Pediatric Research

  • Kimmelman J, Waligora M, Fernandez Lynch H, Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials-Reply, JAMA Pediatrics 2019 Apr 22. doi: 10.1001/jamapediatrics.2019.0797. [Letter]
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  • Kimmelman J, Waligora M, Fernandez Lynch H, Participants Protection in Phase1 Pediatric Cancer Trials, JAMA Pediatrics 2019;173(1):8-9. doi:10.1001/jamapediatrics.2018.3629.
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  • PROTOCOL: Waligora M, Strzebonska K, Wasylewski MT, Koperny M, Polak M, KimmelmanJ, Children in Phase I trials in oncology. Social value and clinical development success rate, PROSPERO 2018 CRD42018106213.
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  • Waligora M, Strzebonska K, Wasylewski MT, Neither the Harm Principle nor the Best Interest Standard Should Be Applied to Pediatric Research, American Journal of Bioethics, 2018 Aug;18(8):72-74. doi: 10.1080/15265161.2018.1485762.
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  • Waligora M, Bala MM, Koperny M, Wasylewski MT, Strzebonska K, Jaeschke RR, Wozniak A, Piasecki J, Sliwka A, Mitus JW, Polak M, Nowis D, Fergusson D, Kimmelman J, Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis, PLOS Medicine 2018 Feb 20;15(2):e1002505. doi: 10.1371/journal.pmed.1002505. 2018.
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  • Protocol: PROSPERO 2015 CRD42015015961
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  • Piasecki J, Waligora M, Dranseika V, Assent in Paediatric Research and Its Consequences, Strech D & Mertz M (eds) Ethics and Governance of Biomedical Research, Springer International Publ 2016, 87-95. doi: 10.1007/978-3-319-28731-7_7.
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  • Waligora M, Rozynska J, Piasecki J, Child’s objection to non-beneficial research: capacity and distress based models, Medicine, Health Care and Philosophy 2016 Mar;19(1):65-70. doi: 10.1007/s11019-015-9643-8 (Open Access)
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  • Piasecki J, Waligora M, Dranseika V, Non-beneficial pediatric research: individual and social interests, Medicine, Health Care and Philosophy 2015, 18(1):103-12. doi: 10.1007/s11019-014-9586-5 (Open Access).
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  • Waligora M, Dranseika V, Piasecki J, Child’s assent in research: Age threshold or personalisation?, BMC Medical Ethics 2014, 15:44. doi: 10.1186/1472-6939-15-44 (Open Access).
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  • Waligora M, Is a requirement of personalised assent realistic? A case from the GABRIEL project, European Journal of Human Genetics (2014) 22, 855. doi: 10.1038/ejhg.2013.259. Letter to the editor. [Giesbertz NA, Bredenoord AL, van Delden JJ, Reply to Waligora M, European Journal of Human Genetics, 2013 Nov 6. doi: 10.1038/ejhg.2013.260].
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  • Waligóra M, Prawo dziecka do odmowy udziału w eksperymencie medycznym, w: Hartman J, Waligóra M (red.), Etyczne aspekty decyzji medycznych, Warszawa: Wolters Kluwer 2011.

 

 

Clinical Endpoints and Novel Trial Design

  • Strzebonska K, Waligora M, Umbrella and basket trials in oncology: ethical challenges, BMC Med Ethics. 2019 Aug 23;20(1):58. doi: 10.1186/s12910-019-0395-5
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  • Kovic B, Jin X, Kennedy SA, Hylands M, Pędziwiatr M, Kuriyama A, Gomaa H, Lee Y, Katsura M, Tada M, Hong BY, Min Cho S, Jiho Hong P, Yu AM, Sivji Y, Toma A, Xie L, Tsoi L, Waligora M, Prasad M, Bhatnagar N, Thabane L, Brundage M, Guyatt G, Xie F, Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology: A Systematic Review and Quantitative Analysis, JAMA Internal Medicine, 2018 Oct 1
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  • Zhang Y, Morgan RL, Alonso-Coello P, Wiercioch W, Bała MM, Jaeschke RR, Styczeń K, Pardo-Hernandez H, Selva A, Begum HA, Morgano GP, Waligora M, Agarwal A, Ventresca M, Strzebonska K, Wasylewski MT, Blanco-Silvente L, Kerth JL, Wang M, Zhang Y, Narsingam S, Fei Y, Guyatt G, Schünemann HJ,
    A systematic review on how patients value chronic obstructive polmonary disease outcomes, European Respiratory Journal, 2018, 52: 1800222; doi: 10.1183/13993003.00222-2018
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Research in Central and Eastern Europe

  • Dranseika V, Gefenas E, Waligora M, Broadening the “Infrastructure Effect”: Lessons from the Early Development of Research Ethics in Eastern Europe, The American Journal of Bioethics, 2016 Jun; 16(6):26-8. doi: 10.1080/15265161.2016.1170243
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  • Broga M, Mijaljica G, Waligora M, Keis A, Marusic A, Publication Ethics in Biomedical Journals from Countries in Central and Eastern Europe, Science and Engineering Ethics 2014; 20: 99–109. doi: 10.1007/s11948-013-9431-x (Open Access).
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  • Waligora M, A European consistency for functioning of RECs? We just lost our chance, Journal of Medical Ethics 2013 Jun; 39(6):408-9. doi: 10.1136/medethics-2012-101228.
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  • Waligora M, Failures in Clinical Trials in the European Union: Lessons from the Polish Experience, Science and Engineering Ethics 2013 Sep; 19(3):1087-98. doi: 10.1007/s11948-012-9400-9 (Open Access).
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  • Różyńska J, Waligóra M (eds.), Badania z udziałem ludzi w biomedycynie. Standardy międzynarodowe, Warszawa: Wolters Kluwer Polska 2012.
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Informed Consent

  • Dranseika V, Piasecki J, Waligora M, Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure, Science and Engineering Ethics, 2017, 23:215 doi: 10.1007/s11948-016-9755-4 (Open Access).More information
  • Dranseika V, Piasecki J, Waligora M, Forensic uses of research biobanks: shoold donors be informed?, Medicine, Health Care and Philosophy, 2016; 19(1):141-146. doi: 10.1007/s11019-015-9667-0 (Open Access).
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Public Health

  • Piasecki J, Dranseika V, Waligora M, Should Epidemiological Studies Be Subject to Ethics Review?, Public Health Ethics, doi: 10.1093/phe/phx016
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  • Piasecki J, Waligora M, Dranseika V, What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review, Science and Engineering Ethics, 2017, 23:743, doi 10.1007/s11948-016-9829-3 (Open Access).
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  • Mezinska S, Kakuk P, Mijaljica G, Waligóra M, O’Mathúna DP, Research in disaster settings: a systematic qualitative review of ethical guidelines, BMC Medical Ethics, 2016, 17:62, doi 10.1186/s12910-016-0148-7 (Open Access).
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Ethics and Research Methodology

  • Piasecki J, Waligora M, Dranseika V, Google Search as an Additional Source in Systematic
    Reviews, Science and Engineering Ethics, 2018 Apr;24(2):809-810. doi: 10.1007/s11948-017-0010-4,
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  • Różyńska J, Spór o fundamenty etyki randomizowanych badan klinicznych, w: Basińska K, Halasz J (red.), Etyka w medycynie wczoraj i dziś. Wybrane zagadnienia, Kraków: Impols 2013.
  • Różyńska J, Waligóra M, Kilka słów o zasadzie równowagi klinicznej, komentarz do Miller FG, Joffe S, Zasada równowagi klinicznej i dylematy etyczne dotyczące badań z randomizacją, Medycyna po Dyplomie, vol20/no8/2011.

Risk in research

  • Strzebonska K, Waligora M, Underestimation of Harms in Phase I Trials, The Journal of Law, Medicine & Ethics, 2019 Jun;47(2):334-335. doi: 10.1177/1073110519857290.
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  • Rozynska J, On the Alleged Right to Participate in High-Risk Research, Bioethics, 2015 Sep; 29(7):451-61. doi: 10.1111/bioe.12146.
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