R. D. Ellis, I. Sagara, A. Durbin, A. Dicko, D. Shaffer, L. Miller, M. H. Assadou, M. Kone, B. Kamate, O. Guindo, M. P. Fay, D. A. Diallo, O. K. Doumbo, E. J. Emanuel & J. Millum
American Journal of Tropical Medicine and Hygiene 83 (4):868-72 (2010)
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Abstract |
Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries.
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Keywords | Informed Consent Clinical Trials Vaccine Malaria Human Subjects |
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References found in this work BETA
Empirical Issues in Informed Consent for Research.James Flory, David Wendler & Ezekiel Emanuel - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 645--60.
Does Informed Consent to Research Require Comprehension?Gopal Sreenivasan - 2007 - The Proceedings of the Twenty-First World Congress of Philosophy 1:85-93.
Evaluation of the Quality of Informed Consent in a Vaccine Field Trial in a Developing Country Setting.Deon Minnies, Tony Hawkridge, Willem Hanekom, Rodney Ehrlich, Leslie London & Greg Hussey - 2008 - BMC Medical Ethics 9 (1):15-.
The Ethical Design of an AIDS Vaccine Trial in Africa.Nicholas A. Christakis - 1988 - Hastings Center Report 18 (3):31-37.
Post-Consent Assessment of Dental Subjects' Understanding of Informed Consent in Oral Health Research in Nigeria.Olaniyi O. Taiwo & Nancy Kass - 2009 - BMC Medical Ethics 10 (1):11.
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Citations of this work BETA
The Quality of Informed Consent: Mapping the Landscape. A Review of Empirical Data From Developing and Developed Countries.Amulya Mandava, Christine Pace, Benjamin Campbell, Ezekiel Emanuel & Christine Grady - 2012 - Journal of Medical Ethics 38 (6):356-365.
The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo.Marion Kalabuanga, Raffaella Ravinetto, Vivi Maketa, Hypolite Muhindo Mavoko, Blaise Fungula, Raquel Inocêncio da Luz, Jean-Pierre Van Geertruyden & Pascal Lutumba - 2016 - Developing World Bioethics 16 (2):64-69.
Informed Consent Procedure in a Double Blind Randomized Anthelminthic Trial on Pemba Island, Tanzania: Do Pamphlet and Information Session Increase Caregivers Knowledge?Marta S. Palmeirim, Amanda Ross, Brigit Obrist, Ulfat A. Mohammed, Shaali M. Ame, Said M. Ali & Jennifer Keiser - 2020 - BMC Medical Ethics 21 (1):1-9.
Contextualizing the Informed Consent Process in Vaccine Trials in Developing Countries.Saidu Yauba - 2013 - Journal of Clinical Research and Bioethics 4 (1).
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