10 found
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  1.  22
    Research Ethics Governance in Times of Ebola.Doris Schopper, Raffaella Ravinetto, Lisa Schwartz, Eunice Kamaara, Sunita Sheel, Michael J. Segelid, Aasim Ahmad, Angus Dawson, Jerome Singh, Amar Jesani & Ross Upshur - 2017 - Public Health Ethics 10 (1).
    The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues (...)
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  2.  16
    The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo.Marion Kalabuanga, Raffaella Ravinetto, Vivi Maketa, Hypolite Muhindo Mavoko, Blaise Fungula, Raquel Inocêncio da Luz, Jean‐Pierre Van Geertruyden & Pascal Lutumba - 2016 - Developing World Bioethics 16 (2):64-69.
    In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of (...)
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  3.  38
    Innovations in Research Ethics Governance in Humanitarian Settings.Doris Schopper, Angus Dawson, Ross Upshur, Aasim Ahmad, Amar Jesani, Raffaella Ravinetto, Michael J. Segelid, Sunita Sheel & Jerome Singh - 2015 - BMC Medical Ethics 16 (1):10.
    Médecins Sans Frontières is one of the world’s leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper.
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  4.  5
    Never Look a Gift Horse in the Mouth? Four Reasons Not to Blur the Line Between Research and Care in Low- and Middle-Income Countries.Wim Pinxten, Raffaella Ravinetto & Anne Buvé - 2016 - American Journal of Bioethics 16 (6):17-19.
  5.  3
    Ethics Preparedness: Facilitating Ethics Review During Outbreaks - Recommendations From an Expert Panel.Abha Saxena, Peter Horby, John Amuasi, Nic Aagaard, Johannes Köhler, Ehsan Shamsi Gooshki, Emmanuelle Denis, Andreas A. Reis & Raffaella Ravinetto - 2019 - BMC Medical Ethics 20 (1):29.
    Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research (...)
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  6.  12
    Informed Consent, Community Engagement, and Study Participation at a Research Site in Kigali, Rwanda.Jennifer Ilo van Nuil, Evelyne Kestelyn, Grace Umutoni, Lambert Mwambarangwe, Marie M. Umulisa, Janneke van de Wijgert & Raffaella Ravinetto - 2018 - Developing World Bioethics 18 (4):349-356.
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  7.  15
    Community Sensitization and Decision‐Making for Trial Participation: A Mixed‐Methods Study From The Gambia.Susan Dierickx, Sarah O'Neill, Charlotte Gryseels, Edna Immaculate Anyango, Melanie Bannister‐Tyrrell, Joseph Okebe, Julia Mwesigwa, Fatou Jaiteh, René Gerrets, Raffaella Ravinetto, Umberto D'Alessandro & Koen Peeters Grietens - forthcoming - Developing World Bioethics.
    Background Ensuring individual free and informed decision-making for research participation is challenging. It is thought that preliminarily informing communities through ‘community sensitization’ procedures may improve individual decision-making. This study set out to assess the relevance of community sensitization for individual decision-making in research participation in rural Gambia. Methods This anthropological mixed-methods study triangulated qualitative methods and quantitative survey methods in the context of an observational study and a clinical trial on malaria carried out by the Medical Research Council Unit Gambia. (...)
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  8.  5
    Quality of Medicines in Resource-Limited Settings: Need for Ethical Guidance.Raffaella Ravinetto, Wim Pinxten & Lembit Rägo - 2018 - Global Bioethics 29 (1):81-94.
    ABSTRACTThe quality of medicines is generally adequately assured by manufacturers and regulatory authorities for well-resourced settings, while the implementation of existing quality standards is challenged in many low- and middle-income countries. This situation of multiple pharmaceutical standards raises the question whether it could ever be ethically justified to compromise on the quality assurance of medicines depending on what individuals, communities, or societies can afford. In this paper, we contend that ethically, any unjustified exceptions to medicines’ quality assurance represents a violation (...)
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  9.  12
    Informed Consent, Community Engagement, and Study Participation at a Research Site in Kigali, Rwanda.Jennifer Ilo Nuil, Evelyne Kestelyn, Grace Umutoni, Lambert Mwambarangwe, Marie M. Umulisa, Janneke Wijgert & Raffaella Ravinetto - 2018 - Developing World Bioethics 18 (4):349-356.
    People enroll in medical research for many reasons ranging from decisions regarding their own or family members' health situation to broader considerations including access to health and financial resources. In socially vulnerable communities the choice to participate is often based on a risk-benefit assessment that goes beyond the medical aspects of the research, and considers the benefits received. In this qualitative study, we examined the motivations of Rwandan women to participate in a non-commercial collaborative research study examining the safety, acceptability, (...)
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  10.  3
    Governance and Standards in International Clinical Research: The Role of Transnational Consortia.Raffaella Ravinetto, Sören L. Becker, Moussa Sacko, Sayda El-Safi, Yodi Mahendradhata, Pascal Lutumba, Suman Rijal, Kruy Lim, Shyam Sundar, Eliézer K. N'Goran, Kristien Verdonck, Jürg Utzinger, François Chappuis & Marleen Boelaert - 2016 - American Journal of Bioethics 16 (10):59-61.