•  5
    Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study
    with Yemisrach Zewdie Seralegne, Cynthia Khamala Wangamati, Bobbie Farsides, Abraham Aseffa, and Martha Zewdie
    Developing World Bioethics 23 (1): 50-58. 2022.
    Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investiga…Read more
  •  10
    Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study
    with Yemisrach Zewdie Seralegne, Cynthia Khamala Wangamati, Bobbie Farsides, Abraham Aseffa, and Martha Zewdie
    Developing World Bioethics 23 (1): 50-58. 2022.
    Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investiga…Read more
  •  25
    Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?
    with Ghislaine J. M. W. van Thiel, Nancy S. Breekveldt, Christine C. Gispen, and Johannes J. M. van Delden
    BMC Medical Ethics 21 (1): 1-8. 2020.
    Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reac…Read more
  •  20
    A survey in Mexico about ethics dumping in clinical research
    with Novoa-Heckel Germán
    BMC Medical Ethics 20 (1): 38. 2019.
    The exportation of unethical practices to low- and middle-income countries has been conceived as a prevalent practice which needs to be examined more closely. Such a practice might point towards the exploitation of vulnerable population groups. We conducted a survey among Mexican research ethics committee members to explore the issue of ethics dumping in Mexico by understanding how its existence and contributing factors and norms are perceived by these ethics committee members. We designed an ex…Read more
  •  44
    The fiduciary obligation of the physician-researcher in phase IV trials
    with Ghislaine Jmw van Thiel, Jan Am Raaijmakers, and Johannes Jm van Delden
    BMC Medical Ethics 15 (1): 11. 2014.
    BackgroundIn this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants.DiscussionWe first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines …Read more
  •  311
    News media coverage of euthanasia: a content analysis of Dutch national newspapers (review)
    with Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers, and Johannes J. M. Van Delden
    BMC Medical Ethics 14 (1): 6-. 2013.
    BackgroundThe Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.MethodsWe did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis.ResultsOf the 284 articles containing the term ‘euthanasia’, 24% referr…Read more
  •  46
    What do international ethics guidelines say in terms of the scope of medical research ethics?
    with Ghislaine J. M. W. van Thiel and Johannes J. M. van Delden
    BMC Medical Ethics 17 (1): 1-18. 2016.
    BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we at…Read more
  •  27
    The Need to Explicate the Ethical Evaluation Tools to Avoid Ethical Inflation
    with Ghislaine van Thiel, Jan Raaijmakers, and Johannes van Delden
    American Journal of Bioethics 9 (11): 56-58. 2009.