26 found
Order:
  1.  42
    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 (...)
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark   10 citations  
  2.  21
    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.
    Direct download (4 more)  
     
    Export citation  
     
    Bookmark   10 citations  
  3.  17
    The ethics of ethics conferences: Is Qatar a desirable location for a bioethics conference?Rieke van der Graaf, Karin Jongsma, Suzanne van de Vathorst, Martine de Vries & Ineke Bolt - 2023 - Bioethics 37 (4):319-322.
    The next World Congress of Bioethics will be held in Doha, Qatar. Although this location provides opportunities to interact with a more culturally diverse audience, to advance dialogue between cultures and religions, offer opportunities for mutual learning, there are also huge moral concerns. Qatar is known for violations of human rights ‐ including the treatment of migrant workers and the rights of women ‐ corruption, criminalization of LGBTQI+ persons, and climate impact. Since these concerns are also key (bio)ethical concern we (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   3 citations  
  4.  10
    The Ethics of Ethics Conferences: Enhancing Further Transparency.Martine Charlotte de Vries & Rieke van der Graaf - 2024 - American Journal of Bioethics 24 (4):41-44.
    We appreciate that the theme “ethics of ethics conferences” that we introduced in 2023 (Van der Graaf et al. 2023) was echoed by the previous and current presidents of the International Association...
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   1 citation  
  5.  31
    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 (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   6 citations  
  6.  46
    Clarifying appeals to dignity in medical ethics from an historical perspective.Rieke van der Graaf & Johannes Jm van Delden - 2008 - Bioethics 23 (3):151-160.
    ABSTRACT Over the past few decades the concept of (human) dignity has deeply pervaded medical ethics. Appeals to dignity, however, are often unclear. As a result some prefer to eliminate the concept from medical ethics, whereas others try to render it useful in this context. We think that appeals to dignity in medical ethics can be clarified by considering the concept from an historical perspective. Firstly, on the basis of historical texts we propose a framework for defining the concept in (...)
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark   12 citations  
  7.  45
    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, (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   11 citations  
  8.  10
    How Should the Precautionary Principle Apply to Pregnant Women in Clinical Research?Indira S. E. van der Zande, Rieke van der Graaf, Martijin A. Oudijk & Johannes J. M. van Delden - 2021 - Journal of Medicine and Philosophy 46 (5):516-529.
    The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in (...)
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark   2 citations  
  9.  9
    Injustice in Bioethics Research Funding: Going Further Upstream.Himani Bhakuni, Rieke van der Graaf & Seye Abimbola - 2022 - American Journal of Bioethics 22 (1):33-35.
    Fabi and Goldberg have helpfully shed some light on the wrongs perpetuated by the current funding architecture on research, sponsorship, and career development in the field of bioethics. The...
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark   1 citation  
  10.  19
    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 - 2018 - Bioethics 33 (3):377-383.
    As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and (...)
    Direct download  
     
    Export citation  
     
    Bookmark   3 citations  
  11.  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 - 2018 - Bioethics 33 (3):377-383.
    As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and (...)
    Direct download  
     
    Export citation  
     
    Bookmark   3 citations  
  12.  72
    On using people merely as a means in clinical research.Rieke van der Graaf & Johannes J. M. van Delden - 2010 - 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 (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   3 citations  
  13.  8
    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.
  14.  33
    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 (...)
    Direct download (5 more)  
     
    Export citation  
     
    Bookmark   1 citation  
  15.  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).
    BackgroundThere 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 (...)
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark   1 citation  
  16.  25
    Conflating Scientific With Clinical Considerations.Rieke van der Graaf & Johannes J. M. van Delden - 2009 - American Journal of Bioethics 9 (9):58-59.
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark   2 citations  
  17.  25
    Response to Open Peer Commentaries on “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 (6-7):7-8.
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark   2 citations  
  18.  25
    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 (...)
    Direct download  
     
    Export citation  
     
    Bookmark   1 citation  
  19.  15
    Stimulating solidarity to improve knowledge on medications used during pregnancy: A contribution from the ConcePTION project.Johannes J. M. van Delden, Miriam C. J. M. Sturkenboom, Rieke van der Graaf & Marieke J. Hollestelle - 2023 - BMC Medical Ethics 24 (1):1-9.
    BackgroundPregnant people have been overlooked or excluded from clinical research, resulting in a lack of scientific knowledge on medication safety and efficacy during pregnancy. Thus far, both the opportunities to generate evidence-based knowledge beyond clinical trials and the role of pregnant people in changing their status quo have not been discussed. Some scholars have argued that for rare disease patients, for whom, just like pregnant people, a poor evidence base exists regarding treatments, solidarity has played an important role in addressing (...)
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark  
  20.  25
    Voluntary Informed Consent in Paediatric Oncology Research.Sara A. S. Dekking, Rieke Van Der Graaf & Johannes J. M. Van Delden - 2015 - 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 (...)
    Direct download  
     
    Export citation  
     
    Bookmark   1 citation  
  21.  10
    The boundary problem: Defining and delineating the community in field trials with gene drive organisms.Nienke de Graeff, Isabelle Pirson, Rieke van der Graaf, Annelien L. Bredenoord & Karin R. Jongsma - 2023 - Bioethics 37 (6):600-609.
    Despite widespread and worldwide efforts to eradicate vector-borne diseases such as malaria, these diseases continue to have an enormous negative impact on public health. For this reason, scientists are working on novel control strategies, such as gene drive technologies (GDTs). As GDT research advances, researchers are contemplating the potential next step of conducting field trials. An important point of discussion regarding these field trials relates to who should be informed, consulted, and involved in decision-making about their design and launch. It (...)
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark  
  22.  30
    Voluntary Informed Consent Is Not Risk Dependent.Sara A. S. Dekking, Rieke van der Graaf, C. Michel Zwaan & Johannes J. M. van Delden - 2019 - American Journal of Bioethics 19 (4):33-35.
    Direct download (3 more)  
     
    Export citation  
     
    Bookmark  
  23.  18
    What constitutes a reasonable compensation for non-commercial oocyte donors: an analogy with living organ donation and medical research participation.Emy Kool, Rieke van der Graaf, Annelies Bos, Bartholomeus Fauser & Annelien Bredenoord - 2019 - Journal of Medical Ethics 45 (11):736-741.
    There is a growing consensus that the offer of a reasonable compensation for oocyte donation for reproductive treatment is acceptable if it does not compromise voluntary and altruistically motivated donation. However, how to translate this ‘reasonable compensation’ in practice remains unclear as compensation rates offered to oocyte donors between different European Union countries vary significantly. Clinics involved in oocyte donation, as well as those in other medical contexts, might be encouraged in calculating a more consistent and transparent compensation for donors (...)
    Direct download (5 more)  
     
    Export citation  
     
    Bookmark  
  24. Social Value.Hans van Delden & Rieke van der Graaf - 2021 - In Graeme T. Laurie (ed.), The Cambridge handbook of health research regulation. New York, NY: Cambridge University Press.
     
    Export citation  
     
    Bookmark  
  25.  17
    The Duty to Support Learning Health Systems: A Broad Rather than a Narrow Interpretation.Rieke van der Graaf, Wouter van Dijk, Sara J. M. Laurijssen, Ewoud Schuit, Diederick E. Grobbee & Martine C. de Vries - 2021 - American Journal of Bioethics 21 (1):14-16.
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark  
  26.  10
    The Duty to Support Learning Health Systems: A Broad Rather than a Narrow Interpretation.Rieke van der Graaf, Wouter van Dijk, Sara J. M. Laurijssen, Ewoud Schuit, Diederick E. Grobbee & Martine C. De Vries - 2020 - American Journal of Bioethics 21 (1):14-16.
    As of October 23, 2020, almost 42 million cases of COVID-19 have been reported globally. Although many different treatments have been applied in infected...
    Direct download (2 more)  
     
    Export citation  
     
    Bookmark