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“Experimental Medical Research Involving Children: Global Perspectives on Research in the Field of Law, Ethics and the Rights of the Child”

UCLan Cyprus School of Law Research Seminar 8, Tuesday 17th Decemeber, 1.45 – 2.45pm (CY115)

Ms Nikola Stepanov (University of Queensland) and Mr Sam Ujewe (UCLan, UK)

Invariably there comes a time in medical research when agents like drugs must be tested for the first time on human beings, or for the first time on a new population of humans such as children. These experimental medical studies are known as early-phase research trials (‘EPR’). EPR trials constitute the vast majority, some 60%, of all clinical trials registered world-wide. The primary objectives of EPR trials are to measure safety by assessing toxicity. They are not designed to directly benefit EPR participants. Moreover, empirical evidence demonstrates that significant potential for harm to participants, including systemic reactions, organ damage, and toxic death, should be expected. Because of the grave level of uncertainty about potential toxic risks, participation in EPR is often restricted to adults and children with life-limiting conditions who are already facing certain death.

In this presentation we use recent examples of research conducted in Nigeria, the United States and the United Kingdom to show why accepting current early phase medical research practices involving children is problematic morally and legally. We argue that enrolling children in experimental research that will be of no benefit to them, but will likely harm them betrays a departure from the human rights standards that ought to apply including the right to bodily integrity, and the right to not be deliberately harmed or killed. Furthermore, deliberately seeking to recruit dying children may illustrate a perception of a reduced moral status of these children that would see their use in EPR as being ‘acceptable’ if their involvement may benefit future others by way of contributing to new knowledge about illness or disease.

Nikola Stepanov is a child ethicist and lecturer in Medical Ethics, Law and Professional Practice at the School of Medicine, University of Queensland (Australia). Nikola will soon complete a PhD (Children’s rights: medicine, philosophy and law) with the Melbourne Medical School and the School of Population & Global Health (The University of Melbourne, Australia). Sam Ujewe is a bioethics PhD scholar at UCLan School of Health, Preston, with specialities in African medical ethics, and ethics & health policy in Africa.