Browsing by Subject "Assent"

Now showing 1 - 2 of 2
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    Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues
    (Frontiers Media, 2021-07-09) Kasperbauer, T. J.; Halverson, Colin; Medicine, School of Medicine
    Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18. There is also significant ethical debate about the age at which adolescents can make authentic, autonomous decisions regarding their research participation. This paper reviews these issues in detail, describes the current state of the ethical discussion, and outlines evidence-based policies for enrolling minors into research biobanks.
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    Pediatric assent for a study of antiretroviral therapy dosing for children in western Kenya: a case study in international research collaboration
    (Regents of the University of California, 2009-03) Vreeman, Rachel C.; Nyandiko, Winstone M.; Meslin, Eric M.
    Multinational collaborators in health research face particular ethical challenges when conducting studies involving vulnerable populations such as children. We use an example from our first attempt to implement pediatric assent in the context of a longstanding research and clinical partnership between Kenyan and American medical schools to highlight the ethical and procedural issues related to pediatric assent that must be considered for multinational, pediatric studies. We consider relevant domestic, professional, and international guidelines for assent in pediatric research subjects, and we discuss the particular ethical challenges related to pediatric assent in the Kenyan context. Finally, we propose a way forward for approaching pediatric assent within our collaborative research program in Kenya that may apply to other multinational research partnerships.