Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia

References

• Expert Working Group. Guidance for Industry E6 Good Clinical Practice; Consolidated Guidance; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) 1996. Available at: https://www.fda.gov/downloads/drugs/guidances/ucm073122.pdf
   Google Scholar
• Scott S, Odutola A, Mackenzie G, Fulford T, Afolabi MO, Lowe Jallow Y, Jasseh M, Jeffries D, Dondeh BL, Howie SR, et al. Coverage and timing of children's vaccination: an evaluation of the expanded programme on immunisation in The Gambia. PLoS One 2014; 9(9):e107280; PMID:25232830; https://doi.org/10.1371/journal.pone.0107280
   PubMed Web of Science ®Google Scholar
• Vallely A, Lees S, Shagi C, Kasindi S, Soteli S, Kavit N, Vallely L, McCormack S, Pool R, Hayes RJ. 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; PMID:20540803; https://doi.org/10.1186/1472-6939-11-10
   PubMed Web of Science ®Google Scholar
• Miller FG RD. The therapeutic orientation to clinical trials. N Engl J Med 2003; 14(348):1383-6; https://doi.org/10.1056/NEJMsb030228
   Web of Science ®Google Scholar
• Pappelbaum PS RL, Lidz CW, Benson P, Winslade W. False Hopes and Best Data: Consent to research and the Therapeutic misconception. Hestings Center Report 1987; 17(2):20-4; https://doi.org/10.2307/3562038
   Web of Science ®Google Scholar
• Niels Lynoe MS, Dahlqvist G, Jacobsson L. informed consent; study of quality of information given to participants in a clinical trial BMJ 1991; 303:610-3.
   Google Scholar
• Fitzgerald DW, Marotte C, Verdier RI, Johnson WD, Pape JW. Comprehension during informed consent in a less-developed country. Lancet 2002; 360(9342):1301-2; https://doi.org/10.1016/S0140-6736(02)11338-9
   PubMed Web of Science ®Google Scholar
• Carvalho AA, Costa LR. Mothers' perceptions of their child's enrollment in a randomized clinical trial: Poor understanding, vulnerability and contradictory feelings. BMC Med Ethics 2013; 14:52; PMID:24325658; https://doi.org/10.1186/1472-6939-14-52
   PubMed Web of Science ®Google Scholar
• Yauba S. Contextualizing the informed consent process in vaccine trials in developing countries. J Clin Res Bioethics 2013; 04:01; https://doi.org/10.4172/2155-9627.1000141
   Google Scholar
• Castelnuovo B, Newell K, Manabe YC, Robertson G. Multi-Media Educational Tool Increases Knowledge of Clinical Trials in Uganda. J Clin Res Bioeth 2014; 5:165; PMID:24795832; https://doi.org/10.4172/2155-9627.1000165
   PubMedGoogle Scholar
• Sonne SC, Andrews JO, Gentilin SM, Oppenheimer S, Obeid J, Brady K, Wolf S, Davis R, Magruder K. Development and pilot testing of a video-assisted informed consent process. Contemp Clin Trials 2013; 36(1):25-31; PMID:23747986; https://doi.org/10.1016/j.cct.2013.05.011
   PubMed Web of Science ®Google Scholar
• Bhutta ZA. Beyond informed consent. Bulletin of the World Health Organisation, 2004; 82: 771–777
   Google Scholar
• Wood SY, Friedland BA, McGrory CE. Informed consent: From good intentions to sound practices: A report of a seminar. New York: Population Council; 2001
   Google Scholar
• Dhai A, Etheredge H, Cleaton-Jones P. A pilot study evaluating an intervention designed to raise awareness of clinical trials among potential participants in the developing world. J Med Ethics 2010; 36(4):238-42; PMID:20338937
   PubMed Web of Science ®Google Scholar
• Castelnuovo B, Newell K, Manabe YC, Robertson G. Multi-media Educational Tool Increases Knowledge of Clinical Trials in Uganda. J Clin Res Bioethics 2014; 5:165; PMID:24795832; https://doi.org/10.4172/2155-9627.1000165
   PubMedGoogle Scholar
• Idoko O, Mboizi R, Okoye M, Laudat F, Ceesay B, Liang J, Ledren-Narayanin N, Jansen K, Gurtman A, Center K, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial. Vaccine 2017; (e-published ahead of print); https://doi.org/10.1016/j.vaccine.2017.04.049
   Google Scholar
• The Gambia Demographic Profile 2013. Available at: http://www.indexmundi.com/the_gambia/demographics_profile.html (accessed 3 May 2014)
   Google Scholar
• Fairhead J, Leach M, Small M. Public engagement with science? Local understandings of a vaccine trial in the Gambia. J Biosoc Sci 2006; 38(1):103-16; PMID:16266443; https://doi.org/10.1017/S0021932005000945
   PubMed Web of Science ®Google Scholar
• Philipp M. Qualitative content analysis. Forum: Qulitative Social Res 2000; 1:2.
   Google Scholar
• Hutchison C, Cowan C, McMahon T, Paul J. A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. Br J Cancer 2007; 97(6):705-11; PMID:17848908; https://doi.org/10.1038/sj.bjc.6603943
   PubMed Web of Science ®Google Scholar
• Hutchison C, Cowan C, Paul J. Patient understanding of research: developing and testing of a new questionnaire. Eur J Cancer Care (Engl) 2007; 16(2):187-95; quiz 195-6; PMID:17371430; https://doi.org/10.1111/j.1365-2354.2006.00732.x
   PubMed Web of Science ®Google Scholar
• Afolabi MO, Bojang K, D'Alessandro U, Imoukhuede EB, Ravinetto RM, Larson HJ, McGrath N, Chandramohan D. Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing. J Clin Res Bioeth 2014; 5(3):178; PMID:25133065
   PubMedGoogle Scholar
• Afolabi MO, McGrath N, D'Alessandro U, Kampmann B, Imoukhuede EB, Ravinetto RM, Alexander N, Larson HJ, Chandramohan D, Bojang K. A multimedia consent tool for research participants in the Gambia: a randomized controlled trial. Bulletin World Health Organization 2015; 93:320-328A; https://doi.org/10.2471/BLT.14.146159
   PubMed Web of Science ®Google Scholar
• Dhai A, Etheredge H, Cleaton-Jones P. A pilot study evaluating an intervention designed to raise awareness of clinical trials among potential participants in the developing world. J Med Ethics 2010; 36(4):238-42; PMID:20338937
   PubMed Web of Science ®Google Scholar