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  1. How to Tackle the Conundrum of Quality Appraisal in Systematic Reviews of Normative Literature/Information? Analysing the Problems of Three Possible Strategies.Marcel Mertz - 2019 - BMC Medical Ethics 20 (1):1-12.
    In the last years, there has been an increase in publication of systematic reviews of normative literature or of normative information in bioethics. The aim of a systematic review is to search, select, analyse and synthesise literature in a transparent and systematic way in order to provide a comprehensive and unbiased overview of the information sought, predominantly as a basis for informed decision-making in health care. Traditionally, one part of the procedure when conducting a systematic review is an appraisal of (...)
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  • Instrumentalist Analyses of the Functions of Ethics Concept-Principles: A Proposal for Synergetic Empirical and Conceptual Enrichment.Eric Racine, M. Ariel Cascio, Marjorie Montreuil & Aline Bogossian - 2019 - Theoretical Medicine and Bioethics 40 (4):253-278.
    Bioethics has made a compelling case for the role of experience and empirical research in ethics. This may explain why the movement for empirical ethics has such a firm grounding in bioethics. However, the theoretical framework according to which empirical research contributes to ethics—and the specific role it can or should play—remains manifold and unclear. In this paper, we build from pragmatic theory stressing the importance of experience and outcomes in establishing the meaning of ethics concepts. We then propose three (...)
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  • Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research.Rebecca L. Walker, Marci D. Cottingham & Jill A. Fisher - 2018 - Journal of Medicine and Philosophy 43 (1):83-114.
    Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...)
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  • Broadening the Debate About Post-Trial Access to Medical Interventions: A Qualitative Study of Participant Experiences at the End of a Trial Investigating a Medical Device to Support Type 1 Diabetes Self-Management.J. Lawton, M. Blackburn, D. Rankin, C. Werner, C. Farrington, R. Hovorka & N. Hallowell - 2019 - Ajob Empirical Bioethics 10 (2):100-112.
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  • Systematic Reviews in Bioethics: Types, Challenges, and Value.R. Mcdougall - 2014 - Journal of Medicine and Philosophy 39 (1):89-97.
    There has recently been interest in applying the techniques of systematic review to bioethics literature. In this paper, I identify the three models of systematic review proposed to date in bioethics: systematic reviews of empirical bioethics research, systematic reviews of normative bioethics literature, and systematic reviews of reasons. I argue that all three types yield information useful to scholarship in bioethics, yet they also face significant challenges particularly in relation to terminology and time. Drawing on my recent experience conducting a (...)
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  • Introduction: The Fogarty International Research Ethics Education and Curriculum Development Program in Historical Context.Joseph Millum, Christine Grady, Gerald Keusch & Barbara Sina - 2013 - Journal of Empirical Research on Human Research Ethics: An International Journal 8 (5):3-16.
    In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research (...)
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  • Post‐Trial Obligations in the Declaration of Helsinki 2013: Classification, Reconstruction and Interpretation.Ignacio Mastroleo - 2016 - Developing World Bioethics 16 (2):80-90.
    The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, specifically, access to (...)
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  • Post-Trial Access to Study Medication: A Brazilian E-Survey with Major Stakeholders in Clinical Research.S. M. Dainesi & M. Goldbaum - 2012 - Journal of Medical Ethics 38 (12):757-762.
    Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors’ groups, respectively. 54 patients answered the questionnaire through (...)
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  • Canadian Research Ethics Board Members’ Attitudes Toward Benefits From Clinical Trials.Kori Cook, Jeremy Snyder & John Calvert - 2015 - BMC Medical Ethics 16 (1):1-7.
    BackgroundWhile ethicists have for many years called for human subject trial participants and, in some cases, local community members to benefit from participation in pharmaceutical and other intervention-based therapies, little is known about how these discussions are impacting the practice of research ethics boards that grant ethical approval to many of these studies.MethodsTelephone interviews were conducted with 23 REB members from across Canada, a major funder country for human subject research internationally. All interviews were digitally recorded and transcribed verbatim. After (...)
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  • Incorporating Ethical Principles Into Clinical Research Protocols: A Tool for Protocol Writers and Ethics Committees.Rebecca H. Li, Mary C. Wacholtz, Mark Barnes, Liam Boggs, Susan Callery-D'Amico, Amy Davis, Alla Digilova, David Forster, Kate Heffernan, Maeve Luthin, Holly Fernandez Lynch, Lindsay McNair, Jennifer E. Miller, Jacquelyn Murphy, Luann Van Campen, Mark Wilenzick, Delia Wolf, Cris Woolston, Carmen Aldinger & Barbara E. Bierer - 2016 - Journal of Medical Ethics 42 (4):229-234.
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  • How to Write a Systematic Review of Reasons.D. Strech & N. Sofaer - 2012 - Journal of Medical Ethics 38 (2):121-126.
    Systematic reviews, which were developed to improve policy-making and clinical decision-making, answer an empirical question based on a minimally biased appraisal of all the relevant empirical studies. A model is presented here for writing systematic reviews of argument-based literature: literature that uses arguments to address conceptual questions, such as whether abortion is morally permissible or whether research participants should be legally entitled to compensation for sustaining research-related injury. Such reviews aim to improve ethically relevant decisions in healthcare, research or policy. (...)
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  • Implementing Post-Trial Access Plans for HIV Prevention Research.Amy Paul, Maria W. Merritt & Jeremy Sugarman - 2018 - Journal of Medical Ethics 44 (5):354-358.
    Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV (...)
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  • Conscientious Objection to Participation in Abortion by Midwives and Nurses: A Systematic Review of Reasons.Valerie Fleming, Lucy Frith, Ans Luyben & Beate Ramsayer - 2018 - BMC Medical Ethics 19 (1):31.
    Freedom of conscience is a core element of human rights respected by most European countries. It allows abortion through the inclusion of a conscience clause, which permits opting out of providing such services. However, the grounds for invoking conscientious objection lack clarity. Our aim in this paper is to take a step in this direction by carrying out a systematic review of reasons by midwives and nurses for declining, on conscience grounds, to participate in abortion. We conducted a systematic review (...)
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  • Did We Describe What You Meant? Findings and Methodological Discussion of an Empirical Validation Study for a Systematic Review of Reasons.Marcel Mertz, Neema Sofaer & Daniel Strech - 2014 - BMC Medical Ethics 15 (1):69.
    The systematic review of reasons is a new way to obtain comprehensive information about specific ethical topics. One such review was carried out for the question of why post-trial access to trial drugs should or need not be provided. The objective of this study was to empirically validate this review using an author check method. The article also reports on methodological challenges faced by our study.
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  • Human Dignity as a Basis for Providing Post-Trial Access to Healthcare for Research Participants: A South African Perspective.Pamela Andanda & Jane Wathuta - 2018 - Medicine, Health Care and Philosophy 21 (1):139-155.
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  • Forthcoming Practical Framework for Ethics Committees and Researchers on Post-Trial Access to the Trial Intervention and Healthcare.N. Sofaer, P. Lewis & H. Davies - 2014 - Journal of Medical Ethics 40 (4):217-218.
    When research concludes, post-trial access to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service and underinsured US participants. Yet, many researchers are unclear about their obligations regarding the post-trial period, and many research ethics committees do not know what to require of researchers. Consequences include participants who reasonably expect but lack PTA to the trial (...)
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  • Pharmaceutical Companies Vs. The State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?Daniel Wei L. Wang & Octavio Luiz Motta Ferraz - 2012 - Journal of Law, Medicine and Ethics 40 (2):188-196.
    This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have (...)
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  • Pharmaceutical Companies Vs. The State: Who is Responsible for Post-Trial Provision of Drugs in Brazil?Daniel Wei L. Wang & Octavio Luiz Motta Ferraz - 2012 - Journal of Law, Medicine and Ethics 40 (2):188-196.
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