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  1. How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi.Helen Mangochi, Kate Gooding, Aisleen Bennett, Michael Parker, Nicola Desmond & Susan Bull - 2019 - BMC Medical Ethics 20 (1):32.
    Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have detailed guidelines (...)
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  • Brain stimulation for treatment and enhancement in children: an ethical analysis.Hannah Maslen, Brian D. Earp, Roi Cohen Kadosh & Julian Savulescu - 2014 - Frontiers in Human Neuroscience 8.
    Davis called for “extreme caution” in the use of non-invasive brain stimulation to treat neurological disorders in children, due to gaps in scientific knowledge. We are sympathetic to his position. However, we must also address the ethical implications of applying this technology to minors. Compensatory trade-offs associated with NIBS present a challenge to its use in children, insofar as these trade-offs have the effect of limiting the child’s future options. The distinction between treatment and enhancement has some normative force here. (...)
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  • What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.Nimit Morakote, Wannachai Sakuludomkan, Kanda Fanhchaksai, Rungrote Natesirinilkul, Pimlak Charoenkwan & Nut Koonrungsesomboon - 2022 - BMC Medical Ethics 23 (1):1-10.
    BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in (...)
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  • Neither the Harm Principle nor the Best Interest Standard Should Be Applied to Pediatric Research.Marcin Waligora, Karolina Strzebonska & Mateusz T. Wasylewski - 2018 - American Journal of Bioethics 18 (8):72-74.
    Application of either the harm principle or the best interest standard to medical decision making conflicts with some types of pediatric research that pose elevated risk without the reasonable prob...
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  • The Best Interest Standard and the Child’s Right to an Open Future.Aliya O. Affdal & Vardit Ravitsky - 2018 - American Journal of Bioethics 18 (8):74-76.
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  • (1 other version)Recruiting pupils for a school-based eye study in Nigeria: Trust and informed consent concerns.Ferdinand Chinedum Maduka-Okafor, Onochie Ike Okoye, Ngozi Oguego, Nnenma Udeh, Ada Aghaji, Obiekwe Okoye, Ifeoma R. Ezegwui, Emmanuel Amaechi Nwobi, Euzebus Ezugwu, Ernest Onwasigwe, Rich E. Umeh & Chiamaka Aneji - 2022 - Research Ethics 18 (1):13-23.
    School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental incident helped to fuel public mistrust in governmental programs and posed a potential (...)
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  • Child’s objection to non-beneficial research: capacity and distress based models.Marcin Waligora, Joanna Różyńska & Jan Piasecki - 2016 - Medicine, Health Care and Philosophy 19 (1):65-70.
    A child’s objection, refusal and dissent regarding participation in non-beneficial biomedical research must be respected, even when the parents or legal representatives have given their permission. There is, however, no consensus on the definition and criteria of a meaningful and valid child’s objection. The aim of this article is to clarify this issue. In the first part we describe the problems of a child’s assent in research. In the second part we distinguish and analyze two models of a child’s objection (...)
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  • To stop or not to stop: dissent and undue burden as reasons to stop participation in paediatric research.Wendy Bos, Anna Westra, Inez de Beaufort & Suzanne van de Vathorst - 2017 - Journal of Medical Ethics 43 (8):519-523.
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  • Personalized assent for pediatric biobanks.Noor A. A. Giesbertz, Karen Melham, Jane Kaye, Johannes J. M. van Delden & Annelien L. Bredenoord - 2016 - BMC Medical Ethics 17 (1):59.
    Pediatric biobanking is considered important for generating biomedical knowledge and improving health care. However, the inclusion of children’s samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that children should be involved through a personalized assent procedure, which means that both the content and the process of assent are adjusted to the individual child. In this paper we provide guidance on how to put personalized assent (...)
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  • Assent, parental consent and reconsent for health research in Africa: thematic analysis of national guidelines and lessons from the SickleInAfrica registry.Ambroise Wonkam, Charmaine Royale, Kofi Anie, Malula Nkanyemka, Hilda Tutuba, Daima Bukini, Okocha Emmanuel Chide, Marsha Treadwell, Lawrence Osei-Tutu, Victoria Nembaware & Nchangwi Syntia Munung - 2022 - BMC Medical Ethics 23 (1):1-10.
    The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may be appropriate and the conditions for (...)
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  • Non-beneficial pediatric research: individual and social interests.Jan Piasecki, Marcin Waligora & Vilius Dranseika - 2015 - Medicine, Health Care and Philosophy 18 (1):103-112.
    Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society (...)
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