{"id":877,"date":"2016-01-28T13:21:51","date_gmt":"2016-01-28T13:21:51","guid":{"rendered":"http:\/\/cbb.uw.edu.pl\/en\/?page_id=877"},"modified":"2024-03-19T14:59:07","modified_gmt":"2024-03-19T14:59:07","slug":"ethics-and-risk-in-biomedical-research","status":"publish","type":"page","link":"https:\/\/cbb.uw.edu.pl\/en\/grants\/ethics-and-risk-in-biomedical-research\/","title":{"rendered":"Ethics and risk in biomedical research"},"content":{"rendered":"<p><strong><span style=\"color: #ff0000;\"><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en.png\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-10642 alignnone\" src=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en.png\" alt=\"\" width=\"378\" height=\"33\" srcset=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en.png 3082w, https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en-300x26.png 300w, https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en-1024x89.png 1024w, https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en-768x67.png 768w, https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en-1536x134.png 1536w, https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en-2048x178.png 2048w, https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2024\/03\/logo-NCN-horozin-en-660x57.png 660w\" sizes=\"auto, (max-width: 378px) 100vw, 378px\" \/><\/a><\/span><\/strong><\/p>\n<p><strong><span style=\"color: #ff0000;\">PROJECT SETTLED<\/span><\/strong><\/p>\n<p><span style=\"color: #000000;\">Project title:<em>\u00a0<\/em><\/span><span style=\"color: #16a1e7;\"><strong>Ethical analysis of risks and potential benefits in biomedical research<\/strong><\/span><br \/>\nPrincipal investigator:<strong>\u00a0dr Joanna R\u00f3\u017cy\u0144ska<\/strong><br \/>\nFinancing: National Science Centre, OPUS 8<br \/>\nProject number: 2014\/15\/B\/HS1\/03829<\/p>\n<p><strong>Project aims:<\/strong> The primary aim of the project is to develop a normative framework for risk-benefit assessment in biomedical research involving human subjects, which will be both sensitive to widely accepted ethical and legal values (such as dignity, autonomy, beneficence, vulnerability, justice and solidarity, precaution) and applicable to actual practice within the field of research involving human subjects.<\/p>\n<p><strong>Key words:<\/strong>\u00a0research ethics, clinical trials, value of research, research benefit, research risk<\/p>\n<hr \/>\n<h2><span style=\"color: #16a1e7;\">Publication of the project results\u00a0<\/span><\/h2>\n<p><strong>Papers (published or accepted for publication)<\/strong><\/p>\n<ul>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2023).\u00a0<a href=\"https:\/\/www.academia.edu\/45188855\/How_risky_can_biomedical_research_be_On_setting_an_upper_limit_of_risk_in_non_beneficial_research_involving_volunteers\">How risky can biomedical research be? On setting an upper limit of risk in non-beneficial research involving volunteers<\/a>. In\u00a0<a href=\"https:\/\/link.springer.com\/book\/9783031126918\"><em>Medical Research Ethics: Challenges in the 21st Century<\/em><\/a>, eds. T. Zima, D.N. Weisstub, Springer Cham.<\/li>\n<li><strong>\u0141uk\u00f3w<\/strong>, P. (2023). Persons and groups. Protection of research participants with vulnerabilities as a process. In\u00a0<a href=\"https:\/\/link.springer.com\/book\/9783031126918\"><em>Medical Research Ethics: Challenges in the 21st Century<\/em><\/a>, eds. T. Zima, D.N. Weisstub, Springer Cham.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2022).\u00a0<a href=\"https:\/\/link.springer.com\/article\/10.1007\/s11673-022-10179-7\">The principle of the primacy of the human subject and minimal risk in non-beneficial paediatric research<\/a>.\u00a0<i>Bioethical Inquiry<\/i>\u00a019, 273\u2013286<\/li>\n<li><strong>\u0141uk\u00f3w<\/strong>, P. (2022).\u00a0<span class=\"articleTitle\"><a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/full\/10.1111\/bioe.13049\">Solidarity and the ethics of exposing others to risk in medical research<\/a>.\u00a0<em>Bioethics\u00a0<\/em>36, 821-828.\u00a0<\/span><\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2021).\u00a0<a href=\"https:\/\/link.springer.com\/article\/10.1007\/s11019-021-10043-2\">Taking the principle of the primacy of the human being seriously<\/a>.\u00a0<i>Medicine Health Care and Philosophy\u00a0<\/i>24, 547\u2013562.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2019),<a href=\"https:\/\/www.tandfonline.com\/doi\/abs\/10.1080\/15265161.2019.1630510?journalCode=uajb20\">\u00a0<em>Passivity, research risks, and worker-type protections for research subjects<\/em><\/a>,\u00a0<em>The American Journal of Bioethic<\/em>s, 19(9), 46-48.<\/li>\n<li><strong>\u0141uk\u00f3w, P.<\/strong>\u00a0(2018),\u00a0<a href=\"https:\/\/link.springer.com\/article\/10.1007\/s12142-018-0500-z\">A difficult legacy: Human dignity as the founding value of human rights<\/a>,\u00a0<em>Human Rights Review<\/em>\u00a019, 313\u2013329.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2017).\u00a0<a href=\"https:\/\/www.academia.edu\/32791297\/Ryzyko_i_potencjalne_korzy%C5%9Bci_badania_biomedycznego_bez_potencja%C5%82u_terapeutycznego_z_udzia%C5%82em_os%C3%B3b_ma%C5%82oletnich_Risks_and_potential_benefits_in_non-beneficial_research_with_minors_-_draft_version\">Ryzyko i potencjalne korzy\u015bci badania biomedycznego\u00a0bez potencja\u0142u terapeutycznego z udzia\u0142em os\u00f3b ma\u0142oletnich<\/a>.\u00a0<em>Prawo i medycyna<\/em>\u00a019(2), .<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016).\u00a0<a href=\"https:\/\/www.academia.edu\/30057986\/Etyczne_i_prawne_aspekty_prowadzenia_bada%C5%84_biomedycznych_z_udzia%C5%82em_os%C3%B3b_w_stanach_nag%C5%82ego_zagro%C5%BCenia_zdrowotnego_emergency_research_Ethical_and_legal_aspects_of_emergency_research_\">Etyczne i prawne aspekty prowadzenia bada\u0144 biomedycznych z udzia\u0142em os\u00f3b w stanach nag\u0142ego zagro\u017cenia zdrowotnego (emergency research).<\/a>\u00a0In\u00a0<em>Etyka w medycynie \u2013 mi\u0119dzy teori\u0105 a praktyk\u0105<\/em>, red. A. Paprocka-Lipi\u0144ska &amp; R. Budzi\u0144ski. Gda\u0144sk, s. 148-175.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska, J<\/strong>. (2016).\u00a0<a href=\"https:\/\/www.academia.edu\/30705036\/Eksperyment_leczniczy_-_dwa_w_jednym_Therapeutic_experiment_-_two_in_one_-_draft_version\">Eksperyment leczniczy \u2013 dwa w jednym?<\/a>.\u00a0<em>Prawo i medycyna<\/em>\u00a018(4), 5-30.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016).\u00a0<a href=\"http:\/\/www.academia.edu\/26771751\/Etyka_i_ryzyko_w_nieterapeutycznych_badaniach_biomedycznych_Ethics_of_risk_in_non-benefitial_biomedical_research_-_draft_version\">Etyka i ryzyko w \u201enieterapeutycznych\u201d badaniach biomedycznych<\/a>.\u00a0<em>Przegl\u0105d Filozoficzny<\/em>. Nowa seria 2(98), 213-226.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016).\u00a0<a href=\"http:\/\/www.academia.edu\/26771277\/Regulacja_ryzyka_i_potencjalnych_korzy%C5%9Bci_badania_biomedycznego_z_udzia%C5%82em_cz%C5%82owieka_w_standardach_mi%C4%99dzynarodowych_Regulation_of_risks_and_potential_benefits_of_biomedical_research_involving_humans_in_international_standards_-_draft_version\">Regulacja ryzyka i potencjalnych korzy\u015bci badania biomedycznego z udzia\u0142em cz\u0142owieka w standardach mi\u0119dzynarodowych<\/a>.\u00a0<em>Prawo i medycyna<\/em>\u00a018(2). 58-78.<\/li>\n<\/ul>\n<p><strong>Conference presentations:<\/strong><\/p>\n<ul>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>\u00a0J. (2019),\u00a0<em>The need for redefining \u201cminimal risk\u201d in the new EU Regulation on clinical trials<\/em>, The 2019 EACME Annual Conference \u2013 Rethinking Ethics in XXI Century Europe. The European Association of Centres of Medical Ethics (EACME). Oxford, UK, September 12-14.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>\u00a0J. (2019),\u00a0<em>The primacy of human being and the ethics of non-beneficial research.\u00a0<\/em>33rd European Conference on Philosophy of Medicine and Health Care. The European Society for Philosophy of Medicine and Health Care (ESMPH). Oslo, Norway, August 7-10.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. &amp; <strong>\u0141uk\u00f3w<\/strong> P. (2018).<em> Taking collective research risks seriously.\u00a0<\/em>PRIM&amp;R 2018 Advancing Ethical Research Conference, San Diego CA , USA, November 15-17 .<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong> J. (2018),\u00a0<em>Zasada prymatu jednostki &#8211; wyzwania interpretacyjne i\u00a0normatywne. <\/em>IF UW\u00a0Etyka, moralno\u015b\u0107 i przestrze\u0144 publiczna, Warsaw, October 24-25.<\/li>\n<li><strong>\u0141uk\u00f3w<\/strong>, P. (2017),\u00a0<em>From Belmont (1979) to Helsinki (2013). A new perspective on vulnerability in CIOMS International Ethical Guidelines for Health-related Research Involving Humans (2016).\u00a0<\/em>PRIM&amp;R 2017 Advancing Ethical Research Conference, San Antonio TX, USA, November 5-8.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2017). [1]\u00a0<a href=\"http:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-Abstract-Bergen2017.pdf\"><em>Fair Access to Clinical Trials for Incompetent Subjects under the new EU Regulation No. 536\/2014<\/em>.<\/a>\u00a0 [2] <span style=\"color: #000000;\"><em>Balancing risks and benefits of experimental interventions offered on \u2018compassionate use\u2019 basis<\/em>. <\/span>6th Conference of the European Association of Health Law. Bergen (Norwegia), 28-29 wrze\u015bnia.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2017).\u00a0<a href=\"http:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-Abstract-Belgrade-2017.pdf\"><em>Risk-benefit assessment in biobank research<\/em><\/a>.<strong>\u00a0<\/strong>31st European Conference on Philosophy of Medicine and Health Care. The European Society for Philosophy of Medicine and Health Care (ESMPH). Belgrad, Serbia, 16-19 August.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2017).\u00a0<a href=\"http:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-Abstract-Baku-2017.pdf\"><em>The concept of risk and international biomedical research<\/em>.\u00a0<\/a>23rd World Association for Medical Law (WAML) World Congress for Medical Law (WAML),\u00a0Baku, Azerbaijan, 10-13 July.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016).\u00a0<em><span style=\"color: #16a1e7;\">Maximal risk threshold<\/span>.\u00a0<\/em>PRIM&amp;R 2016 Advancing Ethical Research Conference, Anaheim LA, USA, 13-16 November.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016). [1] <em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-How-to-best-justify-exposing-children-to-risks-of-non-beneficial-biomedical-research.pdf\">How to best justify exposing children to risks of non-beneficial biomedical research<\/a><\/em>; [2] <em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-A-defense-of-the-non-comparative-minimal-risk-threshold.pdf\">A defense of the non-comparative minimal risk threshold<\/a><\/em>, 10th International Conference on Applied Ethics, Center for Applied Ethics and Philosophy (CEAP), Hokkaido University, Sapporo, Japan,\u00a0October 28-30.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016).\u00a0<em>Problemy etyczne zwi\u0105zane z prowadzeniem eksperyment\u00f3w medycznych w sytuacjach nag\u0142ych i bezpo\u015bredniego zagro\u017cenia \u017cycia (emergency research).\u00a0<\/em>Og\u00f3lnopolska konferencja naukowa&#8221;Etyka w medycynie \u2013 mi\u0119dzy teori\u0105 a praktyk\u0105&#8221;. Gda\u0144sk, Polska, 22-24 September.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016).<span style=\"color: #999999;\"> <em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-Three-party-model-for-risk-analysis-and-the-ethics-of-payment-to-research-subjects-1.pdf\">Three party model for risk analysis and the ethics of payment to research subjects<\/a>.\u00a0<\/em><\/span>The 2016 EACME Annual Conference &#8211; 30 Years of European Bioethics. The\u00a0European Association of Centres of Medical Ethics\u00a0(EACME). Leuven, Belgium, 8-10 September.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016). [1 &#8211; invited talk]\u00a0<span style=\"color: #999999;\"><em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-Justifying-risks-of-experimental-interventions-offered-to-Ebola-patients-outside-the-context-of-research.pdf\">Justifying risks of experimental interventions offered to Ebola patients outside the context of research<\/a>.\u00a0<\/em><\/span>[2]<span style=\"color: #999999;\">\u00a0<\/span><em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-Social-value-and-benefit-sharing-in-international-biomedical-research-.pdf\">Social value and benefit sharing in international biomedical research<\/a><\/em>. 30th European Conference on Philosophy of Medicine and Health Care. The European Society for Philosophy of Medicine and Health Care (ESMPH). Zagreb, Croatia, 17-20 August.<\/li>\n<li><strong>\u0141uk\u00f3w<\/strong>, P. (2016).<span style=\"color: #999999;\"> <em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Lukow-Protection-of-human-dignity-in-research.pdf\">Protection of human dignity in research<\/a><\/em><\/span><em>.\u00a0<\/em>30th European Conference on Philosophy of Medicine and Health Care. The European Society for Philosophy of Medicine and Health Care (ESMPH). \u00a0Zagreb, Croatia, 17-20 August.<\/li>\n<li><span style=\"color: #000000;\"><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2016). <em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-What-makes-clinical-research-socially-valuable.pdf\">What makes clinical research socially valuable<\/a><\/em>?.\u00a013th World Congress of Bioethics \u2013 Individuals, Public Interests and Public Goods:\u00a0What is the Contribution of Bioethics?. The International Association of Bioethics (IAB). Edinburgh, Scotland, 14-17 June.\u00a0 <span style=\"color: #808080;\">[<a style=\"color: #808080;\" href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/JR-Poster-What-makes-research-valuable.pdf\">Poster<\/a>]<\/span><\/span><\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2015). <em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Rozynska-Limiting-risk-in-research-on-healthy-volunteers.pdf\">Limiting risk in research on healthy volunteers<\/a>.<\/em>\u00a011th World Conference Bioethics, Medical Ethics &amp; Health Law. UNESCO Chair in Bioethics, Napoli (Italy), 20-22 October.<\/li>\n<li><strong>\u0141uk\u00f3w<\/strong>, P. (2015). <em><a href=\"https:\/\/cbb.uw.edu.pl\/wp-content\/uploads\/2016\/01\/Lukow-Indispensability-of-dignity.-The-case-of-research-involving-humans.pdf\">Indispensability of dignity. The case of research involving humans<\/a>.<\/em>\u00a011th World Conference Bioethics, Medical Ethics &amp; Health Law. UNESCO Chair in Bioethics. Napoli (Italy), 20-22 October.<\/li>\n<li><strong>R\u00f3\u017cy\u0144ska<\/strong>, J. (2015).\u00a0<em>Etyka i ryzyko\u00a0w badaniach biomedycznych bez potencja\u0142u terapeutycznego<\/em>. X Zjazd Filozoficzny, Pozna\u0144 (Poland),\u00a015-19 September.<\/li>\n<li><strong>\u0141uk\u00f3w<\/strong>, P. (2015).\u00a0<em>Poszanowanie godno\u015bci uczestnik\u00f3w medycznych bada\u0144 naukowych<\/em>. X Zjazd Filozoficzny, Pozna\u0144 (Poland),\u00a0,\u00a015-19 September.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>PROJECT SETTLED Project title:\u00a0Ethical analysis of risks and potential benefits in biomedical research Principal investigator:\u00a0dr Joanna R\u00f3\u017cy\u0144ska Financing: National Science Centre, OPUS 8 Project number: 2014\/15\/B\/HS1\/03829 Project aims: The primary aim of the project is to develop a normative framework for risk-benefit assessment in biomedical research involving human subjects, which will be both sensitive to\u2026 <span class=\"read-more\"><a href=\"https:\/\/cbb.uw.edu.pl\/en\/grants\/ethics-and-risk-in-biomedical-research\/\">Read More &raquo;<\/a><\/span><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":829,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-877","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ethics and risk in biomedical research | CBB<\/title>\n<meta name=\"description\" content=\"Project title:\u00a0Ethical analysis of risks and potential benefits in biomedical research |\u00a0Principal investigator:\u00a0dr Joanna R\u00f3\u017cy\u0144ska\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cbb.uw.edu.pl\/en\/grants\/ethics-and-risk-in-biomedical-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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