What do research ethics committees say about applications to conduct research involving children?

OBJECTIVE: To identify issues raised by research ethics committees (RECs) in letters about applications to conduct research involving children. METHODS: Analysis of 80 provisional and unfavourable opinion decision letters written by RECs in response to applications to conduct research involving child participants. RESULTS: RECs were most likely to be concerned about issues relating to consent, recruitment, care and protection of participants, scientific design and confidentiality. RECs focused on children's status as "vulnerable". They sought to ensure that children would be protected, that appropriate written language would be used to communicate with children and that an appropriate person would give consent for children to participate. IMPLICATIONS: Researchers should be attentive to issues of potential vulnerability when preparing applications. REC letters may be improved by giving clear and explicit reasons for their opinions.