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AIDS and Behavior
Published in: AIDS and Behavior 2/2012

01-02-2012 | Original Paper

Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods

Authors: Amy L. Corneli, James R. Sorenson, Margaret E. Bentley, Gail E. Henderson, J. Michael Bowling, Jacqueline Nkhoma, Agnes Moses, Cynthia Zulu, James Chilima, Yusuf Ahmed, Charles M. Heilig, Denise J. Jamieson, Charles van der Horst, Breastfeeding, Antiretroviral, and Nutrition Informed Consent Study Group

Published in: AIDS and Behavior | Issue 2/2012

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Abstract

Empirical research on informed consent has shown that study participants often do not fully understand consent information. This study assessed participant understanding of three mock consent approaches describing an HIV-prevention clinical trial in Lilongwe, Malawi prior to trial implementation. Pregnant women (n = 297) were systematically selected from antenatal-care waiting lines and sequentially allocated to receive an enhanced standard consent form (group 1), a context-specific consent form (group 2), or context-specific counseling cards (group 3). Understanding of research concepts and study procedures was assessed immediately postintervention and at 1-week follow-up. At postintervention, participants in groups 2 and 3 understood more about research concepts and study procedures compared with group 1. Group 3 participants also understood more about study procedures compared with group 2. At follow-up, participants in groups 2 and 3 continued to understand more about research concepts and study procedures. Context-specific approaches improved understanding of consent information in this study.
Literature
1.
National Commission for the Protection of Human Subjects of Biomedical, Behavioral Research. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: U.S. Government Printing Office; 1979.
2.
Nuremberg Code. In: Trials of war criminals before the nuremberg military. Tribunals under control counsel law, vol. 11. Washington, DC: U.S. Government Printing Office, No. 10, 1949. p. 181–2.
3.
Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS/WHO; 2002.
4.
World Medical Association (WMA). Declaration of Helsinki: ethical principles for medical research involving human subjects, as amended by the 52nd WMA General Assembly, Edinburgh, Scotland; 2000.
5.
Taiwo O, Kass N. Post-consent assessment of dental subject’s understanding of informed consent in oral health research in Nigeria. BMC Med Ethics. 2009;10:11.PubMedCrossRef
6.
Breese P, Burman W, Goldberg S, Weis S. Education level, primary language, and comprehension of the informed consent process. J Empir Res Hum Res Ethics. 2007;2:69–79.PubMedCrossRef
7.
Krosin M, Klitzman R, Levin B, Cheng J, Ranney M. Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clin Trials. 2006;3:302–13.CrossRef
8.
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358:1772–7.PubMedCrossRef
9.
Lynöe N, Hyder Z, Chowdhury M, Ekström L. Obtaining informed consent in Bangladesh. N Engl J Med. 2001;344:460–1.PubMedCrossRef
10.
Leach A, Hilton S, Greenwood BM, et al. 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. Soc Sci Med. 1999;48:139–48.PubMedCrossRef
11.
Daugherty C, Ratain MJ, Grochowsi E, Stocking C, Kodish E, et al. Perceptions of cancer patients and their physicians involved in phase 1 trials. J Clin Oncol. 1995;13:1062–72.PubMed
12.
Riecken HW, Ravich R. Informed consent to biomedical research in Veterans Administration Hospitals. JAMA. 1982;248:344–8.PubMedCrossRef
13.
Mystakidou K, Panagiotou I, Katsaragakis S, Tsilika E, Parpa E. Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries. SAHARA J. 2009;6:46–57.PubMed
14.
Krogstad DJ, Diop S, Diallo A, et al. Informed consent in international research: the rationale for different approaches. Am J Trop Med Hyg. 2010;83:743–7.PubMedCrossRef
15.
Kass P, Hyder A. Attitudes and experiences of U.S. and developed country investigators regarding U.S. human subject regulations. In: Ethical and policy issues in international research: clinical trials in developing countries, volume II: commissioned papers and staff analysis. Bethesda, MD: National Bioethics Advisory Commission; 2001. p. B1–B158
16.
Marshall P. The relevance of culture for informed consent in U.S.-funded international health research. In Ethical and policy issues in international research: clinical trials in developing countries, volume II: commissioned papers and staff analysis. Bethesda, MD: National Bioethics Advisory Commission; 2001. p. C1–C38.
17.
National Bioethics Advisory Commission (NBAC). Report on clinical trials research in developing countries. volume I: report and recommendations of the National Bioethics Advisory Commission. Bethesda, MD: National Bioethics Advisory Commission; 2001.
18.
Ijsselmuiden C, Faden R. Research and informed consent in Africa—another look. In: Mann JM, Gruskin S, Grodin MA, Annas GJ, editors. Health and human rights: a reader. New York: Routledge; 1999. p. 363–72.
19.
Préziosi M, Yam A, Ndiaye M, Simaga A, Simondon F, Wassilak S. Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. N Engl J Med. 1997;336:370–3.PubMedCrossRef
20.
Vallely A, Lees S, Shagi C, Kasindi S, Soteli S, et al. How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Med Ethics. 2010;11:10.PubMedCrossRef
21.
Minnies D, Kawkridge T, Hanekom W, Ehrlich R, London L, Hussey G. Evaluation of the quality of informed consent in a vaccine field trial in a developing country setting. BMC Med Ethics. 2008;9:15.PubMedCrossRef
22.
Pace C, Emanuel E, Cheunyam T, et al. The quality of informed consent in a clinical research study in Thailand. IRB. 2005;1:9–17.CrossRef
23.
Fitzgerald D, Marotte C, Verdier RI, Johnson WD, Pape JW. Comprehension during informed consent in a less-developed country. Lancet. 2002;360:1301–2.PubMedCrossRef
24.
Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA. 2004;292:593–601.CrossRef
25.
Cohn E, Larson E. Improving participant comprehension in the informed consent process. J Nurs Scholarsh. 2007;39:273–80.PubMedCrossRef
26.
Edwards S, Lilford R, Thornton J, Hewison J. Informed consent for clinical trials: in search of the “best” method. Soc Sci Med. 1998;47:1825–40.PubMedCrossRef
27.
Ancker J. Assessing patient comprehension of informed consent forms. Control Clin Trials. 2004;25:72–4.PubMedCrossRef
28.
Kithinji C, Kass N. Assessing the readability of non-English-language consent forms: the case of Kiswahili for research conducted in Kenya. IRB. 2010;32:1–15.
29.
Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003;25:1–7.PubMedCrossRef
30.
Agre P, Campbell F, Goldman B, et al. Improving informed consent: the medium is not the message. IRB. 2003;25:S11–9.PubMedCrossRef
31.
Chasela CS, Hudgens MG, Jamieson DJ, et al. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N Engl J Med. 2010;362:2271–81.PubMedCrossRef
32.
Corneli A, Piwoz E, Bentley M, et al. Involving communities in the design of clinical trial protocols: The BAN Study in Lilongwe, Malawi. Contemp Clin Trials. 2007;28:59–67.PubMedCrossRef
33.
Corneli A, Bentley M, Sorenson J, et al. Using formative research to develop a context-specific approach to informed consent for clinical trials. J Empir Res Hum Res Ethics. 2006;1:45–60.PubMedCrossRef
34.
Joffe S, Cook E, Cleary P, Clark J, Weeks J. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001;93:139–47.PubMedCrossRef
35.
Department of Health, Human Services (DHHS). 45 Code of federal regulations 46. Federal Register. 1991;56:28012.
36.
Paasche-Orlow M, Taylor H, Brancati F. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348:721–6.PubMedCrossRef
37.
Ausubel D. The psychology of meaningful verbal learning. New York: Grune & Stratton, Inc.; 1963.
38.
Ausubel D. The acquisition and retention of knowledge: a cognitive view. Dordrecht, The Netherlands: Kluwer Academic Publishers; 2000.
39.
Kreuter M, Lukwago S, Bucholtz D, Clark E, Sanders-Thompson V. Achieving cultural appropriateness in health promotion programs: target and tailored approaches. Health Education and Behavior. 2003;30:133–46.PubMedCrossRef
40.
Appelbaum P, Roth L, Lidz C, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hasting Center Report. 1987;17:20–4.CrossRef
41.
Lidz C, Appelbaum P. The therapeutic misconception: problems and solutions. Med Care. 2002;40:v55–63.PubMedCrossRef
42.
Moreno J. Abandon all hope? The therapeutic misconception and informed consent. Cancer Invest. 2003;21:481–2.PubMedCrossRef
43.
Westfall P, Tobias R, Rom D, Wolfinger R, Hochberg Y. Multiple comparisons and multiple tests using SAS. Cary, NC: SAS Institute, Inc.; 1999.
44.
Levie W, Lentz R. Effects of text illustrations: a review of research. Educ Commun Technol J. 1982;30:195–232.
45.
Newby T, Ertmer P, Stepich D. Instructional analogies and the learning of concepts. Educ Technol Res Dev. 1995;43:5–18.CrossRef
46.
Murphy D, O’Keefe H, Kaufman A. Improving comprehension and recall of information for an HIV vaccine trial among women at risk for HIV: reading level simplification and inclusion of pictures to illustrate key concepts. AIDS Educ Prev. 1999;11:389–99.PubMed
47.
Stunkel L, Benson M, McLellan L, et al. Comprehension and informed consent: assessing the effectiveness of a short consent form. IRB. 2010;32:1–9.PubMed
48.
Llewellyn-Thomas H, Thiel E, Sem F, Harrison Woermke D. Presenting clinical trial information: a comparison of methods. Patient Educ Couns. 1995;25:97–107.PubMedCrossRef
49.
Lavori P, Sugarman J, Hays M, Feussner J. Improving informed consent in clinical trials: a duty to experiment. Control Clin Trials. 1999;20:187–93.PubMedCrossRef
50.
Black M, Siegel H, Abel Y, Bentley M. Home and videotape intervention delays early complementary feeding among adolescent mothers. Pediatrics. 2001;107:1–8.CrossRef
51.
Creed-Kanashiro H, Uribe T, Bartolini R, et al. Improving dietary intake to prevent anemia in adolescent girls through community kitchens in a periurban population of Lima, Peru. J Nutr 2000;130:459S–461S.
52.
Davis S, Clay T, Smyth M, et al. Pathways curriculum and family interventions to promote healthful eating and physical activity in American Indian schoolchildren. Prev Med. 2003;37:S24–34.PubMedCrossRef
53.
Kelley K, Abraham C. RCT of a theory-based intervention promoting healthy eating and physical activity amongst out-patients older than 65 years. Soc Sci Med. 2003;59:787–97.CrossRef
54.
Miller C, Edwards L, Kissling G, Sanville L. Evaluation of a theory-based nutrition intervention for older adults with diabetes mellitus. J Am Diet Assoc. 2002;102:1069–81.PubMed
Metadata
Title
Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods
Authors
Amy L. Corneli
James R. Sorenson
Margaret E. Bentley
Gail E. Henderson
J. Michael Bowling
Jacqueline Nkhoma
Agnes Moses
Cynthia Zulu
James Chilima
Yusuf Ahmed
Charles M. Heilig
Denise J. Jamieson
Charles van der Horst
Breastfeeding, Antiretroviral, and Nutrition Informed Consent Study Group
Publication date
01-02-2012
Publisher
Springer US
Published in
AIDS and Behavior / Issue 2/2012
Print ISSN: 1090-7165
Electronic ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-011-9977-z

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