Completed projects

Ethics of clinical trials during the COVID-19 pandemic

The COVID-19 pandemic created unprecedented pressures for clinical trials regulators, ethics committees, researchers and other stakeholders to invent and register medicines and vaccines as quickly as possible. The aims of the project are A) to systematically collect and examine new methods and organization accelerators of clinical trials in the time of the COVID-19 pandemic, and B) to perform both ethical analyses of risks and benefits and analyses of the social values of this novel accelerated approach in developing new medicines.



Funding: The National Science Centre
Project number: 2020/01/0/HS1/00024
Principal Investigator: Marcin Waligóra
Duration: 2020-2022


Ethics of biomedical research with children. Risk, benefits and participants’ rights

Over 50% of the medication prescribed to children is used in an off-label way. In order to change this status quo, many institutions introduced new regulations. The aims of the project are to assess the effectiveness of regulatory actions in paediatrics, collect high-quality in a series of systematic reviews data and present recommendations. The project combines aspects of descriptive and normative ethics. The objective of the descriptive section is to assess the risk and benefits of selected paediatric research, taking success and research waste into account. The normative section aims to analyse the ethical principles of paediatric research based on the collected data, as well as to suggest new solutions.



Funding: The National Science Centre
Project number: 2015/18/E/HS1/00354
Principal Investigator: Marcin Waligóra
Duration: 2016-2022


Biomedical Research with Human Subjects. Bioethical Issues

The project developed methodological tools that will facilitate the process of ethical evaluation of biomedical research on human subjects. The project considered in particular four problems: determining conditions of participation for vulnerable populations, risk-assessment methods in biomedical research, the principle of ethical randomisation, and the characteristics of ethical demands on research in epidemiology (principles of Good Epidemiological Practice). 

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Funding: The National Science Centre
Project number: DEC-2011/03/D/HS1/01695
Duration: 2012-2016


Children in phase 1 cancer trials. Risk and social benefit

This project evaluated the risk/social benefit of enrolling children in phase 1 cancer trials. The project had two stages. First, estimate the social value of pediatric phase 1 studies by determining the probability that interventions tested in phase 1 pediatric studies are advanced into randomized trials and/or product labeling revisions. Second, use this estimation of social benefit, combined with our previous estimates of (clinical) risk and direct benefit, to ethically evaluate risk/benefit in pediatric phase 1 cancer studies. The latter benchmarked our estimated risk/benefit against other, morally relevant standards (e.g. risk/benefit in adult studies or risk/benefit for nonparticipation in trials).


Funding: The Fulbright Scholar Program
Duration: Sep 2017-May2018, The Harvard Medical School Center for Bioethics


Disaster Bioethics: addressing ethical issues triggered by disasters

The goal of the European Cooperation in Science and Technology (COST) Action was to improve ethical decision-making for disasters by gathering knowledge of the ethical dilemmas and issues, carefully examining them, and developing training materials and published resources to address disaster ethics (from the Memorandum of Understanding).


Funding: The European Cooperation in Science and Technology, COST
Project number: COST Action IS1201
Duration: 2013–2016


SKILLS – Mentoring, Foundation for Polish Science (FNP)

Marcin Waligóra participated in the programme, working with Prof. Jonathan Kimmelman of McGill University in Canada on a one-to-one mentoring basis.


Funding: Foundation for Polish Science
Duration: 2014–2015


Advanced Certificate Program in Research Ethics in Central and Eastern Europe

Postgraduate study programme featuring a research project. Participation in the research element involved preparation of the publication Badania naukowe z udziałem ludzi w biomedycynie. Standardy międzynarodowe [“Biomedical Research Involving Human Subjects. International Standards”], J. Różyńska, M. Waligóra (eds), Warszawa: Wolters Kluwer Polska 2012.

This project was supported in part by Grant Number R25 TW007085 from the US National Institutes of Health (NIH) Fogarty International Center. Its contents are solely the responsibility of the presenter and do not necessarily represent the official view of the Fogarty International Center or the NIH.


Funding: The National Institutes of Health, USA
Project number: R25 TW007085
Duration: 2011–2012