ANRS 049) visant a reduire la transmission mere-enfant du VIH a Abidjan. Comprehension des principes par les participantes. fre [The Ditrame (ANRS 049) clinical trial aimed at reducing the mother-child transmission of HIV in Abidjan. Participants' understanding of the trial principles]. Presse Medicale (Paris, France: 1983) 32, 343-350.
10. Ekouevi KD, Becquet R, Viho I et al. (2004) Obtaining informed consent from HIV-infected pregnant women, Abidjan, Cote d'Ivoire. AIDS 18, 1486-1488.
11. Ellis RD, Sagara I, Durbin A et al. (2010) Comparing the understanding of subjects receiving a candidate malaria vaccine in the United States and Mali. American Journal of Tropical Medicine and Hygiene 83, 868-872.
12. Fairhead J, Leach M & Small M (2006a) Public engagement with science? Local understandings of a vaccine trial in the Gambia. Journal of Biosocial Science 38, 103-116.
13. Fairhead J, Leach M & Small M (2006b) Where techno-science meets poverty: medical research and the economy of blood in The Gambia, West Africa. Social Science and Medicine 63, 1109-1120.
14. Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK & Peppas G (2009) Informed consent: how much and what do patients understand? American Journal of Surgery 198, 420-435.
15. Friedland B, Apicella L, Schenk K, Sheehy M & Hewett PC (2011a) Evaluation of the informed consent process for male circumcision scale-up in Zambia. http://www.popcouncil.org/pdfs/2011HIV_ZambiaMaleCircIC.pdf (accessed 12 August 2012).
16. Friedland B, Apicella L, Schenk K, Sheehy M & Hewett PC (2011b) Evaluation of the informed consent process for male circumcision scale-up in Swaziland. Population council research and evaluation of male circumcision scale-up - report #3 [Internet]. http://www.popcouncil.org/pdfs/2011HIV_SwazilandMaleCircIC.pdf (accessed 12 August 2012).
17. Higgins JP, Thompson SG, Deeks JJ & Altman DG (2003) Measuring inconsistency in meta-analyses. BMJ 327, 557-560.
18. Hill Z, Tawiah-Agyemang C, Odei-Danso S & Kirkwood B (2008) Informed consent in Ghana: what do participants really understand? Journal of Medical Ethics 34, 48-53.
19. Hussein I & Ahmed A (2011) Pregnant women's satisfaction and comprehension level of information given during HIV counseling and testing for PMTCT in public health facilities in Addis Ababa. Ethiopian Journal of Health Development 25, 126-134.
20. Hyder A & Wali S (2006) Informed consent and collaborative research: perspectives from the developing world. Developing World Bioethics 6, 33-40.
21. Ijsselmuiden C & Faden R (1992) Research and informed consent in Africa-another look. New England Journal of Medicine 326, 830-833.
22. Jefford M & Moore R (2008) Improvement of informed consent and the quality of consent documents. The Lancet Oncology 9, 485-493.
23. Joffe S, Cook EF, Cleary PD, Clark JW & Weeks JC (2001) Quality of informed consent: a new measure of understanding among research subjects. Journal of the National Cancer Institute 93, 139-147.
24. Joubert G, Steinberg H, van der Ryst E & Chikobvu P (2003) Consent for participation in the Bloemfontein vitamin A trial: how informed and voluntary? American Journal of Public Health 93, 582-584.
25. Kiguba R, Kutyabami P, Kiwuwa S, Katabira E & Sewankambo NK (2012) Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study. BMC Medical Ethics 13, 21.
26. Krosin MT, Klitzman R, Levin B, Cheng J & Ranney ML (2006) Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clinical Trials 3, 306-313.
27. Leach A, Hilton S, Greenwood B et al. (1999) 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. Social Science and Medicine 48, 139-148.
28. Manafa O, Lindegger G & Ijsselmuiden C (2007) Informed consent in an antiretroviral trial in Nigeria. Indian Journal of Medical Ethics 4, 26-30.
29. Mandava A, Pace C, Campbell B, Emanuel E & Grady C (2012) The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries. Journal of Medical Ethics 38, 356-365.
30. Marshall P (2006) Informed consent in international health research. Journal of Empirical Research on Human Research Ethics 1, 25-42.
31. Marshall PA, Adebamowo CA, Adeyemo AA et al. (2006) Voluntary participation and informed consent to international genetic research. American Journal of Public Health 96, 1989-1995.
32. Minnies D, Hawkridge T, Hanekom W, Ehrlich R, London L & Hussey G (2008) Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Medical Ethics 9, 15.
33. Molyneux CS, Peshu N & Marsh K (2004) Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast. Social Science and Medicine 59, 2547-2559.
34. Moodley K, Pather M & Myer L (2005) Informed consent and participant perceptions of influenza vaccine trials in South Africa. Journal of Medical Ethics 31, 727-732.
35. NBAC (2001) Ethical and policy issues in international research: clinical trials in developing countries. http://govinfo.library.unt.edu/nbac/clinical/Chap2.html (accessed 27 September 2011)
36. Ndebele PM, Wassenaar D, Munalula E & Masiye F (2012) Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi. BMC Medical Ethics 13, 29.
37. Oduro AR, Aborigo RA, Amugsi D et al. (2008) Understanding and retention of the informed consent process among parents in rural northern Ghana. BMC Medical Ethics 9, 12.
38. Onvomaha Tindana P, Kass N & Akweongo P (2006) The informed consent process in a rural African setting: a case study of the Kassena-Nankana district of Northern Ghana. IRB 28, 1-6.
39. Oria PA, Arunga G, Lebo E et al. (2013) Assessing parents' knowledge and attitudes towards seasonal influenza vaccination of children before and after a seasonal influenza vaccination effectiveness study in low-income urban and rural Kenya, 2010-2011. BMC Public Health 13, 391.
40. Pace C, Talisuna A, Wendler D et al. (2005) Quality of parental consent in a Ugandan malaria study. American Journal of Public Health 95, 1184-1189.
41. Préziosi M-P, Yam A, Ndiaye M, Simaga A, Simondon F & Wassilak SGF (1997) Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. New England Journal of Medicine 336, 370-373.
42. Priestley KA, Campbell C, Valentine CB, Denison DM & Buller NP (1992) Are patient consent forms for research protocols easy to read? BMJ 305, 1263-1264.
43. Ravinetto R, Tinto H, Talisuna A et al. (2010) Health research: the challenges related to ethical review and informed consent in developing countries. Italian Journal of Tropical Medicine 15, 15-20.
44. Saidu Y, Odutola A, Jafali J et al. (2013) Contextualizing the informed consent process in vaccine trials in developing countries. Journal of Clinical Research and Bioethics 4, 141.
45. Sand K, Kassa S & Loge JH (2010) The understanding of informed consent information-definitions and measurements in empirical studies. AJOB Primary Research 1, 4-24.
46. Spreitzer GM & Sonenshein S (2004) Towards the construct definition of a positive deviance. The American Behavioral Scientist 47, 828-847.
47. Sreenivasan G (2003) Does informed consent to research require comprehension? Lancet 362, 2016-2018.
48. Taiwo OO & Kass N (2009) Post-consent assessment of dental subjects' understanding of informed consent in oral health research in Nigeria. BMC Medical Ethics 10, 11.
49. Tekola F, Bull SJ, Farsides B et al. (2009) Tailoring consent to context: designing an appropriate consent process for a biomedical study in a low income setting. PLoS Neglected Tropical Diseases 3, e482.
50. Vallely A, Shagi C, Kasindi S et al. (2007) The benefits of participatory methodologies to develop effective community dialogue in the context of a microbicide trial feasibility study in Mwanza, Tanzania. BMC Public Health 7, 133.
51. Vallely A, Lees S, Shagi C et al. (2010) How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Medical Ethics 11, 10.
52. Vreeman R, Kamaara E, Kamanda A et al. (2012) A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya. BMC Medical Ethics 13, 23.
53. Woodsong C & Karim QA (2005) A model designed to enhance informed consent: experiences from the HIV prevention trials network. American Journal of Public Health 95, 412-419.