Ethics and risk in biomedical research

PROJECT SETTLED

Project title: Ethical analysis of risks and potential benefits in biomedical research
Principal investigator: dr Joanna Różyńska
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 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.

Key words: research ethics, clinical trials, value of research, research benefit, research risk

Publication of the project results 

Papers (published or accepted for publication)

• Różyńska, J. (2023). How risky can biomedical research be? On setting an upper limit of risk in non-beneficial research involving volunteers. In Medical Research Ethics: Challenges in the 21st Century, eds. T. Zima, D.N. Weisstub, Springer Cham.
• Łuków, P. (2023). Persons and groups. Protection of research participants with vulnerabilities as a process. In Medical Research Ethics: Challenges in the 21st Century, eds. T. Zima, D.N. Weisstub, Springer Cham.
• Różyńska, J. (2022). The principle of the primacy of the human subject and minimal risk in non-beneficial paediatric research. Bioethical Inquiry 19, 273–286
• Łuków, P. (2022). Solidarity and the ethics of exposing others to risk in medical research. Bioethics 36, 821-828. 
• Różyńska, J. (2021). Taking the principle of the primacy of the human being seriously. Medicine Health Care and Philosophy 24, 547–562.
• Różyńska, J. (2019), Passivity, research risks, and worker-type protections for research subjects, The American Journal of Bioethics, 19(9), 46-48.
• Łuków, P. (2018), A difficult legacy: Human dignity as the founding value of human rights, Human Rights Review 19, 313–329.
• Różyńska, J. (2017). Ryzyko i potencjalne korzyści badania biomedycznego bez potencjału terapeutycznego z udziałem osób małoletnich. Prawo i medycyna 19(2), .
• Różyńska, J. (2016). Etyczne i prawne aspekty prowadzenia badań biomedycznych z udziałem osób w stanach nagłego zagrożenia zdrowotnego (emergency research). In Etyka w medycynie – między teorią a praktyką, red. A. Paprocka-Lipińska & R. Budziński. Gdańsk, s. 148-175.
• Różyńska, J. (2016). Eksperyment leczniczy – dwa w jednym?. Prawo i medycyna 18(4), 5-30.
• Różyńska, J. (2016). Etyka i ryzyko w „nieterapeutycznych” badaniach biomedycznych. Przegląd Filozoficzny. Nowa seria 2(98), 213-226.
• Różyńska, J. (2016). Regulacja ryzyka i potencjalnych korzyści badania biomedycznego z udziałem człowieka w standardach międzynarodowych. Prawo i medycyna 18(2). 58-78.

Conference presentations:

• Różyńska J. (2019), The need for redefining “minimal risk” in the new EU Regulation on clinical trials, The 2019 EACME Annual Conference – Rethinking Ethics in XXI Century Europe. The European Association of Centres of Medical Ethics (EACME). Oxford, UK, September 12-14.
• Różyńska J. (2019), The primacy of human being and the ethics of non-beneficial research. 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.
• Różyńska, J. & Łuków P. (2018). Taking collective research risks seriously. PRIM&R 2018 Advancing Ethical Research Conference, San Diego CA , USA, November 15-17 .
• Różyńska J. (2018), Zasada prymatu jednostki – wyzwania interpretacyjne i normatywne. IF UW Etyka, moralność i przestrzeń publiczna, Warsaw, October 24-25.
• Łuków, P. (2017), From Belmont (1979) to Helsinki (2013). A new perspective on vulnerability in CIOMS International Ethical Guidelines for Health-related Research Involving Humans (2016). PRIM&R 2017 Advancing Ethical Research Conference, San Antonio TX, USA, November 5-8.
• Różyńska, J. (2017). [1] Fair Access to Clinical Trials for Incompetent Subjects under the new EU Regulation No. 536/2014.  [2] Balancing risks and benefits of experimental interventions offered on ‘compassionate use’ basis. 6th Conference of the European Association of Health Law. Bergen (Norwegia), 28-29 września.
• Różyńska, J. (2017). Risk-benefit assessment in biobank research. 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.
• Różyńska, J. (2017). The concept of risk and international biomedical research. 23rd World Association for Medical Law (WAML) World Congress for Medical Law (WAML), Baku, Azerbaijan, 10-13 July.
• Różyńska, J. (2016). Maximal risk threshold. PRIM&R 2016 Advancing Ethical Research Conference, Anaheim LA, USA, 13-16 November.
• Różyńska, J. (2016). [1] How to best justify exposing children to risks of non-beneficial biomedical research; [2] A defense of the non-comparative minimal risk threshold, 10th International Conference on Applied Ethics, Center for Applied Ethics and Philosophy (CEAP), Hokkaido University, Sapporo, Japan, October 28-30.
• Różyńska, J. (2016). Problemy etyczne związane z prowadzeniem eksperymentów medycznych w sytuacjach nagłych i bezpośredniego zagrożenia życia (emergency research). Ogólnopolska konferencja naukowa”Etyka w medycynie – między teorią a praktyką”. Gdańsk, Polska, 22-24 September.
• Różyńska, J. (2016). Three party model for risk analysis and the ethics of payment to research subjects. The 2016 EACME Annual Conference – 30 Years of European Bioethics. The European Association of Centres of Medical Ethics (EACME). Leuven, Belgium, 8-10 September.
• Różyńska, J. (2016). [1 – invited talk] Justifying risks of experimental interventions offered to Ebola patients outside the context of research. [2] Social value and benefit sharing in international biomedical research. 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.
• Łuków, P. (2016). Protection of human dignity in research. 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.
• Różyńska, J. (2016). What makes clinical research socially valuable?. 13th World Congress of Bioethics – Individuals, Public Interests and Public Goods: What is the Contribution of Bioethics?. The International Association of Bioethics (IAB). Edinburgh, Scotland, 14-17 June.  [Poster]
• Różyńska, J. (2015). Limiting risk in research on healthy volunteers. 11th World Conference Bioethics, Medical Ethics & Health Law. UNESCO Chair in Bioethics, Napoli (Italy), 20-22 October.
• Łuków, P. (2015). Indispensability of dignity. The case of research involving humans. 11th World Conference Bioethics, Medical Ethics & Health Law. UNESCO Chair in Bioethics. Napoli (Italy), 20-22 October.
• Różyńska, J. (2015). Etyka i ryzyko w badaniach biomedycznych bez potencjału terapeutycznego. X Zjazd Filozoficzny, Poznań (Poland), 15-19 September.
• Łuków, P. (2015). Poszanowanie godności uczestników medycznych badań naukowych. X Zjazd Filozoficzny, Poznań (Poland), , 15-19 September.