[Important! New event date] 31st May 2021: Research seminar online - Marcin Waligóra (Jagiellonian University), Tomasz Żuradzki (Jagiellonian University): Why high-risk research with limited prospect of direct benefit can be justified: the case of phase 1 pediatric trials in oncology
We have the pleasure to invite you for a research seminar in the ‘BIOUNCERTAINTY’ research project. The seminar will take place on Monday, May 31st, at 5:30 pm on MS Teams (link below).
Abstract: Some classes of phase 1 pediatric oncology trials: i) offer subjects a (very) limited prospect of direct benefit, and ii), in general, pose greater than a minor increase over minimal risk. Since children in research are considered as a vulnerable population and are protected in a stricter manner than adults, researchers, ethics committees, regulators, and other institutions face the following trilemma. 1) Notwithstanding the above, to treat all or the great majority of these trials as if they gave the prospect of direct benefit (this is a dominant option now in, in particular, it has been defended by the American Society of Clinical Oncology - ASCO). 2) To stop all, or at least the great majority, of such trials, as contradictory to the current regulatory framework. 3) To redefine what counts as "minimal risk" in research ethics. We opt in favour of this last approach, and following the recent works in decision theory on risk function and in philosophical psychology on (un)realistic optimism, we argue that there is a full spectrum of rationally permissible risk attitudes in such situations. In particular, the specificity of the situation of terminally ill children may justify a risk-seeking attitude toward the expected effects of their treatment or trial and may justify an optimistic attitude that would not be reasonable in more standard cases.
Marcin Waligóra - Professor and Vice Dean for Scientific Development, Faculty of Health Science at Jagiellonian University. His research focuses on ethical and policy challenges of pediatric research and structural and social problems of clinical trials in the region of Central and Eastern Europe. Waligora is a leader of the REMEDY, Research Ethics in Medicine Study Group.
Tomasz Żuradzki - the director of the Interdisciplinary Centre for Ethics at the Jagiellonian University, a member of the editorial board of the journal Diametros, and the editor-in-chief of the popular science journal Filozofia w Praktyce [Philosophy in Practice]. In 2018 he was awarded with the ERC Starting Grant (BIOUNCERTAINTY). His recent work focuses on the intersection of metaethics and practical ethics.