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

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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.

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References

  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.

    Google Scholar 

  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.

    Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  9. Lynöe N, Hyder Z, Chowdhury M, Ekström L. Obtaining informed consent in Bangladesh. N Engl J Med. 2001;344:460–1.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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  CAS  Google Scholar 

  12. Riecken HW, Ravich R. Informed consent to biomedical research in Veterans Administration Hospitals. JAMA. 1982;248:344–8.

    Article  PubMed  CAS  Google Scholar 

  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  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  24. Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA. 2004;292:593–601.

    Article  Google Scholar 

  25. Cohn E, Larson E. Improving participant comprehension in the informed consent process. J Nurs Scholarsh. 2007;39:273–80.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  27. Ancker J. Assessing patient comprehension of informed consent forms. Control Clin Trials. 2004;25:72–4.

    Article  PubMed  Google Scholar 

  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.

    Google Scholar 

  29. Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003;25:1–7.

    Article  PubMed  Google Scholar 

  30. Agre P, Campbell F, Goldman B, et al. Improving informed consent: the medium is not the message. IRB. 2003;25:S11–9.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  35. Department of Health, Human Services (DHHS). 45 Code of federal regulations 46. Federal Register. 1991;56:28012.

    Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  37. Ausubel D. The psychology of meaningful verbal learning. New York: Grune & Stratton, Inc.; 1963.

    Google Scholar 

  38. Ausubel D. The acquisition and retention of knowledge: a cognitive view. Dordrecht, The Netherlands: Kluwer Academic Publishers; 2000.

    Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  Google Scholar 

  41. Lidz C, Appelbaum P. The therapeutic misconception: problems and solutions. Med Care. 2002;40:v55–63.

    Article  PubMed  Google Scholar 

  42. Moreno J. Abandon all hope? The therapeutic misconception and informed consent. Cancer Invest. 2003;21:481–2.

    Article  PubMed  Google Scholar 

  43. Westfall P, Tobias R, Rom D, Wolfinger R, Hochberg Y. Multiple comparisons and multiple tests using SAS. Cary, NC: SAS Institute, Inc.; 1999.

    Google Scholar 

  44. Levie W, Lentz R. Effects of text illustrations: a review of research. Educ Commun Technol J. 1982;30:195–232.

    Google Scholar 

  45. Newby T, Ertmer P, Stepich D. Instructional analogies and the learning of concepts. Educ Technol Res Dev. 1995;43:5–18.

    Article  Google Scholar 

  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  CAS  Google Scholar 

  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  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  PubMed  CAS  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  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  Google Scholar 

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Acknowledgments

The authors would like to thank study staff and participants who contributed their time and effort to this research. This work was funded by the Prevention Research Centers Special Interest Project SIP 13-01 U48-CCU409660-09 and SIP 26-04 U48-DP000059-01, Centers for Disease Control and Prevention; supported by the NIAID P30-AI50410 UNC Center for AIDS Research; DHHS/NIH/FIC 2-D43 Tw01039-06 AIDS International Training and Research Program; Elizabeth Glaser Pediatric AIDS Foundation Call to Action Award and International Leadership Award, UNICEF, World Food Programme, GlaxoSmithKline, Boehringer-Ingelheim, Roche Pharmaceuticals, BristolMyersSquibb Company, and the Ministry of Health and Population of Malawi. The drawings were created by the Malawian artist Nyangu Andrew Chodola.

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Correspondence to Amy L. Corneli.

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Members of the Breastfeeding, Antiretroviral, and Nutrition Informed Consent Study Group are Kaja Finkler, David Jones, Peter Kazembe, Francis Martinson, and Allan Steckler.

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Corneli, A.L., Sorenson, J.R., Bentley, M.E. et al. Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods. AIDS Behav 16, 412–421 (2012). https://doi.org/10.1007/s10461-011-9977-z

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