Biomedical Research with Human Subjects. Bioethical Issues

Biomedicine is the branch of medicine that draws upon achievements in biology, biotechnology, biochemistry and biophysics. It can be used to prevent, diagnose and treat diseases. Research in biomedicine contributes greatly to advances in medicine at large and also helps to improve both life expectancy and the overall quality of life. At some point it is carried out on humans. The subjects of biomedical research face the risk of adverse health effects, and in extreme cases – death. This is where we are challenged by the ethical problem: how do we effectively carry out biomedical research and yet ensure the risk for humans is reduced to the minimum? This question has been addressed by a research team led by Marcin Waligóra, PhD, with Jan Piasecki, PhD (Jagiellonian University Medical College), and Vilius Dranseika MA (Vilnius University).

The project seeks to develop methodological tools that would facilitate the process of ethical evaluation of biomedical research on humans. The team sets out to build new and adjust existing mechanisms to reconcile interests that are often at odds: the prospective benefits for science on the one hand and the best interests of the research subject on the other. With respect to particulars, the project deals with four problems: ethical randomization, determining conditions of participation for vulnerable populations, risk-assessment methods in biomedical research, and characteristics of ethical demands on research in epidemiology (principles of Good Epidemiological Practice).

The main reason for attempting research on ethical issues related to biomedical research on humans has been the insufficient scientific attention devoted to the problem thus far in Poland.

Tasks in the project involve regular reviews of existing literature and analysis of legal documents. Results will be made public in the form of articles in internationally circulated scientific journals as well as presentations given at conferences.

Solutions developed in the project may be used for the construction of new legal acts as well as guidelines and recommendations drafted within institutions conducting biomedical research on humans.

The research is being carried out as part of ongoing collaboration between team members. It has so far bore fruit with the publication of Biomedical Research Involving Human Subjects. International Standards [in Polish, Warszawa: Wolters Kluwer Polska 2012], edited by Joanna Różyńska and Marcin Waligóra.

Dr hab. Marcin Waligóra

Assistant professor in the Department of Philosophy and Bioethics, Jagiellonian University Medical College. He graduated from Jagiellonian University (doctorate in philosophy in 2007) and studied at the International Academy of Philosophy in Santiago de Chile (2005). Waligóra also graduated from the Fogarty-Founded Program in Research Ethics in Central and Eastern Europe (2009-2011). Waligóra is currently a member of the Management Committee of the COST Action "Disaster Bioethics: addressing ethical issues triggered by disasters". He edited Principia fenomenologii (Principles of Phenomenology) and collaborated with Jan Hartman in editing Etyczne aspekty decyzji medycznych (Ethical Aspects of Medical Decisions). Waligóra is also the author of Wprowadzenie do fenomenologii (Introduction to Phenomenology, forthcoming). His research interests are bioethics, ethics in biomedical research and phenomenology. Research team web-page: www.remedy.edu.pl.

Date of publication: 10^th Apr, 2013