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The potential for children to be involved in research is changing rapidly, 1 not least because of growing dissatisfaction with the quality of the evidence-base for children's medicines, disquiet at continued prescribing of unlicensed, "off label" or unsuitable formulations and changes in the regulatory and policy environment for drug development and testing of paediatric therapies. 2 However, distinctive ethical issues arise in conducting health-related research involving children. 3
Ethical review of studies involving children must be conducted by a research ethics committee (REC). When it first reviews an application, an NHS REC can issue one of three "opinions": favourable, provisional or unfavourable ( box 1 ). When reviewing applications, RECs are charged, among other things, with assessing the arrangements for consent to research. These vary depending on whether the study is a Clinical Trial of an Investigational Medicinal Product (CTIMP) and thus is governed by the Medicines for Human Use (Clinical Trials) Regulations 2004. 4 The Regulations provide that parents or those with legal responsibility for children <16 years old must give consent for a "minor" taking part in a trial and that such consent represents the child's "presumed will". National Research Ethics Service (NRES) guidance on research involving children specifies that for trials, "children should [...] be asked for their assent, if appropriate." 5 However, assent is not a legally valid concept for purposes of the Regulations, and its use, therefore, has an ethical rather than a legal basis. For non-CTIMPs, UK law is untested. NRES guidance advocates the principle of Gillick competence, 5 though this was developed in the context of treatment rather than research. 6 This allows children who are felt to be competent to consent for themselves (usually if they are aged >=10 years).
Box 1 Decisions a REC can make on first review of an application
A "favourable" opinion means that an application is approved without further revisions; these constitute ~17% of decisions made by RECs at first consideration of an application.
"Provisional" opinions constitute ~66% of decisions at first review and require applicants to make a response addressing issues raised in the letter before a final opinion can be issued. The final opinion may be either favourable or unfavourable.
An "unfavourable" opinion (~8% of all submissions) at first review...