Children and Research: A Risk of Double Jeopardy? LYNN HAGGER Lecturer in Law, University of Sheffield and Chairperson, Sheffield Children’s NHS Trust SIMON WOODS* Senior Lecturer in Bioethics, Policy Ethics and Life Sciences (PEALS) Research Institute, University of Newcastle. On the one hand there has been significant publicity about the lack of research into drugs used to treat children but, on the other, widespread criticism about unethical research carried out in the past. In addition, some current professional guidelines in relation to research on children unable to consent have been cen- sured for being too permissive. Now, recent legislation in relation to clinical research actually appears to be unduly restrictive. In this paper, we set out to defend the guidelines from an ethical and legal perspective and propose that an even more rigorous approach could be adopted to ensure children are engaged in research. This is not to advocate that the children should be subjected to undue risk nor that those close to them should not be involved in any decision- making process. We hope to demonstrate that a more balanced approach is necessary and timely, in the hope that those working in relevant areas gain sufficient confidence to justify their research proposals robustly rather than avoid them because of fear of castigation at the ethics approval stage. This would ensure children are accorded appropriate recognition of their autonomous interests and that they are afforded the same opportunities to benefit from research as adult subjects. Introduction It should be said at the outset that we recognise the vulnerability of the research subject and, in particular, that where the child is involved. It is not difficult to see that the relationship between researcher and participant is unequal in power. It is the researcher who is likely to be seen as imbued with knowledge, status and will be the active partner rather than acquiescent recipient of intervention(s). These factors are exacerbated when considering the subject may well be ill, in unfamiliar surroundings and, if a child, already unequal in The International Journal of Children’s Rights, 13: 51–72, 2005. 51 © 2005. Koninklijke Brill NV. Printed in the Netherlands. CHIL 13,1+2_f3_51-72 5/27/05 3:35 PM Page 51