Bioethics Blogs

The Paediatric Regulation – a work in progress?

The Council’s report on the ethical issues raised by children’s involvement in clinical research was published in May 2015. The report draws on the contributions of over 500 children and young people, parents and professionals, and its recommendations are made accessible in both a magazine format and as an animation. 9 months on from its publication, this post focusses on progress with one of the key recommendations – a review of the European Medicines Agency class waiver system in order to promote research into new medicines for children.

In drawing up this report, the Working Party tackled not only the thorny issue of how children and young people can ethically be recruited to research, but also the more hidden ethical challenges that arise in connection with the ways in which research is prioritised and developed in the first place.

We started from the premise that ‘good’ research (a shorthand for ethically robust and well-designed research that asks questions that are important for the health of children) should be seen as intrinsically good, and as a natural and necessary part of any healthcare system. Building on this point, we made the strong claim that it is not an ethically neutral act to say ‘no’ to research proposals that meet these requirements and might potentially lead to better health care for children. There is similarly a strong ethical imperative actively to promote such research – and the European Paediatric Regulation, which mandates the inclusion of children and young people in clinical trials, unless a waiver has been granted, has a critical role to play in this arena.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.