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  1. Implementation of Japan’s First Clinical Research Regulatory Law: Background, Overview, and Challenges.Akira Akabayashi, Eisuke Nakazawa & Aru Akabayashi - 2019 - HEC Forum 31 (4):283-294.
    In April 2018, Japan’s first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law’s application brings numerous complications, (...)
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  • Research ethics review at University Eduardo Mondlane /Maputo Central Hospital, Mozambique : a descriptive analysis of the start-up of a new research ethics committee.Jahit Sacarlal, Vasco Muchanga, Carlos Mabutana, Matilde Mabui, Arlete Mariamo, Assa Júlio Cuamba, Leida Artur Fumo, Jacinta Silveira, Elizabeth Heitman & Troy D. Moon - 2018 - BMC Medical Ethics 19 (1):37.
    Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine of University Eduardo Mondlane and the Maputo Central Hospital established a joint Institutional Committee on Bioethics for Health. This study examines the experience of the first 4 years of the CIBS FM (...)
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  • Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.Dara Rasoal, Kirsti Skovdahl, Mervyn Gifford & Annica Kihlgren - 2017 - HEC Forum 29 (4):313-346.
    This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they (...)
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  • Conceptualizing and Fostering the Quality of CES Through a Dutch National Network on CES.Laura Hartman, Guy Widdershoven, Eva van Baarle, Froukje Weidema & Bert Molewijk - 2022 - HEC Forum 34 (2):169-186.
    The prevalence of Clinical ethics support services is increasing. Yet, questions about what quality of CES entails and how to foster the quality of CES remain. This paper describes the development of a national network, which aimed to conceptualize and foster the quality of CES in the Netherlands simultaneously. Our methodology was inspired by a responsive evaluation approach which shares some of our key theoretical presuppositions of CES. A responsive evaluation methodology engages stakeholders in developing quality standards of a certain (...)
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