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  1. 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.
    This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...)
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  • Formulating an Ethics of Pharmaceutical Disinvestment.Jessica Pace, Tracey-Lea Laba, Marie-Paul Nisingizwe & Wendy Lipworth - 2020 - Journal of Bioethical Inquiry 17 (1):75-86.
    There is growing interest among pharmaceutical policymakers in how to “disinvest” from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in (...)
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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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  • La obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación.Ignacio Mastroleo - 2012 - Dissertation, Universidad de Buenos Aires
    Todos los días se prueban nuevos psicofármacos, tratamientos para el VIH/SIDA o el cáncer, entre otras enfermedades. Algunos de esos tratamientos son lo suficientemente exitosos como para cronificar enfermedades antes consideradas mortales, como los antirretrovirales para el VIH/SIDA o el imatinib para la leucemia mieloide a principios del 2000. No obstante, antes de que puedan ser comercializados o estar disponibles en los sistemas de salud pública, deben pasar por una serie de rigurosas pruebas de calidad, seguridad y eficacia. Estas pruebas (...)
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  • Modelo de reciprocidad democrática: una justificación de la continuidad de tratamiento beneficioso en la investigación clínica.Ignacio Mastroleo - 2016 - Journal of Science Humanities and Arts 3 (7):1-33.
    En este trabajo desarrollo un modelo normativo sobre la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación desde la perspectiva de la justicia social o distributiva, inspirado en la teoría de la justicia de John Rawls. Llamo a esto, el modelo de reciprocidad democrática. La idea original del modelo de reciprocidad democrática es defender que la obligación de continuidad de tratamiento beneficioso tiene como derecho correlativo el derecho a la salud. Así, dentro del marco rawlsiano, argumento que (...)
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  • MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines. Guidance Document. Version 1.0, December 2016.Carmen Aldinger, Barbara Bierer, Rebecca Li, Luann Van Campen, Mark Barnes, Eileen Bedell, Amanda Brown-Inz, Robin Gibbs, Deborah Henderson, Christopher Kabacinski, Laurie Letvak, Susan Manoff, Ignacio Mastroleo, Ellie Okada, Usharani Pingali, Wasana Prasitsuebsai, Hans Spiegel, Daniel Wang, Susan Briggs Watson & Marc Wilenzik - 2016 - The Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard (MRCT Center).
    I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...)
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  • Introducción al problema de la continuidad del tratamiento beneficioso para los sujetos de investigación.Ignacio Mastroleo - 2015 - In Jorge Alberto Álvarez Díaz (ed.), Ensayos sobre ética de la salud. Ciudad de México: Universidad Autónoma Metropolitana - Unidad Xochimilco. pp. 67 - 99.
    ¿Qué ocurre con la continuidad del tratamiento de los sujetos de investigación después de que realizan la última visita del ensayo en el que participan? En algunos casos, la falta de continuidad de atención de la salud apropiada podría poner en peligro la salud de estas personas. Por lo tanto, es probable que los sujetos de investigación que al terminar su participación en un ensayo todavía se encuentran enfermos, necesiten continuar con el tratamiento en estudio u otra atención de la (...)
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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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  • Introduction: Case Studies in the Ethics of Mental Health Research.J. Millum - 2012 - Journal of Nervous and Mental Disease 200:230-35.
    This collection presents six case studies on the ethics of mental health research, written by scientific researchers and ethicists from around the world. We publish them here as a resource for teachers of research ethics and as a contribution to several ongoing ethical debates. Each consists of a description of a research study that was proposed or carried out and an in-depth analysis of the ethics of the study.
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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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  • 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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  • Incidental Findings in Low‐Resource Settings.Haley K. Sullivan & Benjamin E. Berkman - 2018 - Hastings Center Report 48 (3):20-28.
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  • Mind the Gap: An Empirical Study of Post‐Trial Access in HIV Biomedical Prevention Trials.Bridget Haire & Christopher Jordens - 2015 - Developing World Bioethics 15 (2):85-97.
    The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and (...)
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  • What is Good Medical Ethics? A Clinician's Perspective.W. M. Kong - 2015 - Journal of Medical Ethics 41 (1):79-82.
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  • Philosophical Expertise Beyond Intuitions.Anna Drożdżowicz - 2018 - Philosophical Psychology 31 (2):253-277.
    In what sense, if any, are philosophers experts in their domain of research and what could philosophical expertise be? The above questions are particularly pressing given recent methodological disputes in philosophy. The so-called expertise defense recently proposed as a reply to experimental philosophers postulates that philosophers are experts qua having improved intuitions. However, this model of philosophical expertise has been challenged by studies suggesting that philosophers’ intuitions are no less prone to biases and distortions than intuitions of non-philosophers. Should we (...)
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