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Target Article

Ethical Justifications for Access to Unapproved Medical Interventions: An Argument for (Limited) Patient Obligations

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Jake Earl. (2019) Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine. The American Journal of Bioethics 19:6, pages 7-18.
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Elena Fountzilas, Rabih Said & Apostolia M. Tsimberidou. (2018) Expanded access to investigational drugs: balancing patient safety with potential therapeutic benefits. Expert Opinion on Investigational Drugs 27:2, pages 155-162.
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Agnes Vitry, Tuan Nguyen, Vikky Entwistle & Elizabeth Roughead. (2015) Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study. Journal of Pharmaceutical Policy and Practice 8:1.
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Seema K. Shah, David Wendler & Marion Danis. (2015) Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic. The American Journal of Bioethics 15:4, pages 11-16.
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David Magnus. (2014) Compassion and Research in Compassionate Use. The American Journal of Bioethics 14:11, pages 1-2.
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P. Wicks & J. A. Heywood. (2014) Data Donation Could Power the Learning Health Care System, Including Special Access Programs. The American Journal of Bioethics 14:11, pages 27-29.
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Udo Schuklenk. (2014) Access to Unapproved Medical Interventions in Cases of Catastrophic Illness. The American Journal of Bioethics 14:11, pages 20-22.
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Christopher Lowry. (2014) Right Answer, Wrong Question: Special Access, Knowledge Generation, and Clinical Trial Legitimacy. The American Journal of Bioethics 14:11, pages 22-24.
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Arthur Caplan & Alison Bateman-House. (2014) Compassion for Each Individual's Own Sake. The American Journal of Bioethics 14:11, pages 16-17.
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Jess Rabourn & Richard S. Bedlack. (2014) SAPs: A Different Perspective. The American Journal of Bioethics 14:11, pages 19-20.
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Anthony Vernillo. (2014) Special Access Programs and Clinical Research Trials—An Integration Long Overdue. The American Journal of Bioethics 14:11, pages 29-31.
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Michelle Roth-Cline & Robert Nelson. (2014) FDA Implementation of the Expanded Access Program in the United States. The American Journal of Bioethics 14:11, pages 17-19.
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Articles from other publishers (27)

Zubin Master. (2023) The two-bucket problem of unproven stem cell interventions. Regenerative Medicine 18:1, pages 19-21.
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Eline Bunnik & Marleen Eijkholt. 2023. Medical Research Ethics: Challenges in the 21st Century. Medical Research Ethics: Challenges in the 21st Century 367 384 .
Jeremiah Stout, Cambray Smith, Jan Buckner, Alex A. Adjei, Mark Wentworth, Jon C. Tilburt & Zubin Master. (2021) Oncologists’ reflections on patient rights and access to compassionate use drugs: A qualitative interview study from an academic cancer center. PLOS ONE 16:12, pages e0261478.
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Monica E. Lemmon, Courtney J. Wusthoff, Renee D. Boss & Lisa Anne Rasmussen. (2021) Ethical considerations in the care of encephalopathic neonates treated with therapeutic hypothermia. Seminars in Fetal and Neonatal Medicine 26:5, pages 101258.
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Jane Nielsen, Jenny Kaldor, Adam Irwin, Cameron Stewart & Dianne Nicol. (2021) Bespoke regulation for bespoke medicine? A comparative analysis of bioprinting regulation in Europe, the USA and Australia. Journal of 3D Printing in Medicine 5:3, pages 155-167.
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Eline M. Bunnik & Nikkie Aarts. (2021) The Role of Physicians in Expanded Access to Investigational Drugs: A Mixed-Methods Study of Physicians’ Views and Experiences in The Netherlands. Journal of Bioethical Inquiry 18:2, pages 319-334.
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SUMEL ASHIQUE & TAHAMINA KHATUN. (2021) COMPASSIONATE USE OF INVESTIGATIONAL DRUG DURING EMERGENCY CONDITIONS AND ASSOCIATED ETHICAL ASPECTS, CHALLENGES, AND BENEFITS. Asian Journal of Pharmaceutical and Clinical Research, pages 5-12.
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Jan Borysowski & Andrzej Górski. (2020) Ethics framework for treatment use of investigational drugs. BMC Medical Ethics 21:1.
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Jake Earl & David Wendler. (2020) Ethics of information‐gathering interventions in innovative practice. Internal Medicine Journal 50:12, pages 1583-1587.
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Adam Greif & Martin Šurkala. (2020) Compassionate use of psychedelics. Medicine, Health Care and Philosophy 23:3, pages 485-496.
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Michael Buckley & Collin O’neil. (2020) The Practice of Pharmaceutics and the Obligation to Expand Access to Investigational Drugs. The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 45:2, pages 193-211.
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Carolyn Riley Chapman, Jared Eckman & Alison S. Bateman‐House. (2020) Oversight of Right‐to‐Try and Expanded Access Requests for Off‐Trial Access to Investigational Drugs. Ethics & Human Research 42:1, pages 2-13.
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Kirsten A. Riggan, Richard R. Sharp & Megan Allyse. (2019) Where Will We Draw the Line? Public Opinions of Human Gene Editing. Qualitative Health Research 29:12, pages 1823-1835.
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Jan Borysowski & Andrzej Górski. (2019) Compassionate use of unauthorized drugs: Legal regulations and ethical challenges. European Journal of Internal Medicine 65, pages 12-16.
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Stacey B. Lee & Alexandra Y. Murata. (2017) The Expanded Access Cure: A Twenty-First Century Framework for Companies. Journal of Business Ethics 156:1, pages 155-171.
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David J. Cote. 2019. Ethics of Innovation in Neurosurgery. Ethics of Innovation in Neurosurgery 93 103 .
Seydina B Touré, Erika Kleiderman & Bartha M Knoppers. (2018) Bridging stem cell research and medicine: a learning health system. Regenerative Medicine 13:6, pages 741-752.
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Eline M. Bunnik, Nikkie Aarts & Suzanne van de Vathorst. (2018) Little to lose and no other options: Ethical issues in efforts to facilitate expanded access to investigational drugs. Health Policy 122:9, pages 977-983.
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Jan Borysowski, Abha Saxena, Alison Bateman-House, Marisa Papaluca, Joanna Różyńska, Agata Wnukiewicz-Kozłowska & Andrzej Górski. (2018) Expanded access: growing importance to public health. Journal of Epidemiology and Community Health 72:7, pages 557-558.
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Philippe Calain. (2018) The Ebola clinical trials: a precedent for research ethics in disasters. Journal of Medical Ethics 44:1, pages 3-8.
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Jan Borysowski, Hans-Jörg Ehni & Andrzej Górski. (2017) Ethics review in compassionate use. BMC Medicine 15:1.
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David J. CoteNaci BalakJannick BrennumDaniel T. HolsgroveNeil KitchenHerbert KolendaWouter A. MoojenKarl SchallerPierre A. RobeTiit Mathiesen & Marike L. Broekman. (2017) Ethical difficulties in the innovative surgical treatment of patients with recurrent glioblastoma multiforme. Journal of Neurosurgery 126:6, pages 2045-2050.
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Holger Langhof & Daniel Strech. 2017. Angewandte Ethik in der Neuromedizin. Angewandte Ethik in der Neuromedizin 95 105 .
Tim K. Mackey & Virginia J. Schoenfeld. (2016) Going “social” to access experimental and potentially life-saving treatment: an assessment of the policy and online patient advocacy environment for expanded access. BMC Medicine 14:1.
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Kasper Raus. (2016) An analysis of common ethical justifications for compassionate use programs for experimental drugs. BMC Medical Ethics 17:1.
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Andrzej Górski, Ryszard Międzybrodzki, Beata Weber-Dąbrowska, Wojciech Fortuna, Sławomir Letkiewicz, Paweł Rogóż, Ewa Jończyk-Matysiak, Krystyna Dąbrowska, Joanna Majewska & Jan Borysowski. (2016) Phage Therapy: Combating Infections with Potential for Evolving from Merely a Treatment for Complications to Targeting Diseases. Frontiers in Microbiology 7.
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Wendy Lipworth & Renata Axler. (2016) Towards a bioethics of innovation. Journal of Medical Ethics 42:7, pages 445-449.
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