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  1.  11
    The Social Value of Pragmatic Trials.Shona Kalkman, Ghislaine van Thiel, Rieke van der Graaf, Mira Zuidgeest, Iris Goetz, Diederick Grobbee & Johannes van Delden - 2017 - Bioethics 31 (2):136-143.
    Pragmatic trials aim to directly inform health care decision-making through the collection of so-called ‘real world data’ from observations of comparative treatment effects in clinical practice. In order to ensure the applicability and feasibility of a pragmatic trial, design features may be necessary that deviate from standard research ethics requirements. Examples are traditional requirements to seek written informed consent and to perform extensive data and safety monitoring. Proposals for deviations from standard research ethics practice have resulted in controversy about their (...)
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  2.  26
    What is the Best Standard for the Standard of Care in Clinical Research?Rieke van der Graaf & Johannes J. M. van Delden - 2009 - American Journal of Bioethics 9 (3):35 – 43.
    During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established effective treatment. In this article, (...)
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  3.  33
    Clarifying Appeals to Dignity in Medical Ethics From an Historical Perspective.Rieke van der Graaf & Johannes Jm van Delden - 2009 - Bioethics 23 (3):151-160.
  4.  43
    On Using People Merely as a Means in Clinical Research.Rieke van der Graaf & Johannes J. M. van Delden - 2012 - Bioethics 26 (2):76-83.
    It is often argued that clinical research should not violate the Kantian principle that people must not be used merely as a means for the purposes of others. At first sight, the practice of clinical research itself, however, seems to violate precisely this principle: clinical research is often beneficial to future people rather than to participants; even if participants benefit, all things considered, they are exposed to discomforts which are absent both in regular care for their diseases and in other (...)
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  5.  14
    Response to Open Peer Commentaries on “What is The Best Standard for the Standard of Care in Clinical Research?”.Rieke van Der Graaf & Johannes JM van Delden - 2009 - American Journal of Bioethics 9 (6-7):7-8.
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  6.  1
    Issues in the Use of Stepped Wedge Cluster and Alternative Designs in the Case of Pandemics.Ingeborg van der Tweel & Rieke van der Graaf - 2013 - American Journal of Bioethics 13 (9):23-24.
  7.  13
    A Qualitative Study on Acceptable Levels of Risk for Pregnant Women in Clinical Research.Indira S. E. Van der Zande, Rieke van der Graaf, Martijn A. Oudijk & Johannes J. M. van Delden - 2017 - BMC Medical Ethics 18 (1):35.
    There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as (...)
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  8.  10
    Conflating Scientific With Clinical Considerations.Rieke van Der Graaf & Johannes JM van Delden - 2009 - American Journal of Bioethics 9 (9):58-59.
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  9.  2
    Power Difference and Risk Perception: Mapping Vulnerability Within the Decision Process of Pregnant Women Towards Clinical Trial Participation in an Urban Middle‐Income Setting.Geerte C. den Hollander, Joyce L. Browne, Daniel Arhinful, Rieke van der Graaf & Kerstin Klipstein‐Grobusch - 2018 - Developing World Bioethics 18 (2):68-75.
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  10.  9
    Voluntary Informed Consent in Paediatric Oncology Research.Sara A. S. Dekking, Rieke Van Der Graaf & Johannes J. M. Van Delden - 2016 - Bioethics 30 (6):440-450.
    In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two (...)
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  11.  7
    Voluntary Informed Consent in Paediatric Oncology Research.Sara A. S. Dekking, Rieke Van Der Graaf & Johannes J. M. Van Delden - 2016 - Bioethics 30 (5):440-450.
    In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two (...)
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  12.  2
    Power Difference and Risk Perception: Mapping Vulnerability Within the Decision Process of Pregnant Women Towards Clinical Trial Participation in an Urban Middle‐Income Setting.Geerte C. den Hollander, Joyce L. Browne, Daniel Arhinful, Rieke van der Graaf & Kerstin Klipstein‐Grobusch - 2018 - Developing World Bioethics 18 (2):68-75.
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  13.  1
    Vulnerability of Pregnant Women in Clinical Research.Indira S. E. Van der Zande, Rieke van der Graaf, Martijn A. Oudijk & Johannes J. M. Van Delden - 2017 - Journal of Medical Ethics 43 (10):657-663.
    Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women. Analysis A conceptual analysis supports Hurst's definition (...)
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  14. How the CIOMS Guidelines Contribute to Fair Inclusion of Pregnant Women in Research.Rieke van der Graaf, Indira S. E. Van der Zande & Johannes J. M. Van Delden - forthcoming - Bioethics.
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  15. How the CIOMS Guidelines Contribute to Fair Inclusion of Pregnant Women in Research.Rieke van der Graaf, Indira S. E. van der Zande & Johannes J. M. van Delden - forthcoming - Bioethics.
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