Pediatric Research

  • Wasylewski MT, Strzebonska K, Koperny M, Polak M, Kimmelman J, Waligora M. Clinical development success rates and social value of pediatric Phase 1 trials in oncology. PLoS One. 2020;15(6):e0234911. Published 2020 Jun 24.
    doi:10.1371/journal.pone.0234911.
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  • Kimmelman J, Waligora M, Lynch HF. Ethical Review and Methodologic Innovation in Phase 1 Cancer Trials-Reply. JAMA Pediatr. 2019;173(6):609-610.
    doi:10.1001/jamapediatrics.2019.0797
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  • Kimmelman J, Waligora M, Lynch HF. Participant Protection in Phase 1 Pediatric Cancer Trials. JAMA Pediatr. 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. Am J Bioeth. 2018;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 Med. 2018;15(2):e1002505. Published 2018 Feb 20.
    doi:10.1371/journal.pmed.1002505
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  • PROTOCOL: Waligora M, Bala M, Koperny M, Jaeschke RR, Kargul A, Piasecki J, Nowis D, Kimmelman J, Risk and benefits of pediatric phase I trials in oncology, 2004 through 2014: a systematic review. PROSPERO 2015 CRD42015015961
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  • Piasecki J, Waligora M, Dranseika V, Assent in Paediatric Research and Its Consequences. In: Strech D., Mertz M. (eds) Ethics and Governance of Biomedical Research. Research Ethics Forum, vol 4. Springer, Cham. 2016
    https://doi.org/10.1007/978-3-319-28731-7_7
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  • Waligora M, Różyńska J, Piasecki J. Child’s objection to non-beneficial research: capacity and distress based models. Med Health Care Philos. 2016;19(1):65-70.
    doi:10.1007/s11019-015-9643-8
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  • Piasecki J, Waligora M, Dranseika V. Non-beneficial pediatric research: individual and social interests. Med Health Care Philos. 2015;18(1):103-112.
    doi:10.1007/s11019-014-9586-5
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  • Waligora M, Dranseika V, Piasecki J. Child’s assent in research: age threshold or personalisation?. BMC Med Ethics. 2014;15:44. Published 2014 Jun 13.
    doi:10.1186/1472-6939-15-44
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  • Waligora M. Is a requirement of personalised assent realistic? A case from the GABRIEL project. Eur J Hum Genet. 2014;22(7):855.
    doi:10.1038/ejhg.2013.259
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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;20(1):58. Published 2019 Aug 23.
    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 Intern Med. 2018;178(12):1586-1596.
    doi:10.1001/jamainternmed.2018.4710

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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 of how patients value COPD outcomes. Eur Respir J. 2018;52(1):1800222. Published 2018 Jul 19.
    doi:10.1183/13993003.00222-2018
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Research in Central and Eastern Europe

  • Strzebonska K, Wasylewski MT, Zaborowska L, Riedel N, Wieschowski S, Strech D,4, Waligora M. Results dissemination of registered clinical trials across Polish academic institutions: a cross-sectional analysis. BMJ Open. 2020;10(1):e034666. Published 2020 Jan 22.
    doi:10.1136/bmjopen-2019-034666
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  • Dranseika V, Gefenas E, Waligora M, Broadening the “Infrastructure Effect”: Lessons from the Early Development of Research Ethics in Eastern Europe. Am J Bioeth. 2016;16(6):26-28.
    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. Sci Eng Ethics. 2014;20(1):99-109.
    doi:10.1007/s11948-013-9431-x
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  • Waligora M, A European consistency for functioning of RECs? We just lost our chance. J Med Ethics. 2013;39(6):408-409.
    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. Sci Eng Ethics. 2013;19(3):1087-1098.
    doi:10.1007/s11948-012-9400-9
  • 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. Sci Eng Ethics. 2017;23(1):215-225.
    doi:10.1007/s11948-016-9755-4
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  • Dranseika V, Piasecki J, Waligora M. Forensic uses of research biobanks: should donors be informed?. Med Health Care Philos. 2016;19(1):141-146.
    doi:10.1007/s11019-015-9667-0
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Public Health

  • Piasecki J, Dranseika V, Waligora M, Should Epidemiological Studies Be Subject to Ethics Review?, Public Health Ethics, Volume 11, Issue 2, July 2018, Pages 213–220,
    https://doi.org/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. Sci Eng Ethics. 2017;23(3):743-768.
    doi:10.1007/s11948-016-9829-3
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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 Med Ethics. 2016;17(1):62. Published 2016 Oct 21.
    doi:10.1186/s12910-016-0148-7
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Ethics and Research Methodology

  • Piasecki J, Waligora M, Dranseika V. Google Search as an Additional Source in Systematic Reviews. Sci Eng Ethics. 2018;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. J Law Med Ethics. 2019;47(2):334-335.
    doi:10.1177/1073110519857290
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  • Różyńska J. On the Alleged Right to Participate in High-Risk Research. Bioethics. 2015;29(7):451-461.
    doi:10.1111/bioe.12146
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