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  1. Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial.Rajiv Sarkar, Thuppal V. Sowmyanarayanan, Prasanna Samuel, Azara S. Singh, Anuradha Bose, Jayaprakash Muliyil & Gagandeep Kang - 2010 - BMC Medical Ethics 11 (1):8-.
    BackgroundStudies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent.MethodsParents of children participating in a trial of nutritional supplementation were (...)
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  • A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.Adamu Addissie, Gail Davey, Melanie J. Newport, Thomas Addissie, Hayley MacGregor, Yeweyenhareg Feleke & Bobbie Farsides - 2014 - BMC Medical Ethics 15 (1):35.
    Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.
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  • 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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  • Compliance with research ethics in epidemiological studies targeted to conflict-affected areas in Western Ethiopia: validity of informed consent (VIC) by information comprehension and voluntariness (ICV).Nicki Tiffin, Anja Bedeker, Michelle Nichols, Lami Bayisa, Eba Abdisa, Bizuneh Wakuma, Mekdes Yilma & Gemechu Tiruneh - 2024 - BMC Medical Ethics 25 (1):1-9.
    BackgroundThe conduct of research is critical to advancing human health. However, there are issues of ethical concern specific to the design and conduct of research in conflict settings. Conflict-affected countries often lack strong platform to support technical guidance and monitoring of research ethics, which may lead to the use of divergent ethical standards some of which are poorly elaborated and loosely enforced. Despite the growing concern about ethical issues in research, there is a dearth of information about ethical compliance in (...)
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  • 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 - 2015 - Developing World Bioethics 16 (2):64-69.
    In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of (...)
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  • Effect of child health status on parents' allowing children to participate in pediatric research.Jérémy Vanhelst, Ludovic Hardy, Dina Bert, Stéphane Duhem, Stéphanie Coopman, Christian Libersa, Dominique Deplanque, Frédéric Gottrand & Laurent Béghin - 2013 - BMC Medical Ethics 14 (1):7.
    To identify motivational factors linked to child health status that affected the likelihood of parents’ allowing their child to participate in pediatric research.
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  • 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.
    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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  • National Human Research Ethics: A Preliminary Comparative Case Study of Germany, Great Britain, Romania, and Sweden.Bernard Gallagher, Anne H. Berman, Justyna Bieganski, Adele D. Jones, Liliana Foca, Ben Raikes, Johanna Schiratzki, Mirjam Urban & Sara Ullman - 2016 - Ethics and Behavior 26 (7):586-606.
    Although international research is increasing in volume and importance, there remains a dearth of knowledge on similarities and differences in “national human research ethics”, that is, national ethical guidelines, Institutional Review Boards, and research stakeholder’ ethical attitudes and behaviors. We begin to address this situation by reporting upon our experiences in conducting a multinational study into the mental health of children who had a parent/carer in prison. The study was conducted in 4 countries: Germany, Great Britain, Romania, and Sweden. Data (...)
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  • Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.Michael Parker, Ann Strode, Janet Seeley & Nkosi Busisiwe - 2023 - BMC Medical Ethics 24 (1):1-16.
    BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA (...)
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  • Enrolment of children in clinical research: Understanding Ghanaian caregivers’ perspectives on consent/assent procedures, and their attitudes towards storage of biological samples for future use.George O. Adjei, Amos Laar, Jorgen A. L. Kurtzhals & Bamenla Q. Goka - 2021 - Clinical Ethics 16 (2):122-129.
    Child assent is recommended in addition to parental consent when enrolling children in clinical research; however, appreciation and relevance ascribed to these concepts vary in different contexts, and information on attitudes towards storage of biological samples for future research is limited, especially in developing countries. We assessed caregivers’ understanding and appreciation of consent and assent procedures, and their attitudes towards use of stored blood samples for future research prior to enrolling a child in clinical research. A total of 17 in-depth (...)
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  • Informed consent in paediatric critical care research – a South African perspective.Brenda M. Morrow, Andrew C. Argent & Sharon Kling - 2015 - BMC Medical Ethics 16 (1):62.
    Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources.
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