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

Abstract

ObjectiveTo identify issues raised by Research Ethics Committees (RECs) in letters about applications to conduct research involving children. MethodsAnalysis of 80 provisional and unfavourable opinion decision letters written by RECs in response to applications to conduct research involving child participants. ResultsRECs 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. ImplicationsResearchers 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.Abstract word count: 131 3

Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience

“…Eight studies reported differences in the approach to consent, similar to our experience with the BBOP study (7). In particular, with juvenile subjects, research ethics committees focused on the children's status as vulnerable and expressed concerns about consenting procedures as well as emphasizing the need for children to be protected in research (8). The documented variability in these studies, as well as our experience with the BBOP study, represents an important burden to investigator-initiated multicentre studies, particularly those administered on limited budgets.…”

Making research central to good paediatric practice

“…Historically, ethics research committees have been viewed as the cautious gatekeepers,26 focused on children’s status as ‘vulnerable’. This is not often the case anymore, with regulators promoting a balanced approach, and valuing children’s researchers becoming engaged with developing regulation.…”

Emotional impact of genetic trials in progressive paediatric disorders: a dose‐ranging exon‐skipping trial in Duchenne muscular dystrophy

“…However, even though research ethics committees often express concerns about protecting children they see as specially ‘vulnerable’ (Angell et al . 2010), little is known about the psychological effect that taking part in research trials generally has on children and their families/parents, nor on the specific effects of participating in genetic trials.…”