HEAL UoS

Experimenting on children?

In 2013, Meetings, Research ethics on October 9, 2013 at 7:51 am

Of course the real title of this blog post is, or should be, something along the lines of ‘today’s HEAL meeting: discussing the NCOB’s consultation on ‘Children and clinical research’: a ‘vulnerable’ group and a lacuna in the law?

On 7 August 2013, the Nuffield Council on Bioethics launched its consultation on the ethical issues arising from involving children in clinical research. As noted by the NCOB, there is a lack of clarity around some questions regarding children’s participation in clinical research. For example, there is no reported case law on whether Gillick competency  applies in a clinical research setting, although the legal position for clinical trials for new medicines IS clearly laid out in the relevant regulations (see further MHRA for links to the different versions of the regs and further context), such that children under 16 cannot – in law – make their own decisions about participating in a clinical trial (consent of a parent with parental responsibility is required).

There are complicating factors, including practical and financial issues – ie what will companies fund, in the short and long term? And, more obviously, questions about ‘best interests’ for the children in question – when children have been and are perceived as  a ‘vulnerable’ group (on vulnerability in health care, see further Biggs and Jones, forthcoming 2014, and 2013).

The call for evidence can be be read at http://www.nuffieldbioethics.org/children-and-research/children-and-research-call-evidence. We’re meeting in rm 2055, Law, Highfield, from 3.15pm today, and looking forward to a great discussion.

Caroline Jones

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