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  1. Informed Consent of Human Subjects: A Review.Mohammad Rashedul Islam - 2014 - Bangladesh Journal of Bioethics 5 (1):20-35.
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  • Assessing the Quality of Informed Consent in a Resource-Limited Setting: A Cross-Sectional Study.Nelson K. Sewankambo Ronald Kiguba, Paul Kutyabami, Stephen Kiwuwa, Elly Katabira - 2012 - BMC Medical Ethics 13 (1):21.
    The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.
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  • Application of the Rapid Ethical Assessment Approach to Enhance the Ethical Conduct of Longitudinal Population Based Female Cancer Research in an Urban Setting in Ethiopia.Alem Gebremariam, Alemayehu Worku Yalew, Selamawit Hirpa, Abigiya Wondimagegnehu, Mirgissa Kaba, Mathewos Assefa, Israel Mitiku, Eva Johanna Kantelhardt, Ahmedin Jemal & Adamu Addissie - 2018 - BMC Medical Ethics 19 (1):87.
    Rapid Ethical Assessment is an approach used to design context tailored consent process for voluntary participation of participants in research including human subjects. There is, however, limited evidence on the design of ethical assessment in studies targeting cancer patients in Ethiopia. REA was conducted to explore factors that influence the informed consent process among female cancer patients recruited for longitudinal research from Addis Ababa Population-based Cancer Registry. Qualitative study employing rapid ethnographic approach was conducted from May–July, 2017, at the Tikur (...)
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  • 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-.
    BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent.Cross-sectional (...)
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  • Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.Adamu Addissie, Serebe Abay, Yeweyenhareg Feleke, Melanie Newport, Bobbie Farsides & Gail Davey - 2016 - BMC Medical Ethics 17 (1):1.
    _BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...)
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  • Process for Obtaining Informed Consent: Women’s Opinions.Silvana Ferreira Bento, Ellen Hardy & Maria José Duarte Osis - 2008 - Developing World Bioethics 8 (3):197-206.
    In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96. 1 Consent must be obtained through a specific structured process. Objective: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. Subjects and Methods: Eight focus groups were conducted, involving a total of 51 women (...)
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  • Informed Consent in Ghana: What Do Participants Really Understand?Z. Hill, C. Tawiah-Agyemang, S. Odei-Danso & B. Kirkwood - 2008 - Journal of Medical Ethics 34 (1):48-53.
    Objectives: To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15–45 years perceive the trial and whether they know that not all trial capsules are the same, and to identify factors associated with this knowledge.Methods: 60 semistructured interviews and 12 focus groups were conducted to explore subjects’ perceptions of the trial. Steps were taken to address areas of low comprehension, including retraining fieldworkers. 1971 trial subjects were randomly selected for a survey measuring their knowledge (...)
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  • Assessing the Quality of Informed Consent in a Resource-Limited Setting: A Cross-Sectional Study.Kiguba Ronald, Kutyabami Paul, Kiwuwa Stephen, Katabira Elly & K. Sewankambo Nelson - 2012 - BMC Medical Ethics 13 (1):21.
    Background The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies (...)
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  • The Quality of Informed Consent: Mapping the Landscape. A Review of Empirical Data From Developing and Developed Countries.A. Mandava, C. Pace, B. Campbell, E. Emanuel & C. Grady - 2012 - Journal of Medical Ethics 38 (6):356-365.
    Objective Some researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings. Methods We conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants (...)
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  • How Participatory is Parental Consent in Low Literacy Rural Settings in Low Income Countries? Lessons Learned From a Community Based Study of Infants in South India.Divya Rajaraman, Nelson Jesuraj, Lawrence Geiter, Sean Bennett, Harleen Ms Grewal & Mario Vaz - 2011 - BMC Medical Ethics 12 (1):3.
    BackgroundA requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed.AimsThe aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis research study in India actively participated during the informed consent discussion, and to identify correlates of that participation.MethodsIn an observational cohort study of (...)
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