Repeated assessments of informed consent comprehension among hiv-infected participants of a three-year clinical trial in botswana

PLoS ONE

Volumn 6, Issue 10, 2011, Pages

  Chaisson, Lelia H ^a   Kass, Nancy E ^a,b   Chengeta, Bafanana ^c   Mathebula, Unami ^d   Samandari, Taraz ^c,d  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c Botswana USA Partnership ^*  (Botswana)

^d CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; BOTSWANA; COMPREHENSION; CONTROLLED STUDY; EDUCATION; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; PATIENT ATTITUDE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL (TOPIC); CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; EDUCATIONAL STATUS; ETHICS; INTERNATIONAL COOPERATION; MIDDLE AGED; PATIENT EDUCATION; PATIENT SELECTION; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL; STANDARD;

ADULT; AGED; BOTSWANA; COMPREHENSION; EDUCATIONAL STATUS; FEMALE; HIV INFECTIONS; HUMANS; INFORMED CONSENT; INTERNATIONAL COOPERATION; MALE; MIDDLE AGED; PATIENT EDUCATION AS TOPIC; PATIENT SELECTION; QUESTIONNAIRES; YOUNG ADULT;

EID: 80055044959     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0022696     Document Type: Article

References (66)

1. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC, (2001) Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 358 (9295): 1772-1777.
2. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC, (2001) Quality of informed consent: A new measure of understanding among research subjects. J Natl Cancer Inst 93 (2): 139-147.
3. 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 (3): 306-313.
4. Taiwo OO, Kass N, (2009) Post-consent assessment of dental subjects' understanding of informed consent in oral health research in nigeria. BMC Med Ethics 10: 11.
5. 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 (1): 48-53.
6. Kodish E, Eder M, Noll R, Ruccione K, Lange B, et al. (2004) Communication of randomization in childhood leukemia trials. JAMA 291 (4): 470-475.
7. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W, (1987) False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep 17 (2): 20-24.
8. Robinson EJ, Kerr CE, Stevens AJ, Lilford RJ, Braunholtz DA, et al. (2005) Lay public's understanding of equipoise and randomisation in randomised controlled trials. Health Technol Assess 9 (8): 1-192, iii- iv.
9. Dunn LB, Palmer BW, Keehan M, (2006) Understanding of placebo controls among older people with schizophrenia. Schizophr Bull 32 (1): 137-146.
10. Cassileth BR, Zupkis RV, Sutton-Smith K, March V, (1980) Informed consent - why are its goals imperfectly realized? N Engl J Med 302 (16): 896-900.
11. Fortun P, West J, Chalkley L, Shonde A, Hawkey C, (2008) Recall of informed consent information by healthy volunteers in clinical trials. QJM 101 (8): 625-629.
12. Daugherty CK, Banik DM, Janish L, Ratain MJ, (2000) Quantitative analysis of ethical issues in phase I trials: A survey interview of 144 advanced cancer patients. IRB 22 (3): 6-14.
13. Cheng JD, Hitt J, Koczwara B, Schulman KA, Burnett CB, et al. (2000) Impact of quality of life on patient expectations regarding phase I clinical trials. J Clin Oncol 18 (2): 421-428.
14. Tomamichel M, Jaime H, Degrate A, de Jong J, Pagani O, et al. (2000) Proposing phase I studies: Patients', relatives', nurses' and specialists' perceptions. Ann Oncol 11 (3): 289-294.
15. Mason SA, Allmark PJ, (2000) Obtaining informed consent to neonatal randomised controlled trials: Interviews with parents and clinicians in the euricon study. The Lancet 356 (9247): 2045-2051.
16. Harth SC, Thong YH, (1995) Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med 40 (11): 1573-7.
17. Penman DT, Holland JC, Bahna GF, Morrow G, Schmale AH, et al. (1984) Informed consent for investigational chemotherapy: Patients' and physicians' perceptions. J Clin Oncol 2 (7): 849-855.
18. Lynoe N, Sandlund M, Dahlqvist G, Jacobsson L, (1991) Informed consent: Study of quality of information given to participants in a clinical trial. BMJ 303 (6803): 610-613.
19. Riecken HW, Ravich R, (1982) Informed consent to biomedical research in veterans administration hospitals. Journal of the American Medical Association 248 (3): 344-348 May 4, 2011.
20. Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G, (2009) Informed consent: How much and what do patients understand? Am J Surg 198 (3): 420-435.
21. Berger O, Gronberg BH, Sand K, Kaasa S, Loge JH, (2008) The length of consent documents in oncological trials is doubled in twenty years. Ann Oncol.
22. Paasche-Orlow MK, Taylor HA, Brancati FL, (2003) Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 348 (8): 721-726.
23. Beardsley E, Jefford M, Mileshkin L, (2007) Longer consent forms for clinical trials compromise patient understanding: So why are they lengthening? J Clin Oncol 25 (9): e13-4.
24. Christopher PP, Foti ME, Roy-Bujnowski K, Appelbaum PS, (2007) Consent form readability and educational levels of potential participants in mental health research. Psychiatr Serv 58 (2): 227-232.
25. Tindana PO, 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: Ethics & Human Research 28 (3): 1-6.
26. Minnies D, Hawkridge T, Hanekom W, Ehrlich R, London L, et al. (2008) Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Medical Ethics 9 (1): 15.
27. Jegede AS, (2009) Understanding informed consent for participation in international health research. Dev World Bioeth 9 (2): 81-87.
28. Lansimies-Antikainen H, Laitinen T, Rauramaa R, Pietila AM, (2009) Evaluation of informed consent in health research: A questionnaire survey. Scand J Caring Sci.
29. Prentice KJ, Appelbaum PS, Conley RR, Carpenter WT, (2007) Maintaining informed consent validity during lengthy research protocols. IRB 29 (6): 1-6.
30. Olver IN, Buchanan L, Laidlaw C, Poulton G, (1995) The adequacy of consent forms for informing patients entering oncological clinical trials. Ann Oncol 6 (9): 867-870.
31. Bergler JH, Pennington AC, Metcalfe M, Freis ED, (1980) Informed consent: How much does the patient understand? Clinical Pharmacology and Therapeutics 27 (4): 435-440 May 4, 2011.
32. CIOMS (2002) International ethical guidelines for biomedical research involving human subjects.
33. Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO) (2002) International ethical guidelines for biomedical research involving human subjects.
34. Agard A, (2005) Informed consent: Theory versus practice. Nat Clin Pract Cardiovasc Med 2 (6): 270-271.
35. Wendler D, (2004) Can we ensure that all research subjects give valid consent? Arch Intern Med 164: 2201-2204.
36. McGrath JW, George K, Svilar G, Ihler E, Mafigiri D, et al. (2001) Knowledge about vaccine trials and willingness to participate in an HIV/AIDS vaccine study in the ugandan military. JAIDS 27 (4): 381-388.
37. Dormandy E, Tsui EYL, Marteau TM, (2007) Development of a measure of informed choice suitable for use in low literacy populations. Patient Educ Couns 66 (3): 278-295.
38. Harrison K, Vlahov D, Jones K, Charron K, Clements ML, (1995) Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum Retrovirol 10 (3): 386-390.
39. MacQueen KM, Vanichseni S, Kitayaporn D, Lin LS, Buavirat A, et al. (1999) Willingness of injection drug users to participate in an HIV vaccine efficacy trial in bangkok, thailand. J Acquir Immune Defic Syndr 21 (3): 243-251.
40. McGrath JW, Mafigiri D, Kamya M, George K, Senvewo R, et al. (2001) Developing AIDS vaccine trials educational programs in uganda. JAIDS 26 (2): 176-181.
41. Howard JM, DeMets D, (1981) How informed is informed consent?: The BHAT experience. Control Clin Trials 2 (4): 287-303.
42. DCCT Research Group (1989) Implementation of a multicomponent process to obtain informed consent in the diabetes control and complications trial. Control Clin Trials 10: 83-96.
43. Mosimaneotsile B, Mathoma A, Chengeta B, Nyirenda S, Agizew T, et al. (2010) Isoniazid tuberculosis preventive therapy in HIV-infected adults accessing antiretroviral therapy: A botswana experience, 2004-2006. JAIDS 54 (1): 71-77.
44. Dunn LB, Jeste DV, (2001) Enhancing informed consent for research and treatment. Neuropsychopharmacology 24 (6): 595-607.
45. Flory J, Emanuel E, (2004) Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA 292 (13): 1593-1601.
46. Steinke EE, (2004) Research ethics, informed consent, and participant recruitment. Clin Nurse Spec 18 (2): 88-95; quiz 96-7.
47. Taub HA, Baker MT, Sturr JF, (1986) Informed consent for research. effects of readability, patient age, and education. J Am Geriatr Soc 34 (8): 601-606.
48. Kripalani S, Bengtzen R, Henderson LE, Jacobson TA, (2008) Clinical research in low-literacy populations: Using teach-back to assess comprehension of informed consent and privacy information. IRB: Ethics and Human Research 30 (2): 13-19.
49. Jefford M, Moore R, (2008) Improvement of informed consent and the quality of consent documents. Lancet Oncol 9 (5): 485-493.
50. Rounsaville DB, Hunkele K, Easton CJ, Nich C, Carroll KM, (2008) Making consent more informed: Preliminary results from a multiple-choice test among probation-referred marijuana users entering a randomized clinical trial. J Am Acad Psychiatry Law 36 (3): 354-359.
51. Leroy T, Christophe V, Penel N, Antoine P, Clisant S, (2009) Factual understanding of randomized clinical trials: A multicenter case-control study in cancer patients. Investigational New Drugs 10.1007/s10637-009-9315-8. Available: http://www.springerlink.com/content/e701620475407744/fulltext.pdf. Accessed 2011May 4.
52. Ridpath JR, Wiese CJ, Greene SM, (2009) Looking at research consent forms through a participant-centered lens: The PRISM readability toolkit. Am J Health Promot 23 (6): 371-375.
53. Aaronson NK, Visser-Pol E, Leenhouts GH, Muller MJ, van der Schot AC, et al. (1996) Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol 14 (3): 984-996.
54. Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW, (2002) Comprehension during informed consent in a less-developed country. Lancet 360 (9342): 1301-1302.
55. Kucia AM, Horowitz JD, (2000) Is informed consent to clinical trials an "upside selective" process in acute coronary syndromes? Am Heart J 140 (1): 94-97.
56. Ndebele P, (2009) Email re: Setswana-english translations. Email communication.
57. Moodley K, Pather M, Myer L, (2005) Informed consent and participant perceptions of influenza vaccine trials in south africa. J Med Ethics 31 (12): 727-732.
58. Dawson L, Kass NE, (2005) Views of US researchers about informed consent in international collaborative research. Soc Sci Med 61 (6): 1211-1222.
59. McCabe M, Morgan F, Curley H, Begay R, Gohdes DM, (2005) The informed consent process in a cross-cultural setting: Is the process achieving the intended result? Ethn Dis 15 (2): 300-304.
60. Marshall PA, (2006) Informed consent in international health research. Journal of Empirical Research on Human Research Ethics 1 (1): 25-42.
61. Achrekar A, Shaffer N, (1998) Informed consent for a clinical trial in thailand. NEJM 339 (18): 1331-1332.
62. Kass N, Hyder A, (2001) Attitudes and experiences of U.S. and developing country investigators regarding U.S. human subjects regulations. Volume II: Commissioned Papers: B1-B189.
63. Marshall P, (2001) The relevance of culture for informed consent in US- funded international health research. In: Anonymous Ethical and Policy Issues in Internation Research: Clinical Trials in Developing Countries.: National Bioethics Advisory Commission C-1; C-38.
64. Molyneux CS, Peshu N, Marsh K, (2004) Understanding of informed consent in a low-income setting: Three case studies from the kenyan coast. Soc Sci Med 59 (12): 2547-2559.
65. Lindegger G, Milford C, Slack C, Quayle M, Xaba X, et al. (2006) Beyond the checklist: Assessing understanding for HIV vaccine trial participants in south africa. J Acquir Immune Defic Syndr 43 (5): 560-566.
66. Faden RR, Beauchamp TL, King NMP, (1986) A history and theory of informed consent Oxford University Press US.