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  1. Research ethics committee members’ perspectives on paediatric research: a qualitative interview study.Kajsa Norberg Wieslander, Anna T. Höglund, Sara Frygner-Holm & Tove Godskesen - 2023 - Research Ethics 19 (4):494-518.
    Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported (...)
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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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  • Operationalization of assent for research participation in pre-adolescent children: a scoping review.Florence Cayouette, Katie O’Hearn, Shira Gertsman & Kusum Menon - 2022 - BMC Medical Ethics 23 (1):1-10.
    Background Seeking assent from children for participation in medical research is an ethical imperative of numerous institutions globally. However, none of these organizations provide specific guidance on the criteria or process to be used when obtaining assent. The primary objective of this scoping review was to determine the descriptions of assent discussed in the literature and the reported criteria used for seeking assent for research participation in pre-adolescent children. Methods Medline and Embase databases were searched until November 2020 using the (...)
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